Expanded Access Protocol of BHV-0223 for Patients With Amyotrophic Lateral Sclerosis (ALS)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03537807 |
Expanded Access Status :
No longer available
First Posted : May 25, 2018
Last Update Posted : July 26, 2019
|
Sponsor:
Biohaven Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Biohaven Pharmaceuticals, Inc.
- Study Details
- Tabular View
- Disclaimer
- How to Read a Study Record
Brief Summary:
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.
Condition or disease | Intervention/treatment |
---|---|
Amyotrophic Lateral Sclerosis ALS Lou Gehrig Disease Lou Gehrig's Disease Lou-Gehrigs Disease Motor Neuron Disease, Amyotrophic Lateral Sclerosis | Drug: 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.
Study Type : | Expanded Access |
Expanded Access Type : | Treatment IND/Protocol |
Official Title: | BHV-0223 Expanded Access Protocol in Patients With Amyotrophic Lateral Sclerosis |
Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics:
Amyotrophic lateral sclerosis
Juvenile primary lateral sclerosis
MedlinePlus related topics:
Amyotrophic Lateral Sclerosis
Drug Information available for:
Riluzole
Intervention Details:
- Drug: Riluzole
For adult patients, one 40mg of BHV-0223, administered sublingually, on a twice daily basis (approximately every 12 hours).Other Name: Riluzole Zydis® sublingual
Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Criteria
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
No Contacts or Locations Provided
Responsible Party: | Biohaven Pharmaceuticals, Inc. |
ClinicalTrials.gov Identifier: | NCT03537807 |
Other Study ID Numbers: |
BHV0223-401 |
First Posted: | May 25, 2018 Key Record Dates |
Last Update Posted: | July 26, 2019 |
Last Verified: | July 2019 |
Keywords provided by Biohaven Pharmaceuticals, Inc.:
Amyotrophic Lateral Sclerosis ALS Lou Gehrig Disease Lou Gehrig's Disease Lou-Gehrigs Disease Motor Neuron Disease, Amyotrophic Lateral Sclerosis Riluzole |
Rilutek® Sublingual Oral formulation Neuroprotective Agents Administration, Sublingual Administration, Oral Biological Availability |
Additional relevant MeSH terms:
Motor Neuron Disease Amyotrophic Lateral Sclerosis Sclerosis Pathologic Processes Neurodegenerative Diseases Nervous System Diseases Neuromuscular Diseases Spinal Cord Diseases Central Nervous System Diseases TDP-43 Proteinopathies Proteostasis Deficiencies |
Metabolic Diseases Riluzole Anticonvulsants Excitatory Amino Acid Antagonists Excitatory Amino Acid Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Neuroprotective Agents Protective Agents |