Placebo-Controlled Double-Blind Crossover Comparative Study of KW-6500

Parkinson's Disease Clinical Trial

— 6500-004  

Official title:

Phase 3 Study of KW-6500 (Placebo-Controlled Double-Blind Crossover Comparative Study in Patients With Parkinson's Disease)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01058291
• Other study ID #: 6500-004
• Status: Completed
• Phase: Phase 3
• First received: January 27, 2010
• Last updated: February 28, 2017
• Start date: January 2010
• Est. completion date: October 2010

Study information

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

Clinical Trial Summary

This is a placebo-controlled double-blind crossover comparative study of KW-6500 in Parkinson's disease patients with motor response complications on levodopa therapy. The efficacy of KW-6500 is evaluated using the change of UPDRS part III score at double blind period after 12 weeks subcutaneous self-injections.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• 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 Parkinson's disease

• Patients who have been on a stable regimen of levodopa plus at least one other antiparkinsonian agent and who have OFF state

• Patients who meet stage 4 or 5 while in the OFF state and stage 0 to 3 while in the ON state on the Modified Hoehn and Yahr Scale

• Patients who have experienced a 30% or more improvement in Unified Parkinson's Disease Rating Scale (UPDRS) part? score when tested for responsiveness to levodopa during the baseline period

• Patients who have at least one OFF state per day

• Patients who can understand the expression of OFF state, ON state, and dyskinesia

• Patients or their families have a desire for self-injection of KW-6500

Exclusion Criteria:

• Patients with an illness of the cardiac, hematologic, hepatic, renal, pancreatic, metabolic, respiratory, gastrointestinal, endocrinologic, or neurologic system (excluding Parkinson's disease)

• Patients with orthostatic hypotension

• Patients with a history of intolerance to morphine or its derivatives, sulfur, sulfur-containing pharmaceutical products, or sulfite

• Patients with a history of malignant syndrome

• Patients with a diagnosis of cancer or evidence of continued disease

• Patients who do not test negative in the direct Coombs' test

• Pregnant or lactating women, women who are planning to have children, women who test positive in the pregnancy test, or women who cannot adhere to a reliable method of contraception

• Patients who have received MAO inhibitors except selegiline

• Patients with a history of mental disease (excluding psychiatric symptoms associated with Parkinson's disease)

• Patients with a Mini-Mental State Examination score of 23 or less

• Patients who are taking antipsychotics or central dopamine antagonists (excluding domperidone)

• Patients who are receiving methyldopa or 5-HT3 receptor antagonists

• Patients who are receiving reserpine or papaverine

• Patients who have had a neurosurgical operation for Parkinson's disease

• Patients who have had transcranial magnetic stimulation

• Patients with a history of drug or alcohol abuse or dependence

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Drug:
• KW-6500
Twelve weeks subcutaneous injection of 1 to 6 mg for the OFF state
• KW-6500 Placebo
Twelve weeks subcutaneous injection for the OFF state

Locations

Country	Name	City	State
Japan	Ehime University Hospital	Toon	Ehime

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	The raw score change in UPDRS part III score		At the double blind period
Secondary	The percent score change in UPDRS part III score and response ratio		At the double blind period