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Dopamine Agonist

Pramipexole for Restless Legs Syndrome in ALD

Phase 4
Recruiting
Led By Florian S Eichler, MD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 18-75 years
Women with ALD who have Restless Leg Syndrome (IRLS > 15)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 8 and week 17
Awards & highlights

Study Summary

This trial will study whether a medication called pramipexole can help reduce symptoms of restless leg syndrome (RLS) in women with a rare disorder called X-linked adrenoleukodystrophy (ALD).

Who is the study for?
This trial is for women aged 18-75 with X-linked adrenoleukodystrophy (ALD) who suffer from moderate to severe Restless Leg Syndrome (RLS). Participants must have a confirmed diagnosis of ALD, be able to consent, and comply with study procedures. Exclusions include recent alcohol or drug dependence, pregnancy, prior RLS treatment with dopamine agonists, certain medical conditions like renal disease or inflammatory brain issues, and use of dopaminergic drugs within the last month.Check my eligibility
What is being tested?
The study aims to determine how common RLS is in women with ALD and if pramipexole can improve their symptoms. It will also look at sleep quality and walking ability. Women participating will either receive pramipexole or a placebo without knowing which one they are taking.See study design
What are the potential side effects?
Pramipexole may cause dizziness, nausea, sleepiness during daytime activities; it might also lead to sudden onset of sleep which could be dangerous while driving or doing other tasks that require alertness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 75 years old.
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I am a woman with ALD and have severe restless leg syndrome.
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I have been diagnosed with ALD through genetic or metabolic testing.
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I can give my verbal consent.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-intervention
This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-intervention for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in the International Restless Legs Severity (IRLS) score
Prevalence of Restless Leg Syndrome in Women with X-linked Adrenoleukodystrophy
Secondary outcome measures
Change in quality of sleep and leg movements per hour of sleep measured by Polysomnography
Change in sleep/wake parameters measured by actigraphy
Change in the 13-item Spasticity Screening Tool score
+10 more

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: PramipexoleActive Control1 Intervention
Participants will be on the pramipexole arm for 2 months and will then cross over to the placebo arm for 2 months
Group II: PlaceboPlacebo Group1 Intervention
Participants will be on the placebo arm for 2 months and will then cross over to the pramipexole arm for 2 months

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
2,933 Previous Clinical Trials
13,198,533 Total Patients Enrolled
European Leukodystrophy AssociationOTHER
6 Previous Clinical Trials
134 Total Patients Enrolled
2 Trials studying Adrenoleukodystrophy
99 Patients Enrolled for Adrenoleukodystrophy
Florian S Eichler, MDPrincipal InvestigatorMassachusetts General Hospital
1 Previous Clinical Trials
18 Total Patients Enrolled

Media Library

Pramipexole (Dopamine Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT05003648 — Phase 4
Adrenoleukodystrophy Research Study Groups: Placebo, Pramipexole
Adrenoleukodystrophy Clinical Trial 2023: Pramipexole Highlights & Side Effects. Trial Name: NCT05003648 — Phase 4
Pramipexole (Dopamine Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05003648 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Treating Leg Symptoms in Women With X-linked Adrenoleukodystrophy
Florian Eichler 2023. "Treating Leg Symptoms in Women With X-linked Adrenoleukodystrophy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05003648.
All > Krabbe Disease
~11 spots leftby Apr 2025
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