Trial · NCT02847650
Efficacy, Safety and Tolerability of PF-06649751 in Parkinson's Disease Patients at Early Stage of the Disease
NCT02847650, Phase 2, Terminated, Pfizer; results first posted 2019-01-15
3 sourcestrials-2026-11-12-0.4.0
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ConductScience Library. Efficacy, Safety and Tolerability of PF-06649751 in Parkinson's Disease Patients at Early Stage of the Disease. Trials, record NCT02847650. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02847650
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy, Safety and Tolerability of PF-06649751 in Parkinson's Disease Patients at Early Stage of the Disease
- NCT number
- NCT02847650
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 57 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Parkinson Disease
- Interventions
- Placebo, PF-06649751
- First posted
- 2016-07-28
- Last updated
- 2020-11-23
- Other registries' IDs
- eudract:2016-001575-71
- Results first posted
- 2019-01-15
- Limitations and caveats
- This study was terminated early by the sponsor due to a companion study, B7601003 (NCT02687542; a dose ranging, Phase 2b study in motor fluctuators) meeting futility criteria at Interim Analysis.
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in the Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III Total Score at Week 15 | Baseline (Day -1/randomization), Week 15 | MDS-UPDRS Part III was used to assess the motor signs of Parkinson's disease. It was comprised of 33 sub-scores based on 18 items, several with right, left or other body distribution scores. Each question was anchored with 5 responses that were linked to commonly accepted clinical terms: 0=normal, 1=slight, 2=mild, 3=moderate, and 4=severe. The MDS-UPDRS Part III total score range is 0-132. Higher score indicates more severe motor signs of Parkinson's disease. A negative change from baseline represents an improvement in motor function. |
| Secondary | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | From first dose of study treatment up to 28 days after last dose (up to Day 133) | An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening (immediate risk of death); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. Treatment-emergent AEs were those with initial onset or increasing in severity after the first dose of study treatment. |
| Secondary | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Baseline (Day -1/randomization) up to Day 119 follow-up visit | Following safety laboratory parameters were assessed against pre-defined abnormality criteria: hematology (hemoglobin, hematocrit, red blood cell count, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, platelet count, white blood cell count, absolute total neutrophils, absolute eosinophils, absolute basophils, absolute monocytes, and absolute lymphocytes); chemistry (blood urea nitrogen/urea and creatinine, glucose , calcium, sodium, potassium, chloride, total bicarbonate, aspartate aminotransferase \[AST\], alanine aminotransferase \[ALT\], total bilirubin, alkaline phosphatase, uric acid, albumin, total protein); urinalysis (pH, qualitative glucose, qualitative protein, qualitative blood, ketones, nitrites, leukocyte esterase, urine bilirubin, urobilinogen, urine creatinine, microscopy, and specific gravity). |
| Secondary | Number of Participants With Vital Signs Data Meeting Categorical Summarization and Orthostatic Hypotension Criteria | Baseline (Day -1/randomization) up to Day 119 follow-up visit | Vital signs categorical summarization criteria: 1) supine and standing systolic blood pressure (SBP) \<90 millimeters of mercury (mmHg); 2) supine and standing diastolic blood pressure (DBP) \<50 mmHg; 3) supine pulse rate \<40 or \>120 beats per minute (bpm); 4) standing pulse rate \<40 or \>140 bpm; 5) maximum change from baseline (increase or decrease) in supine and standing DBP greater than or equal to (\>=) 20 mmHg; 6) maximum change from baseline (increase or decrease) in supine and standing SBP \>=30 mmHg. Orthostatic hypotension criterion was defined as a decrease of \>=20 mmHg for SBP or \>=10 mmHg for DBP 2 minutes after standing from a supine position. |
| Secondary | Number of Participants Meeting the Categorical Summarization Criteria for Electrocardiogram (ECG) Parameters | Baseline (Day -1/randomization) up to Day 119 follow-up visit | ECG categorical summarization criteria: 1) QRS duration (time from ECG Q wave to the end of the S wave corresponding to ventricle depolarization): \>=140 milliseconds (msec), \>=50% increase from baseline; 2) PR interval (the interval between the start of the P wave and the start of the QRS complex, corresponding to the time between the onset of the atrial depolarization and onset of ventricular depolarization): \>=300 msec, \>=25% increase when baseline is \> 200 msec or \>=50% increase when baseline is less than or equal to (\<=) 200 msec; 3) QT interval (time from ECG Q wave to the end of the T wave corresponding to electrical systole): absolute value of \>=500 msec; 4) QTcF interval (QT corrected for heart rate using Fridericia's formula): absolute value of 450 to \<480 msec, 480 to \<500 msec, \>=500 msec; an increase from baseline of 30 to \<60 msec or \>=60 msec. |
| Secondary | Number of Participants With Worsening and New Onset Suicidality as Assessed by Columbia Suicide Severity Rating Scale (C-SSRS) | Baseline (Day -1/randomization) up to Day 119 follow-up visit | The C-SSRS is an interview based rating scale to systematically assess suicidal ideation and suicidal behavior. C-SSRS responses were mapped to the Columbia Classification Algorithm of Suicide Assessment (C-CASA). Participants with new onset suicidality were those without suicidal ideation and behavior at baseline and reported any suicidal behavior or ideation post-baseline as assessed by C-CASA code mapped from C-SSRS data. Participants with worsening suicidality were those who moved to a lower numbered C-CASA category than was reported at baseline. |
| Secondary | Change From Baseline in Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease - Rating Scale (QUIP-RS) Total Score at Days 35, 63, and 105 | Baseline (Day -1 or randomization); Days 35, 63, 105 | The QUIP-RS has 4 primary questions pertaining to commonly reported thoughts, urges/desires, and behaviors associated with impulsive-compulsive disorder , each applied to the 4 impulsive-compulsive disorders (compulsive gambling, buying, eating, and sexual behavior) and 3 related disorders (medication use, punding, and hobbyism). Each question is anchored with the following 5 responses: Never (0), Rarely (1), Sometimes (2), Often (3), and Very Often (4). The scoring range for each item (ie, disorder) is 0-16. The QUIP-RS total score range is 0-64. Higher score indicates a greater level of the impulsive compulsive disorder. |
