CompletedPhase 1

Open-label Study to Evaluate Safety, Tolerability and PK of BHV-0223 in ALS

United States22 participantsStarted 2018-02-02

Plain-language summary

Phase 1, open-label study of BHV-0223 in ALS.

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Subjects with diagnosed ALS by the revised El Escorial diagnostic criteria, including laboratory supported probable, probable, or definite ALS;
✓. Subjects who have never taken riluzole tablets, OR Subjects who previously took riluzole tablets but discontinued at least 1 month prior to the screening visit. Subjects must not have had ALT or AST \> 5 x ULN while taking riluzole tablets, or any other clinically significant tolerability issues (e.g., hypersensitivity reactions) in the judgement of the investigator;
✓. Subjects determined by the investigator to be medically stable;
✓. Subjects determined by the investigator to be willing and physically able to complete the study as designed, with or without caregiver assistance.

✕. Target Disease Exceptions
✕. Medical History Exceptions
✕. Subject is known to have a current diagnosis of acute or chronic viral hepatitis;
✕. Subject is known to have any other acute or chronic liver disease that is clinically significant in the investigator's judgment;
✕. Subject has a history of a clinically significant medical condition that would interfere with the subject's ability to comply with study instructions, would place the subject at increased risk, or might confound the interpretation of the study results in the investigator's judgment;
✕. Any other sound medical, psychiatric and/or social reason in the investigator's judgment;
✕. Physical and Laboratory Test Findings
✕. Positive urine pregnancy test in WOCBP at screening;

Incidence of Treatment Emergent Adverse Events (Safety and Tolerability)

Timeframe: Through Week 8 (Day 57)

NCT IDNCT03520517

SponsorBiohaven Pharmaceuticals, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-10-08

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Subjects with diagnosed ALS by the revised El Escorial diagnostic criteria, including laboratory supported probable, probable, or definite ALS;
✓. Subjects who have never taken riluzole tablets, OR Subjects who previously took riluzole tablets but discontinued at least 1 month prior to the screening visit. Subjects must not have had ALT or AST \> 5 x ULN while taking riluzole tablets, or any other clinically significant tolerability issues (e.g., hypersensitivity reactions) in the judgement of the investigator;
✓. Subjects determined by the investigator to be medically stable;
✓. Subjects determined by the investigator to be willing and physically able to complete the study as designed, with or without caregiver assistance.

✕. Target Disease Exceptions
✕. Medical History Exceptions
✕. Subject is known to have a current diagnosis of acute or chronic viral hepatitis;
✕. Subject is known to have any other acute or chronic liver disease that is clinically significant in the investigator's judgment;
✕. Subject has a history of a clinically significant medical condition that would interfere with the subject's ability to comply with study instructions, would place the subject at increased risk, or might confound the interpretation of the study results in the investigator's judgment;
✕. Any other sound medical, psychiatric and/or social reason in the investigator's judgment;
✕. Physical and Laboratory Test Findings
✕. Positive urine pregnancy test in WOCBP at screening;