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Expanded Access Protocol of BHV-0223 for Patients With Amyotrophic Lateral Sclerosis (ALS)

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ClinicalTrials.gov Identifier: NCT03537807
Expanded Access Status : Available
First Posted : May 25, 2018
Last Update Posted : June 7, 2018
Sponsor:
Information provided by (Responsible Party):
Biohaven Pharmaceuticals, Inc.

Study Description
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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

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.

Study Design
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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

Drug Information available for: Riluzole

Interventions
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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
Eligibility Criteria
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Information from the National Library of Medicine

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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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03537807


Contacts
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Contact: Early Access Care 1-888-315-5797 Ext 6 BHV0223.ExpandedAccess@earlyaccesscare.com

Sponsors and Collaborators
Biohaven Pharmaceuticals, Inc.
More Information
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Responsible Party: Biohaven Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT03537807     History of Changes
Other Study ID Numbers: BHV0223-401
First Posted: May 25, 2018    Key Record Dates
Last Update Posted: June 7, 2018
Last Verified: June 2018

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:
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Sclerosis
Motor Neuron Disease
Amyotrophic Lateral 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