A Phase 2 interventional study of AVP-923-45 and Placebo in Dyskinesia and Parkinson's Disease, sponsored by Avanir Pharmaceuticals. Completed at 3 sites in 2 countries. Open to participants aged 30 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-04-29.
Sponsored by Avanir Pharmaceuticals (part of Otsuka Holdings Co., Ltd.) · Phase 2, Interventional, and Treatment
To evaluate the efficacy, safety, and tolerability of AVP-923 capsules containing 45 mg dextromethorphan and 10 mg quinidine (AVP-923-45) compared to placebo for the treatment of levodopa-induced dyskinesia (LID) in patients with Parkinson's disease (PD).
Proof-of-concept phase 2a, double-blind, randomized, placebo-controlled, crossover study.
179 studies on the registry are indexed under Dyskinesias; 24 are open to participants now.
This study's enrollment of 14 is below the median of 36 across 139 interventional studies indexed under Dyskinesias.
Browse Dyskinesias studies →Avanir Pharmaceuticals is the lead sponsor of 13 studies on the registry; none are open to participants now.
First submitted before Avanir Pharmaceuticals became part of Otsuka Holdings Co., Ltd..
Counted across the registry records on this site, refreshed daily.
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.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
AVP-923-45 twice daily for 14 days
Drug: AVP-923-45
Placebo twice a day for 14 days
Drug: Placebo
One capsule twice daily for 14 days
Also known as: dextromethorphan/quinidine
One capsule twice daily for 14 days
Least Squares Mean Dyskinesia Severity Area Under the Curve (AUC) Score As Assessed By Modified Movement Disorder Society-Unified Dyskinesia Rating Scale (MDS-UDysRS) Part 3
The MDS-UDysRS was developed to evaluate involuntary movements often associated with treated Parkinson's disease (PD). Levodopa-Induced Dyskinesia severity was assessed via video analysis by unbiased blinded central raters, and was calculated using the Intensity Scale from Part 3 of the MDS-UDysRS. The Intensity Scale was made up of seven body parts: face, neck, right arm/shoulder, left arm/shoulder, trunk, right leg/hip, and left leg/hip. Each body part was scored on a variety of disability items (communication, drinking, and ambulation \[walking\]) on a scale of 0 (normal) to 4 (incapacitating dyskinesia) with a maximum total score of 28. For each body part, the highest disability score was summed to calculate the intensity score. A score of '0' was assigned to questions associated with the dressing task which were not performed due to the placement of the treatment infusion (IV) line. A higher score indicated more severe symptoms.
Time frame: Over the 2-hour levodopa infusion period on the last day of each treatment period (Day 14 and Day 42)
Least Squares Mean Disability Area Under the Curve (AUC) Score As Assessed By Modified Movement Disorder Society-Unified Dyskinesia Rating Scale (MDS-UDysRS) Part 4
The MDS-UDysRS was developed to evaluate involuntary movements often associated with treated PD. Part 4 of the MDS-UDysRS objectively measures the disability associated with levodopa-induced dyskinesia. Disability was assessed via video analysis by unbiased blinded central raters. Disability was evaluated for communication, drinking from a cup, and ambulation items. Each item was rated from 0 (no dyskinesia) to 4 (most severe disability), with a sum range of 0 to 12. A score of '0' was assigned to questions associated with the dressing task because it was not performed due to placement of the IV line. A higher score indicated more severe symptoms.
Time frame: Over the 2-hour levodopa infusion period on the last day of each treatment period (Day 14 and Day 42)
Least Squares Mean Motor Movement Area Under the Curve Score As Assessed by Modified Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS), Part III
The Modified MDS-UPDRS (4 parts) was used to assess the severity of parkinsonian disability. Part III of the MDS-UPDRS was used as an objective measure of the severity of parkinsonian disability per motor examination with focus on the treated side tremor and motor fluctuations. The motor examination were videotaped using a standardized protocol for review by an expert central rater blinded to the treatment schedule. A total of 11 items were scored as follows: 0 (normal), 1 (slight), 2 (mild), 3 (moderate), 4 (severe), with a maximum total score of 44. For each part, a higher score indicated more severe symptoms. Due to placement of the IV line, a score of '0' was assigned to rigidity questions.
Time frame: Over the 2-hour levodopa infusion period on the last day of each treatment period (Day 14 and Day 42)
Least Squares Mean Timed Finger Tapping Area Under the Curve (AUC) Score
Timed finger tapping test was used to quantify the upper extremity impairment in participants with idiopathic PD. Timed finger tapping was assessed using the Objective Parkinson's Disease Measurement (OPDM) System. Participants were instructed to tap for 60 seconds while speed and accuracy were assessed across 4 tests; right and left two finger test (m,n keystrokes) and one finger test (p,q keystrokes). The mean peak finger tapping score was calculated using the individual peak values. A higher score signifies improvement (faster typing, more accuracy), while a lower score signifies increased symptom severity.
