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

NCT01058291 | Completed Phase 3

• 1 other identifier: 6500-004
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Parkinson's Disease

Outcome Measures

Primary Outcomes (1)

• The raw score change in UPDRS part III score

  At the double blind period

Secondary Outcomes (1)

• The percent score change in UPDRS part III score and response ratio

  At the double blind period

Study Arms (2)

KW-6500

EXPERIMENTAL

Drug: KW-6500

KW-6500 Placebo

PLACEBO COMPARATOR

Drug: KW-6500 Placebo

Interventions

KW-6500 DRUG

Twelve weeks subcutaneous injection of 1 to 6 mg for the OFF state

Also known as: Apomorphine hydroshloride (USAN)

KW-6500

KW-6500 Placebo DRUG

Twelve weeks subcutaneous injection for the OFF state

KW-6500 Placebo

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kyowa Kirin Co., Ltd.: lead

Study Sites (1)

Ehime University Hospital

Tōon, Ehime, Japan

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2010
• First Posted: January 28, 2010
• Study Start: January 1, 2010
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: March 3, 2017

Record last verified: 2017-02

Locations

JP (1)