Open-label Study to Evaluate Safety, Tolerability and PK of BHV-0223 in ALS
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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 : October 6, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Amyotrophic Lateral Sclerosis ALS Lou Gehrig Disease Lou Gehrig's Disease Lou-Gehrigs Disease Motor Neuron Disease, Amyotrophic Lateral Sclerosis | Drug: BHV-0223 | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 22 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Open-Label Study to Evaluate Safety, Tolerability and Pharmacokinetics of Multiple Doses of BHV-0223 in Subjects With Amyotrophic Lateral Sclerosis |
Actual Study Start Date : | February 2, 2018 |
Actual Primary Completion Date : | October 8, 2018 |
Actual Study Completion Date : | October 8, 2018 |

Arm | Intervention/treatment |
---|---|
Experimental: BHV-0223
riluzole 40 mg sublingual tablet
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Drug: BHV-0223
BHV-0223, 40 mg BID |
- 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.
- 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.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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
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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;
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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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03520517
United States, Florida | |
Holy Cross Neuroscience Research Institute | |
Fort Lauderdale, Florida, United States, 33334 | |
United States, Nebraska | |
Somnos/Neurology Associates Clinical Research | |
Lincoln, Nebraska, United States, 68506 | |
United States, North Carolina | |
Neurosciences Institute, Neurology - Charlotte | |
Charlotte, North Carolina, United States, 28207 | |
United States, Tennessee | |
Wesley Neurology Clinic | |
Cordova, Tennessee, United States, 38018 | |
United States, Texas | |
Texas Neurology | |
Dallas, Texas, United States, 75214 |
Responsible Party: | Biohaven Pharmaceuticals, Inc. |
ClinicalTrials.gov Identifier: | NCT03520517 |
Other Study ID Numbers: |
BHV0223-103 |
First Posted: | May 9, 2018 Key Record Dates |
Last Update Posted: | October 6, 2022 |
Last Verified: | February 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Amyotrophic Lateral Sclerosis ALS Biohaven Motor Neuron Disease, Amyotrophic Lateral Sclerosis Lou Gehrig's Disease Lou-Gehrigs Disease Lou Gehrig Disease |
Riluzole Rilutek® Neuroprotective Agents Administration, Sublingual Administration, Oral Biological Availability |
Motor Neuron Disease Amyotrophic Lateral Sclerosis Sclerosis Pathologic Processes Neurodegenerative Diseases Nervous System Diseases |
Neuromuscular Diseases Spinal Cord Diseases Central Nervous System Diseases TDP-43 Proteinopathies Proteostasis Deficiencies Metabolic Diseases |