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Efficacy and Safety of Amantadine Hydrochloride (HCl) ER Tablets to Treat Parkinson's Disease Patients With LID.

NCT02153645 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 87

Last updated 2022-02-16

Study results available
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Summary

This study was terminated early due to slow enrollment with 87 of 162 planned subjects enrolled. The purpose of this multi-center, randomized, double-blind, parallel-group, 16 week study is to compare the efficacy and safety of two different dose levels of Amantadine Extended Release Tablets to placebo for the treatment of levodopa induced dyskinesia in patients with Parkinson's disease.

Conditions

Interventions

DRUG

240mg Amantadine HCl ER tablets

DRUG

Placebo tablets

DRUG

320mg Amantadine HCl ER tablets

Sponsors & Collaborators

  • Adamas Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Angela Dentiste, MBA · Osmotica Pharmaceutical US LLC

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
2014-08-18
Primary Completion
2016-05-20
Completion
2016-05-20

Countries

  • United States
  • Canada
  • 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 NCT02153645 on ClinicalTrials.gov