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Treating Leg Symptoms in Women With X-linked Adrenoleukodystrophy

NCT05003648 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2026-03-02

No results posted yet for this study

Summary

The investigators recently observed that up to 25% of women with X-linked adrenoleukodystrophy (ALD) have moderate to severe Restless Leg Syndrome (RLS). In this study, the investigators aim to estimate the prevalence of RLS among women with ALD and to assess whether pramipexole improves RLS symptoms as well as sleep and gait measures in women with ALD.

Conditions

  • Adrenoleukodystrophy
  • Restless Legs Syndrome

Interventions

DRUG

Pramipexole

Participants will be started on 0.125 mg pramipexole for the first week. If this dose is well tolerated but not effective, the dose can be increased to 0.25 mg for the following week. If this dose is well tolerated but not effective, the dose can be further increased to 0.5 mg for the remainder of the 2-month period.

DRUG

Placebo

Matching placebo

Sponsors & Collaborators

  • European Leukodystrophy Association

    collaborator OTHER

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Florian S Eichler, MD · Massachusetts General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-01
Primary Completion
2025-07-15
Completion
2026-05-01
FDA Drug
Yes

Countries

  • United States
  • Netherlands

Study Locations

More Related Trials

Entities

Drugs

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 NCT05003648 on ClinicalTrials.gov