Trial · NCT02687542

Efficacy, Safety and Tolerability of PF-06649751 in Parkinson's Disease Patients With Motor Fluctuations

NCT02687542, Phase 2, Terminated, Pfizer; results first posted 2018-12-24

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 With Motor Fluctuations. Trials, record NCT02687542. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02687542

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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 With Motor Fluctuations
NCT number: NCT02687542
Status: Terminated
Phases: Phase 2
Enrollment: 108 participants, actual
Lead sponsor: Pfizer
Conditions: Parkinson Disease
Interventions: Placebo, PF-06649751 low dose (1 mg QD), PF-06649751 middle dose 1 (3 mg QD), PF-06649751 middle dose 2 (7 mg QD), PF-06649751 high dose (15 mg QD)
First posted: 2016-02-22
Last updated: 2020-11-23
Other registries' IDs: eudract:2015-004912-39
Results first posted: 2018-12-24
Limitations and caveats: The study was terminated prematurely due to insufficient efficacy and not due to safety reasons.

Source ClinicalTrials.gov

Registered outcomes13

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change From Baseline in Daily OFF Time at Week 10	Week 10; Baseline was defined as the average daily OFF time (using 3 Hauser patient diary days) prior to Day -1 (study derived day and equalled to nominal visit day 0).	A paper Hauser diary was utilized to record motor state for half-hour intervals. Participants completed the diary by answering whether they had been OFF for 3 consecutive days in the week prior to each visit (except Day 28 visit), including 3 consecutive days during the week prior to Day 0 (Randomization). The daily OFF time was calculated as the average of the 3 consecutive daily OFF hours from the Hauser diary at each visit.
Secondary	Change From Baseline in Daily OFF Time	Weeks 3, 5, 10 and 15; Baseline was defined as the average daily OFF time (using 3 Hauser patient diary days) prior to Day -1 (study derived day and equalled to nominal visit day 0).	A paper Hauser diary was utilized to record motor state for half hour intervals. Participants completed the diary by answering whether they had been OFF for 3 consecutive days in the week prior to each visit (except Day 28 visit), including 3 consecutive days during the week prior to Day 0 (Randomization). The daily OFF time was calculated as the average of the 3 consecutive daily OFF hours from the Hauser diary at each visit. Results at Week 15 should be interpreted with caution given almost half the participants were not available for this analysis at Week 15 as compared to Week 10 and the complicated nature of protocol changes that impacted the study design after Week 10.
Secondary	Change From Baseline in Daily ON Time With Troublesome Dyskinesia	Weeks 3, 5, 10 and 15; Baseline was defined as the average daily ON time with Troublesome Dyskinesia (using 3 Hauser patient diary Days) prior to Day -1 (study derived day and equalled to nominal visit Day 0).	A paper Hauser diary was utilized to record motor state for half hour intervals. The participants answered the Hauser diary on whether they had been ON with troublesome dyskinesia. A diary day started with the interval 24:00-0:30 through 23:30-24:00 on each chronological day for 3 consecutive days. On the days recording the home diary, participants made an entry every 30 minutes during their normal waking time and upon awakening from time asleep. The daily ON hours was calculated as the average of the 3 consecutive daily ON hours from the Hauser diary at each visit. Results at Week 15 should be interpreted with caution given almost half the participants were not available for this analysis at Week 15 as compared to Week 10 and the complicated nature of protocol changes that impacted the study design after Week 10.
Secondary	Change From Baseline in Daily ON Time Without Troublesome Dyskinesia	Weeks 3, 5, 10 and 15; Baseline was defined as the average daily ON time without Troublesome Dyskinesia (using 3 Hauser patient diary days) prior to Day -1 (study derived day and equalled to nominal visit Day 0)	A paper Hauser diary was utilized to record motor state for half hour intervals. The participants answered the Hauser diary on whether they had been ON without troublesome dyskinesia. A diary day started with the interval 24:00-0:30 through 23:30-24:00 on each chronological day for 3 consecutive days. On the days recording the home diary, participants made an entry every 30 minutes during their normal waking time and upon awakening from time asleep. The daily ON hours was calculated as the average of the 3 consecutive daily ON hours from the Hauser diary at each visit. Results at Week 15 should be interpreted with caution given almost half the participants were not available for this analysis at Week 15 as compared to Week 10 and the complicated nature of protocol changes that impacted the study design after Week 10.
