A Phase 2 interventional study of 1 mg QD to 15 mg QD PF-06649751 and 3 mg QD to 15 mg QD PF-06649751 in Parkinson's Disease With Motor Fluctuations, sponsored by Pfizer. Terminated at 9 sites in United States. Open to participants aged 40 Years to 87 Years. Per ClinicalTrials.gov, last updated 2019-04-12.
Sponsored by Pfizer · Phase 2, Interventional, and Treatment
The purpose of this study is to evaluate the long term safety and tolerability of PF-06649751 in Parkinson's disease patients who experience motor-fluctuations.
This is an open label study evaluating the long term safety and tolerability of PF-06649751 in Parkinson's disease patients who experience motor-fluctuations. Subjects who completed Ph2 study B7601003 will be randomized to one of 4 treatment groups (15 mg QD, 7 mg QD, 3 mg QD, or 1 mg QD group) depending on the treatment received in B7601003 and titrated up to 15 mg QD over a 3 week period, as appropriate. All subjects who were blindly down-titrated during the B7601003 study will remain at/or be titrated to 7 mg QD only and remain at that dose for the rest of the B7601017 study in order to protect the blind for the prior study. Subjects who successfully titrate to 15 mg QD will enter the Adjustment Period at that dose.
Subjects who cannot tolerate 15 mg QD at any time during the study will be allowed to down-titrate to 7 mg QD (but not lower) and will stay at that dose for the rest of the study.
Subjects who cannot remain at a stable dose (7 mg or 15 mg QD) will be discontinued.
4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.
This study's enrollment of 5 is below the median of 40 across 3,294 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.
Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.
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Exclusion Criteria:
Up titration from 1 mg QD to 15 mg QD PF-06649751
Drug: 1 mg QD to 15 mg QD PF-06649751
Up titration from 3 mg QD to 15 mg QD PF-06649751
Drug: 3 mg QD to 15 mg QD PF-06649751
Up titration from 7 mg QD to 15 mg QD PF-06649751
Drug: 7 mg QD to 15 mg QD PF-06649751
15 mg QD PF-06649751 remains at 15 mg QD PF-06649751
Drug: 15 mg QD PF-06649751
Up titration from 1 to 7 mg QD PF-06649751 if de-escalated in parent study
Drug: 1 mg QD to 7 mg QD PF-06649751 (if de-escalated in parent study)
Up titration from 3 to 7 mg QD PF-06649751 if de-escalated in parent study
Drug: 3 mg QD to 7 mg QD PF-06649751 (de-escalated in parent study)
7 mg QD remains at 7 mg QD PF-06649751 if de-escalated in parent study
Drug: 7 mg QD to 7 mg QD PF-06649751 (de-escalated in parent study)
15 mg QD de-escalated to 7 mg QD in parent study B7601003 remain at 15 mg QD PF-06649751
Drug: 15 mg QD de-escalated to 7 mg QD PF-06649751 in parent study remain at 7 mg QD
Up titration from 1 mg QD to 15 mg QD PF-06649751
Up titration from 3 mg QD to 15 mg QD PF-06649751
Up titration from 7 mg QD to 15 mg QD PF-06649751
15 mg QD PF-06649751 remaining at 15 mg QD PF-06649751
Up titration from 1 mg QD to 7 mg QD PF-06649751 for subject at 1 mg QD who were blindly de-escalated in the parent study
Up titration from 3 mg QD to 7 mg QD PF-06649751 for 3 mg QD subjects who were blindly de-escalated in parent study
7 mg QD to remain at 7 mg QD PF-06649751 for subjects who were blindly de-escalated in parent study
7mg QD PF-06649751 for subjects assigned to 15 mg QD who were blindly de-escalated to 7 mg QD PF-06649751 in parent study
Number of Participants With Treatment-Emergent Adverse Events (All Causalities)
An adverse event (AE) is any untoward medical occurrence in a study participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. Any AE occurring following the start of treatment or occurring before treatment but increasing in severity afterward were counted as treatment-emergent AE (TEAE).
Time frame: Baseline to last visit after termination (up to approximately 3 months)
Number of Participants With Treatment-Emergent Adverse Events (Treatment Related)
An adverse event (AE) is any untoward medical occurrence in a study participant administered a product or medical device. Any AE occurring following the start of treatment or occurring before treatment but increasing in severity afterward were counted as treatment-emergent AE (TEAE).
