Adults 40 to 87, any sex, with Parkinson's Disease With Motor Fluctuations. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants With Treatment-Emergent Adverse Events (All Causalities)Primary· 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).
Group
Value
95% CI
PF-06649751 15 mg
3
Number of Participants With Treatment-Emergent Adverse Events (Treatment Related)Primary· 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).
Group
Value
95% CI
PF-06649751 15 mg
2
Number of Participants With Clinically Significant Findings in Physical ExaminationPrimary· 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.
Group
Value
95% CI
PF-06649751 15 mg
0
Number of Participants With Clinically Significant Findings in Neurological ExaminationPrimary· 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 cl
Group
Value
95% CI
PF-06649751 15 mg
0
Number of Participants With Abnormalities in Laboratory Test (Without Regard to Baseline Abnormality)Primary· 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 bilirub
Group
Value
95% CI
PF-06649751 15 mg
1
Number of Participants With Vital Signs Data Meeting Pre-defined CriteriaPrimary· 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.
Standing DBP increase from baseline >= 20 mm Hg
Group
Value
95% CI
PF-06649751 15 mg
0
Standing SBP increase from baseline >= 30 mm Hg
Group
Value
95% CI
PF-06649751 15 mg
1
Supine DBP increase from baseline >= 20 mm Hg
Group
Value
95% CI
PF-06649751 15 mg
0
Supine SBP increase from baseline >= 30 mm Hg
Group
Value
95% CI
PF-06649751 15 mg
2
Standing DBP decrease from baseline >= 20 mm Hg
Group
Value
95% CI
PF-06649751 15 mg
0
Standing SBP decrease from baseline >= 30 mm Hg
Group
Value
95% CI
PF-06649751 15 mg
0
Supine DBP decrease from baseline >= 20 mm Hg
Group
Value
95% CI
PF-06649751 15 mg
0
Supine SBP decrease from baseline >= 30 mm Hg
Group
Value
95% CI
PF-06649751 15 mg
0
Number of Participants With Vital Signs Data of Orthostatic Hypotension Meeting Pre-defined CriteriaPrimary· 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.
DBP postural difference>=10 mm Hg(Supine-Standing)
Group
Value
95% CI
PF-06649751 15 mg
3
SBP postural difference>=20 mm Hg(Supine-Standing)
Group
Value
95% CI
PF-06649751 15 mg
4
Number of Participants With Electrocardiogram Data Meeting Pre-defined CriteriaPrimary· 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 durati
PR Interval (aggregate) >= 300 msec
Group
Value
95% CI
PF-06649751 15 mg
0
QRS Duration (aggregate) >= 140 msec
Group
Value
95% CI
PF-06649751 15 mg
0
QT Interval (aggregate) >= 500 msec
Group
Value
95% CI
PF-06649751 15 mg
0
QTcF Interval (aggregate) >= 450 msec, <480msec
Group
Value
95% CI
PF-06649751 15 mg
0
QTcF Interval (aggregate) >= 480 msec, <500msec
Group
Value
95% CI
PF-06649751 15 mg
0
QTcF Interval (aggregate) >= 500 msec
Group
Value
95% CI
PF-06649751 15 mg
0
Number of Participants With Worsening Suicidality and New Onset SuicidalityPrimary· 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
New Onset
Group
Value
95% CI
PF-06649751 15 mg
0
Worsening
Group
Value
95% CI
PF-06649751 15 mg
0
Number of Participants With Benzodiazepine Discontinuation Symptoms Based on Physician Withdrawal Checklist (PWC-20)Primary· 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. Summ
Anxiety, Nervousness
Group
Value
95% CI
PF-06649751 15 mg
3
PF-06649751 15 mg
1
PF-06649751 15 mg
0
PF-06649751 15 mg
0
Difficult Concentrating, Remembering
Group
Value
95% CI
PF-06649751 15 mg
3
PF-06649751 15 mg
1
PF-06649751 15 mg
0
PF-06649751 15 mg
0
Dysphoric Mood, Depression
Group
Value
95% CI
PF-06649751 15 mg
3
PF-06649751 15 mg
1
PF-06649751 15 mg
0
PF-06649751 15 mg
0
Fatigue, Lethargy, Lack of Energy
Group
Value
95% CI
PF-06649751 15 mg
2
PF-06649751 15 mg
1
PF-06649751 15 mg
1
PF-06649751 15 mg
0
Insomnia
Group
Value
95% CI
PF-06649751 15 mg
2
PF-06649751 15 mg
1
PF-06649751 15 mg
1
PF-06649751 15 mg
0
Irritability
Group
Value
95% CI
PF-06649751 15 mg
3
PF-06649751 15 mg
0
PF-06649751 15 mg
1
PF-06649751 15 mg
0
Muscle Aches or Stiffness
Group
Value
95% CI
PF-06649751 15 mg
3
PF-06649751 15 mg
0
PF-06649751 15 mg
1
PF-06649751 15 mg
0
Poor Coordination
Group
Value
95% CI
PF-06649751 15 mg
2
PF-06649751 15 mg
1
PF-06649751 15 mg
1
PF-06649751 15 mg
0
Change From Baseline for Hauser Participant Diary Data in Daily OFF TimeSecondary· Baseline, Day 21 and Day 35
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.
Baseline
Group
Value
95% CI
PF-06649751 15 mg
3.25
± NA
Day 21
Group
Value
95% CI
PF-06649751 15 mg
0.00
± NA
Day 35
Group
Value
95% CI
PF-06649751 15 mg
-0.42
± NA
Change From Baseline for Hauser Participant Diary Data in Daily ON Time With Troublesome DyskinesiaSecondary· Baseline, Day 21 and Day 35
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 moto
Baseline
Group
Value
95% CI
PF-06649751 15 mg
0.00
± NA
Day 21
Group
Value
95% CI
PF-06649751 15 mg
0.00
± NA
Day 35
Group
Value
95% CI
PF-06649751 15 mg
0.00
± NA
Adverse events — posted to ClinicalTrials.gov
Time frame: Baseline to last visit after termination (up to approximately 3 months).
Reporting threshold: 1%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Pfizer
Last refreshed: 12 April 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03185481.