Placebo-Controlled Double-Blind Crossover Comparative Study of KW-6500 (6500-004)

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

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.

Study Overview

• Status: Completed
• Conditions: Parkinson's Disease
• Intervention / Treatment: Drug: KW-6500; Drug: KW-6500 Placebo

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Phase 3

Contacts and Locations

Study Locations

• Japan
  • Ehime
    • Toon, Ehime, Japan
      • Ehime University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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) partⅢ 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: KW-6500	Drug: KW-6500; Twelve weeks subcutaneous injection of 1 to 6 mg for the OFF state; Other Names: Apomorphine hydroshloride (USAN)
Placebo Comparator: KW-6500 Placebo	Drug: KW-6500 Placebo; Twelve weeks subcutaneous injection for the OFF state

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The raw score change in UPDRS part III score	At the double blind period

Secondary Outcome Measures

Outcome Measure	Time Frame
The percent score change in UPDRS part III score and response ratio	At the double blind period

Collaborators and Investigators

• Sponsor: Kyowa Kirin Co., Ltd.

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Actual): October 1, 2010
• Study Completion (Actual): October 1, 2010

Study Registration Dates

• First Submitted: January 27, 2010
• First Submitted That Met QC Criteria: January 27, 2010
• First Posted (Estimate): January 28, 2010

Study Record Updates

• Last Update Posted (Actual): March 3, 2017
• Last Update Submitted That Met QC Criteria: February 28, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Gastrointestinal Agents; Dopamine Agonists; Dopamine Agents; Emetics; Apomorphine
• Other Study ID Numbers: 6500-004