| Secondary | Total Physician Withdrawal Checklist (PWC-20) Score | Day 119 | The PWC-20 is a 20-item reliable and sensitive instrument for the assessment of benzodiazepine-like discontinuation symptoms. The total PWC-20 score is the sum of 20 item scores and ranges between 0 and 60. The higher score indicates more frequent/severe symptoms. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in the Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III Total Score at Week 15 | Baseline (Day -1/randomization), Week 15 | All participants who received at least 1 dose of study treatment (PF-06649751 or placebo) and had a baseline and Week 15 MDS-UPDRS score Part III. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | From first dose of study treatment up to 28 days after last dose (up to Day 133) | All participants who received at least 1 dose of study treatment (PF-06649751 or placebo). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Baseline (Day -1/randomization) up to Day 119 follow-up visit | All participants who received at least 1 dose of study treatment (PF-06649751 or placebo) and had at least 1 observation of the given laboratory test. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Vital Signs Data Meeting Categorical Summarization and Orthostatic Hypotension Criteria | Baseline (Day -1/randomization) up to Day 119 follow-up visit | All participants who received at least 1 dose of study treatment (PF-06649751 or placebo). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Meeting the Categorical Summarization Criteria for Electrocardiogram (ECG) Parameters | Baseline (Day -1/randomization) up to Day 119 follow-up visit | All participants who received at least 1 dose of study treatment (PF-06649751 or placebo). Number Analyzed represents the number of participants evaluable for each specified category. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Worsening and New Onset Suicidality as Assessed by Columbia Suicide Severity Rating Scale (C-SSRS) | Baseline (Day -1/randomization) up to Day 119 follow-up visit | All participants who received at least 1 dose of study treatment (PF-06649751 or placebo). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease - Rating Scale (QUIP-RS) Total Score at Days 35, 63, and 105 | Baseline (Day -1 or randomization); Days 35, 63, 105 | All participants who received at least 1 dose of study treatment (PF-06649751 or placebo). Number Analyzed = Participants evaluable for this outcome measure at specified time points. | units on a scale | MEAN |
| SECONDARY | Total Physician Withdrawal Checklist (PWC-20) Score | Day 119 | All participants who received at least 1 dose of study treatment (PF-06649751 or placebo) and had PWC-20 evaluation. | units on a scale | MEDIAN |
Source ClinicalTrials.gov
Results by group76
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in the Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III Total Score at Week 15 | PF-06649751 | -9.0 | Standard Error 1.54 | units on a scale | |
| Change From Baseline in the Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III Total Score at Week 15 | Placebo | -4.3 | Standard Error 1.65 | units on a scale | |
| Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | PF-06649751 | AEs | 25 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Placebo | AEs | 18 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | PF-06649751 | SAEs | 1 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Placebo | SAEs | 0 | Participants | |
| Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | PF-06649751 | 19 | Participants | ||
| Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Placebo | 19 | Participants | ||
| Number of Participants With Vital Signs Data Meeting Categorical Summarization and Orthostatic Hypotension Criteria | PF-06649751 | Supine SBP <90 mmHg | 0 | Participants | |
| Number of Participants With Vital Signs Data Meeting Categorical Summarization and Orthostatic Hypotension Criteria | Placebo | Supine SBP <90 mmHg | 0 | Participants |
1 to 10 of 76Source ClinicalTrials.gov
See all 76 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | PF-06649751 | 29 | |
| Overall Study | STARTED | Placebo | 28 | |
| Overall Study | COMPLETED | PF-06649751 | 25 | |
| Overall Study | COMPLETED | Placebo | 22 | |
| Overall Study | NOT COMPLETED | PF-06649751 | 4 | |
| Overall Study | NOT COMPLETED | Placebo | 6 |
Source ClinicalTrials.gov
Adverse events54
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Dry mouth | Gastrointestinal disorders | PF-06649751 | 5 | 29 | 6 |
| other | Dry mouth | Gastrointestinal disorders | Placebo | 0 | 28 | 0 |
| other | Nausea | Gastrointestinal disorders | PF-06649751 | 9 | 29 | 15 |
| other | Nausea | Gastrointestinal disorders | Placebo | 2 | 28 | 2 |
| other | Fatigue | General disorders | PF-06649751 | 3 | 29 | 4 |
| other | Fatigue | General disorders | Placebo | 3 | 28 | 3 |
| other | Decreased appetite | Metabolism and nutrition disorders | PF-06649751 | 3 | 29 | 4 |
| other | Decreased appetite | Metabolism and nutrition disorders | Placebo | 0 | 28 | 0 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | PF-06649751 | 3 | 29 | 3 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Placebo | 0 | 28 | 0 |
1 to 10 of 54Source ClinicalTrials.gov
See all 54 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | PF-06649751 | 0 | 29 |
| Total, all-cause mortality | Placebo | 0 | 28 |
| Total, other adverse events | PF-06649751 | 22 | 29 |
| Total, other adverse events | Placebo | 12 | 28 |
| Total, serious adverse events | PF-06649751 | 1 | 29 |
| Total, serious adverse events | Placebo | 0 | 28 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 32201505 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| PF-06649751 vs Placebo: Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Trial comparisons |
| PF-06649751 vs Placebo: deaths from any cause | Trial comparisons |
| PF-06649751 vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
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