Expanded Access Protocol of BHV-0223 for Patients With Amyotrophic Lateral Sclerosis (ALS)
NCT03537807 · Status: NO_LONGER_AVAILABLE · Type: EXPANDED_ACCESS
Last updated 2019-07-26
Summary
This is an open label expanded access protocol for the treatment of up to approximately 250 adult patients with amyotrophic lateral sclerosis (ALS) who have difficulty swallowing oral riluzole tablets and may be able to derive benefit from treatment with an alternative oral formulation of riluzole.
Conditions
- Amyotrophic Lateral Sclerosis
- ALS
- Lou Gehrig Disease
- Lou Gehrig's Disease
- Lou-Gehrigs Disease
- Motor Neuron Disease, Amyotrophic Lateral Sclerosis
Interventions
- DRUG
-
For adult patients, one 40mg of BHV-0223, administered sublingually, on a twice daily basis (approximately every 12 hours).
Sponsors & Collaborators
-
Biohaven Pharmaceuticals, Inc.
lead INDUSTRY
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
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