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

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.

Disease:

Amyotrophic Lateral Sclerosis (ALS),  Familial ALS,  Sporadic ALS

Study Type:

Study Category:

Expanded Access - Treatment IND/Protocol

Study Status:

Enrolling

Phase:

Not Applicable

Study Chair(s)/Principal Investigator(s):

Clinicaltrials.gov ID (11 digit #):

NCT03537807

Neals Affiliated?

No

Coordinating Center Contact Information


Early Access Care / .(JavaScript must be enabled to view this email address) / 1-888-315-5797 Ext 6
.(JavaScript must be enabled to view this email address) United States

Full Study Summary:

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 Sponsor:

Biohaven Pharmaceuticals, Inc.

Participant Duration:

Estimated Enrollment:

250

Estimated Study Start Date:

Estimated Study Completion Date:

Posting Last Modified Date:

12/19/2018

Date Study Added to alsconsortium.org:

12/19/2018
  • Eligibility Criteria

    Gender:

    Female, Male

    Minimum Age:

    18

    Maximum Age:

    N/A

    Time since Symptom Onset:

    N/A

    Time since Diagnosis:

    N/A

    Can participants use Riluzole?

    Yes


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taken riluzole oral tablets, or patients who have successfully completed a clinical trial with BHV-0223 and were not withdrawn prematurely due to adverse events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

  • Site Contact Information