An expanded access record providing Riluzole in Amyotrophic Lateral Sclerosis, ALS and Lou Gehrig Disease, sponsored by Biohaven Pharmaceuticals, Inc.. No longer available. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-07-26.
Sponsored by Biohaven Pharmaceuticals, Inc. · Expanded access
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.
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.
717 studies on the registry are indexed under Motor Neuron Disease; 137 are open to participants now.
Browse Motor Neuron Disease studies →Biohaven Pharmaceuticals, Inc. is the lead sponsor of 15 studies on the registry; 1 is open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 6 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
For adult patients, one 40mg of BHV-0223, administered sublingually, on a twice daily basis (approximately every 12 hours).
Also known as: Riluzole Zydis® sublingual
No study locations are listed for this record.
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No contact was published for this record. The registry link below has the sponsor’s details.
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Biohaven Pharmaceuticals, Inc.