Efficacy, Safety And Tolerability Study In Subjects With Parkinson's Disease

Pfizer

Status and phase: Completed; Phase 1

Conditions: Parkinson's Disease

Treatments: Drug: PF-06412562; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02006290

B7441003

Details and patient eligibility

About

The B7441003 study will assess PF-06412562 for motor benefit in Parkinson's disease subjects. Safety, tolerability and PK of PF-06412562 in Parkinson's disease subjects will also be evaluated.

Enrollment: 19 patients

Sex: All

Ages: 30 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female subjects with a diagnosis of idiopathic Parkinson's disease.
• Daily L-dopa dose between 300 and 1200 mg.
• MBRS score >1.

Exclusion criteria

• Surgical intervention for Parkinson's disease.
• History of troublesome dyskinesias.
• Any significant AXIS I psychiatric disease.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

---

19 participants in 2 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: PF-06412562

2

Placebo Comparator group

Treatment:

Drug: Placebo