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A 12-week Randomized Study to Evaluate Oral Istradefylline in Subjects With Moderate to Severe Parkinson's Disease

NCT01968031 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 613

Last updated 2024-04-25

Study results available
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Summary

This is a study to assess the efficacy and safety of oral Istradefylline (KW-6002) in patients with moderate to severe Parkinson's Disease. While on this study, participants will continue to take their usual, prescribed, stable regimen of Levodopa/Carbidopa or Levodopa/Benserazide therapy plus adjunct Parkinson's medications. Patients will be randomized 1:1:1 to receive either Istradefylline 20 mg per day, or Istradefylline 40 mg per day or an equivalent placebo. Patients will be treated for a 12 week period to demonstrate the effectiveness of Istradefylline in improving Parkinson's disease symptoms (referred to as improvement in patient OFF time) and that Istradefylline has an acceptable safety profile in this group.

Conditions

  • Idiopathic Parkinson's Disease

Interventions

DRUG

Istradefylline 40 mg

Istradefylline 40 mg and placebo

DRUG

Istradefylline 20 mg

Istradefylline 20 mg and placebo

DRUG

Placebo

Placebo

Sponsors & Collaborators

  • Kyowa Hakko Kirin Pharma, Inc.

    collaborator INDUSTRY

  • Kyowa Kirin Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Kyowa Hakko Kirin Pharma, Inc. · Kyowa Hakko Kirin Pharma, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2016-10-31
Completion
2016-10-31

Countries

  • United States
  • Canada
  • Czechia
  • Germany
  • Israel
  • Italy
  • Poland
  • Serbia

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01968031 on ClinicalTrials.gov