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

Sponsor

Biohaven Pharmaceuticals, Inc. (Industry)

Overall Status

No longer available

CT.gov ID

NCT03537807

Collaborator

(none)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Amyotrophic Lateral Sclerosis ALS Lou Gehrig Disease Lou Gehrig's Disease Lou-Gehrigs Disease Motor Neuron Disease, Amyotrophic Lateral Sclerosis	Drug: Riluzole

Detailed Description

Riluzole is indicated in the U.S. for the treatment of patients with amyotrophic lateral sclerosis (ALS). The commercially available dosage form is a 50mg oral tablet. This expanded access protocol (EAP) is designed to provide access to a dissolving tablet formulation of riluzole designed for sublingual (SL) administration, in patients with ALS who, in the opinion and clinical judgement of the treating physician, would benefit from treatment with BHV-0223.

Study Design

Study Type:

Expanded Access

Official Title:

BHV-0223 Expanded Access Protocol in Patients With Amyotrophic Lateral Sclerosis

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

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taken riluzole oral tablets, or patients who have successfully completed a clinical trial with BHV-0223 and were not withdrawn prematurely due to adverse events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