NCT04987463RecruitingPhase 2/3
Comparison of the efficacy and safety of rapamycin versus vigabatrin in the prevention of Tuberous Sclerosis Complex symptoms in infants in the randomized clinical trial
Randomized, placebo-controlled, double-blind and double-dummy clinical trial comparing the safety, tolerability, and efficacy of vigabatrin and rapamycin in a preventive treatment of infants with Tuberous Sclerosis Complex
Source: EU CTIS (euclinicaltrials.eu) · Last updated 25 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The objective of the ViRap study is to investigate safety and efficacy of rapamycin versus vigabatrin in the preventive treatment of infants with TSC.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 16 Oct 2024
- Start date
- 20 May 2021
- Lead sponsor
- Instytut Pomnik Centrum Zdrowia Dziecka
- Diseases
- Epilepsy, Childhood cancers
- NCT number
- NCT04987463
- EU CT number
- 2024-513068-25-00
- EudraCT number
- 2020-003231-19
What you commit to
- Study type: Interventional · Phase 2/3
- Planned participants: 60
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study, not your situation.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- history of seizures prior to randomization
- live vaccination within 4 weeks prior to randomization
- Use of an investigational drug within 1 month prior to randomization
- history of treatment with mTOR inhibitor
- SEGA or other TSC- associated lesion requiring urgent surgical intervention
- recent surgery within 1 month prior to the randomization
Other illness
- lack of first hepatitis B vaccination
- history of antiepileptic treatment
- intercurrent infection at the date of randomization
- known history of HIV seropositivity
Lab values
- Any significant clinical, laboratory , ECG or other abnormalities, comorbidity or concomitant treatment which, in the opinion of the investigator, may either put a patient at significant risk associated with the participation in the study or may influence the results of the study.
Age
- gestational age below 41 weeks at the day of randomization
Other
- body weight lower than 3 kg at the day of randomization
Who the study is looking for
- Male or female aged up to 16 weeks (41-56 weeks of gestational age) at the day of randomization
- Parents/caregivers are willing to and able to give informed consent form for the participation in the study
- Parents/caregivers are willing to and able to comply with all study requirements
- Definite diagnosis of TSC according to the Consensus criteria (Northrup,2013)
- At least 1 focus of cortical dysplasia disclosed on brain MRI
Age in the registry: - to 17 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Institute Of Polish Mother's Health Center Coordinator of this site? Confirm its status | Lodz | Poland | Recruiting |
| Instytut Pomnik Centrum Zdrowia Dziecka Coordinator of this site? Confirm its status | Warsaw | Poland | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.