A Phase 2 interventional study of Irsenontrine and Placebo in Dementia With Lewy Bodies, sponsored by Eisai Inc.. Completed at 74 sites in 7 countries. Open to participants aged 50 Years to 85 Years. Per ClinicalTrials.gov, last updated 2022-08-01.
Sponsored by Eisai Inc. · Phase 2, Interventional, and Treatment
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Among 110 studies in Lewy Body Disease with a site in United States — 32 open to participants now, 40 under way, 1 of them phase 3. Lewy Body Disease · United States.
Among the 110 studies in Lewy Body Disease with a site in United States, this one is the 18th largest by enrollment of the 78 interventional ones that give a count, is one of 8 that started in 2018, is one of 21 in phase 2, and was the 33rd registered.
239 studies on the registry are indexed under Lewy Body Disease; 88 are open to participants now.
Browse Lewy Body Disease studies →32 of the 110 studies in Lewy Body Disease with a site in United States are open now. Recruiting first, the newest first:
University of Washington · Sites in United States
Ages 18+
NYU Langone Health · Sites in United States
Ages 18–90 · Healthy volunteers
Eli Lilly and Company · Sites in United States, Japan, Korea, Republic of and 1 more country
Ages 55–85
Innervate Radiopharmaceuticals LLC (Formerly: Illumina Radiopharmaceuticals LLC) · Sites in United States
Ages 18+
University of Pennsylvania · Sites in United States
Ages 18+ · Healthy volunteers
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 63 Lewy Body Disease studies recruiting now, 41 (65%) set no upper age limit and none (0%) stop at 75 or younger; 10 take children under 18; 31 take healthy volunteers.
This study: 50 Years to 85 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
110 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 8 · Phase 2 24 · Phase 3 4 · Phase 4 8
First in 2002; this study’s year is marked. 8 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 326 is above the median of 89 across 152 interventional studies indexed under Lewy Body Disease.
Median enrollment 86 across the 78 interventional studies, 225 across the 31 observational. Of the 66 that completed or were terminated, 33 (50%) have results posted.
This tab as a report to print or save as PDF → With an account.
29 of 110 have an industry lead sponsor. The 10 most frequent:
This study is registered under Eisai Inc., one of the names counted as Eisai Co., Ltd.. Under that name alone:
Eisai Inc. is the lead sponsor of 368 studies on the registry; 7 are open to participants now.
Of its 83 completed or terminated interventional studies of FDA-regulated products, 56 (67%) have results posted.
Eisai Co., Ltd. has 8 studies filed under Lewy Body Disease — fewer than ten, so there is no comparison to draw.
13 of the studies in Lewy Body Disease with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06098612Massachusetts General HospitalPET Imaging Evaluation of [11C]SY08 | 2026-11 |
| NCT01799915NYU Langone HealthNatural History Study of Synucleinopathies | 2026-12-30 |
| NCT03233646Duke UniversityRetinal Imaging in Neurodegenerative Disease | 2026-12-31 |
| NCT03702907Georgetown UniversityDC Longitudinal Study on Aging and Specimen Bank | 2027-01 |
| NCT04246437Daniel Claassen[18F]F-DOPA Imaging in Patients With Autonomic Failure | 2027-02-01 |
Add all 13 to your calendar (.ics) → With an account.
Among the 110 studies in Lewy Body Disease with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This study will be conducted to compare Irsenontrine to placebo on the cognitive endpoint of Montreal Cognitive Assessment (MoCA) and the global clinical endpoint of Clinician's Interview Based Impression of Change Plus (CIBIC-Plus) Caregiver Input in participants with dementia with Lewy bodies after 12 weeks of treatment.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will be randomized to receive a 50 milligram (mg) once daily oral dose of Irsenontrine for 12 weeks.
Drug: Irsenontrine
Participants will be randomized to receive a 50 mg once daily oral dose of Irsenontrine-matched placebo for 12 weeks.
Drug: Placebo
Oral hypromellose capsules.
Also known as: E2027
Oral hypromellose capsules.
Change From Baseline in the Montreal Cognitive Assessment (MoCA) Total Score at Week 12 of Treatment
The MoCA scale is used for detecting cognitive impairment. The scores range between 0 to 30 points; a score of 26 or above was considered normal. Higher values represent a better outcome.
