Phase 1
N=19
PF-06669571 In Subjects With Idiopathic Parkinson's Disease
Idiopathic Parkinson's Disease
Bottom Line
View on ClinicalTrials.gov: NCT02565628 ↗Enrolled (actual)
19
Serious AEs
0.0%
Results posted
Aug 2017
Primary outcome: Primary: Maximum Percent Change From Baseline in Movement Disorder Society-Sponsor Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III at Day 7. — -19.24; -14.21 Percentage — p=0.6382
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- PF-06669571 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 45+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- May 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Percent Change From Baseline in Movement Disorder Society-Sponsor Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III at Day 7. |
-19.24; -14.21 | 0.6382 |
| PRIMARY Number of Participants in Each Columbia Classification Algorithm of Suicide Assessment (C-CASA) Category by Study Visit on Day -2, Day 8 or Early Withdrawal, and Early Withdrawal/Follow-Up Visit |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants With New Onset and Worsening of Post-Baseline Suicidality. |
0; 0 | — |
| PRIMARY Number of Participants With Treatment Emergent Adverse Events (All Causalities) |
6; 5 | — |
| PRIMARY Number of Participants With Supine and Standing Vital Sign Abnormalities of Potential Clinical Concern (Absolute Values) |
0; 0; 1; 0; 0; 0 | — |
| PRIMARY Number of Participants With Supine and Standing Vital Sign Abnormalities of Potential Clinical Concern (Increase From Baseline) |
1; 1; 0; 1; 0; 1 | — |
| PRIMARY Number of Participants With Supine and Standing Vital Sign Abnormalities (Decrease From Baseline) |
5; 3; 4; 2; 3; 3 | — |
| PRIMARY Number of Participants With Electrocardiogram (ECG) That Met Categorical Criteria for Concern (Absolute Value) |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Primary: Number of Participants With Electrocardiogram (ECG) That Met Categorical Criteria for Concern(Increase From Baseline) |
0; 0; 0; 0; 2; 0 | — |
| PRIMARY Number of Participants With Laboratory Abnormalities That Met Categorical Criteria for Concern (Without Regard to Baseline Abnormality) |
8; 5 | — |
| SECONDARY Maximum Observed Plasma Concentration (Cmax) of PF-06669571 on Day 1 and Day 7 |
16.87; 92.51 | — |
| SECONDARY Area Under Curve From Time Zero to 12 Hours (AUC12) of PF-06669571 on Day 1 and Day 7 |
150.8; 917.5 | — |
| SECONDARY Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-06669571 on Day 1 and Day 7 |
3.35; 3.19 | — |
| SECONDARY Area Under Curve From Time Zero to 24 Hours (AUC24) of PF-06669571 on Day 7 |
1626 | — |
Summary
This study is designed to assess safety, tolerability and pharmacokinetic data for multiple doses of PF-06669571 in subjects with idiopathic Parkinson's disease. In addition, this study will assess whether PF-06669571 is able to demonstrate superior efficacy compared with placebo in the treatment of the motor symptoms of idiopathic Parkinson's disease.
Eligibility Criteria
Inclusion Criteria
- Subjects must have a clinical diagnosis of idiopathic Parkinson's disease and presence of at least 2 out of 3 cardinal characteristics (tremor, rigidity and/or bradykinesia).
- Must be Hoehn & Yahr Stage II-III inclusive and experiencing motor fluctuations in the form of end-of-dose wearing off during the morning hours or early morning akinesia.
- Subjects should be able to recognize their "wearing off" symptoms and verify that they usually improve after their next dose of Parkinson's disease medication. Subjects should be able to recognize drug-induced dyskinesias and verify whether or not they are troublesome.
Exclusion Criteria
- History or clinical features consistent with an atypical parkinsonian syndrome, (for example: ataxia, dystonia, clinically significant orthostatic hypotension.
Data sourced from ClinicalTrials.gov (NCT02565628). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.