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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
Biohaven Pharmaceuticals, Inc.
About
Eligibility
Locations
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All Sexes

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taken riluzole oral tablets, or patients who have successfully completed a clinical trial with BHV-0223 and were not withdrawn prematurely due to adverse events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

    First Posted
    May 9, 2018
    Last Updated
    July 24, 2019
    Sponsor
    Biohaven Pharmaceuticals, Inc.
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    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
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    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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