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New treatment option for Amyotrophic Lateral Sclerosis ALS
Official title Intestinal Microbiome Transplant in ALS
ClinicalTrials.gov ID: NCT07017946
What this study is testing
What is MTP-101C?
MTP-101C is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for amyotrophic lateral sclerosis als.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a 24-week study of intestinal microbiome transplant in people with ALS. All participants will be evaluated clinically in person for 4 visits.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Diagnosis of ALS according to Gold Coast Criteria
- Age: 18+ years at enrollment
- Fast-progressing (ALSFRS-R change of at least 1.5 points per month between last 2 measurements at screening)
- Modestly but not severely affected (ALSFRS-R score at or above 24 at screening)
- Able to swallow capsules and expected to be able to for the duration of the trial (ALSFRS-R "swallowing" score of 3 or 4 at screening)
You likely can't join if
- Concurrent illness or laboratory abnormalities that could confound the measurement of ALS progression or the microbiome or interfere with the ability...
- Taking probiotics, nutraceuticals, or herbal remedies within 2 weeks of screening
- Taking antibiotics within 3 months of screening.
- Taking any investigational study drug within 30 days of screening or five half-lives of the prior agent.
- Previous exposure to MTT.
- Pregnancy.
See the full eligibility criteria
- Diagnosis of ALS according to Gold Coast Criteria
- Age: 18+ years at enrollment
- Fast-progressing (ALSFRS-R change of at least 1.5 points per month between last 2 measurements at screening)
- Modestly but not severely affected (ALSFRS-R score at or above 24 at screening)
- Able to swallow capsules and expected to be able to for the duration of the trial (ALSFRS-R "swallowing" score of 3 or 4 at screening)
- Expected to survive for the duration of the trial
- Taking any combination of riluzole, edaravone, and/or tofersen at a stable dose for 30 days prior to screening, or not taking any of these and not expected to during the study.
- Capable of giving written consent.
- If sexually active, must agree to use contraceptive or abstinence for duration of treatment.
- Females of child-bearing age must have negative pregnancy test at screening.
- Concurrent illness or laboratory abnormalities that could confound the measurement of ALS progression or the microbiome or interfere with the ability to complete the study.
- Taking probiotics, nutraceuticals, or herbal remedies within 2 weeks of screening
- Taking antibiotics within 3 months of screening.
- Taking any investigational study drug within 30 days of screening or five half-lives of the prior agent.
- Previous exposure to MTT.
- Pregnancy.
- Known specific food allergy with anaphylaxis
- Other co-morbid conditions that, in the opinion of the study investigator, place the participant at increased risk of complications, interfere with study participation or compliance, or confound study objectives.
The study team makes the final eligibility decision.
Where it's taking place
- Durham, North Carolina, United States
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 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Durham, North Carolina, United States. 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 ClinicalTrials.gov; the study team decides eligibility.