drugset / Trial / NCT04106050
Pharmacodynamic Study of BIIB095 and BIIB074 in Healthy Participants and Participants With Painful Diabetic Polyneuropathy
RandomizedParallel-groupTriple-blindTreatment
Summary
Part A: Primary objective is to determine the effects of BIIB095 on nerve excitability in healthy participants. Secondary and exploratory objectives include determining the effects of BIIB095 on nerve excitability in diabetic polyneuropathy (DPN) and assessing the safety, tolerability and pharmacokinetics of BIIB095. Part B (optional): Equivalent objectives are pursued for BIIB074.
Timeline
- Start
- 2020-09-30
- Primary completion
- 2022-01-21
- Completion
- 2022-01-21
Outcome
Outcome not reported
Stopped (Business): “Sponsor Decision”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | BIIB095 | Small molecule | — | Oral |
| Subject | Vixotrigine | Small molecule | — | Oral |
| Comparator | Lidocaine | Other / unclassified | — | Other |