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

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Pfizer

Status and phase

Terminated
Phase 2

Conditions

Parkinson Disease

Treatments

Drug: PF-06649751 middle dose 1 (3 mg QD)
Drug: PF-06649751 high dose (15 mg QD)
Drug: PF-06649751 middle dose 2 (7 mg QD)
Drug: Placebo
Drug: PF-06649751 low dose (1 mg QD)

Study type

Interventional

Funder types

Industry

Identifiers

NCT02687542
B7601003
A-ROSE PD (Other Identifier)
A-ROSE (Other Identifier)
2015-004912-39 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy, safety and tolerability of PF-06649751 in Parkinson's disease patients who experience motor-fluctuations.

Full description

The study has a randomized, double-blind, placebo-controlled parallel group design. Approximately 198 subjects will be randomized to 5 treatment groups. Each subject will participate in the study for approximately 23 weeks including a 30 day screening period, 15 week double blind treatment period, and an approximately 28 day follow-up period.

Enrollment

108 patients

Sex

All

Ages

40 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Females of non-childbearing potential and/or male subjects between the ages of 40 and 85 years, inclusive.
  • Clinical diagnosis of Parkinson's disease.
  • Able to refrain from any Parkinson's disease medication not permitted by the protocol.

Exclusion criteria

  • Female of childbearing potential
  • History or presence of atypical Parkinsonian syndrome.
  • History of surgical intervention for Parkinson's disease.
  • Severe acute or chronic medical or psychiatric condition or laboratory abnormality.
  • Any condition possibly affecting drug absorption.
  • Participation in other studies involving investigational drug(s), or treatment with any investigational drug within 30 days.

Trial design

108 participants in 5 patient groups, including a placebo group

Placebo
Placebo Comparator group
Description:
Placebo
Treatment:
Drug: Placebo
PF-06649751 low dose (1 mg QD)
Experimental group
Description:
PF-06649751 low dose level (1 mg QD)
Treatment:
Drug: PF-06649751 low dose (1 mg QD)
PF-06649751 middle dose 1 (3 mg QD)
Experimental group
Description:
PF-06649751 lower middle dose 1 (3 mg QD)
Treatment:
Drug: PF-06649751 middle dose 1 (3 mg QD)
PF-06649751 middle dose 2 (7 mg QD)
Experimental group
Description:
PF-06649751 higher middle dose 2 (7 mg QD)
Treatment:
Drug: PF-06649751 middle dose 2 (7 mg QD)
PF-06649751 high dose (15 mg QD)
Experimental group
Description:
PF-06649751 high dose (15 mg QD)
Treatment:
Drug: PF-06649751 high dose (15 mg QD)

Trial documents
2

Trial contacts and locations

57

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Data sourced from clinicaltrials.gov

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