NCT06849115CompletedPhase 4
Effects of L-Carnitine in Amyotrophic Lateral Sclerosis Patients With CHCHD10 Mutations
Source: ClinicalTrials.gov · Last updated 8 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The study was designed as a single-center, open-label, single-arm pilot study to estimate the safety and efficacy L-carnitine in ALS patients with CHCHD10 mutations.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 4 (actual)
- First submitted
- 23 Feb 2025
- Start date
- 18 Jul 2024
- Primary completion date
- 19 Dec 2024
- Lead sponsor
- ChaodongWang
- Diseases
- ALS (motor neurone disease)
- NCT number
- NCT06849115
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 4
- From 18 Jul 2024 to the primary completion date, 19 Dec 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- History of known allergy to L-carnitine
- Clinically significant unstable medical condition (other than ALS) that would pose a risk to the subject if they were to participate in the study
Lab values
- Abnormal liver function defined as AST and/or ALT \> 3 times the upper limit of the normal
- Renal insufficiency as defined by eGFR \< 60 mL/min/1.73m2
Other
- Presence of tracheostomy
- Pregnant women or women currently breastfeeding
- Anything that, in the opinion of the Site Investigator, would place the subject at increased risk or preclude the subject's full compliance with or completion of the study.
Who the study is looking for
- Male or female, 18-80 years old
- ALS diagnosed as definite or probable as defined by the World Federation of Neurology revised El Escorial criteria
- Carrying pathogenic CHCHD10 mutations
- Capable of providing informed consent and following trial procedures
- Forced Vital Capacity (FVC) \>40% of predicted value for gender, height, and age at the Screening Visit
- Subjects develop at less moderate degree of motor dysfunction, with ALS-FRS-R total scores less than 46
- Both male and female patients must agree to use adequate birth control for the whole duration of the study within 30 weeks
- Subjects are willing and expected to complete the 30-week follow up, including 3 times hospitalization.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Xuanwu Hospital, Capital Medical University Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.