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NCT02352363 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study, sponsored by Acorda Therapeutics.

Completed
Registry status
Phase 3
Development phase
408
Enrollment target

NCT02352363: Completed Phase 3 study, sponsored by Acorda Therapeutics.

NCT02352363 is a Phase 3 study that has completed, run by Acorda Therapeutics. The registered enrollment target is 408 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (47% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02352363, a Phase 3 study, has completed, sponsored by Acorda Therapeutics.

COMPLETED
Registry status
Phase 3
Development phase
408 participants
Enrollment target

Study 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.

Primary Outcome

To characterize the pulmonary safety, as assessed by spirometry (forced expiratory volume in 1 second \[FEV1\], over a 12 month period.

Interventions

  • DRUG CVT-301
  • OTHER Observational cohort

Trial Details

FieldValue
Enrollment Target 408 participants
Start Date 2015-03
Est. Completion 2017-05
Phase Phase 3
Acorda Therapeutics

36 total trials

What the finished NCT02352363 record still lists

NCT02352363 is an interventional study that assigns participants to a tested intervention. The registered 408 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (47% lower).

The record links to 0 conditions, and to 2 interventions - of which CVT-301 is the first listed.

NCT02352363 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02352363 about?

NCT02352363 is a clinical study titled "Randomized Safety Study of CVT-301 Compared to an Observational Control Group". 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...

What is the current status of trial NCT02352363?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 408 participants. The study started on 2015-03. Estimated completion is 2017-05.

What interventions are being tested in trial NCT02352363?

The interventions under investigation include: CVT-301 (DRUG), Observational cohort (OTHER).

Who is sponsoring clinical trial NCT02352363?

This trial is sponsored by Acorda Therapeutics, which has 36 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02352363's enrollment target sits among peer trials

408 911th of 2000 higher than 1,088 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02352363, the US trial registry maintained by the National Library of Medicine. NCT02352363 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.