Extended Long-Term Safety Study of KW-6500

Parkinson's Disease Clinical Trial

— 6500-005  

Official title:

Phase 3 Study of KW-6500 (Safety Study for Extended Long-Term Self-Injection at Home in Patients With Parkinson's Disease)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01063621
• Other study ID #: 6500-005
• Status: Completed
• Phase: Phase 3
• First received: February 4, 2010
• Last updated: March 14, 2017
• Start date: January 2010
• Est. completion date: March 2012

Study information

• Verified date: March 2017
• Source: Kyowa Hakko Kirin Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: March 2012
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Patients who have given written informed consent

• Patients who have completed the 6500-004 study

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Drug:
• KW-6500
Subcutaneous injection of 1 to 6 mg for the OFF state during 52 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kyowa Hakko Kirin Co., Ltd

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events and related adverse events		From first administration of study drug through Study Week 52
Secondary	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