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

Quick Info

Status

Ongoing, But Not Recruiting

Estimated Enrollment

250

Phase

EAP

Treatment Type

Orally Disolving Tablet (Sublingual)

Trial Type

Expanded Access Protocol (EAP)

Sponsor

Biohaven Pharmaceutical

Primary Investigator

Easy Access Care

Contact Information

1-888-315-5797 Ext 6
bhv0223.expandedaccess@earlyaccesscare.com

Locations

Anywhere in USA

Enrollment Criteria

Breathing Ability

Percent lung function (FVC) or (SVC)

no limit

Months Since Onset

Number of months since first symptoms of ALS.

no limit

Non-Invasive Ventilation (NIV)

Can PALS use a BiPAP in the trial?

yes

Diaphragm Pacer (DPS)

Can PALS use a DPS in the trial?

yes

Edaravone Usage

Can a PALS use edaravone (Radicut/Radicava) while enrolled in the trial?

Yes

Update Notes

Recruitment status updated

7/29/2019

No significant updates.

7/9/2019

No significant updates

6/6/2018

Trial added

5/15/2018

Other Information

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.

Eligibility

Diagnosed with ALS, adequate hepatic function

Details

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.

Collaborator(s)

News Articles and Summaries

ALS Forum

Trial Protocol as Published on Clinicaltrials.gov

NCT03537807 (First Published: 5/25/2018)