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NCT02812394 · ClinicalTrials.gov registry record · Phase 1

A Study to Compare Two Dose Strengths of CVT-301 (Levodopa Inhalation Powder) With an Oral Dose of Sinemet® (Carbidopa-levodopa) Tablets

A Phase 1 study, sponsored by Acorda Therapeutics.

Completed
Registry status
Phase 1
Development phase
24
Enrollment target

NCT02812394: Completed Phase 1 study, sponsored by Acorda Therapeutics.

NCT02812394 is a Phase 1 study that has completed, run by Acorda Therapeutics. The registered enrollment target is 24 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02812394, a Phase 1 study, has completed, sponsored by Acorda Therapeutics.

COMPLETED
Registry status
Phase 1
Development phase
24 participants
Enrollment target

Study Summary

This study will be an open-label, randomized, three-period cross-over pharmacokinetic evaluation of CVT-301 compared with the Reference Listed Drug (RLD), orally administered carbidopa/levodopa, in healthy volunteers.

Interventions

  • DRUG CVT-301 (Dose Level 1)
  • DRUG CVT-301 (Dose Level 2)
  • DRUG Sinemet®

Trial Details

FieldValue
Enrollment Target 24 participants
Start Date 2016-06
Est. Completion 2016-09
Phase Phase 1
Acorda Therapeutics

36 total trials

What the finished NCT02812394 record still lists

NCT02812394 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower).

The record links to 0 conditions, and to 3 interventions - of which CVT-301 (Dose Level 1) is the first listed.

NCT02812394 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02812394 about?

NCT02812394 is a clinical study titled "A Study to Compare Two Dose Strengths of CVT-301 (Levodopa Inhalation Powder) With an Oral Dose of Sinemet® (Carbidopa-levodopa) Tablets". This study will be an open-label, randomized, three-period cross-over pharmacokinetic evaluation of CVT-301 compared with the Reference Listed Drug (RLD), orally administered carbidopa/levodopa, in healthy volunteers.

What is the current status of trial NCT02812394?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2016-06. Estimated completion is 2016-09.

What interventions are being tested in trial NCT02812394?

The interventions under investigation include: CVT-301 (Dose Level 1) (DRUG), CVT-301 (Dose Level 2) (DRUG), Sinemet® (DRUG).

Who is sponsoring clinical trial NCT02812394?

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 NCT02812394's enrollment target sits among peer trials

24 1520th of 2000 higher than 405 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 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 NCT02812394, the US trial registry maintained by the National Library of Medicine. NCT02812394 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.