Time frame: Over the 2-hour levodopa infusion period on the last day of each treatment period (Day 14 and Day 42)
Change From Baseline in MDS-UPDRS Scores for Part I, II, and IV
The MDS-UPDRS was used to assess the status of PD. Parts I and II (completed by the participant) and Part IV (completed by a rater) of the MDS-UPDRS provided a subjective measure of parkinsonian disability. Part I measured non-motor experiences of daily living, Part II measured motor experiences of daily living, and Part IV measures motor complications associated with PD. Each part was comprised of a series of questions, and each question was scored from 0 (normal) to 4 (severe). Part I and Part II were each comprised of 13 items; the total score ranges from 0 (normal) to 52 (severe). Part III was comprised of 33 items; the total score ranges from 0 (normal) to 132 (severe). Part IV was comprised of 6 items; the total score ranged from 0 (normal) to 24 (severe). For each part, a higher score indicated more severe symptoms. Post-Baseline was Visit 2 (Day 14) or Visit 4 (Day 42). Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Time frame: Baseline (Day 1); Post-Baseline (Day 14 or 42)
Change From Baseline in MDS-UDysRS Scores for Part 1 and 2
The MDS-UDysRS was developed to evaluate involuntary movements often associated with treated PD. Part 1 (On-Dyskinesia \['jerking or twisting movements that occur when your medicine is working'\]) and Part 2 (Off-Dyskinesia \["spasms or cramps that can be painful and occur when your PD medications are not taken or are not working\]) of the MDS-UDysRS were assessed by a blinded rater. Parts 1B and 2B (participant questionnaires) were completed at home by the participant. Part 1 comprised of 11 items, and Part 2 comprised of 4 items. All items were assigned a score of: 0, normal; 1, slight; 2, mild; 3, moderate; 4, severe. The total score for Parts 1 and 2 ranged from 0 to 44 and from 0 to 16, respectively. Higher scores indicate increased symptom severity. Post-Baseline was Visit 2 (Day 14) or Visit 4 (Day 42). Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Time frame: Baseline (Day 1); Post-Baseline (Day 14 or 42)
Change From Baseline in PD Motor Diary Ratings Of Duration Of "On-time Without Bothersome Dyskinesia"
The PD motor diary is a home diary used to assess functional status in participants with PD with motor fluctuations and dyskinesia. Participants were instructed to complete the PD motor diary at home for a minimum of 3 consecutive days within the 7 days prior to Visits 2 and 4 (Days 14 and 42). Baseline is Visit 1 (Day 1) or Visit 3 (Day 29); Post-Baseline is Visit 2 (Day 14) or Visit 4 (Day 42). Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Time frame: Baseline; Post-Baseline (Days 14 and 42)
Change From Baseline in Parkinson's Disease Questionnaire-39 (PDQ-39) Domain Scores at the End of Each Treatment Period
The PDQ-39 was a self-reported questionnaire consisting of 39 questions assessing Parkinson's disease-specific health quality of life covering 8 aspects of quality of life: mobility; activities of daily living; emotional wellbeing; stigma; social support; cognitive impairment (cognitions); communication; bodily discomfort. Each item was scored on 5-point scale: 0 = Never (better in outcome), 1 = Occasionally, 2 = Sometimes, 3 = Often, 4 = Always (worse in outcome). Total scores ranged between 0 to 156. Higher scores indicated poor quality of life. Baseline was Visit 1 (Day 1) or Visit 3 (Day 29); Post-Baseline was Visit 2 (Day 14) or Visit 4 (Day 42). Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Time frame: Baseline; Post-Baseline (Day 14 or 42)
Change From Baseline in PDQ-39 Single Index (PDQ-39-SI) Scores at the End of Each Treatment Period
The PDQ-39 was the most widely used PD-specific measure of health status. It consists of 39 questions, covering 8 aspects of quality of life: mobility; activities of daily living; emotional wellbeing; stigma; social support; cognitive impairment (cognitions); communication; bodily discomfort. The instrument was developed on the basis of interviews with people diagnosed with PD. The PDQ-39-SI) score was calculated as the weighted addition of scores on all 8 dimensions of the PDQ-39. The total score ranged from 0 (no disease impact) to 100 (severe disease impact). Baseline was Visit 1 (Day 1) or Visit 3 (Day 29); Post-Baseline was Visit 2 (Day 14) or Visit 4 (Day 42). Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Time frame: Baseline; Post-Baseline (Day 14 or 42)
Change From Screening in the Montreal Cognitive Assessment (MoCA) Calculated Score at the End of Each Treatment Period
The MoCA was designed as a rapid screening instrument for mild cognitive dysfunction. It assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation. The total score is calculated by summing the items from each domain. Total scores can range from 0 to 30; lower scores indicate cognitive dysfunction. A final total score of 26 and above is considered normal. Change from Screening was calculated as the post-Screening value minus the Screening value.