Time frame: Baseline and Week 12
Number of Participants Based on Clinician's Interview Based Impression of Change Plus Caregiver Input (CIBIC-Plus) Scale at Week 12 of Treatment
Number of participants are reported categorized in grades based on the CIBIC-Plus scale. The CIBIC-Plus scale is designed to measure various domains that describe participant function: general, mental/cognitive state, behavior, and activities of daily living. It is a semi-structured global rating derived from a comprehensive interview with the participant and caregiver or informant by an independent rater who has no access to the source data or other psychometric test scores conducted post-randomization as part of the protocol. The CIBIC-Plus was a 7-point scale and scores were: 1 (marked improvement), 2 (moderate improvement), 3 (minimal improvement), 4 (no change), 5 (minimal worsening), 6 (moderate worsening), and 7 (marked worsening). Higher values represent a worse outcome.
Time frame: Week 12
Clinician's Global Impression of Change - In Dementia With Lewy Bodies (CGIC-DLB) Scale at Week 12 of Treatment
Number of participants are reported categorized in grades based on the CGIC-DLB scale. The CGIC-DLB scale provided an overall clinician-determined summary measure of change from the participant's clinical status that takes into account all available information from the efficacy endpoints (which include cognitive function, non-cognitive symptoms, behavior, and the impact of the symptoms on the participant's ability to function) and safety data. The (CGIC-DLB) was a 7-point scale and scores were: 1 (marked improvement), 2 (moderate improvement), 3 (minimal improvement), 4 (no change), 5 (minimal worsening), 6 (moderate worsening), and 7 (marked worsening). Higher values represent a worse outcome.
Time frame: Week 12
Mean Change From Baseline in the Cognitive Fluctuation Inventory (CFI) Score at Week 12 of Treatment
The CFI scale assessed cognitive fluctuation. It evaluates fluctuation in various domains including attention, ability to perform daily functions, orientation, verbal communication and behavior. The score was based on frequency and severity with a score range of 0 to 12. The scale also assessed the degree of caregiver or informant distress engendered by the symptoms. Higher scores indicating greater impairment.
Time frame: Baseline and Week 12
Mean Change From Baseline in the Mini-Mental State Examination (MMSE) Total Score Week 12 of Treatment
The MMSE is a 30-point scale that measured orientation to time and place, registration, immediate and delayed recall, attention, language, and drawing. The total score ranges from 0 (most impaired) to 30 (no impairment). The lower score means severe cognitive deficit and higher score indicates better function.
Time frame: Baseline and Week 12
Mean Change From Baseline in the Neuropsychiatric Inventory (NPI-12) Total Score at Week 12 of Treatment
The NPI-12 scale assessed the frequency and severity of 12 neuropsychiatric symptoms commonly described in dementia participants: delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, motor disturbance, nighttime behaviors, and appetite/eating changes. The scale also assessed the degree of caregiver or informant distress engendered by each of the symptoms. The sum of the composite scores for the 12 domains yielded the NPI-12 total score. NPI-12 total score ranged from 0 (minimum severity) to 144 (maximum severity); higher score indicates greater neuropsychiatric disturbance.
Time frame: Baseline and Week 12
Change From Baseline in NPI-4 Subscore at Week 12
The NPI scale assesses the frequency and severity of 12 neuropsychiatric symptoms commonly described in dementia participants: delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, motor disturbance, nighttime behaviors, and appetite/eating changes. NPI-4 is the subscore covering the domains of delusions, hallucinations, apathy and depression. NPI-4 total subscore ranged from 0 to 48, with higher scores indicating a greater neuropsychiatric disturbance.
Time frame: Baseline and Week 12
Change From Baseline in NPI-10 Subscore at Week 12
The NPI-10 assessed range of behaviors seen in dementia for both frequency and severity. It is a 10 item questionnaire with the following domains: delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/liability and aberrant motor behavior. The total score was a sum of the 10 domains, where the score of each domain was calculated as frequency (scale: 1=occasionally to 4=very frequently)\*Severity (scale: 1=Mild to 3=Severe). Each domain has a maximum score of 12 and all domains were equally weighted for total score, the range for total score is 0 to 120. Higher scores indicating a greater neuropsychiatric disturbance.
