Trial · NCT03185481

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

NCT03185481, Phase 2, Terminated, Pfizer; results first posted 2019-04-12

3 sourcestrials-2026-11-12-0.4.0

Cite this record

ConductScience Library. Safety and Tolerability of PF-06649751 in Parkinson's Disease Patients With Motor Fluctuations. Trials, record NCT03185481. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03185481

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Safety and Tolerability of PF-06649751 in Parkinson's Disease Patients With Motor Fluctuations
NCT number: NCT03185481
Status: Terminated
Phases: Phase 2
Enrollment: 5 participants, actual
Lead sponsor: Pfizer
Conditions: Parkinson's Disease With Motor Fluctuations
Interventions: 1 mg QD to 15 mg QD PF-06649751, 3 mg QD to 15 mg QD PF-06649751, 7 mg QD to 15 mg QD PF-06649751, 15 mg QD PF-06649751, 1 mg QD to 7 mg QD PF-06649751 (if de-escalated in parent study), 3 mg QD to 7 mg QD PF-06649751 (de-escalated in parent study), 7 mg QD to 7 mg QD PF-06649751 (de-escalated in parent study), 15 mg QD de-escalated to 7 mg QD PF-06649751 in parent study remain at 7 mg QD
First posted: 2017-06-14
Last updated: 2019-04-12
Other registries' IDs: eudract:2017-000128-81
Results first posted: 2019-04-12
Limitations and caveats: This study was early terminated,not due to safety concern,but lack of sufficient demonstrated efficacy of the study drug to improve PD symptoms.

Source ClinicalTrials.gov

Registered outcomes14

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

List	Outcome	Time frame	Description
Primary	Number of Participants With Treatment-Emergent Adverse Events (All Causalities)	Baseline to last visit after termination (up to approximately 3 months)	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).
Primary	Number of Participants With Treatment-Emergent Adverse Events (Treatment Related)	Baseline to last visit after termination (up to approximately 3 months)	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).
Primary	Number of Participants With Clinically Significant Findings in Physical Examination	Baseline to last visit after termination (up to approximately 3 months)	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.
Primary	Number of Participants With Clinically Significant Findings in Neurological Examination	Baseline to last visit after termination (up to approximately 3 months)	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.
Primary	Number of Participants With Abnormalities in Laboratory Test (Without Regard to Baseline Abnormality)	Baseline to last visit after termination(up to approximately 3 months)	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).
Primary	Number of Participants With Vital Signs Data Meeting Pre-defined Criteria	Baseline to last visit after termination (up to approximately 3 months)	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.
Primary	Number of Participants With Vital Signs Data of Orthostatic Hypotension Meeting Pre-defined Criteria	Baseline to last visit after termination (up to approximately 3 months)	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.
Primary	Number of Participants With Electrocardiogram Data Meeting Pre-defined Criteria	Baseline to last visit after termination (up to approximately 3 months)	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.
Primary	Number of Participants With Worsening Suicidality and New Onset Suicidality	Baseline to last visit after termination (up to approximately 3 months)	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.
Primary	Number of Participants With Benzodiazepine Discontinuation Symptoms Based on Physician Withdrawal Checklist (PWC-20)	At last visit	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.

