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

NCT00610103 | Completed Phase 2

• 1 other identifier: 6500-0702
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Parkinson's Disease

Outcome Measures

Primary Outcomes (1)

• 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

  At 20 minutes after administering KW-6500 or placebo

Secondary Outcomes (1)

• The incidence of adverse events/adverse drug reactions and their nature

  1 week after starting treatment

Study Arms (2)

KW-6500

ACTIVE COMPARATOR

Drug: KW-6500 (apomorphine hydrochloride (USAN))

Drug: apomorphine hydrochloride

Placebo

PLACEBO COMPARATOR

Placebo

Drug: apomorphine hydrochloride

Interventions

apomorphine hydrochloride DRUG

Apomorphine hydrochloride (started at 1 mg and titrated to a maximum of 6 mg) is subcutaneously administered.

Also known as: KW-6500

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:

• 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.)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kyowa Kirin Co., Ltd.: lead

Study Sites (4)

Unknown Facility

Tōon, Ehime, Japan

Location

Unknown Facility

Tsukuba, Ibaraki, Japan

Location

Unknown Facility

Bunkyo-ku, Tokyo, Japan

Location

Unknown Facility

Fukuoka, Japan

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Apomorphine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Aporphines; Benzylisoquinolines; Alkaloids; Heterocyclic Compounds; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 4 or More Rings

Study Officials

• Study Director

  Kyowa Kirin Co., Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2008
• First Posted: February 7, 2008
• Study Start: November 1, 2007
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: August 28, 2020

Record last verified: 2020-08

Locations

JP (4)