Extended Long-Term Safety Study of KW-6500 (6500-005)

Kyowa Kirin

Status and phase: Completed; Phase 3

Conditions: Parkinson's Disease

Treatments: Drug: KW-6500

Study type: Interventional

Funder types: Industry

Identifiers

NCT01063621

6500-005

Details and patient eligibility

About

This is a extended long-term safety study in Parkinson's disease patients who have motor response complications on levodopa therapy and completed 12 weeks administrations of KW-6500 in 6500-004 study. The safety and efficacy of long-term subcutaneous self-injections of KW-6500 are evaluated.

Enrollment: 27 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Patients who have given written informed consent
• Patients who have completed the 6500-004 study

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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27 participants in 1 patient group

KW-6500

Experimental group

Treatment:

Drug: KW-6500