Phase
Condition
Amyotrophic Lateral Sclerosis (Als)
Neurologic Disorders
Scar Tissue
Treatment
VHB837
Placebo
VHB937
Clinical Study ID
Ages 18-100 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
are 18 years of age or older
male or female, if of childbearing potential, strict contraception required
have ALS confirmed by the trial doctors using different tests.
have mild symptoms of ALS as measured by the ALSFRS-R questionnaire (total score >=30).
have had symptoms of ALS (weakness) within 24 months of taking part in this trial.
have not received treatment for ALS or are currently on a stable dose of an approvedtreatment for ALS.
have the ability to slowly exhale a volume of air at least 60% of what is expectedfor the participant's sex, height and age.
Exclusion
Exclusion Criteria:
Use of other investigational drugs within 5 half-lives of screening, or within 30days (e.g., small molecules) / or until the expected pharmacodynamic effect hasreturned to baseline (e.g., biologics), whichever is longer; or longer if requiredby local regulations.
Women of child-bearing potential, defined as all women physiologically capable ofbecoming pregnant, unless they are using highly effective methods of contraceptionwhile taking study treatment and for 24 weeks after stopping study medication.
History or current diagnosis of cardiac conditions or ECG abnormalities indicatingsignificant risk of safety for participants in the study.
Clinical evidence of liver or renal disease/injury.
Laboratory evidence of hematological abnormalities
Presence of unstable psychiatric disease, cognitive impairment, neurological diseaseother than ALS, dementia or substance abuse that would impair ability of theparticipant to provide informed consent, in the investigator's opinion.
Participants that reported 'yes' on any suicidal ideation section except for the "Non-Suicidal Self-Injurious Behavior" in the past 2 years as per C-SSRS.
Presence of cancer, HIV, Hep B, Hep C, tuberculosis, uncontrolled diabetes
History of active severe respiratory disease, including Chronic ObstructivePulmonary Disease, interstitial lung disease or pulmonary fibrosis.
Taking any prohibited medications
Study Design
Study Description
Connect with a study center
Nerve and Muscle Center of Texas
Houston, Texas 77030
United StatesActive - Recruiting
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