Time frame: Baseline to last visit after termination (up to approximately 3 months)
Number of Participants With Clinically Significant Findings in Physical Examination
A full physical examination included head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, gastrointestinal and musculoskeletal systems. The clinical significance was determined by the investigator.
Time frame: Baseline to last visit after termination (up to approximately 3 months)
Number of Participants With Clinically Significant Findings in Neurological Examination
The full neurological examination included assessment of the visual fields and of the right and left optic fundus; cranial nerves; mental state; muscle strength and tone, abnormal movements; deep tendon reflexes; sensory exam, coordination, gait and station. Higher cortical and motor function was considered part of the complete neurological exam. The brief neurological exam included observation for cerebellar (intention) tremor and for non cerebellar tremors (eg, resting or positional), finger to nose, heel to shin, Romberg, gait and tandem walking, positional and gaze evoked nystagmus. The clinical significance was determined by the investigator.
Time frame: Baseline to last visit after termination (up to approximately 3 months)
Number of Participants With Abnormalities in Laboratory Test (Without Regard to Baseline Abnormality)
Laboratory tests included hematology(hemoglobin,hematocrit,red and white blood cell count,mean corpuscular volume,mean corpuscular hemoglobin,mean corpuscular hemoglobin concentration,platelet count,neutrophils,eosinophils,monocytes, basophils,lymphocytes), chemistry(blood urea nitrogen/urea and creatinine,fasting glucose, calcium,sodium,potassium, chloride,total carbon dioxide,aspartate and alanine aminotransferase,total bilirubin,alkaline phosphatase,uric acid,albumin,total protein),urinalysis(pH,qualitative glucose protein,blood,ketones,nitrites,leukocyte esterase,urobilinogen,urine bilirubin,microscopy,specific gravity,urine creatinine),other tests(urine drug screen,follicle stimulating hormone,anti neutrophil cytoplasmic antibody panel,qualitative antinuclear antibody,fibrinogen,C reactive protein,erythrocyte sedimentation rate,C3, C4, CH50/CH100,rheumatoid factor,immunoglobulin panel,if anti- neutrophil cytoplasmic antibody positive:proteinase 3 Ab,myeloperoxidase Ab tests).
Time frame: Baseline to last visit after termination(up to approximately 3 months)
Number of Participants With Vital Signs Data Meeting Pre-defined Criteria
Number of participants with vital signs findings meeting the following criteria is presented:(1) standing DBP increase from baseline\>= 20 mm Hg; (2) standing SBP increase from baseline\>= 30 mm Hg; (3) supine DBP increase from baseline \>=20 mm Hg; (4) supine SBP increase from baseline \>=30 mm Hg; (5)standing DBP decrease from baseline\>= 20 mm Hg; (6) standing SBP decrease from baseline\>= 30 mm Hg; (7) supine DBP decrease from baseline \>=20 mm Hg; (8) supine SBP decrease from baseline \>=30 mm Hg.
Time frame: Baseline to last visit after termination (up to approximately 3 months)
Number of Participants With Vital Signs Data of Orthostatic Hypotension Meeting Pre-defined Criteria
Orthostatic hypotension was defined as a decrease of \>=20 mmHg for systolic blood pressure (SBP) or \>=10 mmHg for diastolic blood pressure (DBP) 2 minutes after standing from a supine position.
Time frame: Baseline to last visit after termination (up to approximately 3 months)
Number of Participants With Electrocardiogram Data Meeting Pre-defined Criteria
PR interval (time from the beginning of P wave to the start of QRS complex, corresponding to the end of atrial depolarization and onset of ventricular depolarization), QRS duration (time from Q wave to the end of S wave, corresponding to ventricle depolarization), QT interval (time from the beginning of Q wave to the end of T wave) and QTcF interval ( QT interval corresponding to electrical systole corrected for heart rate using Fridericia's formula) are summarized. Number of participants with ECG findings meeting the following criteria is presented: (1) PR interval \>=300 msec; (2) QRS duration \>=140 msec; (3) QT interval \>= 500; (4) QTcF interval: 450 to \<480 msec; (5) QTcF interval: 480 to \<500 msec; (6) QTcF interval \>=500 msec.
