A Long-Term, Safety Study With a Flexible Dose Range of KW-6002 in Patients With Motor Response Complications on Levodopa/Carbidopa Therapy

NCT00955045 | Completed Phase 2

• 1 other identifier: 6002-US-007
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study was to establish the long-term tolerability and safety of istradefylline treatment in subjects with Parkinson's disease treated with levodopa/carbidopa. In addition, treatment response and maintenance of response were assessed.

Conditions

Parkinson's Disease

Keywords

long-term tolerability and safety; istradefylline treatment; levodopa/carbidopa

Study Arms (1)

istradefylline

EXPERIMENTAL

Drug: istradefylline

Interventions

istradefylline DRUG

istradefylline

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Eligible subjects were:
• male or female
• at least 30 years of age
• had completed participation in a prior double-blind istradefylline trial
• met United Kingdom's Parkinson's Disease Society (UKPDS) brain bank criteria (Step 1 and Step 2) for Parkinson's disease and the severity of the Parkinson's disease was defined as Stages 2-4 on the Modified Hoehn and Yahr Scale while in the OFF state
• had been treated with levodopa for at least 1 year
• had been on a stable Parkinson's disease regimen within normal therapeutic ranges including levodopa for at least 4 weeks before Baseline
• were currently taking at least 4 doses of levodopa per day (3 doses per day if at least 2 doses contained slow-release formulation)
• had predictable end-of-dose wearing-off

You may not qualify if:

• none

Sponsors & Collaborators

• Kyowa Kirin, Inc.: lead

Study Sites (1)

48 Centers in the US and 4 in Canada

Princeton, New Jersey, 08540, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

istradefylline

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2009
• First Posted: August 7, 2009
• Study Start: August 1, 2002
• Primary Completion: October 1, 2003
• Study Completion: October 1, 2003
• Last Updated: April 25, 2024

Record last verified: 2024-04

Locations

US (1)