Extended Long-Term Safety Study of KW-6500

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01063621

Acronym

6500-005

Enrollment

Registered

2010-02-05

Start date

2010-01-31

Completion date

2012-03-31

Last updated

2017-03-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson's Disease

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.

Interventions

DRUGKW-6500

Subcutaneous injection of 1 to 6 mg for the OFF state during 52 weeks

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026