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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03520517
Recruitment Status : Completed
First Posted : May 9, 2018
Last Update Posted : August 22, 2019
Sponsor:
Collaborator:
Cognitive Research Corporation
Information provided by (Responsible Party):
Biohaven Pharmaceuticals, Inc.

Tracking Information
First Submitted Date  ICMJE April 17, 2018
First Posted Date  ICMJE May 9, 2018
Last Update Posted Date August 22, 2019
Actual Study Start Date  ICMJE February 2, 2018
Actual Primary Completion Date October 8, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 8, 2018)
Incidence of Treatment Emergent Adverse Events (Safety and Tolerability) [ Time Frame: Through Week 8 (Day 57) ]
Incidence of treatment emergent adverse events (safety and tolerability) as measured through laboratory tests and physical exam findings.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 8, 2018)
BHV-0223 Concentrations in Blood at Days 1, 29 and 57 [ Time Frame: Through Week 8 (Day 57) ]
BHV-0223 concentrations at days 1, 29 and 57 through blood collections at days 1, 29 and 57.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Open-label Study to Evaluate Safety, Tolerability and PK of BHV-0223 in ALS
Official Title  ICMJE Open-Label Study to Evaluate Safety, Tolerability and Pharmacokinetics of Multiple Doses of BHV-0223 in Subjects With Amyotrophic Lateral Sclerosis
Brief Summary Phase 1, open-label study of BHV-0223 in ALS.
Detailed Description 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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Amyotrophic Lateral Sclerosis
  • ALS
  • Lou Gehrig Disease
  • Lou Gehrig's Disease
  • Lou-Gehrigs Disease
  • Motor Neuron Disease, Amyotrophic Lateral Sclerosis
Intervention  ICMJE Drug: BHV-0223
BHV-0223, 40 mg BID
Study Arms  ICMJE Experimental: BHV-0223
riluzole 40 mg sublingual tablet
Intervention: Drug: BHV-0223
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 3, 2018)
22
Original Estimated Enrollment  ICMJE
 (submitted: May 8, 2018)
20
Actual Study Completion Date  ICMJE October 8, 2018
Actual Primary Completion Date October 8, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Subjects with diagnosed ALS by the revised El Escorial diagnostic criteria, including laboratory supported probable, probable, or definite ALS;
  2. 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;
  3. Subjects determined by the investigator to be medically stable;
  4. Subjects determined by the investigator to be willing and physically able to complete the study as designed, with or without caregiver assistance.

Exclusion Criteria:

  1. Target Disease Exceptions
  2. Medical History Exceptions

    1. Subject is known to have a current diagnosis of acute or chronic viral hepatitis;
    2. Subject is known to have any other acute or chronic liver disease that is clinically significant in the investigator's judgment;
    3. 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;
    4. Any other sound medical, psychiatric and/or social reason in the investigator's judgment;
  3. Physical and Laboratory Test Findings

    1. Positive urine pregnancy test in WOCBP at screening;
    2. 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;
    3. Subject has liver function testing abnormalities (ALT, AST , or total bilirubin) that are > 1 x ULN;
  4. Other Exclusions a. Subjects who are unable to be compliant with the visit schedule or protocol procedures.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03520517
Other Study ID Numbers  ICMJE BHV0223-103
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Biohaven Pharmaceuticals, Inc.
Study Sponsor  ICMJE Biohaven Pharmaceuticals, Inc.
Collaborators  ICMJE Cognitive Research Corporation
Investigators  ICMJE Not Provided
PRS Account Biohaven Pharmaceuticals, Inc.
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP