BridgeMD
A clinical trial to learn about the effects of VHB937 in people with amyotrophic lateral sclerosis (ALS)
EU CTIS ID: 2024-512536-29-00
What this study is testing
To compare the efficacy of VHB937 vs. placebo on a composite of permanent assisted ventilation (PAV) free survival and function in DB epoch
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Signed informed consent must be obtained prior to participation in the study.
- Sporadic or familial ALS diagnosed using the revised El Escorial criteria as clinically possible, probable, lab-supported probable, or definite ALS.
- Age 18 years or older (19 years of age for S. Korea population according to the local adult age standard).
- Onset of ALS symptoms within 24 months.
- Slow Vital Capacity (SVC) greater or equal to 60% of predicted capacity for age, height, and sex.
- ALSFRS-R total score greater or equal to 30
You likely can't join if
- Use of other investigational drugs within 5 half-lives of screening, or within 30 days (e.g., small molecules) / or until the expected pharmacodynamic effect has returned to baseline (e.g., biologics), whichever is longer; or longer if required by local regulations.
- Taking any prohibited medications as listed on Table 6-4 of the protocol.
- Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception while taking study treatment and for 24 weeks after stopping study medication.
- History or current diagnosis of cardiac conditions or ECG abnormalities indicating significant risk of safety for participants in the study.
- Clinical evidence of liver or renal disease/injury.
- Laboratory evidence of hematological abnormalities
See the full eligibility criteria
- Signed informed consent must be obtained prior to participation in the study.
- Sporadic or familial ALS diagnosed using the revised El Escorial criteria as clinically possible, probable, lab-supported probable, or definite ALS.
- Age 18 years or older (19 years of age for S. Korea population according to the local adult age standard).
- Onset of ALS symptoms within 24 months.
- Slow Vital Capacity (SVC) greater or equal to 60% of predicted capacity for age, height, and sex.
- ALSFRS-R total score greater or equal to 30
- Treated or untreated with SoC therapy for ALS. If treated, must be on a stable dose of riluzole, for ≥ 30 days and/or edaravone oral or i.v. having completed at least one on-drug cycle prior to randomization.
- Able and willing to travel to the site with or without assistance from their support network.
- Use of other investigational drugs within 5 half-lives of screening, or within 30 days (e.g., small molecules) / or until the expected pharmacodynamic effect has returned to baseline (e.g., biologics), whichever is longer; or longer if required by local regulations.
- Taking any prohibited medications as listed on Table 6-4 of the protocol.
- Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception while taking study treatment and for 24 weeks after stopping study medication.
- History or current diagnosis of cardiac conditions or ECG abnormalities indicating significant risk of safety for participants in the study.
- Clinical evidence of liver or renal disease/injury.
- Laboratory evidence of hematological abnormalities
- Active moderate or severe psychiatric disease, cognitive impairment, neurological disease other than ALS, dementia or substance abuse that would impair ability of the participant 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, uncontrolled diabetes
- History of active severe respiratory disease.
The study team makes the final eligibility decision.
Where it's taking place
- Australia
- China
- Korea, Republic of
- Japan
- Canada
- United States
- Switzerland
- United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Australia; China; Korea, Republic of; Japan; Canada; United States and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.