Time frame: Screening (Day -28); End of each treatment period (Days 14 or 42)
Change From Baseline in the Dyskinesia and Other PD Symptoms Score As Assessed by Patient Global Impression of Change (PGIC)
The PGIC was a 7-point scale used to assess treatment response as judged by the participant. The participant was asked to assess change in dyskinesia symptoms and change in overall PD symptoms (e.g., slowness, stiffness, balance) on a score range of 1, much improved; 2, improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, worse; 7, much worse. The average PGIC score was calculated at each visit by treatment group. Baseline is Visit 1 (Day 1) or Visit 3 (Day 29); Post-Baseline is Visit 2 (Day 14) or Visit 4 (Day 42). Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Time frame: Baseline; Post-Baseline (Days 14 and 42)
| Milestone | AVP-923-45; Placebo | Placebo; AVP-923-45 |
|---|---|---|
| Started | 7 | 7 |
| Completed | 6 | 7 |
| Not completed | 1 | 0 |
| Withdrew: Adverse event | 1 | 0 |
| Milestone | AVP-923-45; Placebo | Placebo; AVP-923-45 |
|---|---|---|
| Started | 6 | 7 |
| Completed | 6 | 7 |
| Not completed | 0 | 0 |
The MDS-UDysRS was developed to evaluate involuntary movements often associated with treated Parkinson's disease (PD). Levodopa-Induced Dyskinesia severity was assessed via video analysis by unbiased blinded central raters, and was calculated using the Intensity Scale from Part 3 of the MDS-UDysRS. The Intensity Scale was made up of seven body parts: face, neck, right arm/shoulder, left arm/shoulder, trunk, right leg/hip, and left leg/hip. Each body part was scored on a variety of disability items (communication, drinking, and ambulation \[walking\]) on a scale of 0 (normal) to 4 (incapacitating dyskinesia) with a maximum total score of 28. For each body part, the highest disability score was summed to calculate the intensity score. A score of '0' was assigned to questions associated with the dressing task which were not performed due to the placement of the treatment infusion (IV) line. A higher score indicated more severe symptoms.
| (Score on a scale)*hour | AVP-923-45 | Placebo |
|---|---|---|
| Least Squares Mean Dyskinesia Severity Area Under the Curve (AUC) Score As Assessed By Modified Movement Disorder Society-Unified Dyskinesia Rating Scale (MDS-UDysRS) Part 3 | 966.0 ± 42.22 | 1049.4 ± 42.22 |
The MDS-UDysRS was developed to evaluate involuntary movements often associated with treated PD. Part 4 of the MDS-UDysRS objectively measures the disability associated with levodopa-induced dyskinesia. Disability was assessed via video analysis by unbiased blinded central raters. Disability was evaluated for communication, drinking from a cup, and ambulation items. Each item was rated from 0 (no dyskinesia) to 4 (most severe disability), with a sum range of 0 to 12. A score of '0' was assigned to questions associated with the dressing task because it was not performed due to placement of the IV line. A higher score indicated more severe symptoms.
| (Score on a scale)*hour | AVP-923-45 | Placebo |
|---|---|---|
| Least Squares Mean Disability Area Under the Curve (AUC) Score As Assessed By Modified Movement Disorder Society-Unified Dyskinesia Rating Scale (MDS-UDysRS) Part 4 | 409.4 ± 14.87 | 428.3 ± 14.87 |
The Modified MDS-UPDRS (4 parts) was used to assess the severity of parkinsonian disability. Part III of the MDS-UPDRS was used as an objective measure of the severity of parkinsonian disability per motor examination with focus on the treated side tremor and motor fluctuations. The motor examination were videotaped using a standardized protocol for review by an expert central rater blinded to the treatment schedule. A total of 11 items were scored as follows: 0 (normal), 1 (slight), 2 (mild), 3 (moderate), 4 (severe), with a maximum total score of 44. For each part, a higher score indicated more severe symptoms. Due to placement of the IV line, a score of '0' was assigned to rigidity questions.
