Trials / Completed
CompletedNCT03520517
Open-label Study to Evaluate Safety, Tolerability and PK of BHV-0223 in ALS
Open-Label Study to Evaluate Safety, Tolerability and Pharmacokinetics of Multiple Doses of BHV-0223 in Subjects With Amyotrophic Lateral Sclerosis
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 22 (actual)
- Sponsor
- Biohaven Pharmaceuticals, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Phase 1, open-label study of BHV-0223 in ALS.
Detailed description
This is a phase 1, open-label, single arm study to evaluate the safety, tolerability and pharmacokinetics of multiple doses of BHV-0223 in subjects with ALS.
Conditions
- Amyotrophic Lateral Sclerosis
- ALS
- Lou Gehrig Disease
- Lou Gehrig's Disease
- Lou-Gehrigs Disease
- Motor Neuron Disease, Amyotrophic Lateral Sclerosis
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | BHV-0223 | BHV-0223, 40 mg BID |
Timeline
- Start date
- 2018-02-02
- Primary completion
- 2018-10-08
- Completion
- 2018-10-08
- First posted
- 2018-05-09
- Last updated
- 2022-10-06
Locations
5 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03520517. Inclusion in this directory is not an endorsement.