Amyotrophic Lateral Sclerosis Clinical Trial
Official title:
BHV-0223 Expanded Access Protocol in Patients With Amyotrophic Lateral Sclerosis
NCT number | NCT03537807 |
Other study ID # | BHV0223-401 |
Secondary ID | |
Status | No longer available |
Phase | |
First received | |
Last updated |
Verified date | July 2019 |
Source | Biohaven Pharmaceuticals, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | 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.
Status | No longer available |
Enrollment | 0 |
Est. completion date | |
Est. primary completion date | |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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taken riluzole oral tablets, or patients who have successfully completed a clinical trial with BHV-0223 and were not withdrawn prematurely due to adverse events - Swallowing difficulties, or patient or caregiver report choking one or more times per week, or investigator deems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 RilutekĀ® - 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 |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Biohaven Pharmaceuticals, Inc. |
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