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Open-label Study to Evaluate Safety, Tolerability and PK of BHV-0223 in ALS | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

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

NCT03520517•Biohaven Pharmaceuticals, Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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;
+1 more criteria

Locations (5)

Holy Cross Neuroscience Research Institute

Fort Lauderdale, Florida, United States

Somnos/Neurology Associates Clinical Research

Lincoln, Nebraska, United States

Neurosciences Institute, Neurology - Charlotte

Charlotte, North Carolina, United States

Wesley Neurology Clinic

Cordova, Tennessee, United States

Texas Neurology

Dallas, Texas, United States

Key Dates

Start Date

February 2, 2018

Primary Completion Date

October 8, 2018

Completion Date

October 8, 2018

Last Updated

October 6, 2022

Enrollment

ACTUAL participants

Conditions

Amyotrophic Lateral SclerosisALSLou Gehrig DiseaseLou Gehrig's DiseaseLou-Gehrigs DiseaseMotor Neuron Disease, Amyotrophic Lateral Sclerosis

Interventions

BHV-0223

DRUG

Turkish Validity and Reliability Study of PRevention of Toxic Chemicals in the Environment for Children Tool

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Healthy Adult ParticipantsToxic Chemicals+1 more

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RECRUITINGNA

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Cerebral Palsy

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 6, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Turkish Validity and Reliability Study of PRevention of Toxic Chemicals in the Environment for Children Tool

Effects of Treadmill Training and Whole-body Vibration in Children With Cerebral Palsy

The EXOPULSE Study - a Database for Routine Follow-up of Clinical Outcomes

Pridopidine Phase 3 Study to Evaluate Efficacy and Safety in ALS

Sleep Quality and Caregiver Burden in Children With Cerebral Palsy

Effects of Play Based Neural Mobilisation Activities on Hand Grip Strength and Dexterity in Cerebral Palsy Children