Expanded Access Protocol of BHV-0223 for Patients With Amyotrophic Lateral Sclerosis (ALS)
Primary Purpose
Amyotrophic Lateral Sclerosis, ALS, Lou Gehrig Disease
Status
No longer available
Phase
Locations
Study Type
Expanded Access
Intervention
Riluzole
Sponsored by
About this trial
This is an expanded access trial for Amyotrophic Lateral Sclerosis focused on measuring 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
Eligibility 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taken riluzole oral tablets, or patients who have successfully completed a clinical trial with BHV-0223 and were not withdrawn prematurely due to adverse events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
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT03537807
First Posted
May 9, 2018
Last Updated
July 24, 2019
Sponsor
Biohaven Pharmaceuticals, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT03537807
Brief Title
Expanded Access Protocol of BHV-0223 for Patients With Amyotrophic Lateral Sclerosis (ALS)
Official Title
BHV-0223 Expanded Access Protocol in Patients With Amyotrophic Lateral Sclerosis
Study Type
Expanded Access
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
No longer available
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biohaven Pharmaceuticals, Inc.
4. Oversight
5. Study Description
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amyotrophic Lateral Sclerosis, ALS, Lou Gehrig Disease, Lou Gehrig's Disease, Lou-Gehrigs Disease, Motor Neuron Disease, Amyotrophic Lateral Sclerosis
Keywords
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
7. Study Design
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Riluzole
Other Intervention Name(s)
Riluzole Zydis® sublingual
Intervention Description
For adult patients, one 40mg of BHV-0223, administered sublingually, on a twice daily basis (approximately every 12 hours).
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Eligibility 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
12. IPD Sharing Statement
Learn more about this trial
Expanded Access Protocol of BHV-0223 for Patients With Amyotrophic Lateral Sclerosis (ALS)
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