STRENGTH Study: Supplement Treatment Evaluation of L-carnitine for Muscle Fatigue and Weakness in Children with Neurofibromatosis Type 1

Phase 3

• Conditions: eurofibromatosis Type 1; Neurofibromatosis Type 1; Musculoskeletal - Other muscular and skeletal disorders; Metabolic and Endocrine - Other metabolic disorders; Human Genetics and Inherited Disorders - Other human genetics and inherited disorders

• Registration Number: ACTRN12624000781549
• Lead Sponsor: Royal North Shore Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-06-25
• Last Update Posted: 8 July 2024

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1.Patients aged 8 to 12 years and 13-17 years of age in the expanded age range, in the event of recruitment difficulty who fulfill the National Institutes of Health Consensus Conference diagnostic criteria for NF1 who have a self-reported history of muscle weakness will be invited to participate and

2.Must have given written informed consent (signed and dated) and any authorizations required by local law and be able to comply with all study requirements.

Exclusion Criteria

1.Have a severe cognitive impairment.
2.Unable to understand the PICF, and the study including requirements, benefits, and risks even with the assistance of an interpreter or a translator
3.Seizures
4.Skeletal abnormalities, e.g., tibial bowing and pseudarthrosis, acute foot or lower limb injuries, e.g., fracture and ankle sprain
5.Incapacity to comply with a research protocol, e.g., prolonged absence.
6.Have taken carnitine within the last month before commencing the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified