PF-06669571 In Subjects With Idiopathic Parkinson's Disease

NCT ID: NCT02565628

Last Updated: 2023-07-24

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-16

Study Completion Date

2016-05-13

Brief Summary

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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.

Detailed Description

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Conditions

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Idiopathic Parkinson's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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PF-06669571

Once daily (QD) for 7 days

Group Type EXPERIMENTAL

PF-06669571

Intervention Type DRUG

1 milligram (mg) QD for 3 days followed by 3 mg QD for 4 days

Placebo

QD for 7 days

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

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PF-06669571

1 milligram (mg) QD for 3 days followed by 3 mg QD for 4 days

Intervention Type DRUG

Placebo

Placebo

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

45 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer New Haven Clinical Research Unit

New Haven, Connecticut, United States

Site Status

MD Clinical

Hallandale, Florida, United States

Site Status

QPS-MRA, LLC (Broward Research Group)

Hollywood, Florida, United States

Site Status

Qps-Mra Llc

South Miami, Florida, United States

Site Status

QPS-MRA, LLC (Miami research Associates)

South Miami, Florida, United States

Site Status

QPS-MRA, LLC (MRA Clinical Research)

South Miami, Florida, United States

Site Status

Atlanta Center for Medical Research

Atlanta, Georgia, United States

Site Status

CRI Worldwide, LLC

Marlton, New Jersey, United States

Site Status

CTI Clinical Research Center

Cincinnati, Ohio, United States

Site Status

Countries

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United States

References

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Gurrell R, Duvvuri S, Sun P, DeMartinis N. A Phase I Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of the Novel Dopamine D1 Receptor Partial Agonist, PF-06669571, in Subjects with Idiopathic Parkinson's Disease. Clin Drug Investig. 2018 Jun;38(6):509-517. doi: 10.1007/s40261-018-0632-6.

Reference Type DERIVED
PMID: 29478239 (View on PubMed)

Other Identifiers

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B7821002

Identifier Type: -

Identifier Source: org_study_id

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