Efficacy and Safety of Amantadine Hydrochloride (HCl) ER Tablets to Treat Parkinson's Disease Patients With LID.
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.
Timeline
- Start
- 2014-08-18
- Primary completion
- 2016-05-20
- Completion
- 2016-05-20
Outcome
Missed primary endpoint
registry analysis (unspecified test); 240 mg Amantadine HCl ER Tablets vs 320 mg Amantadine HCl ER Tablets vs Placebo Amantadine HCl ER Tablets; p = 0.179; Mean Difference (Final Values) -5.6 (95% CI -13.9 to 2.6); ANCOVA NCT02153645 ↗
registry analysis (superiority test); 320 mg Amantadine HCl ER Tablets; p = 0.458; Mean Difference (Final Values) -3.1 (95% CI -11.2 to 5.1); ANCOVA NCT02153645 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Amantadine | Unknown | 240 mg | — |
| Subject | Amantadine | Unknown | 320 mg | — |