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ACTIVE NOT RECRUITING
NCT05003648
PHASE4

Treating Leg Symptoms in Women With X-linked Adrenoleukodystrophy

Sponsor: Massachusetts General Hospital

View on ClinicalTrials.gov

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.

Official title: Treating Leg Symptoms in Women With X-linked Adrenoleukodystrophy: A Key to Improving Sleep and Gait Performance

Key Details

Gender

FEMALE

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

24

Start Date

2023-04-01

Completion Date

2026-05-01

Last Updated

2026-03-02

Healthy Volunteers

No

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

Locations (2)

Massachusetts General Hospital

Boston, Massachusetts, United States

University Medical Center of Amsterdam

Amsterdam, Netherlands