Expanded Access Protocol of BHV-0223 for Patients With Amyotrophic Lateral Sclerosis (ALS)

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03537807
• Date of registration: 09/05/2018
• Prospective Registration: Yes
• Primary sponsor: Biohaven Pharmaceuticals, Inc.
• Public title: Expanded Access Protocol of BHV-0223 for Patients With Amyotrophic Lateral Sclerosis (ALS)
• Scientific title: BHV-0223 Expanded Access Protocol in Patients With Amyotrophic Lateral Sclerosis
• Date of first enrolment: June 2018
• Recruitment status: No longer available
• URL: https://clinicaltrials.gov/show/NCT03537807
• Study type: Expanded Access

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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trial with BHV-0223 and were not withdrawn prematurely due to adverse events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

Exclusion Criteria:

- 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Amyotrophic Lateral Sclerosis

Motor Neuron Disease, Amyotrophic Lateral Sclerosis

Lou Gehrig Disease

Lou Gehrig's Disease

ALS

Lou-Gehrigs Disease

Intervention(s)

Drug: Riluzole

Secondary ID(s)

BHV0223-401

Source(s) of Monetary Support

Please refer to primary and secondary sponsors