Time frame: Baseline and Week 12
Change From Baseline in NPI-D (Caregiver Distress) Total Score at Week 12
The NPI-D scale assesses the frequency and severity of 12 neuropsychiatric symptoms commonly described in dementia participants: delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, motor disturbance, nighttime behaviors, and appetite/eating changes. The scale assesses the degree of caregiver distress engendered by each of the symptoms. The caregiver distress (NPI-D) is rated by caregiver based on his or her own stress on a five point scale from 0 to 5, where: 0(no distress), 1(minimal), 2(mild), 3(moderate), 4(moderately severe), 5(very severe or extreme). NPI-D total score is calculated by summing the scores of the 12 sub-scale distress scores. The NPI-D total scores ranges from 0 to 60 with higher scores indicating greater distress.
Time frame: Baseline and Week 12
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Severe TEAEs, Serious TEAEs, Adverse Events (AEs) Resulting in Study Discontinuation
A TEAE was defined as an AE that emerged or worsened in severity relative to baseline during treatment or within 28 days after the last dose of study drug. Severe TEAE was defined as inability to work or to perform normal daily activity. A Serious TEAE is any untoward medical occurrence that at any dose: results in death; is life threatening (that is, the participant was at immediate risk of death from the adverse event as it occurred; this does not include an event that, had it occurred in a more severe form or was allowed to continue, might have caused death) requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect or is medically important due to other reasons than the above mentioned criteria. An adverse event (AE) was defined as any untoward medical occurrence in a participant administered an investigational product.
Time frame: From first dose of study drug up to Week 16
Number of Participants With Orthostatic Hypotension
Orthostatic hypotension was defined as drop in standing systolic blood pressure greater than or equal to (\>=) 20 Millimeter of mercury (mmHg) compared to supine, or drop in standing diastolic blood pressure \>=10 mmHg compared to supine.
Time frame: Week 2, Week 4, Week 6, Week 9 and Week 12
Number of Participants With Orthostatic Tachycardia
Orthostatic tachycardia by numerical criteria was defined by the following numerical criteria: Standing heart rate (HR) increased by \>30 beats/min compared to supine and absolute standing HR was \>100 beats/min.
Time frame: From first dose of study drug up to Week 16
Number of Participants With Markedly Abnormal Laboratory Values
A laboratory value was determined to be a markedly abnormal value if the postbaseline common toxicity criteria grade increased from baseline and the post-baseline grade was greater than or equal to 2.
Time frame: From first dose of study drug up to Week 16
Number of Participants With Abnormal Electrocardiogram (ECG) Findings
Time frame: From first dose of study drug up to Week 16
Number of Participants With Suicidal Ideation or Suicidal Behavior as Measured Using Columbia Suicide Severity Rating Scale (C-SSRS)
The C-SSRS (mapped to Columbia Classification Algorithm of Suicide Assessment (C-CASA) categories); is an interview-based instrument to systematically assess suicidal ideation and suicidal behavior. C-SSRS assess whether participant experience any of the following: completed suicide; suicide attempt (response of "yes" on "actual attempt"); preparatory acts toward imminent suicidal behavior ("yes" on "preparatory acts or behavior", "aborted attempt" or "interrupted attempt"), suicidal ideation ("yes" on "wish to be dead", "non-specific active suicidal thoughts", "active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent, any self-injurious behavior with no suicidal intent ("yes" on "has participant engaged in non-suicidal self-injurious behavior"). Here, number of participants with positive response ("yes") to suicidal behavior or/and Ideation, any non-suicidal self-injurious behavior was reported.
Time frame: From first dose of study drug up to Week 16
Change From Baseline in Total Score of Unified Parkinson's Disease Rating Scale Part III: Motor Examination (UPDRS-III)
The UPDRS scale evaluates extrapyramidal features in motor function in Parkinson's disease. It contains 33 items in 18 categories: (1) speech, (2) facial expression, (3) rigidity, (4) finger tapping, (5) hand movements, (6) supinational and pronation movements of hands, (7) toe tapping, (8) leg agility, (9) arising from chair, (10) gait, (11) freezing of gait, (12) postural stability, (13) posture, (14) body bradykinesia, (15) postural tremor of hands, (16) kinetic tremor of hands, (17) rest tremor amplitude and (18) constancy of rest tremor. Each item is scored 0 to 4, giving a total score range 0 to 132. Higher scores indicating more severe symptoms.
