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NCT02274766 · ClinicalTrials.gov registry record · Phase 3

Efficacy and Safety Study of ADS-5102 in PD Patients With Levodopa-Induced Dyskinesia

A Phase 3 study of Parkinsons Disease (PD) and Dyskinesia, sponsored by Adamas Pharmaceuticals.

Completed
Registry status
Phase 3
Development phase
77
Enrollment target
20
Study locations

NCT02274766 is a Phase 3 study of Parkinsons Disease (PD) and Dyskinesia that has completed, run by Adamas Pharmaceuticals. The registered enrollment target is 77 participants, below the 115-participant average among 19 other Parkinsons Disease (PD) trials with a reported enrollment target (33% lower). The trial reports 20 study locations across 13 states.

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The verdict

NCT02274766, a Phase 3 study of Parkinsons Disease (PD) and Dyskinesia, has completed, sponsored by Adamas Pharmaceuticals.

COMPLETED
Registry status
Phase 3
Development phase
77 participants
Enrollment target
20
Study locations

Study Summary

This is a multi-center, randomized, double-blind, placebo-controlled, 2-arm, parallel group study to evaluate the efficacy and safety of ADS-5102 extended release (ER) capsules, an investigational formulation of amantadine, dosed once nightly at bedtime for the treatment of levodopa-induced dyskinesia (LID) in subjects with Parkinson's disease (PD). The novel pharmacokinetic profile of ADS-5102 is expected to achieve i) maximal concentrations in the early morning through mid-day, when LID can be troublesome, and ii) lower concentrations in the evening, potentially reducing the negative impact of amantadine on sleep. This pharmacokinetic profile could enable higher doses to be tolerated with a once-nightly ER formulation than can be tolerated with an immediate-release formulation. The once-nightly dosing regimen may also provide enhanced convenience and compliance. In a previous clinical study, ADS-5102 met its primary endpoint; LID was significantly reduced as measured by the change in UDysRS score over 8 weeks vs. placebo.

Conditions Studied

Parkinsons Disease (PD) Dyskinesia Levodopa Induced Dyskinesia (LID)

Interventions

  • OTHER Placebo
  • DRUG ADS-5102

Study Locations (20)

Florida

  • - Boca Raton
  • - Jacksonville
  • - Port Charlotte
  • - Sunrise
  • - Tampa

California

  • - Fountain Valley
  • - Sunnyvale

Maryland

  • - Baltimore
  • - Elkridge

North Carolina

  • - Greensboro
  • - Raleigh

Georgia

  • - Atlanta

Illinois

  • - Chicago

Kansas

  • - Kansas City

Massachusetts

  • - Boston

Trial Details

FieldValue
Enrollment Target 77 participants
Start Date 2014-10
Est. Completion 2016-03-10
Phase Phase 3

Sponsor

Adamas Pharmaceuticals

10 total trials

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What the Registry Record Tells You About NCT02274766

The ClinicalTrials.gov registry entry for NCT02274766 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 77 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 115-participant average among 19 other Parkinsons Disease (PD) trials with a reported enrollment target (33% lower). The listed sponsor is Adamas Pharmaceuticals, which has 10 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Parkinsons Disease (PD) appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT02274766 reports 20 study locations spanning 13 distinct geographic areas - top geographies include Florida, California, Maryland.

Frequently Asked Questions

What is clinical trial NCT02274766 about?

NCT02274766 is a clinical study titled "Efficacy and Safety Study of ADS-5102 in PD Patients With Levodopa-Induced Dyskinesia". This is a multi-center, randomized, double-blind, placebo-controlled, 2-arm, parallel group study to evaluate the efficacy and safety of ADS-5102 extended release (ER) capsules, an investigational formulation of amantadine, dosed once nightly at bedtime for the treatment of levodopa-induced dyskines...

What is the current status of trial NCT02274766?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 77 participants. The study started on 2014-10. Estimated completion is 2016-03-10.

What conditions does trial NCT02274766 study?

This clinical trial studies the following conditions: Parkinsons Disease (PD), Dyskinesia, Levodopa Induced Dyskinesia (LID).

What interventions are being tested in trial NCT02274766?

The interventions under investigation include: Placebo (OTHER), ADS-5102 (DRUG).

Who is sponsoring clinical trial NCT02274766?

This trial is sponsored by Adamas Pharmaceuticals, which has 10 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02274766 being conducted?

This trial has 20 study locations across California, Florida, Georgia, Illinois, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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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.