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Randomized Safety Study of CVT-301 Compared to an Observational Control Group

NCT02352363 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 408

Last updated 2019-05-28

Study results available
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Summary

This study is a 12-month, open-label, randomized, multicenter study which will evaluate the safety and efficacy of CVT-301 for the treatment of up to 5 OFF episodes per day in Parkinson's Disease (PD) patients experiencing motor fluctuations (OFF episodes) and will include a concurrent observational cohort of PD patients managed using the usual standards of care.

Conditions

  • Idiopathic Parkinson's Disease

Interventions

DRUG

CVT-301

OTHER

Observational cohort

Sponsors & Collaborators

  • Acorda Therapeutics

    lead INDUSTRY

Principal Investigators

  • Charles Oh, MD · Acorda Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2017-05-31
Completion
2017-05-31

Countries

  • United States
  • Austria
  • Belgium
  • Czechia
  • France
  • Germany
  • Hungary
  • Israel
  • Netherlands
  • Poland
  • Romania
  • Serbia
  • Spain
  • United Kingdom

Study Locations

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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 NCT02352363 on ClinicalTrials.gov