Time frame: Baseline to last visit after termination (up to approximately 3 months)
Number of Participants With Worsening Suicidality and New Onset Suicidality
The Columbia Suicide Severity Rating Scale (C-SSRS) is an interview based rating scale to systematically assess suicidal ideation and suicidal behavior. At each suicidality assessment, participants felt to have significant suicidal ideation with actual plan and intent or suicidal behavior, must be evaluated by a clinician/mental health professional (MHP) skilled in the evaluation of suicidality in the participants by virtue of training or experience who determined if it is safe for the participants to participate/continue in the trial. The denominator used in the percentages was the number of participants assessed for suicidality or worsening, the denominator included the subset of participants who had any level of suicidality reported at baseline. For new onset, the denominator included the subset of participants with no suicidality reported at baseline.
Time frame: Baseline to last visit after termination (up to approximately 3 months)
Number of Participants With Benzodiazepine Discontinuation Symptoms Based on Physician Withdrawal Checklist (PWC-20)
The PWC-20 is a physician-completed, 20-item reliable and sensitive instrument for the assessment of benzodiazepine discontinuation symptoms, including anxiety and nervous, depersonalization and derealization, diarrhea, diaphoresis, difficulty concentrating and remembering, dizziness-lightheadedness, depression, fatigue, lethargy and lack of energy, headaches, increased acuity for sound, smell, touch, or pain, insomnia, irritability, loss of appetite, muscle aches or stiffness, nausea-vomiting paresthesias, poor coordination, restlessness and agitation, tremor-tremulousness, and weakness. Summaries of the count of participants experiencing symptoms and severity listed in the PWC-20 were provided.
Time frame: At last visit
Change From Baseline for Hauser Participant Diary Data in Daily OFF Time
Available diaries are designed to record participant motor state for half hour intervals. These diaries are a way for participant to assess their own health status without clinician bias or interpretation. In participant diaries, "OFF" time is defined as a period when medication has worn off and is no longer providing benefit with regard to mobility, slowness, and stiffness. During this period, Parkinson's Disease (PD) participants experience relatively poor overall function with worsening of tremor, rigidity, balance, or bradykinesia.
Time frame: Baseline, Day 21 and Day 35
Change From Baseline for Hauser Participant Diary Data in Daily ON Time With Troublesome Dyskinesia
Available diaries are designed to record participant motor state for half hour intervals. These diaries are a way for participants to assess their own health status without clinician bias or interpretation. "ON" time is defined as the time when medication is providing benefit with regard to mobility, slowness, and stiffness. "ON" time can be classified as associated with or without troublesome dyskinesia that interfere with activities of daily living.It has been demonstrated that "ON" time with troublesome dyskinesia are generally considered by participants to be "bad time" with regard to motor function.
Time frame: Baseline, Day 21 and Day 35
Change From Baseline for Hauser Participant Diary Data in Daily ON Time Without Troublesome Dyskinesia
Available diaries are designed to record participant motor state for half hour intervals. These diaries are a way for participants to assess their own health status without clinician bias or interpretation. "ON" time is defined as the time when medication is providing benefit with regard to mobility, slowness, and stiffness. "ON" time can be classified as associated with or without troublesome dyskinesia that interfere with activities of daily living. "ON" time without dyskinesia and on time with non troublesome dyskinesia are generally considered to be "good time".
Time frame: Baseline, Day 21 and Day 35
Change From Baseline in Movement Disorder Society Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts I, II, III, IV, and Total Score
The total MDS-UPDRS score developed by the Movement Disorder Society is the most common method of evaluating the severity of Parkinson's Disease (PD). Part I assesses non motor experiences of daily living(range 0-52).Part II assesses motor experiences of daily living(0-52). Part III assesses the motor signs of PD.Part IV assesses motor complications, dyskinesias, and motor fluctuations(0-24).Total Score:The sum of Parts I, II, III, and IV.Each question is anchored with five responses:0=normal, 1=slight, 2=mild, 3= moderate, 4=severe.Higher part and total scores indicate more severe signs of PD.There are four subscales in Part III:the tremor subscale(range 0-36),the rigidity subscale(0-20),the bradykinesia subscale(0-36),the postural instability and gait disorder (PIGD) subscale(0-12).
