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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
EU CTIS ID: 2024-513068-25-00
What this study is testing
The objective of the ViRap study is to investigate safety and efficacy of rapamycin versus vigabatrin in the preventive treatment of infants with TSC.
- Phase II and Phase III (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- history of seizures prior to randomization
- live vaccination within 4 weeks prior to randomization
- lack of first hepatitis B vaccination
- 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.
- Use of an investigational drug within 1 month prior to randomization
- history of antiepileptic treatment
See the full eligibility criteria
- 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
- history of seizures prior to randomization
- live vaccination within 4 weeks prior to randomization
- lack of first hepatitis B vaccination
- 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.
- Use of an investigational drug within 1 month prior to randomization
- history of antiepileptic treatment
- history of treatment with mTOR inhibitor
- gestational age below 41 weeks at the day of randomization
- body weight lower than 3 kg at the day of randomization
- SEGA or other TSC- associated lesion requiring urgent surgical intervention
- recent surgery within 1 month prior to the randomization
- intercurrent infection at the date of randomization
- known history of HIV seropositivity
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.