Multiple Ascending Dose Study of PRX002 in Patients With Parkinson's Disease

Prothena

Status and phase: Completed; Phase 1

Conditions: Parkinson's Disease

Treatments: Drug: PRX002; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02157714

PRX002-CL002

Details and patient eligibility

About

This multiple ascending dose study is to determine safety, tolerability, pharmacokinetics and immunogenicity of PRX002 in approximately 60 patients with Parkinson's disease.

Enrollment: 64 estimated patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Idiopathic Parkinson's disease, Hoehn and Yahr 1-3
• Body weight range of ≥ 45kg/99 lbs to ≤ 110 kg/242 lbs
• Female subjects must be surgically sterile or post-menopausal or if of child-bearing potential must use contraception
• Male subjects and their partners of childbearing potential must use contraception

Exclusion criteria

• Significant cardiac history
• Abnormal MRI
• Significant laboratory abnormalities

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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64 participants in 2 patient groups, including a placebo group

PRX002

Experimental group

Description:

PRX002

Treatment:

Drug: PRX002

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Other: Placebo