Time frame: Baseline to last visit after termination (up to approximately 3 months)
| Milestone | PF-06649751 15 mg |
|---|---|
| Started | 5 |
| Completed | 0 |
| Not completed | 5 |
| Withdrew: Adverse event | 1 |
| Withdrew: Study terminated by sponsor | 4 |
An adverse event (AE) is any untoward medical occurrence in a study participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. Any AE occurring following the start of treatment or occurring before treatment but increasing in severity afterward were counted as treatment-emergent AE (TEAE).
| Participants | PF-06649751 15 mg |
|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (All Causalities) | 3 |
An adverse event (AE) is any untoward medical occurrence in a study participant administered a product or medical device. Any AE occurring following the start of treatment or occurring before treatment but increasing in severity afterward were counted as treatment-emergent AE (TEAE).
| Participants | PF-06649751 15 mg |
|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (Treatment Related) | 2 |
A full physical examination included head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, gastrointestinal and musculoskeletal systems. The clinical significance was determined by the investigator.
| Participants | PF-06649751 15 mg |
|---|---|
| Number of Participants With Clinically Significant Findings in Physical Examination | 0 |
The full neurological examination included assessment of the visual fields and of the right and left optic fundus; cranial nerves; mental state; muscle strength and tone, abnormal movements; deep tendon reflexes; sensory exam, coordination, gait and station. Higher cortical and motor function was considered part of the complete neurological exam. The brief neurological exam included observation for cerebellar (intention) tremor and for non cerebellar tremors (eg, resting or positional), finger to nose, heel to shin, Romberg, gait and tandem walking, positional and gaze evoked nystagmus. The clinical significance was determined by the investigator.
| Participants | PF-06649751 15 mg |
|---|---|
| Number of Participants With Clinically Significant Findings in Neurological Examination | 0 |
Laboratory tests included hematology(hemoglobin,hematocrit,red and white blood cell count,mean corpuscular volume,mean corpuscular hemoglobin,mean corpuscular hemoglobin concentration,platelet count,neutrophils,eosinophils,monocytes, basophils,lymphocytes), chemistry(blood urea nitrogen/urea and creatinine,fasting glucose, calcium,sodium,potassium, chloride,total carbon dioxide,aspartate and alanine aminotransferase,total bilirubin,alkaline phosphatase,uric acid,albumin,total protein),urinalysis(pH,qualitative glucose protein,blood,ketones,nitrites,leukocyte esterase,urobilinogen,urine bilirubin,microscopy,specific gravity,urine creatinine),other tests(urine drug screen,follicle stimulating hormone,anti neutrophil cytoplasmic antibody panel,qualitative antinuclear antibody,fibrinogen,C reactive protein,erythrocyte sedimentation rate,C3, C4, CH50/CH100,rheumatoid factor,immunoglobulin panel,if anti- neutrophil cytoplasmic antibody positive:proteinase 3 Ab,myeloperoxidase Ab tests).
| Participants | PF-06649751 15 mg |
|---|---|
| Number of Participants With Abnormalities in Laboratory Test (Without Regard to Baseline Abnormality) | 1 |
Number of participants with vital signs findings meeting the following criteria is presented:(1) standing DBP increase from baseline\>= 20 mm Hg; (2) standing SBP increase from baseline\>= 30 mm Hg; (3) supine DBP increase from baseline \>=20 mm Hg; (4) supine SBP increase from baseline \>=30 mm Hg; (5)standing DBP decrease from baseline\>= 20 mm Hg; (6) standing SBP decrease from baseline\>= 30 mm Hg; (7) supine DBP decrease from baseline \>=20 mm Hg; (8) supine SBP decrease from baseline \>=30 mm Hg.
| Participants | PF-06649751 15 mg |
|---|---|
| Standing DBP increase from baseline >= 20 mm Hg | 0 |
| Standing SBP increase from baseline >= 30 mm Hg | 1 |
| Supine DBP increase from baseline >= 20 mm Hg | 0 |
| Supine SBP increase from baseline >= 30 mm Hg | 2 |
| Standing DBP decrease from baseline >= 20 mm Hg | 0 |
| Standing SBP decrease from baseline >= 30 mm Hg | 0 |
| Supine DBP decrease from baseline >= 20 mm Hg | 0 |
| Supine SBP decrease from baseline >= 30 mm Hg | 0 |
Orthostatic hypotension was defined as a decrease of \>=20 mmHg for systolic blood pressure (SBP) or \>=10 mmHg for diastolic blood pressure (DBP) 2 minutes after standing from a supine position.
| Participants | PF-06649751 15 mg |
|---|---|
| DBP postural difference>=10 mm Hg(Supine-Standing) | 3 |
| SBP postural difference>=20 mm Hg(Supine-Standing) | 4 |
PR interval (time from the beginning of P wave to the start of QRS complex, corresponding to the end of atrial depolarization and onset of ventricular depolarization), QRS duration (time from Q wave to the end of S wave, corresponding to ventricle depolarization), QT interval (time from the beginning of Q wave to the end of T wave) and QTcF interval ( QT interval corresponding to electrical systole corrected for heart rate using Fridericia's formula) are summarized. Number of participants with ECG findings meeting the following criteria is presented: (1) PR interval \>=300 msec; (2) QRS duration \>=140 msec; (3) QT interval \>= 500; (4) QTcF interval: 450 to \<480 msec; (5) QTcF interval: 480 to \<500 msec; (6) QTcF interval \>=500 msec.
