Quick Info
Status
Ongoing, But Not Recruiting
Estimated Enrollment
250
Phase
EAP
Treatment Type
Orally Disolving Tablet (Sublingual)
Trial Type
Expanded Access Protocol (EAP)
Primary Investigator
Easy Access Care
Contact Information
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)
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News Articles and Summaries
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ALS Forum
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Trial Protocol as Published on Clinicaltrials.gov
NCT03537807 (First Published: 5/25/2018)
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