Time frame: Baseline up to Week 16
Participants took part in the study at 65 investigative sites in the United States, Japan, United Kingdom, France, Spain, Germany, and Italy from 04 May 2018 to 15 April 2020.
| Milestone | Placebo | Irsenontrine 50 mg | Randomised, Not Treated Due to Site Closure |
|---|---|---|---|
| Started | 100 | 100 | 6 |
| Treated | 97 | 99 | 0 |
| Completed | 84 | 89 | 0 |
| Not completed | 16 | 11 | 6 |
| Withdrew: Adverse event | 4 | 5 | 0 |
| Withdrew: Subject choice | 1 | 3 | 0 |
| Withdrew: Lost to follow-up | 1 | 0 | 0 |
| Withdrew: Withdrawal by subject | 4 | 2 | 0 |
| Withdrew: Others | 3 | 0 | 0 |
| Withdrew: Not treated | 3 | 1 | 6 |
The MoCA scale is used for detecting cognitive impairment. The scores range between 0 to 30 points; a score of 26 or above was considered normal. Higher values represent a better outcome.
| score on a scale | Placebo | Irsenontrine 50 mg |
|---|---|---|
| Baseline | 13.9 ± 5.40 | 13.8 ± 5.18 |
| Change at Week 12 | -0.6 ± 2.63 | -0.4 ± 3.41 |
Number of participants are reported categorized in grades based on the CIBIC-Plus scale. The CIBIC-Plus scale is designed to measure various domains that describe participant function: general, mental/cognitive state, behavior, and activities of daily living. It is a semi-structured global rating derived from a comprehensive interview with the participant and caregiver or informant by an independent rater who has no access to the source data or other psychometric test scores conducted post-randomization as part of the protocol. The CIBIC-Plus was a 7-point scale and scores were: 1 (marked improvement), 2 (moderate improvement), 3 (minimal improvement), 4 (no change), 5 (minimal worsening), 6 (moderate worsening), and 7 (marked worsening). Higher values represent a worse outcome.
| Participants | Placebo | Irsenontrine 50 mg |
|---|---|---|
| Marked improvement | 0 | 0 |
| Moderate improvement | 5 | 3 |
| Minimal improvement | 13 | 18 |
| No change | 32 | 32 |
| Minimal worsening | 30 | 28 |
| Moderate worsening | 6 | 8 |
| Marked worsening | 0 | 0 |
Number of participants are reported categorized in grades based on the CGIC-DLB scale. The CGIC-DLB scale provided an overall clinician-determined summary measure of change from the participant's clinical status that takes into account all available information from the efficacy endpoints (which include cognitive function, non-cognitive symptoms, behavior, and the impact of the symptoms on the participant's ability to function) and safety data. The (CGIC-DLB) was a 7-point scale and scores were: 1 (marked improvement), 2 (moderate improvement), 3 (minimal improvement), 4 (no change), 5 (minimal worsening), 6 (moderate worsening), and 7 (marked worsening). Higher values represent a worse outcome.
| Participants | Placebo | Irsenontrine 50 mg |
|---|---|---|
| Marked improvement | 1 | 0 |
| Moderate improvement | 3 | 10 |
| Minimal improvement | 20 | 15 |
| No change | 36 | 30 |
| Minimal worsening | 22 | 27 |
| Moderate worsening | 1 | 8 |
| Marked worsening | 0 | 0 |
The CFI scale assessed cognitive fluctuation. It evaluates fluctuation in various domains including attention, ability to perform daily functions, orientation, verbal communication and behavior. The score was based on frequency and severity with a score range of 0 to 12. The scale also assessed the degree of caregiver or informant distress engendered by the symptoms. Higher scores indicating greater impairment.
| score on a scale | Placebo | Irsenontrine 50 mg |
|---|---|---|
| Baseline | 3.4 ± 2.68 | 3.1 ± 2.48 |
| Change at Week 12 | 0.1 ± 3.20 | 0.3 ± 3.25 |
The MMSE is a 30-point scale that measured orientation to time and place, registration, immediate and delayed recall, attention, language, and drawing. The total score ranges from 0 (most impaired) to 30 (no impairment). The lower score means severe cognitive deficit and higher score indicates better function.
