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Study on Pramipexole for Treating Restless Legs in Women with X-linked Adrenoleukodystrophy

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a medication called Pramipexole Viatris on women with a rare genetic condition known as X-linked adrenoleukodystrophy (X-ALD). This condition can lead to various symptoms, including issues with leg movement, often referred to as restless legs syndrome (RLS). The purpose of the study is to explore how common RLS is in women with X-ALD and to see if the medication can help improve symptoms related to leg movement, sleep, and walking.

Participants in the study will take the medication in the form of a tablet, which is taken orally. The study will last for a period of up to 16 weeks. During this time, researchers will monitor changes in sleep patterns, mood, and overall quality of life. The study will also assess how the medication affects the ability to walk and perform daily activities. Some participants may receive a placebo instead of the actual medication to help compare the effects.

The trial aims to gather valuable information that could lead to better treatment options for women with X-ALD who experience restless legs. By understanding the impact of Pramipexole Viatris on these symptoms, researchers hope to improve the quality of life for those affected by this condition. The study is expected to conclude by the end of 2025.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Participation begins with the confirmation of eligibility. This includes being a woman aged 18 or older with a confirmed diagnosis of X-linked adrenoleukodystrophy (ALD).

    Verbal consent is required to proceed with the study.

  2. Step 2

    Phase 1 participation

    During this phase, the focus is on determining the prevalence of Restless Leg Syndrome (RLS) in women with ALD.

    Participants must demonstrate a willingness and ability to comply with study procedures.

  3. Step 3

    Phase 2 eligibility

    Eligibility for Phase 2 requires participation in Phase 1 and a diagnosis of Restless Leg Syndrome with a score greater than 15 on the International Restless Legs Scale (IRLS).

    Written informed consent is necessary to continue.

  4. Step 4

    Medication administration

    Participants will receive Pramipexole Viatris 0.088 mg tablets to be taken orally.

    The medication is administered to address leg symptoms associated with ALD and improve sleep and gait performance.

  5. Step 5

    Monitoring and assessment

    Primary endpoints include subjective assessments of total sleep time, sleep latency, and time awake after sleep onset.

    Additional evaluations involve depressive and anxiety symptoms, quality of life measures, and functional assessments.

  6. Step 6

    Completion of study

    The study is estimated to conclude by December 31, 2025.

    Participants will be monitored throughout the study duration to assess the effectiveness of the treatment.

Who can join the trial?

9 criteria

  • Participants must be women.
  • Participants must be able to provide verbal consent, meaning they can agree to participate by speaking.
  • Participants must be willing and able to follow the study procedures, which are the steps and activities involved in the study.
  • Participants must be 18 years old or older.
  • Participants must have a confirmed diagnosis of ALD, which means they have been medically tested and found to have X-linked adrenoleukodystrophy.
  • Participants must have taken part in Phase 1 of the study.
  • Participants must be able to provide written informed consent, meaning they can agree to participate by signing a document.
  • Participants must be women with ALD who also have Restless Leg Syndrome with a score greater than 15 on the IRLS scale, which measures the severity of Restless Leg Syndrome.
  • Participants must use adequate contraception, which means they must use effective methods to prevent pregnancy.

Who cannot join the trial?

4 criteria

  • Men cannot participate in the study. Only women are eligible.
  • Individuals who do not have the medical condition called X-linked adrenoleukodystrophy (ALD) cannot participate. ALD is a genetic disorder that affects the nervous system and adrenal glands.
  • Individuals who do not have Restless Legs Syndrome (RLS) cannot participate. RLS is a condition that causes an uncontrollable urge to move the legs, usually due to an uncomfortable sensation.
  • Children under the age of 3 and adults over the age of 4 cannot participate. The study is focused on a specific age range.
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Verified sites

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  • Amsterdam UMC

    Responsive

    The NetherlandsAmsterdam, The Netherlands

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Investigated drugs

Ropinirole is a medication used in this trial to help manage symptoms of Restless Legs Syndrome (RLS). It works by mimicking the action of dopamine, a natural substance in the brain that helps control movement. This medication is often used to improve sleep and reduce discomfort in the legs, which can be particularly beneficial for women with X-linked Adrenoleukodystrophy (ALD) experiencing RLS.

What is already known about the treatment

Gabapentin – Gabapentin is typically administered orally in the form of capsules, tablets, or an oral solution. It is currently well-documented in medical literature and is widely used in clinical practice. The main therapeutic indications for gabapentin include the treatment of restless legs syndrome (RLS) and certain types of nerve pain. At the molecular level, gabapentin works by affecting the way nerves send messages to the brain, which helps to reduce symptoms of nerve pain and discomfort. It is classified as an anticonvulsant and is also used to treat seizures.

Investigated diseases

  • X-linked adrenoleukodystrophy

    This is a genetic disorder that affects the nervous system and adrenal glands. It is caused by mutations in the ABCD1 gene, leading to the accumulation of very long-chain fatty acids in the body. The disease primarily affects males and can lead to a range of neurological symptoms. These symptoms may include muscle stiffness, weakness, and problems with coordination. Over time, individuals may experience progressive neurological decline. The severity and progression can vary widely among those affected.

  • Restless legs syndrome

    This is a condition characterized by an uncontrollable urge to move the legs, usually due to uncomfortable sensations. It typically occurs in the evening or nighttime hours when a person is sitting or lying down. Moving the legs often provides temporary relief from the discomfort. The sensations can range from mild to severe and may disrupt sleep. The exact cause is not fully understood, but it may involve an imbalance of dopamine in the brain. The condition can affect daily activities and quality of life.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-518989-27-01Protocol codeRLSEstimated enrolment50 patientsSponsorAmsterdam UMC Stichting

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