Open-Label Study to Evaluate Safety, Tolerability and Pharmacokinetics of Multiple Doses of BHV-0223 in Subjects With Amyotrophic Lateral Sclerosis

Study Purpose:

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

Disease:

Amyotrophic Lateral Sclerosis (ALS),  Familial ALS,  Sporadic ALS

Study Type:

Interventional Trial

Study Category:

Drug Trial

Study Status:

Enrolling

Phase:

Phase I

Study Chair(s)/Principal Investigator(s):

Clinicaltrials.gov ID (11 digit #):

NCT03520517

Neals Affiliated?

No

Coordinating Center Contact Information


Robert Berman, MD / .(JavaScript must be enabled to view this email address) / 203-404-0410
.(JavaScript must be enabled to view this email address) United States

Full Study Summary:

This is a phase 1, open-label, single arm study to evaluate the safety, tolerability and pharmacokinetics of multiple doses of BHV-0223 in subjects with ALS.

Study Sponsor:

Biohaven Pharmaceutical Holding Company Ltd.

Participant Duration:

Estimated Enrollment:

20

Estimated Study Start Date:

02/02/2018

Estimated Study Completion Date:

07/31/2018

Posting Last Modified Date:

05/29/2018

Date Study Added to alsconsortium.org:

05/29/2018
  • Eligibility Criteria

    Gender:

    Female, Male

    Minimum Age:

    18

    Maximum Age:

    N/A

    Time since Symptom Onset:

    Time since Diagnosis:

    Can participants use Riluzole?

    Yes


    Inclusion Criteria:

    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.

    Exclusion Criteria:

    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;
    • Subject has evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, or other determinations beyond what is consistent with the target population, in the investigator's judgment;
    • Subject has liver function testing abnormalities (ALT, AST , or total bilirubin) that are > 1 x ULN;

    Other Exclusions a. Subjects who are unable to be compliant with the visit schedule or protocol procedures.

  • Site Contact Information

    Holy Cross Neuroscience Research Institute
    Franco A Salas, RMA / .(JavaScript must be enabled to view this email address) / 954-229-7965
    Fort Lauderdale, Florida 33334
    United States

    Somnos/Neurology Associates Clinical Research
    Desi Eschiti, LPN / .(JavaScript must be enabled to view this email address) / 402-486-3410
    Kelli Ferguson / .(JavaScript must be enabled to view this email address) / 402-486-3410
    Lincoln, Nebraska 68506
    United States

    Neurosciences Institute, Neurology
    Lisa H Ranziger, RN / .(JavaScript must be enabled to view this email address) / 704-446-0803
    Charlotte, North Carolina 28207
    United States

    Wesley Neurology Clinic
    Cindy Benzel, LPN / .(JavaScript must be enabled to view this email address) / 901-752-3784
    Cordova, Tennessee 38018
    United States

    Texas Neurology
    Todd Morgan / .(JavaScript must be enabled to view this email address) / 214-827-3610
    Dallas, Texas 75214
    United States