Secondary	Change From Baseline in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III	Weeks 1, 2, 3, 4, 5, 10 and 15; Baseline was defined as the Day -1 (study derived day and equalled to nominal visit Day 0) measurement	MDS-UPDRS Part III assessed the motor signs of Parkinson's disease and was administered by the investigator. 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. If more than 7 of the Part III items were missing, the score for that time point was missing, otherwise MDS-UPDRS Part III score was imputed as sum of the non-missing items\*(total number of items)/ (number of items non-missing). The MDS-UPDRS Part III total score range is 0-132. Higher score indicated more severe motor signs of Parkinson's disease. Results at Week 15 should be interpreted with caution given almost half the participants were not available for this analysis at Week 15 as compared to Week 10 and the complicated nature of protocol changes that impacted the study design after Week 10.
Secondary	Change From Baseline in Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts I, II, IV, and Total Score	Weeks 5, 10 and 15; Baseline was defined as the Day -1 (study derived day and equalled to nominal visit Day 0) measurement	Each question of Part I,II or IV with 5 responses was linked to the same clinical terms as Part III.The score was missing if more than 7 items were missing for a time point; otherwise Part I,II or IV score was imputed as sum of non-missing items\*(total number of items)/(number of items non-missing).•PartI (Non-Motor Aspects of Experiences of Daily Living) assessed non-motor experiences of daily living using 13questions(Range:0-52).•PartII(Motor Aspects of Experiences of Daily Living) assessed motor experiences of daily living using 13questions(Range:0-52).•PartIV(Motor Complications) assessed motor complications,dyskinesias, and motor fluctuations using historical and objective information with 6questions(Range:0-24).•MDS-UPDRS Total Score:the sum of Parts I,II,III,and IV(Range:0-260).Higher score indicated more severe motor signs of Parkinson's disease.Week15's results were interpreted cautiously given almost half participants were not available for the analysis as compared to Week10
Secondary	Number of Participants With Laboratory Abnormalities Without Regard to Baseline Abnormality	Baseline (Day 0) to Week 17	The safety laboratory tests including Hematology, Clinical Chemistry and Urinalysis were performed. Determination if there were any laboratory data abnormalities of potential clinical concern was based on Pfizer Data Standards. Incidence of laboratory test abnormalities (without regard to baseline abnormality) was summarized within each treatment group.
Secondary	Number of Participants With Vital Sign Results Meeting the Criteria for Categorical Summarization	Baseline (Day 0) to Week 17	Vital Signs including blood pressure and pulse rate were measured. Vital signs were collected first while the participant was in the supine position and then in the standing position.
Secondary	Number of Participants With Electrocardiogram (ECG) Results Meeting the Criteria for Categorical Summarization	Baseline (Day 0) to Week 17	The average of the triplicate readings of ECG data was collected at each assessment time. Number of participants with ECG results meeting the criteria for categorical summarization for time from the beginning of the P wave until the beginning of the QRS complex (PR Interval), time from ECG Q wave to the end of the S wave corresponding to ventricle depolarization (QRS Duration), time between the start of the Q wave and the end of the T wave in the heart's electrical cycle (QT Interval) and corrected QT (Fridericia correction) (QTcF Interval) were presented.
Secondary	Number of Participants With Suicidal Ideation Assessed Using the Columbia Suicide Severity Rating Scale (C-SSRS) at Post-baseline Visits	Days 0 (Baseline), 7, 14, 21, 28, 35, 70, 77, 84, 91, 105 and 119	The Columbia Suicide Severity Rating Scale (C-SSRS) was an interview based rating scale to systematically assess suicidal ideation and suicidal behavior. C-SSRS responses were mapped to the C-CASA. There were 3 key endpoints for suicidality data analysis and evaluation: * Suicidal Behavior: A participant was said to have suicidal behavior if the participant had experienced completed suicide / suicide attempt / reparatory acts toward imminent suicidal behavior. * Suicidal Ideation: Any observed suicidal ideation mapped to a single C-CASA category. * Suicidal Behavior or Ideation (participants with new onset suicidality): A participant was considered to have a new onset of suicidality if the participant reported no ideation and no behavior at the baseline assessment and reported any behavior or ideation post-baseline. Data observed at screening was not considered in the definition of worsening.

