Ongoing Clinical Trials for Cerebellar Ataxia
This article provides information about ongoing clinical trials for cerebellar ataxia, a condition affecting balance and coordination. Currently, there is 1 clinical trial investigating potential treatments for patients with this condition, particularly when associated with mitochondrial disorders. The trial is being conducted in Spain and focuses on testing a form of coenzyme Q10 called Ubiquinol.
Clinical trial locations
Study on the Effects of Ubiquinol and Ascorbic Acid for Patients with Mitochondrial Disorders and Cerebellar Ataxias
This clinical trial investigates whether Ubiquinol, a form of coenzyme Q10, can help patients who have cerebellar ataxia with or without mitochondrial disorders. Coenzyme Q10 is a substance naturally found in the body that helps cells produce energy. The study provides Ubiquinol as a powder mixed with liquid and taken by mouth over an 18-month period.
Who can participate:
- Patients aged 1 to 90 years old
- Those with a confirmed genetic diagnosis of mitochondrial disease, or those with cerebellar ataxia (with or without a specific genetic diagnosis)
- People with a Gross Motor Function Classification System level of less than 4, meaning they have some ability to move and perform activities
- Participants must stop taking other forms of coenzyme Q10 supplements and statin medications for 30 days before starting the study and throughout the trial
- Those who can have children must agree to use effective birth control during the study and for 30 days after the last dose
- For children under 18, parents or legal guardians must provide consent, and participants aged 12 to 18 should sign an agreement showing they understand the study
Who cannot participate:
- Patients without a confirmed genetic diagnosis of mitochondrial disorder or cerebellar ataxia
- Those outside the specified age range
- Individuals not meeting the clinical trial group criteria
What the study involves:
The trial aims to determine how safe and effective Ubiquinol is for managing these conditions. Participants receive a medication called Quinol 10, which contains 150 mg of Ubiquinol and ascorbic acid (vitamin C) per sachet. During the 18-month treatment period, participants attend regular follow-up visits where doctors monitor their progress and check for any side effects.
The study assesses several important areas including cognitive function (thinking and memory), language skills, quality of life, and the severity of symptoms. Blood samples are taken at specific visits to measure coenzyme Q10 levels and other biomarkers that help understand how the treatment is working. At the end of the study, doctors conduct a final assessment to evaluate any changes from the beginning of the trial.
Main goal: This research aims to provide valuable information about whether Ubiquinol can be a beneficial treatment option for people with mitochondrial disorders and cerebellar ataxias. The findings could lead to improved management of these conditions and potentially enhance quality of life for those affected.
Summary
Currently, there is one ongoing clinical trial for cerebellar ataxia, taking place in Spain. The trial focuses specifically on patients who have cerebellar ataxia either alone or in combination with mitochondrial disorders. The study is investigating Ubiquinol, a form of coenzyme Q10, which works as an antioxidant and helps cells produce energy.
This trial accepts a wide age range of participants, from children as young as one year old to adults up to 90 years old, making it accessible to many patients affected by these conditions. The 18-month duration allows researchers to thoroughly evaluate both the safety and effectiveness of the treatment over an extended period.
The study represents an important step in understanding whether supporting cellular energy production through Ubiquinol supplementation can help manage the symptoms of cerebellar ataxia and mitochondrial disorders.