1 to 10 of 14Source ClinicalTrials.gov

See all 14 registered outcomes

Outcomes14

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Participants With Treatment-Emergent Adverse Events (All Causalities)	Baseline to last visit after termination (up to approximately 3 months)	The study population included all participants who received at least 1 dose of study medication during the study period.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Number of Participants With Treatment-Emergent Adverse Events (Treatment Related)	Baseline to last visit after termination (up to approximately 3 months)	The study population included all participants who received at least 1 dose of study medication during the study period.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Number of Participants With Clinically Significant Findings in Physical Examination	Baseline to last visit after termination (up to approximately 3 months)	The study population included all participants who received at least 1 dose of study medication during the study period and had a post-baseline physical examination.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Number of Participants With Clinically Significant Findings in Neurological Examination	Baseline to last visit after termination (up to approximately 3 months)	The study population included all participants who received at least 1 dose of study medication during the study period and had a post-baseline neurological examination.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Number of Participants With Abnormalities in Laboratory Test (Without Regard to Baseline Abnormality)	Baseline to last visit after termination(up to approximately 3 months)	The study population included all participants who received at least 1 dose of study medication during the study period.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Number of Participants With Vital Signs Data Meeting Pre-defined Criteria	Baseline to last visit after termination (up to approximately 3 months)	The study population included all participants who received at least 1 dose of study medication during the study period.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Number of Participants With Vital Signs Data of Orthostatic Hypotension Meeting Pre-defined Criteria	Baseline to last visit after termination (up to approximately 3 months)	The study population included all participants who received at least 1 dose of study medication during the study period.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Number of Participants With Electrocardiogram Data Meeting Pre-defined Criteria	Baseline to last visit after termination (up to approximately 3 months)	The study population included all participants who received at least 1 dose of study medication during the study period.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Number of Participants With Worsening Suicidality and New Onset Suicidality	Baseline to last visit after termination (up to approximately 3 months)	The study population included all participants who received at least 1 dose of study medication during the study period.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Number of Participants With Benzodiazepine Discontinuation Symptoms Based on Physician Withdrawal Checklist (PWC-20)	At last visit	The population for PWC-20 included participants who completed study treatment and who participated the first visit of follow-up	Participants	COUNT_OF_PARTICIPANTS

1 to 10 of 14Source ClinicalTrials.gov

See all 14 outcomes

Results by group81

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Number of Participants With Treatment-Emergent Adverse Events (All Causalities)	PF-06649751 15 mg		3	Participants
Number of Participants With Treatment-Emergent Adverse Events (Treatment Related)	PF-06649751 15 mg		2	Participants
Number of Participants With Clinically Significant Findings in Physical Examination	PF-06649751 15 mg		0	Participants
Number of Participants With Clinically Significant Findings in Neurological Examination	PF-06649751 15 mg		0	Participants
Number of Participants With Abnormalities in Laboratory Test (Without Regard to Baseline Abnormality)	PF-06649751 15 mg		1	Participants
Number of Participants With Vital Signs Data Meeting Pre-defined Criteria	PF-06649751 15 mg	Standing DBP increase from baseline >= 20 mm Hg	0	Participants
Number of Participants With Vital Signs Data Meeting Pre-defined Criteria	PF-06649751 15 mg	Standing SBP increase from baseline >= 30 mm Hg	1	Participants
Number of Participants With Vital Signs Data Meeting Pre-defined Criteria	PF-06649751 15 mg	Supine DBP increase from baseline >= 20 mm Hg	0	Participants
Number of Participants With Vital Signs Data Meeting Pre-defined Criteria	PF-06649751 15 mg	Supine SBP increase from baseline >= 30 mm Hg	2	Participants
Number of Participants With Vital Signs Data Meeting Pre-defined Criteria	PF-06649751 15 mg	Standing DBP decrease from baseline >= 20 mm Hg	0	Participants

1 to 10 of 81Source ClinicalTrials.gov

See all 81 results by group

Participant flow3

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

Period	Milestone	Group	Participants
Overall Study	STARTED	PF-06649751 15 mg	5
Overall Study	COMPLETED	PF-06649751 15 mg	0
Overall Study	NOT COMPLETED	PF-06649751 15 mg	5

Source ClinicalTrials.gov

Adverse events4

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
other	Fall	Injury, poisoning and procedural complications	PF-06649751 15 mg	1	5
other	Headache	Nervous system disorders	PF-06649751 15 mg	2	5
other	Orthostatic hypotention	Vascular disorders	PF-06649751 15 mg	2	5
serious	Hip Fracture	Injury, poisoning and procedural complications	PF-06649751 15 mg	1	5

Source ClinicalTrials.gov

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	PF-06649751 15 mg	0	5
Total, other adverse events	PF-06649751 15 mg	3	5
Total, serious adverse events	PF-06649751 15 mg	1	5

Source ClinicalTrials.gov

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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