| (Score on a scale)*hour | AVP-923-45 | Placebo |
|---|---|---|
| Least Squares Mean Motor Movement Area Under the Curve Score As Assessed by Modified Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS), Part III | 6568.9 ± 383.26 | 6397.0 ± 383.26 |
Timed finger tapping test was used to quantify the upper extremity impairment in participants with idiopathic PD. Timed finger tapping was assessed using the Objective Parkinson's Disease Measurement (OPDM) System. Participants were instructed to tap for 60 seconds while speed and accuracy were assessed across 4 tests; right and left two finger test (m,n keystrokes) and one finger test (p,q keystrokes). The mean peak finger tapping score was calculated using the individual peak values. A higher score signifies improvement (faster typing, more accuracy), while a lower score signifies increased symptom severity.
| (Score on a scale)*hour | AVP-923-45 | Placebo |
|---|---|---|
| Least Squares Mean Timed Finger Tapping Area Under the Curve (AUC) Score | 820.9 ± 40.80 | 772.1 ± 40.80 |
The MDS-UPDRS was used to assess the status of PD. Parts I and II (completed by the participant) and Part IV (completed by a rater) of the MDS-UPDRS provided a subjective measure of parkinsonian disability. Part I measured non-motor experiences of daily living, Part II measured motor experiences of daily living, and Part IV measures motor complications associated with PD. Each part was comprised of a series of questions, and each question was scored from 0 (normal) to 4 (severe). Part I and Part II were each comprised of 13 items; the total score ranges from 0 (normal) to 52 (severe). Part III was comprised of 33 items; the total score ranges from 0 (normal) to 132 (severe). Part IV was comprised of 6 items; the total score ranged from 0 (normal) to 24 (severe). For each part, a higher score indicated more severe symptoms. Post-Baseline was Visit 2 (Day 14) or Visit 4 (Day 42). Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
| score on a scale | AVP-923-45 | Placebo |
|---|---|---|
| Part I | -1.2 ± 0.43 | -0.1 ± 0.43 |
| Part II | -0.0 ± 0.92 | -0.2 ± 0.92 |
| Part IV | -2.9 ± 0.84 | -0.5 ± 0.84 |
The MDS-UDysRS was developed to evaluate involuntary movements often associated with treated PD. Part 1 (On-Dyskinesia \['jerking or twisting movements that occur when your medicine is working'\]) and Part 2 (Off-Dyskinesia \["spasms or cramps that can be painful and occur when your PD medications are not taken or are not working\]) of the MDS-UDysRS were assessed by a blinded rater. Parts 1B and 2B (participant questionnaires) were completed at home by the participant. Part 1 comprised of 11 items, and Part 2 comprised of 4 items. All items were assigned a score of: 0, normal; 1, slight; 2, mild; 3, moderate; 4, severe. The total score for Parts 1 and 2 ranged from 0 to 44 and from 0 to 16, respectively. Higher scores indicate increased symptom severity. Post-Baseline was Visit 2 (Day 14) or Visit 4 (Day 42). Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
| score on a scale | AVP-923-45 | Placebo |
|---|---|---|
| Part 1 | -3.9 ± 1.34 | 0.00 ± 1.34 |
| Part 2 | -0.7 ± 0.77 | 0.6 ± 0.77 |
The PD motor diary is a home diary used to assess functional status in participants with PD with motor fluctuations and dyskinesia. Participants were instructed to complete the PD motor diary at home for a minimum of 3 consecutive days within the 7 days prior to Visits 2 and 4 (Days 14 and 42). Baseline is Visit 1 (Day 1) or Visit 3 (Day 29); Post-Baseline is Visit 2 (Day 14) or Visit 4 (Day 42). Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
| hours | AVP-923-45 | Placebo |
|---|---|---|
| Change From Baseline in PD Motor Diary Ratings Of Duration Of "On-time Without Bothersome Dyskinesia" | 0.5 ± 1.01 | 0.5 ± 0.93 |
The PDQ-39 was a self-reported questionnaire consisting of 39 questions assessing Parkinson's disease-specific health quality of life covering 8 aspects of quality of life: mobility; activities of daily living; emotional wellbeing; stigma; social support; cognitive impairment (cognitions); communication; bodily discomfort. Each item was scored on 5-point scale: 0 = Never (better in outcome), 1 = Occasionally, 2 = Sometimes, 3 = Often, 4 = Always (worse in outcome). Total scores ranged between 0 to 156. Higher scores indicated poor quality of life. Baseline was Visit 1 (Day 1) or Visit 3 (Day 29); Post-Baseline was Visit 2 (Day 14) or Visit 4 (Day 42). Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
