Extended Long-Term Safety Study of KW-6500

Phase 3

Completed

• Conditions: Parkinson's Disease
• Interventions: Drug: KW-6500

• Registration Number: NCT01063621
• Lead Sponsor: Kyowa Kirin Co., Ltd.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-02-04
• Study First Submitted QC: 2010-02-04
• Study First Posted: 2010-02-05
• Primary Completion: 2011-08
• Study Completion: 2012-03
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-14
• Last Update Posted: 2017-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

Inclusion Criteria

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
KW-6500	KW-6500	-

Primary Outcome Measures

Name	Time	Method
Adverse events and related adverse events	From first administration of study drug through Study Week 52

Secondary Outcome Measures

Name	Time	Method
Time to expression of the ON state, continuous time of the ON state, raw score change and percent score change in UPDRS part III, response ratio, and UPDRS part II score	From first administration of study drug through Study Week 52