drugset / Trial / NCT05148884
Study to Assess the Safety, Tolerability and Preliminary Efficacy of NLX-112 Versus Placebo in L-dopa-induced Dyskinesia
Phase 2
Completed
27 enrolled
Neurolixis SAS
CTC Clinical Trial Consultants AB · collabMichael J. Fox Foundation for Parkinson's Research · collabParkinson's UK · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This is a double-blind, randomized, placebo-controlled Phase 2a study evaluating the safety, tolerability, and preliminary efficacy of up to 2 mg/day (1 mg BID) of NLX-112 versus placebo in patients with moderate to severe L-DOPA induced dyskinesia (LID) in Parkinson's disease (PD). NLX-112 will be up-titrated to either 2 mg/day or to the highest well-tolerated dose less than 2 mg/day over 4 weeks, maintained at the well-tolerated dose for an additional 2 weeks, and then down-titrated over 2 weeks.
Timeline
- Start
- 2021-11-09
- Primary completion
- 2023-01-18
- Completion
- 2023-01-18
Outcome
Met primary endpoint
release “Beyond meeting the primary outcome of safety and tolerability, NLX-112 also achieved significant reductions in LID scores, whereas placebo group changes were not significant.” neurolixis.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | BEFIRADOL | Small molecule | 2 mg | — |