Study Purpose: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.
No longer available
Amyotrophic Lateral Sclerosis , ALS , Lou Gehrig Disease , Lou Gehrig's Disease , Lou-Gehrigs Disease , Motor Neuron Disease, Amyotrophic Lateral Sclerosis
Type of Intervention:
Study Chair(s)/Principal Investigator(s):
Coordinating Center Contact Information
Full Study Summary:
Biohaven Pharmaceuticals, Inc.
Posting Last Modified Date:
07 / 26 / 2019
Date Study Added to neals.org:
05 / 25 / 2018
Can participants use Riluzole?
- Patients with diagnosed ALS of any type or duration
- Current or previous treatment with oral riluzole tablets, or patients who have never taken riluzole oral tablets, or patients who have successfully completed a clinical trial with BHV-0223 and were not withdrawn prematurely due to adverse events
- Swallowing difficulties, or patient or caregiver report choking one or more times per week, or investigator deems appropriate to treat with sublingual BHV-0223 because (s)he deems the patient cannot be satisfactorily treated with Rilutek®
- Adequate hepatic function
- Patient with history of severe hypersensitivity reaction to riluzole oral tablets or BHV-0223
- Patient is known to have any other acute or chronic liver disease