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New treatment option for Amyotrophic Lateral Sclerosis (ALS)
Official title Hypercaloric PEG Nutrition in ALS to Sustain Energy Homeostasis
ClinicalTrials.gov ID: NCT06877143
What this study is testing
- What it's testing
- Weight loss is a known negative prognostic factor in amyotrophic lateral sclerosis (ALS). Over the last years, various interventional studies targeting the energy deficit in ALS yielded promising results; however,it is still unclear which kind of nutrition or nutritional supplement is most beneficial.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
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
- Possible, probable (clinically or laboratory) or definite ALS according to the revised version of the El Escorial World Federation of Neurology...
- Loss of ALS functional rating scale revised (ALSFRS-R) of ≥ 0.33 points per month since onset (first paresis) based on the formula: (48 - Score at...
- Nutrition via PEG
- Age ≥18 years
- Intake of a stable dose of riluzole for at least 4 weeks, or no riluzole
You likely can't join if
- Previous participation in another treatment study within the preceding 4 weeks
- Absence of adequate social support and cooperation, or personal motivation (in the judgment of the investigator) to complete the study satisfactorily
- Pregnancy or breast-feeding females
- Evidence of a major psychiatric disorder or clinically evident dementia
See the full eligibility criteria
- Possible, probable (clinically or laboratory) or definite ALS according to the revised version of the El Escorial World Federation of Neurology criteria 1
- Loss of ALS functional rating scale revised (ALSFRS-R) of ≥ 0.33 points per month since onset (first paresis) based on the formula: (48 - Score at Screening Visit) / (Months between Onset and Screening Visit)
- Nutrition via PEG
- Age ≥18 years
- Intake of a stable dose of riluzole for at least 4 weeks, or no riluzole
- Capable of thoroughly understanding all information given and giving full informed consent according to GCP
- Previous participation in another treatment study within the preceding 4 weeks
- Absence of adequate social support and cooperation, or personal motivation (in the judgment of the investigator) to complete the study satisfactorily
- Pregnancy or breast-feeding females
- Evidence of a major psychiatric disorder or clinically evident dementia
The study team makes the final eligibility decision.
Where it's taking place
- Ulm, Baden-Wurttemberg, Germany
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 Ulm, Baden-Wurttemberg, Germany. Enter your location above to see the nearest site and check your eligibility.
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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.