NCT03537807

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

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

• Status: No Longer Available
• Phase: —
• Study type: Expanded Access
• Enrollment: —
• Sponsor: Biohaven Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

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.

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.

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	Riluzole	For adult patients, one 40mg of BHV-0223, administered sublingually, on a twice daily basis (approximately every 12 hours).

Timeline

• First posted: 2018-05-25
• Last updated: 2019-07-26