| score on a scale | Placebo | Irsenontrine 50 mg |
|---|---|---|
| Baseline | 21.0 ± 3.63 | 21.1 ± 3.22 |
| Change at Week 12 | -1.1 ± 3.63 | -1.7 ± 3.58 |
The NPI-12 scale assessed the frequency and severity of 12 neuropsychiatric symptoms commonly described in dementia participants: delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, motor disturbance, nighttime behaviors, and appetite/eating changes. The scale also assessed the degree of caregiver or informant distress engendered by each of the symptoms. The sum of the composite scores for the 12 domains yielded the NPI-12 total score. NPI-12 total score ranged from 0 (minimum severity) to 144 (maximum severity); higher score indicates greater neuropsychiatric disturbance.
| score on a scale | Placebo | Irsenontrine 50 mg |
|---|---|---|
| Baseline | 17.6 ± 14.32 | 19.1 ± 16.07 |
| Change at Week 12 | -0.2 ± 11.07 | -2.0 ± 15.36 |
The NPI scale assesses the frequency and severity of 12 neuropsychiatric symptoms commonly described in dementia participants: delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, motor disturbance, nighttime behaviors, and appetite/eating changes. NPI-4 is the subscore covering the domains of delusions, hallucinations, apathy and depression. NPI-4 total subscore ranged from 0 to 48, with higher scores indicating a greater neuropsychiatric disturbance.
| score on a scale | Placebo | Irsenontrine 50 mg |
|---|---|---|
| Baseline | 8.2 ± 6.40 | 8.6 ± 7.18 |
| Change at Week 12 | -0.4 ± 5.15 | -0.6 ± 6.79 |
The NPI-10 assessed range of behaviors seen in dementia for both frequency and severity. It is a 10 item questionnaire with the following domains: delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/liability and aberrant motor behavior. The total score was a sum of the 10 domains, where the score of each domain was calculated as frequency (scale: 1=occasionally to 4=very frequently)\*Severity (scale: 1=Mild to 3=Severe). Each domain has a maximum score of 12 and all domains were equally weighted for total score, the range for total score is 0 to 120. Higher scores indicating a greater neuropsychiatric disturbance.
| score on a scale | Placebo | Irsenontrine 50 mg |
|---|---|---|
| Baseline | 13.5 ± 11.22 | 14.9 ± 13.54 |
| Change at Week 12 | 0.6 ± 9.32 | -1.4 ± 12.53 |
The NPI-D scale assesses the frequency and severity of 12 neuropsychiatric symptoms commonly described in dementia participants: delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, motor disturbance, nighttime behaviors, and appetite/eating changes. The scale assesses the degree of caregiver distress engendered by each of the symptoms. The caregiver distress (NPI-D) is rated by caregiver based on his or her own stress on a five point scale from 0 to 5, where: 0(no distress), 1(minimal), 2(mild), 3(moderate), 4(moderately severe), 5(very severe or extreme). NPI-D total score is calculated by summing the scores of the 12 sub-scale distress scores. The NPI-D total scores ranges from 0 to 60 with higher scores indicating greater distress.
| score on a scale | Placebo | Irsenontrine 50 mg |
|---|---|---|
| Baseline | 8.8 ± 7.65 | 9.4 ± 8.44 |
| Change at Week 12 | -0.2 ± 6.18 | -0.6 ± 7.28 |
A TEAE was defined as an AE that emerged or worsened in severity relative to baseline during treatment or within 28 days after the last dose of study drug. Severe TEAE was defined as inability to work or to perform normal daily activity. A Serious TEAE is any untoward medical occurrence that at any dose: results in death; is life threatening (that is, the participant was at immediate risk of death from the adverse event as it occurred; this does not include an event that, had it occurred in a more severe form or was allowed to continue, might have caused death) requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect or is medically important due to other reasons than the above mentioned criteria. An adverse event (AE) was defined as any untoward medical occurrence in a participant administered an investigational product.