| Participants | PF-06649751 15 mg |
|---|---|
| PR Interval (aggregate) >= 300 msec | 0 |
| QRS Duration (aggregate) >= 140 msec | 0 |
| QT Interval (aggregate) >= 500 msec | 0 |
| QTcF Interval (aggregate) >= 450 msec, <480msec | 0 |
| QTcF Interval (aggregate) >= 480 msec, <500msec | 0 |
| QTcF Interval (aggregate) >= 500 msec | 0 |
The Columbia Suicide Severity Rating Scale (C-SSRS) is an interview based rating scale to systematically assess suicidal ideation and suicidal behavior. At each suicidality assessment, participants felt to have significant suicidal ideation with actual plan and intent or suicidal behavior, must be evaluated by a clinician/mental health professional (MHP) skilled in the evaluation of suicidality in the participants by virtue of training or experience who determined if it is safe for the participants to participate/continue in the trial. The denominator used in the percentages was the number of participants assessed for suicidality or worsening, the denominator included the subset of participants who had any level of suicidality reported at baseline. For new onset, the denominator included the subset of participants with no suicidality reported at baseline.
| Participants | PF-06649751 15 mg |
|---|---|
| New Onset | 0 |
| Worsening | 0 |
The PWC-20 is a physician-completed, 20-item reliable and sensitive instrument for the assessment of benzodiazepine discontinuation symptoms, including anxiety and nervous, depersonalization and derealization, diarrhea, diaphoresis, difficulty concentrating and remembering, dizziness-lightheadedness, depression, fatigue, lethargy and lack of energy, headaches, increased acuity for sound, smell, touch, or pain, insomnia, irritability, loss of appetite, muscle aches or stiffness, nausea-vomiting paresthesias, poor coordination, restlessness and agitation, tremor-tremulousness, and weakness. Summaries of the count of participants experiencing symptoms and severity listed in the PWC-20 were provided.
| Participants | PF-06649751 15 mg |
|---|---|
| Anxiety, Nervousness — Not Present | 3 |
| Anxiety, Nervousness — Mild | 1 |
| Anxiety, Nervousness — Moderate | 0 |
| Anxiety, Nervousness — Severe | 0 |
| Difficult Concentrating, Remembering — Not Present | 3 |
| Difficult Concentrating, Remembering — Mild | 1 |
| Difficult Concentrating, Remembering — Moderate | 0 |
| Difficult Concentrating, Remembering — Severe | 0 |
| Dysphoric Mood, Depression — Not Present | 3 |
| Dysphoric Mood, Depression — Mild | 1 |
| Dysphoric Mood, Depression — Moderate | 0 |
| Dysphoric Mood, Depression — Severe | 0 |
| Fatigue, Lethargy, Lack of Energy — Not Present | 2 |
| Fatigue, Lethargy, Lack of Energy — Mild | 1 |
| Fatigue, Lethargy, Lack of Energy — Moderate | 1 |
| Fatigue, Lethargy, Lack of Energy — Severe | 0 |
| Insomnia — Not Present | 2 |
| Insomnia — Mild | 1 |
| Insomnia — Moderate | 1 |
| Insomnia — Severe | 0 |
| Irritability — Not Present | 3 |
| Irritability — Mild | 0 |
| Irritability — Moderate | 1 |
| Irritability — Severe | 0 |
| Muscle Aches or Stiffness — Not Present | 3 |
| Muscle Aches or Stiffness — Mild | 0 |
| Muscle Aches or Stiffness — Moderate | 1 |
| Muscle Aches or Stiffness — Severe | 0 |
| Poor Coordination — Not Present | 2 |
| Poor Coordination — Mild | 1 |
| Poor Coordination — Moderate | 1 |
| Poor Coordination — Severe | 0 |
| Restlessness, Agitation — Not Present | 3 |
| Restlessness, Agitation — Mild | 0 |
| Restlessness, Agitation — Moderate | 1 |
| Restlessness, Agitation — Severe | 0 |
| Tremor-Tremulousness — Not Present | 3 |
| Tremor-Tremulousness — Mild | 0 |
| Tremor-Tremulousness — Moderate | 0 |
| Tremor-Tremulousness — Severe | 1 |
| Weakness — Not Present | 2 |
| Weakness — Mild | 2 |
| Weakness — Moderate | 0 |
| Weakness — Severe | 0 |
Available diaries are designed to record participant motor state for half hour intervals. These diaries are a way for participant to assess their own health status without clinician bias or interpretation. In participant diaries, "OFF" time is defined as a period when medication has worn off and is no longer providing benefit with regard to mobility, slowness, and stiffness. During this period, Parkinson's Disease (PD) participants experience relatively poor overall function with worsening of tremor, rigidity, balance, or bradykinesia.
