MedTrace Logo

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

NCT02274766 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 77

Last updated 2018-01-10

Study results available
· View outcomes & findings →

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

  • Dyskinesia
  • Levodopa-Induced Dyskinesia (LID)
  • Parkinson's Disease (PD)

Interventions

DRUG

ADS-5102

Oral capsules to be administered once nightly at bedtime, for 13 weeks.

OTHER

Placebo

Oral capsules to be administered once nightly at bedtime, for 13 weeks.

Sponsors & Collaborators

  • Adamas Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Clinical Trials Director · Adamas Pharmaceuticals, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2016-03-10
Completion
2016-03-10

Countries

  • United States
  • Austria
  • France
  • Germany
  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02274766 on ClinicalTrials.gov