1 to 10 of 13Source ClinicalTrials.gov

See all 13 registered outcomes

Outcomes13

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 Daily OFF Time at Week 10	Week 10; Baseline was defined as the average daily OFF time (using 3 Hauser patient diary days) prior to Day -1 (study derived day and equalled to nominal visit day 0).	Full Analysis Set consisted of all participants randomized who completed at least 1 post-dose efficacy measurement (Hauser home diary).	Hours	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Daily OFF Time	Weeks 3, 5, 10 and 15; Baseline was defined as the average daily OFF time (using 3 Hauser patient diary days) prior to Day -1 (study derived day and equalled to nominal visit day 0).	Full Analysis Set consisted of all participants randomized who completed at least 1 post-dose efficacy measurement (Hauser home diary).	Hours	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Daily ON Time With Troublesome Dyskinesia	Weeks 3, 5, 10 and 15; Baseline was defined as the average daily ON time with Troublesome Dyskinesia (using 3 Hauser patient diary Days) prior to Day -1 (study derived day and equalled to nominal visit Day 0).	Full Analysis Set consisted of all participants randomized who completed at least 1 post-dose efficacy measurement (Hauser home diary).	Hours	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Daily ON Time Without Troublesome Dyskinesia	Weeks 3, 5, 10 and 15; Baseline was defined as the average daily ON time without Troublesome Dyskinesia (using 3 Hauser patient diary days) prior to Day -1 (study derived day and equalled to nominal visit Day 0)	Full Analysis Set consisted of all participants randomized who completed at least 1 post-dose efficacy measurement (Hauser home diary).	Hours	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III	Weeks 1, 2, 3, 4, 5, 10 and 15; Baseline was defined as the Day -1 (study derived day and equalled to nominal visit Day 0) measurement	Full Analysis Set consisted of all participants randomized who completed at least 1 post-dose efficacy measurement (Hauser home diary).	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts I, II, IV, and Total Score	Weeks 5, 10 and 15; Baseline was defined as the Day -1 (study derived day and equalled to nominal visit Day 0) measurement	Full Analysis Set included all participants randomized who completed at least 1 postdose efficacy measurement(Hauser home diary).	units on a scale	MEAN
SECONDARY	Number of Participants With Laboratory Abnormalities Without Regard to Baseline Abnormality	Baseline (Day 0) to Week 17	Safety Analysis Set included all participants who received at least 1 dose of PF-06649751 or placebo.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants With Vital Sign Results Meeting the Criteria for Categorical Summarization	Baseline (Day 0) to Week 17	Safety Analysis Set included all participants who received at least 1 dose of PF-06649751 or placebo and had evaluable data at specified categories.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants With Electrocardiogram (ECG) Results Meeting the Criteria for Categorical Summarization	Baseline (Day 0) to Week 17	Safety Analysis Set included all participants who received at least 1 dose of PF-06649751 or placebo and had evaluable data at specified categories.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants With Suicidal Ideation Assessed Using the Columbia Suicide Severity Rating Scale (C-SSRS) at Post-baseline Visits	Days 0 (Baseline), 7, 14, 21, 28, 35, 70, 77, 84, 91, 105 and 119	Safety Analysis Set included all participants who received at least 1 dose of PF-06649751 or placebo and had evaluable data at specified time points.	Participants	COUNT_OF_PARTICIPANTS

