Trials / Completed
CompletedNCT00610103
Phase 2 Clinical Study of KW-6500 in Parkinson's Disease Patients With Motor Response Complication on Levodopa Therapy
A Phase 2 Clinical Study of KW-6500 (Apomorphine Hydrochloride) in Patients With Parkinson's Disease
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 16 (actual)
- Sponsor
- Kyowa Kirin Co., Ltd. · Industry
- Sex
- All
- Age
- 20 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the efficacy of KW-6500 versus placebo when administered as a subcutaneous injection at the individualized maintenance dose level in an OFF state in Parkinson's disease patients with motor response complications on levodopa therapy.
Detailed description
The efficacy of KW-6500 as a subcutaneous injection at the individualized maintenance dose level (1 mg to 6 mg per dose) when used in combination with domperidone (30 mg/day) will be evaluated in comparison with that of placebo in Parkinson's disease patients with motor response complications on levodopa therapy. The maintenance dose level for each subject will be determined using a titration scheme in 1 mg increments.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | apomorphine hydrochloride | Apomorphine hydrochloride (started at 1 mg and titrated to a maximum of 6 mg) is subcutaneously administered. |
Timeline
- Start date
- 2007-11-01
- Primary completion
- 2008-10-01
- Completion
- 2008-10-01
- First posted
- 2008-02-07
- Last updated
- 2020-08-28
Locations
4 sites across 1 country: Japan
Source: ClinicalTrials.gov record NCT00610103. Inclusion in this directory is not an endorsement.