Restless Legs SyndromeNCT06324760
Alpha-lipoic Acid Combined With B Vitamins Shows Promise for Treating Restless Legs Syndrome
An observational study of Restless Legs Syndrome, run by Uriach Consumer Healthcare at 1 site in Spain.
Trial summary
Investigating Tiobec® 400's efficacy in alleviating Restless Legs Syndrome symptoms sheds light on promising therapeutic avenues. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Restless Legs Syndrome
- What is being tested?
- Alpha-lipoic acid combined with B vitamins
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- 4 Mar 2020to 2 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Adult, Older adult
Study population: The data will be collected from patients who meet the selection criteria.
Who may be able to join
- Participants must be a minimum of 18 years of age.
- They must have a primary diagnosis of RLS without prior therapeutic interventions for the ailment.
- They need to provide explicit consent via an informed consent document.
Who cannot join
- Patients diagnosed with pathologies other than RLS that affect sleep quality.
- Those with persistent renal diseases or any other chronic, severe medical condition.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Usefulness of Alpha-lipoic Acid Combined With B Vitamins for the Treatment of Restless Legs Syndrome
Investigating Tiobec® 400's efficacy in alleviating Restless Legs Syndrome symptoms sheds light on promising therapeutic avenues.
Read the detailed description
Restless legs syndrome, also known as Willis-Ekbom disease, is a neurological disorder characterised by uncomfortable sensations in the legs and an urge to move them. In Spain, its prevalence range is estimated to be between 11.6% - 19.5% in adults, but it is difficult to know due to underdiagnosis. Alpha-lipoic acid (ALA) and B vitamins have emerged as potential treatments due to their roles in reducing oxidative stress and associated vitamin deficiencies. The Tiobec® 400 (T400) supplement combines ALA, B vitamins, E, and C, and its efficacy and safety in alleviating RLS symptoms, along with its impact on anthropometric measures, are under investigation. This study aims to explore therapeutic options for managing RLS, with promising results.
- Conditions
- Restless Legs Syndrome
- Being tested
- Alpha-lipoic acid combined with B vitamins
- Keywords
- RLS
- Medical subject headings
- Restless Legs Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alpha-lipoic acid combined with B vitaminsDietary supplement
The investigational product utilized in this research, Tiobec® 400 is a dietary supplement enriched with ALA, B vitamins, and vitamins E and C. T400 is designed to mitigate oxidative stress and support the optimal functioning of the nervous system
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure the subjective RLS symptoms of the participants through the IRLSSG rating scale (IRLS)
This scale contains 10 items, rated from 0 to 4, according to the severity reported by the patient (0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe.). The cumulative scores are categorized as mild (1-10), moderate (11-20), severe (21-30), and very severe (31-40).
Measured: 6 months
Secondary outcomes (5)
Anthropometric parameters of the patients.
Weight (kg).
Measured: 6 Months
Patients' body measurements
Body mass index (BMI) (kg/m²).
Measured: 6 Months
Measurements of patient anatomy
Total fat mass (kg).
Measured: 6 Months
Patients' body characteristics.
Visceral fat mass (kg).
Measured: 6 Months
Measurements of patient anatomy.
Muscle mass (kg).
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2024
- Study start4 Mar 2020
- Primary completion2 Jun 2021
- Study completion2 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Restless Legs SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uriach Consumer Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Javier Albares, Doctor, Principal investigator, Centro Medico Teknon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06324760
- Sponsor's protocol ID
- LIPOICSPI2018
- Status last verified
- Mar 2024
- First submitted
- 12 Mar 2024
- Last updated
- 22 Mar 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Usefulness of Alpha-lipoic Acid Combined With B Vitamins for the Treatment of Restless Legs Syndrome
- ClinicalTrials.gov ID
- NCT06324760
- Acronym / sponsor ID
- LIPOICSPI2018
- Conditions
- Restless Legs Syndrome
- Keywords
- RLS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Uriach Consumer HealthcareIndustry (pharma, biotech, devices)
- Study start
- 4 Mar 2020 (actual)
- Primary completion
- 2 Jun 2021 (actual)
- Study completion
- 2 Jun 2021 (actual)
- First posted
- 22 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Investigating Tiobec® 400's efficacy in alleviating Restless Legs Syndrome symptoms sheds light on promising therapeutic avenues.
Detailed description
Restless legs syndrome, also known as Willis-Ekbom disease, is a neurological disorder characterised by uncomfortable sensations in the legs and an urge to move them. In Spain, its prevalence range is estimated to be between 11.6% - 19.5% in adults, but it is difficult to know due to underdiagnosis. Alpha-lipoic acid (ALA) and B vitamins have emerged as potential treatments due to their roles in reducing oxidative stress and associated vitamin deficiencies. The Tiobec® 400 (T400) supplement combines ALA, B vitamins, E, and C, and its efficacy and safety in alleviating RLS symptoms, along with its impact on anthropometric measures, are under investigation. This study aims to explore therapeutic options for managing RLS, with promising results.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The data will be collected from patients who meet the selection criteria.
Key inclusion criteria (3 listed)
- Participants must be a minimum of 18 years of age.
- They must have a primary diagnosis of RLS without prior therapeutic interventions for the ailment.
- They need to provide explicit consent via an informed consent document.
Key exclusion criteria (2 listed)
- Patients diagnosed with pathologies other than RLS that affect sleep quality.
- Those with persistent renal diseases or any other chronic, severe medical condition.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alpha-lipoic acid combined with B vitaminsThe investigational product utilized in this research, Tiobec® 400 is a dietary supplement enriched with ALA, B vitamins, and vitamins E and C. T400 is designed to mitigate oxidative stress and support the optimal functioning of the nervous system | Dietary supplement | – |
Primary outcome
Measure the subjective RLS symptoms of the participants through the IRLSSG rating scale (IRLS)
Time frame: 6 months
This scale contains 10 items, rated from 0 to 4, according to the severity reported by the patient (0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe.). The cumulative scores are categorized as mild (1-10), moderate (11-20), severe (21-30), and very severe (31-40).
5 secondary outcomes
Anthropometric parameters of the patients.
Time frame: 6 Months
Patients' body measurements
Time frame: 6 Months
Measurements of patient anatomy
Time frame: 6 Months
Patients' body characteristics.
Time frame: 6 Months
Measurements of patient anatomy.
Time frame: 6 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Javier Albares, Doctor principal investigator
Centro Medico Teknon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Restless Legs Syndrome, run by Uriach Consumer Healthcare at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure the subjective RLS symptoms of the participants through the IRLSSG rating scale (IRLS) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2024.