1 to 10 of 13Source ClinicalTrials.gov

See all 13 outcomes

Results by group395

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 Daily OFF Time at Week 10	Placebo		-0.969	Standard Error 0.4092	Hours
Change From Baseline in Daily OFF Time at Week 10	PF-06649751 1 mg QD		-1.173	Standard Error 0.3482	Hours
Change From Baseline in Daily OFF Time at Week 10	PF-06649751 3 mg QD		-1.316	Standard Error 0.3289	Hours
Change From Baseline in Daily OFF Time at Week 10	PF-06649751 7 mg QD		-1.480	Standard Error 0.3460	Hours
Change From Baseline in Daily OFF Time at Week 10	PF-06649751 15 mg QD		-1.663	Standard Error 0.4297	Hours
Change From Baseline in Daily OFF Time	Placebo	Change at Week 3	-0.67	Standard Error 0.620	Hours
Change From Baseline in Daily OFF Time	PF-06649751 1 mg QD	Change at Week 3	-0.82	Standard Error 1.237	Hours
Change From Baseline in Daily OFF Time	PF-06649751 3 mg QD	Change at Week 3	-0.55	Standard Error 1.091	Hours
Change From Baseline in Daily OFF Time	PF-06649751 7 mg QD	Change at Week 3	-1.82	Standard Error 1.182	Hours
Change From Baseline in Daily OFF Time	PF-06649751 15 mg QD	Change at Week 3	-1.01	Standard Error 0.464	Hours

1 to 10 of 395Source ClinicalTrials.gov

See all 395 results by group

Participant flow15

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	23
Overall Study	STARTED	PF-06649751 1 mg QD	13
Overall Study	STARTED	PF-06649751 3 mg QD	15
Overall Study	STARTED	PF-06649751 7 mg QD	13
Overall Study	STARTED	PF-06649751 15 mg QD	44
Overall Study	COMPLETED	Placebo	15
Overall Study	COMPLETED	PF-06649751 1 mg QD	1
Overall Study	COMPLETED	PF-06649751 3 mg QD	1
Overall Study	COMPLETED	PF-06649751 7 mg QD	3
Overall Study	COMPLETED	PF-06649751 15 mg QD	24

1 to 10 of 15Source ClinicalTrials.gov

See all 15 participant flow

Adverse events350

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	Ventricular extrasystoles	Cardiac disorders	Placebo	0	23	0
other	Ventricular extrasystoles	Cardiac disorders	PF-06649751 1 mg QD	0	13	0
other	Ventricular extrasystoles	Cardiac disorders	PF-06649751 3 mg QD	1	15	1
other	Ventricular extrasystoles	Cardiac disorders	PF-06649751 7 mg QD	0	13	0
other	Ventricular extrasystoles	Cardiac disorders	PF-06649751 15 mg QD	1	44	1
other	Abdominal pain	Gastrointestinal disorders	Placebo	1	23	1
other	Abdominal pain	Gastrointestinal disorders	PF-06649751 1 mg QD	1	13	1
other	Abdominal pain	Gastrointestinal disorders	PF-06649751 3 mg QD	0	15	0
other	Abdominal pain	Gastrointestinal disorders	PF-06649751 7 mg QD	0	13	0
other	Abdominal pain	Gastrointestinal disorders	PF-06649751 15 mg QD	0	44	0

1 to 10 of 350Source ClinicalTrials.gov

See all 350 adverse events

Adverse event totals15

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo	1	23
Total, all-cause mortality	PF-06649751 1 mg QD	0	13
Total, all-cause mortality	PF-06649751 3 mg QD	0	15
Total, all-cause mortality	PF-06649751 7 mg QD	0	13
Total, all-cause mortality	PF-06649751 15 mg QD	1	44
Total, other adverse events	Placebo	15	23
Total, other adverse events	PF-06649751 1 mg QD	7	13
Total, other adverse events	PF-06649751 3 mg QD	11	15
Total, other adverse events	PF-06649751 7 mg QD	10	13
Total, other adverse events	PF-06649751 15 mg QD	31	44

1 to 10 of 15Source ClinicalTrials.gov

See all 15 adverse event totals

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

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 comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

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.

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