A.O.U. Policlinico G. Martino Di Messina
Verified
Messina, Italy
RecruitingRare disease
Study of Riluzole for Patients with Spinocerebellar Ataxia Type 7
Fast replyRegistered drug
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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 a condition called Spinocerebellar Ataxia type 7 (SCA7), which is a rare genetic disorder that affects movement and coordination. The study is testing a medication called Riluzole, which is available in a form known as Glentek 50 mg film-coated tablets. The purpose of the study is to compare the effects of Riluzole with a placebo, which is a substance with no active medication, to see if Riluzole can help patients maintain stability in their movement and vision over time.
Participants in the study will be randomly assigned to receive either Riluzole or the placebo. The study will be conducted in a double-blind manner, meaning neither the participants nor the researchers will know who is receiving the actual medication or the placebo. This helps ensure that the results are not influenced by expectations. The trial will last for a period of 18 months, during which participants will be monitored for changes in their condition, specifically looking at their movement abilities and vision clarity.
Throughout the study, participants will undergo various assessments to track their progress. These assessments will include tests for movement coordination and vision, such as the SARA score, which measures ataxia symptoms, and visual acuity tests. The safety of Riluzole will also be evaluated by monitoring any side effects or changes in health. The goal is to determine if Riluzole can help stabilize the symptoms of SCA7 and improve the quality of life for those affected by this condition.
The research process
The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.
Who can join the trial?
4 criteria
- Both males and females can participate.
- Participants must be older than 6 years.
- A positive genetic test for Spinocerebellar ataxia type 7 (SCA7) is required.
- A signed informed consent is necessary. For minors, this must be obtained from parents or a legal representative.
Who cannot join the trial?
10 criteria
- Patients with any other serious health condition that could interfere with the study.
- Patients who are pregnant or breastfeeding.
- Patients who have participated in another clinical trial within the last 30 days.
- Patients who have a history of drug or alcohol abuse within the past year.
- Patients who are unable to comply with the study procedures.
- Patients who have a known allergy to any of the study medications.
- Patients with a history of certain eye diseases that could affect the study results.
- Patients who have had a major surgery within the last 3 months.
- Patients with uncontrolled high blood pressure.
- Patients with severe liver or kidney disease.
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Verified sites
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Azienda Unita Sanitaria Locale Di Bologna
VerifiedBologna, ItalyUniversita Degli Studi Di Roma La Sapienza
ResponsiveRome, Italy
Trial locations
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Investigated drugs
Riluzole is a medication that is being tested in this clinical trial for its potential benefits in patients with SpinoCerebellar Ataxia type 7. This condition affects the brain and can lead to problems with movement and coordination. Riluzole is already used to treat another neurological condition called Amyotrophic Lateral Sclerosis (ALS), where it helps to slow down the progression of symptoms. In this trial, researchers want to see if Riluzole can help patients with SpinoCerebellar Ataxia type 7 by keeping their symptoms stable, particularly focusing on their movement abilities and vision over an 18-month period.
What is already known about the treatment
Riluzole (Glentek) – Riluzole is administered orally in the form of tablets. It is currently being studied in clinical trials for its potential use in treating Spinocerebellar Ataxia type 7 (SCA7), a rare genetic disorder. The main therapeutic indication for Riluzole in this trial is to help stabilize patients' motor function and visual acuity over an 18-month period. At the molecular level, Riluzole works by modulating the activity of certain neurotransmitters in the brain, which may help protect nerve cells from damage. It is classified pharmacologically as a neuroprotective agent.
Investigated diseases
Spinocerebellar ataxia type 7 (SCA7) – Spinocerebellar ataxia type 7 is a genetic disorder characterized by progressive problems with movement and coordination. It primarily affects the cerebellum, the part of the brain that controls balance and coordination, leading to symptoms such as unsteady walking, difficulty with fine motor tasks, and slurred speech. Over time, individuals with SCA7 may experience worsening of these symptoms, along with vision problems due to retinal degeneration. The disease is caused by a mutation in the ATXN7 gene, which leads to the production of an abnormal protein that accumulates in cells, causing damage. As the condition progresses, individuals may also develop muscle weakness and difficulty swallowing. SCA7 is inherited in an autosomal dominant pattern, meaning one copy of the altered gene in each cell is sufficient to cause the disorder.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-518962-29-00Protocol codeAIFA-2016-02365063Estimated enrolment34 patientsSponsorUniversita Degli Studi Di Roma La Sapienza
sourced from the EU Clinical Trials Register and site verification
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