Phase
Condition
Neurologic Disorders
Amyotrophic Lateral Sclerosis (Als)
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
Novartis Investigative Site
North Ryde, New South Wales 2109
AustraliaActive - Recruiting
Novartis Investigative Site
Randwick, New South Wales 2031
AustraliaActive - Recruiting
Novartis Investigative Site
Herston, Queensland 4029
AustraliaActive - Recruiting
Novartis Investigative Site
Cauldfield, Victoria 3162
AustraliaActive - Recruiting
Novartis Investigative Site
SouthPort, 4215
AustraliaActive - Recruiting
Novartis Investigative Site
Leuven, 3000
BelgiumActive - Recruiting
Novartis Investigative Site
Liege, 4000
BelgiumActive - Recruiting
Novartis Investigative Site
Hamilton, Ontario L8N 3Z5
CanadaActive - Recruiting
Novartis Investigative Site
Montreal, Quebec H4A 3T2
CanadaActive - Recruiting
Novartis Investigative Site
Beijing, 100191
ChinaActive - Recruiting
Novartis Investigative Site
Aalborg, 9000
DenmarkActive - Recruiting
Novartis Investigative Site
Kobenhavn N V, 2400
DenmarkActive - Recruiting
Novartis Investigative Site
Nice, 06001
FranceActive - Recruiting
Novartis Investigative Site
Tours, 37044
FranceActive - Recruiting
Novartis Investigative Site
Luebeck, 23538
GermanyActive - Recruiting
Novartis Investigative Site
Munchen, 81675
GermanyActive - Recruiting
Novartis Investigative Site
Dublin, DUBLIN 9
IrelandActive - Recruiting
Novartis Investigative Site
Sendai city, Miyagi 980 8574
JapanActive - Recruiting
Novartis Investigative Site
Yangsan Si, Gyeongsangnam Do 50612
Korea, Republic ofActive - Recruiting
Novartis Investigative Site
Seoul, 05505
Korea, Republic ofActive - Recruiting
Novartis Investigative Site
Utrecht, 3584
NetherlandsActive - Recruiting
Novartis Investigative Site
Bydgoszcz, 85-163
PolandActive - Recruiting
Novartis Investigative Site
Krakow, 30-721
PolandActive - Recruiting
Novartis Investigative Site
Warszawa, 01-684
PolandActive - Recruiting
Novartis Investigative Site
Barcelona, Catalunya 08003
SpainActive - Recruiting
Novartis Investigative Site
Malmo, 214 28
SwedenActive - Recruiting
Novartis Investigative Site
Umea, SE-90185
SwedenActive - Recruiting
Novartis Investigative Site
Basel, 4031
SwitzerlandActive - Recruiting
Novartis Investigative Site
St Gallen, 9007
SwitzerlandActive - Recruiting
Novartis Investigative Site
London, WC1N 3BG
United KingdomActive - Recruiting
University of California San Diego
La Jolla, California 92037
United StatesActive - Recruiting
Keck Medical Center USC
Los Angeles, California 90033
United StatesActive - Recruiting
UC San Francisco Medical Center
San Francisco, California 94143
United StatesActive - Recruiting
Orlando Health Clinical Trials
Orlando, Florida 32806
United StatesActive - Recruiting
Emory University School of Medicine
Atlanta, Georgia 30322
United StatesActive - Recruiting
University Of Kansas Medical Center
Kansas City, Kansas 66160
United StatesActive - Recruiting
Massachusetts General Hospital
Boston, Massachusetts 02114
United StatesActive - Recruiting
Neurology Associates P C
Lincoln, Nebraska 68506-2960
United StatesActive - Recruiting
Lange Neurology PC
New York, New York 10065
United StatesActive - Recruiting
University of Cincinnati Medical Center
Cincinnati, Ohio 45219
United StatesActive - Recruiting
The Ohio State University
Columbus, Ohio 43210
United StatesActive - Recruiting
AMR Knoxville
Knoxville, Tennessee 37920
United StatesActive - Recruiting
Nerve and Muscle Center of Texas
Houston, Texas 77030
United StatesActive - Recruiting
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