Long-Term Safety Study of KW-6500 in Patients With Parkinson's Disease

Parkinson's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00955318
• Other study ID #: 6500-003
• Status: Completed
• Phase: Phase 3
• First received: August 7, 2009
• Last updated: March 14, 2017
• Start date: July 2009
• 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

The purpose of this study is to evaluate the safety and efficacy of KW-6500 when administered as long-term subcutaneous self-injections in Parkinson's disease patients with motor response complications on levodopa therapy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: March 2012
• Est. primary completion date: December 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 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 (MMSE) 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
Subcutaneous injection of 1to 6 mg of KW-6500 for the OFF state

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	The incidence of adverse events after administration of KW-6500		From first administration of study drug through Study Week 52
Primary	Time to expression of the ON state, continuous time of the ON state, raw score change and percent score change in Unified Parkinson's Disease Rating Scale (UPDRS) part III, response ratio, and UPDRS part II score		From first administration of study drug through Study Week 52