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NCT02240030 · ClinicalTrials.gov registry record · Phase 3

Efficacy and Safety Study of CVT-301 In Parkinson's Disease Patients With OFF Episodes

A Phase 3 study of Idiopathic Parkinson´s Disease, sponsored by Acorda Therapeutics.

Completed
Registry status
Phase 3
Development phase
351
Enrollment target
20
Study locations

NCT02240030 is a Phase 3 study of Idiopathic Parkinson´s Disease that has completed, run by Acorda Therapeutics. The registered enrollment target is 351 participants, above the 170-participant average among 7 other Idiopathic Parkinson´s Disease trials with a reported enrollment target (106% higher). The trial reports 20 study locations across 4 states.

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The verdict

NCT02240030, a Phase 3 study of Idiopathic Parkinson´s Disease, has completed, sponsored by Acorda Therapeutics.

COMPLETED
Registry status
Phase 3
Development phase
351 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. Patients who successfully complete this study will be eligible to enroll into a 12 month treatment extension (CVT-301-004E) study.

Interventions

  • OTHER Placebo
  • DRUG CVT-301 Low Dose
  • DRUG CVT-301 High Dose

Study Locations (20)

California

  • Acorda Site #5042 - Fresno
  • Acorda Site #5064 - Fullerton
  • Acorda Site #5035 - Loma Linda
  • Acorda Site #5027 - Long Beach
  • Acorda Site #5037 - Los Angeles
  • Acorda Site #5070 - Pasadena
  • Acorda Site #5047 - Reseda
  • Acorda Site #5068 - Santa Ana
  • Acorda Site #5069 - Torrance

Florida

  • Acorda Site #5046 - Atlantis
  • Acorda Site #5053 - Aventura
  • Acorda Site #5013 - Boca Raton
  • Acorda Site #5016 - Jacksonville
  • Acorda Site #5071 - Maitland
  • Acorda Site #5044 - Orlando
  • Acorda Site #5060 - Palm Beach Gardens
  • Acorda Site #5001 - Port Charlotte
  • Acorda Site #5065 - St. Petersburg

Arizona

  • Acorda Site #5020 - Scottsdale

District of Columbia

  • Acorda Site #5052 - Washington D.C.

Trial Details

FieldValue
Enrollment Target 351 participants
Start Date 2014-11
Est. Completion 2016-12
Phase Phase 3

Sponsor

Acorda Therapeutics

36 total trials

What the Registry Record Tells You About NCT02240030

The ClinicalTrials.gov registry entry for NCT02240030 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 351 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 170-participant average among 7 other Idiopathic Parkinson´s Disease trials with a reported enrollment target (106% higher). 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 3 interventions - of which Placebo is the first listed.

NCT02240030 reports 20 study locations spanning 4 distinct geographic areas - top geographies include California, Florida, Arizona.

Frequently Asked Questions

What is clinical trial NCT02240030 about?

NCT02240030 is a clinical study titled "Efficacy and Safety Study of CVT-301 In Parkinson's Disease Patients With 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. Patients who successfully c...

What is the current status of trial NCT02240030?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 351 participants. The study started on 2014-11. Estimated completion is 2016-12.

What conditions does trial NCT02240030 study?

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

What interventions are being tested in trial NCT02240030?

The interventions under investigation include: Placebo (OTHER), CVT-301 Low Dose (DRUG), CVT-301 High Dose (DRUG).

Who is sponsoring clinical trial NCT02240030?

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

Where is trial NCT02240030 being conducted?

This trial has 20 study locations across Arizona, California, District of Columbia, Florida. 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

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