Phase 2 Clinical Study of KW-6500 in Parkinson's Disease Patients With Motor Response Complication on Levodopa Therapy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kyowa Hakko Kirin Company, Limited
ClinicalTrials.gov Identifier:
NCT00610103
First received: January 22, 2008
Last updated: August 30, 2012
Last verified: August 2012
  Purpose

The purpose of this study is to evaluate the efficacy of KW-6500 versus placebo when administered as a subcutaneous injection at the individualized maintenance dose level in an OFF state in Parkinson's disease patients with motor response complications on levodopa therapy.


Condition Intervention Phase
Parkinson's Disease
Drug: apomorphine hydrochloride
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2 Clinical Study of KW-6500 (Apomorphine Hydrochloride) 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 change (response ratio, raw score change, percent score change) in UPDRS (Unified Parkinson's Disease Rating Scale ) Part 3 score at the maintenance dose level [ Time Frame: At 20 minutes after administering KW-6500 or placebo ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The incidence of adverse events/adverse drug reactions and their nature [ Time Frame: 1 week after starting treatment ] [ Designated as safety issue: Yes ]

Enrollment: 16
Study Start Date: November 2007
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: KW-6500
Drug: KW-6500 (apomorphine hydrochloride (USAN))
Drug: apomorphine hydrochloride
Apomorphine hydrochloride (started at 1 mg and titrated to a maximum of 6 mg) is subcutaneously administered.
Other Name: KW-6500
Placebo Comparator: Placebo
Placebo
Drug: apomorphine hydrochloride
Apomorphine hydrochloride (started at 1 mg and titrated to a maximum of 6 mg) is subcutaneously administered.
Other Name: KW-6500

Detailed Description:

The efficacy of KW-6500 as a subcutaneous injection at the individualized maintenance dose level (1 mg to 6 mg per dose) when used in combination with domperidone (30 mg/day) will be evaluated in comparison with that of placebo in Parkinson's disease patients with motor response complications on levodopa therapy. The maintenance dose level for each subject will be determined using a titration scheme in 1 mg increments.

  Eligibility

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

Inclusion Criteria:

  • Men and women aged 20 years or older at the time of giving informed consent.
  • Patients who have idiopathic Parkinson's disease.
  • Patients who have been on a stable regimen of levodopa (at least three times daily) plus at least one other antiparkinsonian agent being administered or more frequently for at least 30 days before the preliminary evaluation and who have predictable end-of-dose wearing-off.
  • Patients who meet both of the following criteria on the Modified Hoehn and Yahr Scale during the preliminary evaluation and on the day before starting study drug (Day -1).

    • Stage IV or V while in the OFF state
    • Stage II to III while in the ON state
  • Patients who have experienced a 30% or more improvement in UPDRS Part 3 score when tested for responsiveness to levodopa during the baseline period.
  • Patients who have at least one wearing-off episode per day and a daily average OFF time of at least two hours two days before starting study drug (Day -2) and on Day -1.
  • Patients who can understand the OFF state or have a family member who can understand it.
  • Patients who have given written informed consent. (Alternatively, the patient's legally acceptable representative may give written consent following the patient's oral consent, if his/her condition makes handwriting difficult.)

Exclusion Criteria:

  • Patients with an illness of the cardiac, hematologic, hepatic, renal, pancreatic, metabolic, respiratory, gastrointestinal, endocrinologic, or neurologic system or a tumor that is clinically significant for their participation in the study.
  • Patients with orthostatic hypotension.
  • Patients with a history of drug allergies.
  • 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 within five years before starting study drug.
  • Patients who have been taking domperidone at a dose level of more than 30 mg/day since before the preliminary evaluation.
  • Patients who do not test negative in the direct Coombs' test as part of the preliminary evaluation.
  • Pregnant or lactating women, women who are planning to have children, women who test positive in the pregnancy test during the preliminary evaluation or on Day -1, or women who cannot adhere to a reliable method of contraception throughout the study.
  • Patients who have received MAO inhibitors except selegiline within three months before starting study drug.
  • Patients with a current or past history of mental disease or dementia (excluding psychiatric symptoms associated with Parkinson's disease).
  • Patients with a Mini-Mental State Examination (MMSE) score of 23 or less on or before Day -1.
  • Patients who are taking antipsychotics or dopamine antagonists.
  • Patients who are receiving methyldopa, 5-HT3 receptor antagonists, or reserpine.
  • Patients who are receiving papaverine.
  • Patients who have had a neurosurgical operation for Parkinson's disease.
  • Patients who have had transcranial magnetic stimulation (TMS) within six months before starting study drug.
  • Patients with a history of drug or alcohol abuse or dependence (DSM-IV criteria) within two years before starting study drug.
  • Patients previously treated with apomorphine.
  • Patients who have been treated with any other investigational product within four months before starting study drug.
  • Patients who, for any reason, are judged by the investigator or subinvestigator to be inappropriate for this study.
  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: NCT00610103

Sponsors and Collaborators
Kyowa Hakko Kirin Company, Limited
Investigators
Study Director: Study Director Kyowa Hakko Kirin Company, Limited
  More Information

No publications provided

Responsible Party: Kyowa Hakko Kirin Company, Limited
ClinicalTrials.gov Identifier: NCT00610103     History of Changes
Other Study ID Numbers: 6500-0702
Study First Received: January 22, 2008
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
Apomorphine
Emetics
Physiological Effects of Drugs
Pharmacologic Actions
Autonomic Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 22, 2014