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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00955318
Recruitment Status : Completed
First Posted : August 10, 2009
Last Update Posted : March 15, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Drug: KW-6500 Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 3 Study of KW-6500 (Safety Study for Long-Term Self-Administration at Home in Patients With Parkinson's Disease
Study Start Date : July 2009
Primary Completion Date : December 2010
Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: KW-6500 Drug: KW-6500
Subcutaneous injection of 1to 6 mg of KW-6500 for the OFF state
Other Name: Apomorphine hydroshloride (USAN)


Outcome Measures

Primary Outcome Measures :
  1. The incidence of adverse events after administration of KW-6500 [ Time Frame: From first administration of study drug through Study Week 52 ]
  2. 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 [ Time Frame: From first administration of study drug through Study Week 52 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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 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 (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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00955318


Locations
Japan
Tokyo, Japan
Sponsors and Collaborators
Kyowa Hakko Kirin Co., Ltd
More Information

Responsible Party: Kyowa Hakko Kirin Co., Ltd
ClinicalTrials.gov Identifier: NCT00955318     History of Changes
Other Study ID Numbers: 6500-003
First Posted: August 10, 2009    Key Record Dates
Last Update Posted: March 15, 2017
Last Verified: March 2017

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