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Restless leg drug tested for rare disease in women

NCT ID NCT05003648

Symptom relief Sponsor: Massachusetts General Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 02, 2026 · Updated 2 times

Summary

This study looks at whether pramipexole, a drug used for restless leg syndrome, can ease leg symptoms in women with X-linked adrenoleukodystrophy (ALD). About 24 women will take the drug or a placebo for two months. The goal is to see if it improves sleep, walking, and quality of life.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Pramipexole
What this could lead to
If it works, this could point toward a treatment for restless leg syndrome in women with adrenoleukodystrophy, improving sleep and quality of life.
What could go wrong
This is a small, early-phase study with only 24 participants, so results may not apply to everyone. The drug may not work better than placebo, and side effects are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 24 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2023

Expected to finish

Sep 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

PHASE 1 (PREVALENCE STUDY) Inclusion Criteria: 1. Women of any ethnic origin. 2. Ability to provide verbal consent 3. A willingness and ability to comply with study procedures. 4. Age 18-75 years 5. Metabolically or genetically confirmed diagnosis of ALD Exclusion Criteria: 1\. Inflammatory brain demyelination PHASE 2 (CROSS-OVER STUDY) Inclusion Criteria: 1. Participation in Phase 1 2. Ability to provide written informed consent 3. Women with ALD who have Restless Leg Syndrome (IRLS \> 15) Exclusion Criteria: 1. Pregnant. Research staff perform pregnancy tests upon visit to center. 2. Participants with active or unstable major psychiatric disorder other than ALD, who, in the investigators' judgement, require further treatment 3. Use of dopaminergic agonists or antagonists within the last 30 days 4. Alcohol use disorder within the last 30 days 5. History of being treated for restless legs syndrome, specifically with dopamine agonist medications 6. Methamphetamine or benzodiazepine dependence in the last 30 days 7. Neurological disorder or cardiovascular disease raising safety concerns about use of pramipexole and/or judged to interfere with ability to assess efficacy of the treatment 8. Medical instability considered to interfere with study procedures 9. Renal disease judged to interfere with drug metabolism and excretion

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Conditions

The condition(s) this trial relates to.

adrenoleukodystrophy restless legs syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Adrenoleukodystrophy Restless legs syndrome

Contacts and locations

Locations

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • University Medical Center of Amsterdam

    Amsterdam, Netherlands

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