| Hours | PF-06649751 15 mg |
|---|---|
| Baseline | 3.25 ± NA |
| Day 21 | 0.00 ± NA |
| Day 35 | -0.42 ± NA |
Available diaries are designed to record participant motor state for half hour intervals. These diaries are a way for participants to assess their own health status without clinician bias or interpretation. "ON" time is defined as the time when medication is providing benefit with regard to mobility, slowness, and stiffness. "ON" time can be classified as associated with or without troublesome dyskinesia that interfere with activities of daily living.It has been demonstrated that "ON" time with troublesome dyskinesia are generally considered by participants to be "bad time" with regard to motor function.
| Hours | PF-06649751 15 mg |
|---|---|
| Baseline | 0.00 ± NA |
| Day 21 | 0.00 ± NA |
| Day 35 | 0.00 ± NA |
Available diaries are designed to record participant motor state for half hour intervals. These diaries are a way for participants to assess their own health status without clinician bias or interpretation. "ON" time is defined as the time when medication is providing benefit with regard to mobility, slowness, and stiffness. "ON" time can be classified as associated with or without troublesome dyskinesia that interfere with activities of daily living. "ON" time without dyskinesia and on time with non troublesome dyskinesia are generally considered to be "good time".
| Hours | PF-06649751 15 mg |
|---|---|
| Baseline | 9.58 ± NA |
| Day 21 | 1.17 ± NA |
| Day 35 | 2.42 ± NA |
The total MDS-UPDRS score developed by the Movement Disorder Society is the most common method of evaluating the severity of Parkinson's Disease (PD). Part I assesses non motor experiences of daily living(range 0-52).Part II assesses motor experiences of daily living(0-52). Part III assesses the motor signs of PD.Part IV assesses motor complications, dyskinesias, and motor fluctuations(0-24).Total Score:The sum of Parts I, II, III, and IV.Each question is anchored with five responses:0=normal, 1=slight, 2=mild, 3= moderate, 4=severe.Higher part and total scores indicate more severe signs of PD.There are four subscales in Part III:the tremor subscale(range 0-36),the rigidity subscale(0-20),the bradykinesia subscale(0-36),the postural instability and gait disorder (PIGD) subscale(0-12).
| Units on a scale | PF-06649751 15 mg |
|---|---|
| Part I Score | -1.5 (-15 to 9) |
| Part II Score | 0 (-10 to 9) |
| Part III Score | -2.5 (-9 to 11) |
| Part IV Score | 0 (-3 to 6) |
| Total Score | 0 (-32 to 19) |
Collected over Baseline to last visit after termination (up to approximately 3 months). Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| PF-06649751 15 mg | 0/5 (0%) | 1/5 (20%) | 3/5 (60%) |
| Event | PF-06649751 15 mg |
|---|---|
| Hip FractureInjury, poisoning and procedural complications | 1/5 |
| Event | PF-06649751 15 mg |
|---|---|
| HeadacheNervous system disorders | 2/5 |
| Orthostatic hypotentionVascular disorders | 2/5 |
| FallInjury, poisoning and procedural complications | 1/5 |
| Age, Continuous(Years) | PF-06649751 15 mg |
|---|---|
| Mean | 63 ± 11.73 |
| Sex: Female, Male(Participants) | PF-06649751 15 mg |
|---|---|
| Female | 0 |
| Male | 5 |
| Ethnicity (NIH/OMB)(Participants) | PF-06649751 15 mg |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 5 |
| Unknown or Not Reported | 0 |
| Race/Ethnicity, Customized(Participants) | PF-06649751 15 mg |
|---|---|
| White | 5 |
| Black or African American | 0 |
| Asian | 0 |
| American Indian or Alaska Native | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Other | 0 |
| Unknown | 0 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
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