| Participants | Placebo | Irsenontrine 50 mg |
|---|---|---|
| TEAEs | 67 | 70 |
| Severe TEAEs | 6 | 2 |
| Serious TEAEs | 9 | 7 |
| AE Leading to Discontinuation from Study | 7 | 6 |
Orthostatic hypotension was defined as drop in standing systolic blood pressure greater than or equal to (\>=) 20 Millimeter of mercury (mmHg) compared to supine, or drop in standing diastolic blood pressure \>=10 mmHg compared to supine.
| Participants | Placebo | Irsenontrine 50 mg |
|---|---|---|
| Week 2 | 10 | 2 |
| Week 4 | 9 | 7 |
| Week 6 | 6 | 11 |
| Week 9 | 13 | 9 |
| Week 12 | 7 | 9 |
Orthostatic tachycardia by numerical criteria was defined by the following numerical criteria: Standing heart rate (HR) increased by \>30 beats/min compared to supine and absolute standing HR was \>100 beats/min.
| Participants | Placebo | Irsenontrine 50 mg |
|---|---|---|
| Number of Participants With Orthostatic Tachycardia | 1 | 0 |
A laboratory value was determined to be a markedly abnormal value if the postbaseline common toxicity criteria grade increased from baseline and the post-baseline grade was greater than or equal to 2.
| Participants | Placebo | Irsenontrine 50 mg |
|---|---|---|
| Albumin: Markedly Abnormal Low | 1 | 0 |
| Bilirubin: Markedly Abnormal High | 1 | 0 |
| Calcium: Markedly Abnormal Low | 1 | 0 |
| Creatinine: Markedly Abnormal High | 0 | 2 |
| Gamma Glutamyl Transferase: Markedly Abnormal High | 2 | 0 |
| Hemoglobin: Markedly Abnormal Low | 0 | 1 |
| Leukocytes: Markedly Abnormal Low | 0 | 1 |
| Lymphocytes: Markedly Abnormal Low | 4 | 1 |
| Neutrophils: Markedly Abnormal Low | 1 | 1 |
| Phosphate: Markedly Abnormal Low | 0 | 1 |
| Potassium: Markedly Abnormal Low | 1 | 0 |
| Potassium: Markedly Abnormal High | 2 | 0 |
| Participants | Placebo | Irsenontrine 50 mg |
|---|---|---|
| QTcF prolongation by >60 milliseconds (ms) from baseline and absolute QTcF >450 ms | 2 | 0 |
| QTcF prolongation to >500 ms | 2 | 0 |
| Change from baseline of PR >= 25 percent (%) to an absolute PR value of >220 msec | 1 | 1 |
| Change from baseline of QRS >= 25% to an absolute QRS value of >120 msec | 1 | 0 |
The C-SSRS (mapped to Columbia Classification Algorithm of Suicide Assessment (C-CASA) categories); is an interview-based instrument to systematically assess suicidal ideation and suicidal behavior. C-SSRS assess whether participant experience any of the following: completed suicide; suicide attempt (response of "yes" on "actual attempt"); preparatory acts toward imminent suicidal behavior ("yes" on "preparatory acts or behavior", "aborted attempt" or "interrupted attempt"), suicidal ideation ("yes" on "wish to be dead", "non-specific active suicidal thoughts", "active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent, any self-injurious behavior with no suicidal intent ("yes" on "has participant engaged in non-suicidal self-injurious behavior"). Here, number of participants with positive response ("yes") to suicidal behavior or/and Ideation, any non-suicidal self-injurious behavior was reported.
| Participants | Placebo | Irsenontrine 50 mg |
|---|---|---|
| Completed Suicide | 0 | 0 |
| Suicide Attempt | 0 | 0 |
| Preparatory Actions Towards Imminent Suicidal Behavior | 0 | 2 |
| Wish to Die | 6 | 8 |
| Actual Suicidal Thoughts; Non-specific | 1 | 1 |
| Actual Suicidal Thoughts with Method; No Intent | 0 | 1 |
| Active Thoughts with Intent | 0 | 0 |
| Active Thoughts with Plan and Intent | 0 | 0 |
| Self-injurious Behavior; No Intent | 0 | 0 |
The UPDRS scale evaluates extrapyramidal features in motor function in Parkinson's disease. It contains 33 items in 18 categories: (1) speech, (2) facial expression, (3) rigidity, (4) finger tapping, (5) hand movements, (6) supinational and pronation movements of hands, (7) toe tapping, (8) leg agility, (9) arising from chair, (10) gait, (11) freezing of gait, (12) postural stability, (13) posture, (14) body bradykinesia, (15) postural tremor of hands, (16) kinetic tremor of hands, (17) rest tremor amplitude and (18) constancy of rest tremor. Each item is scored 0 to 4, giving a total score range 0 to 132. Higher scores indicating more severe symptoms.
