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NCT01777555 · ClinicalTrials.gov registry record · Phase 2

Efficacy and Safety Study of Inhaled CVT 301 in Parkinson's Disease Patients for Treatment of OFF Episodes

A Phase 2 study of Idiopathic Parkinson´s Disease, sponsored by Acorda Therapeutics.

Completed
Registry status
Phase 2
Development phase
89
Enrollment target
20
Study locations

NCT01777555 is a Phase 2 study of Idiopathic Parkinson´s Disease that has completed, run by Acorda Therapeutics. The registered enrollment target is 89 participants, below the 207-participant average among 7 other Idiopathic Parkinson´s Disease trials with a reported enrollment target (57% lower). The trial reports 20 study locations across 9 states.

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The verdict

NCT01777555, a Phase 2 study of Idiopathic Parkinson´s Disease, has completed, sponsored by Acorda Therapeutics.

COMPLETED
Registry status
Phase 2
Development phase
89 participants
Enrollment target
20
Study locations

Study Summary

This randomized, multicenter, placebo-controlled, double-blind study will evaluate the efficacy and safety of inhaled CVT 301 compared with placebo in PD patients experiencing motor response fluctuations (OFF phenomena) as an outpatient (i.e., at home) and in the clinic.

Conditions Studied

Idiopathic Parkinson´s Disease

Interventions

  • DRUG Placebo
  • DRUG CVT-301

Study Locations (20)

Other

  • Civitas Investigational Site 4003 - Cassino
  • Civitas Investigational Site 4002 - Chieti
  • Civitas Investigational Site 4001 - Rome
  • Civitas Investigational Site 3001 - Belgrade
  • Civitas Investigational Site 3002 - Belgrade
  • Civitas Investigational Site 2004 - Cambridge
  • Civitas Investigational Site 200 - Glasgow

Michigan

  • Civitas Investigational Site 1001 - Bingham Farms
  • Civitas Investigational Site 1008 - Roseville
  • Civitas Investigational Site 1009 - Saint Louis
  • Civitas Investigational Site 1005 - West Bloomfield

Florida

  • Civitas Investigational Site 1004 - Boca Raton
  • Civitas Investigational Site 1002 - Port Charlotte
  • Civitas Investigational Site 1015 - Tampa

Arkansas

  • Civitas Investigational Site 1013 - Little Rock

Kansas

  • Civitas Investigational Site 1007 - Kansas City

Massachusetts

  • Civitas Investigational Site 1010 - Boston

New York

  • Civitas Investigational Site 1011 - Kingston

Ohio

  • Civitas Investigational Site 1014 - Cleveland

Trial Details

FieldValue
Enrollment Target 89 participants
Start Date 2013-04
Est. Completion 2014-01
Phase Phase 2

Sponsor

Acorda Therapeutics

36 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01777555

The ClinicalTrials.gov registry entry for NCT01777555 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 89 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 207-participant average among 7 other Idiopathic Parkinson´s Disease trials with a reported enrollment target (57% lower). The listed sponsor is Acorda Therapeutics, which has 36 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Idiopathic Parkinson´s Disease appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT01777555 reports 20 study locations spanning 9 distinct geographic areas - top geographies include Other, Michigan, Florida.

Frequently Asked Questions

What is clinical trial NCT01777555 about?

NCT01777555 is a clinical study titled "Efficacy and Safety Study of Inhaled CVT 301 in Parkinson's Disease Patients for Treatment of OFF Episodes". This randomized, multicenter, placebo-controlled, double-blind study will evaluate the efficacy and safety of inhaled CVT 301 compared with placebo in PD patients experiencing motor response fluctuations (OFF phenomena) as an outpatient (i.e., at home) and in the clinic.

What is the current status of trial NCT01777555?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 89 participants. The study started on 2013-04. Estimated completion is 2014-01.

What conditions does trial NCT01777555 study?

This clinical trial studies the following conditions: Idiopathic Parkinson´s Disease.

What interventions are being tested in trial NCT01777555?

The interventions under investigation include: Placebo (DRUG), CVT-301 (DRUG).

Who is sponsoring clinical trial NCT01777555?

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

Where is trial NCT01777555 being conducted?

This trial has 20 study locations across Arkansas, Florida, Kansas, Massachusetts, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.