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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kyowa Hakko Kirin Company, Limited
ClinicalTrials.gov Identifier:
NCT01058291
First received: January 27, 2010
Last updated: August 30, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention Phase
Parkinson's Disease
Drug: KW-6500
Drug: KW-6500 Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Phase 3 Study of KW-6500 (Placebo-Controlled Double-Blind Crossover Comparative Study in Patients With Parkinson's Disease)

Resource links provided by NLM:


Further study details as provided by Kyowa Hakko Kirin Company, Limited:

Primary Outcome Measures:
  • The raw score change in UPDRS part III score [ Time Frame: At the double blind period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The percent score change in UPDRS part III score and response ratio [ Time Frame: At the double blind period ] [ Designated as safety issue: No ]

Enrollment: 31
Study Start Date: January 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: KW-6500 Drug: KW-6500
Twelve weeks subcutaneous injection of 1 to 6 mg for the OFF state
Other Name: Apomorphine hydroshloride (USAN)
Placebo Comparator: KW-6500 Placebo Drug: KW-6500 Placebo
Twelve weeks subcutaneous injection for the OFF state

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01058291

Locations
Japan
Ehime University Hospital
Toon, Ehime, Japan
Sponsors and Collaborators
Kyowa Hakko Kirin Company, Limited
  More Information

No publications provided

Responsible Party: Kyowa Hakko Kirin Company, Limited
ClinicalTrials.gov Identifier: NCT01058291     History of Changes
Other Study ID Numbers: 6500-004
Study First Received: January 27, 2010
Last Updated: August 30, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on April 20, 2014