| score on a scale | AVP-923-45 | Placebo |
|---|---|---|
| Mobility | 0.2 ± 2.45 | 2.0 ± 2.69 |
| Activities of Daily Living | -4.6 ± 2.14 | 3.9 ± 2.14 |
| Emotional Well Being | -4.5 ± 2.90 | 2.9 ± 2.90 |
| Stigma | -3.7 ± 4.10 | 0.3 ± 4.10 |
| Social support | -6.0 ± 3.60 | 3.8 ± 3.60 |
| Cognitive impairment (Cognitions) | -4.1 ± 3.64 | 0.2 ± 3.64 |
| Communication | -3.7 ± 2.43 | 2.4 ± 2.43 |
| Bodily discomfort | -7.4 ± 4.60 | -2.2 ± 4.60 |
The PDQ-39 was the most widely used PD-specific measure of health status. It consists of 39 questions, covering 8 aspects of quality of life: mobility; activities of daily living; emotional wellbeing; stigma; social support; cognitive impairment (cognitions); communication; bodily discomfort. The instrument was developed on the basis of interviews with people diagnosed with PD. The PDQ-39-SI) score was calculated as the weighted addition of scores on all 8 dimensions of the PDQ-39. The total score ranged from 0 (no disease impact) to 100 (severe disease impact). Baseline was Visit 1 (Day 1) or Visit 3 (Day 29); Post-Baseline was Visit 2 (Day 14) or Visit 4 (Day 42). Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
| score on a scale | AVP-923-45 | Placebo |
|---|---|---|
| Change From Baseline in PDQ-39 Single Index (PDQ-39-SI) Scores at the End of Each Treatment Period | -4.2 ± 1.60 | 2.2 ± 1.76 |
The MoCA was designed as a rapid screening instrument for mild cognitive dysfunction. It assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation. The total score is calculated by summing the items from each domain. Total scores can range from 0 to 30; lower scores indicate cognitive dysfunction. A final total score of 26 and above is considered normal. Change from Screening was calculated as the post-Screening value minus the Screening value.
| score on a scale | AVP-923-45 | Placebo |
|---|---|---|
| Change From Screening in the Montreal Cognitive Assessment (MoCA) Calculated Score at the End of Each Treatment Period | 0.1 ± 0.27 | 0.6 ± 0.27 |
The PGIC was a 7-point scale used to assess treatment response as judged by the participant. The participant was asked to assess change in dyskinesia symptoms and change in overall PD symptoms (e.g., slowness, stiffness, balance) on a score range of 1, much improved; 2, improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, worse; 7, much worse. The average PGIC score was calculated at each visit by treatment group. Baseline is Visit 1 (Day 1) or Visit 3 (Day 29); Post-Baseline is Visit 2 (Day 14) or Visit 4 (Day 42). Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
| score on a scale | AVP-923-45 | Placebo |
|---|---|---|
| Dyskinesia | 2.7 ± 0.35 | 3.7 ± 0.35 |
| Other PD symptoms | 4.2 ± 0.26 | 4.1 ± 0.26 |
Collected over up to Day 42. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| AVP-923-45 | 0/14 (0%) | 0/14 (0%) | 11/14 (78.6%) |
| Placebo | 0/13 (0%) | 0/13 (0%) | 2/13 (15.4%) |
| Event | AVP-923-45 | Placebo |
|---|---|---|
| FatigueGeneral disorders | 3/14 | 0/13 |
| SomnolenceNervous system disorders | 3/14 | 0/13 |
| ConstipationGastrointestinal disorders | 2/14 | 1/13 |
| DizzinessNervous system disorders | 2/14 | 0/13 |
| ParkinsonismNervous system disorders | 2/14 | 0/13 |
| Upper respiratory tract infectionInfections and infestations | 0/14 | 1/13 |
| PalpitationsCardiac disorders | 1/14 | 0/13 |
| TinnitusEar and labyrinth disorders | 1/14 | 0/13 |
| FlatulenceGastrointestinal disorders | 1/14 | 0/13 |
| Paraesthesia oralGastrointestinal disorders | 1/14 | 0/13 |
| Age, Continuous(years) | All Study Participants |
|---|---|
| Mean | 64.1 ± 7.32 |
| Sex: Female, Male(Participants) | All Study Participants |
|---|---|
| Female | 9 |
| Male | 5 |
| Race/Ethnicity, Customized(Participants) | All Study Participants |
|---|---|
| White | 13 |
| Indian Sub-Continent | 1 |
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