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Dimethyl Fumarate in Adrenomyeloneuropathy

NCT06513533 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-07-25

No results posted yet for this study

Summary

The goal of this clinical trial is to determine if dimethyl fumarate is effective in treating motor problems in adults with Adrenomyeloneuropathy. The trial will also assess the safety of dimethyl fumarate and explore the molecular mechanisms underlying the disease. The primary questions it aims to answer are:

* Does dimethyl fumarate improve motor problems in participants?
* What medical issues do participants experience while taking dimethyl fumarate? Researchers will compare the effects of dimethyl fumarate to a placebo (a substance that looks like the drug but contains no active ingredients) to evaluate its effectiveness in treating Adrenomyeloneuropathy.

Participants will:

* Take either dimethyl fumarate or a placebo daily for 36 months.
* Visit the clinic at the start of the trial, then at 3 months, 6 months, and every 6 months thereafter for checkups and tests.

Conditions

  • Adrenomyeloneuropathy Without Cerebral Involvement

Interventions

OTHER

Placebo

1 tablet twice daily (one in the morning and one in the evening) for the first 7 days as a starter dose followed by 2 tablets (240 mg) twice daily

DRUG

Dimethyl fumarate

1 tablet twice daily (one in the morning and one in the evening) for the first 7 days as a starter dose followed by 2 tablets (240 mg) twice daily

Sponsors & Collaborators

  • Instituto de Salud Carlos III

    collaborator OTHER_GOV

  • Spanish Clinical Research Network - SCReN

    collaborator NETWORK

  • Institut d'Investigació Biomèdica de Bellvitge

    collaborator OTHER

  • Pujol, Aurora, M.D.

    lead INDIV

Principal Investigators

  • Carlos Casasnovas, MD, PhD · Bellvitge University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-23
Primary Completion
2028-03-31
Completion
2028-06-30

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06513533 on ClinicalTrials.gov