ALS Therapy Development Institute

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

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

Quick Info:

Status:
Currently Recruiting
Estimated Enrollment:
250
Phase:
EAP
Treatment Type:
Orally Disolving Tablet (Sublingual)
Trial Type:
Expanded Access Protocol (EAP)
Sponsor:
Biohaven Pharmaceutical Holding Company
Primary Investigator:
Contact Information:

Enrollment Criteria:

Forced Ventilation

Breathing Ability

Percent lung function (FVC) or (SVC)
no limit
Months/Onset

Months Since Onset

Number of months since first
symptoms of ALS
no limit
BiPap Allowed

Non-Invasive Ventilation (NIV)

Can PALS use a BiPAP in the trial?
yes
DPS Allowed

Diaphragm Pacer (DPS)

Can PALS use a DPS in the trial?
yes
Edaravone Usage

Edaravone Usage

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

Update Notes:

7/9/2019No significant updates.
6/6/2018No significant updates
5/15/2018Trial added

Locations:

Anywhere in USA

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:
First Published on Clinicaltrials.gov: 5/25/2018
ClinicalTrials.gov ID: NCT03537807
Trial Protocol as Published on Clinicaltrials.gov:
ClinicalTrials.gov