| score on a scale | Placebo | Irsenontrine 50 mg |
|---|---|---|
| Baseline | 31.3 ± 18.51 | 34.5 ± 18.12 |
| Change at Week 16 | -1.2 ± 10.97 | 1.0 ± 9.22 |
Collected over From first dose of study drug up to follow up (Week 16). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | 1/97 (1%) | 9/97 (9.3%) | 65/97 (67%) |
| Irsenontrine 50 mg | 0/99 (0%) | 7/99 (7.1%) | 68/99 (68.7%) |
| Event | Placebo | Irsenontrine 50 mg |
|---|---|---|
| Dementia with Lewy bodiesNervous system disorders | 1/97 | 2/99 |
| Ileal perforationGastrointestinal disorders | 1/97 | 0/99 |
| InfluenzaInfections and infestations | 1/97 | 0/99 |
| PeritonitisInfections and infestations | 1/97 | 0/99 |
| PneumoniaInfections and infestations | 1/97 | 0/99 |
| Accidental overdoseInjury, poisoning and procedural complications | 1/97 | 0/99 |
| Femur fractureInjury, poisoning and procedural complications | 1/97 | 0/99 |
| Ligament sprainInjury, poisoning and procedural complications | 1/97 | 0/99 |
| Colon cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/97 | 0/99 |
| Cerebrovascular accidentNervous system disorders | 1/97 | 0/99 |
| Event | Placebo | Irsenontrine 50 mg |
|---|---|---|
| FallInjury, poisoning and procedural complications | 15/97 | 10/99 |
| Hallucination, visualPsychiatric disorders | 9/97 | 7/99 |
| Urinary tract infectionInfections and infestations | 5/97 | 4/99 |
| NasopharyngitisInfections and infestations | 3/97 | 5/99 |
| DizzinessNervous system disorders | 1/97 | 5/99 |
| ConstipationGastrointestinal disorders | 4/97 | 1/99 |
| DiarrhoeaGastrointestinal disorders | 3/97 | 4/99 |
| Dementia with Lewy bodiesNervous system disorders | 0/97 | 4/99 |
| NauseaGastrointestinal disorders | 3/97 | 1/99 |
| ContusionInjury, poisoning and procedural complications | 3/97 | 1/99 |
The safety analysis set included the group of participants who received at least 1 dose of study drug and had at least 1 post randomization safety assessment.
| Age, Continuous(Years) | Placebo | Irsenontrine 50 mg | Total |
|---|---|---|---|
| Mean | 73.8 ± 6.60 | 75.3 ± 6.44 | 74.5 ± 6.54 |
| Sex: Female, Male(Participants) | Placebo | Irsenontrine 50 mg | Total |
|---|---|---|---|
| Female | 36 | 37 | 73 |
| Male | 61 | 62 | 123 |
| Ethnicity (NIH/OMB)(Participants) | Placebo | Irsenontrine 50 mg | Total |
|---|---|---|---|
| Hispanic or Latino | 11 | 17 | 28 |
| Not Hispanic or Latino | 73 | 76 | 149 |
| Unknown or Not Reported | 13 | 6 | 19 |
| Race (NIH/OMB)(Participants) | Placebo | Irsenontrine 50 mg | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 33 | 34 | 67 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 1 | 2 |
| White | 48 | 55 | 103 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 15 | 9 | 24 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from May 2018 to primary completion in Apr 2020, 23 months.
Results were first posted in Aug 2022, 2 years 3 months after primary completion. A results delay was requested in Apr 2021.
Of 24 phase 2 interventional studies under Lewy Body Disease, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 45. This study's 23 months is below that.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: Irsenontrine