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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 28, 2014