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COMPLETED Phase 3

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

NCT02274766 · View on ClinicalTrials.gov ↗

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.

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

3 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02274766

The ClinicalTrials.gov registry entry for NCT02274766 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 77 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Adamas Pharmaceuticals, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 3 conditions, with Parkinson's Disease (PD) appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT02274766 reports 20 study locations spanning 13 distinct geographic areas — top geographies include Florida, California, Maryland. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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: Parkinson's Disease (PD), Dyskinesia, Levodopa-Induced Dyskinesia (LID). These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT02274766?

The interventions under investigation include: Placebo (OTHER), ADS-5102 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02274766?

This trial is sponsored by Adamas Pharmaceuticals, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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