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Roll-over study in patients with TSC and refractory seizures who are judged by the Investigator to benefit from continued treatment with everolimus after completion of study CRAD001M2304
EU CTIS ID: 2024-516746-19-00
What this study is testing
To evaluate long term safety data
- Therapeutic confirmatory (Phase III)
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
- Patient is currently enrolled in the Novartis-sponsored EXIST-3 study receiving everolimus and has fulfilled all its requirements
- Patient is currently benefiting from treatment with everolimus, as determined by the Investigator
- Patient has demonstrated compliance, as assessed by the Investigator, with the parent study protocol requirements.
- Willingness and ability to comply with scheduled visits and treatment plans
- Written informed consent/adolescent assent obtained prior to enrolling into the roll-over study
You likely can't join if
- Patient has been permanently discontinued from everolimus study treatment in EXIST-3.
- Patient’s indication of TSC with refractory seizures is currently approved and reimbursed for everolimus in the local country
- Patients who are receiving everolimus in combination with unapproved or experimental treatments for seizure control (AEDs are allowed for the purpose of seizure control).
- Sexually active males, unless they use a condom during intercourse while taking drug and for 8 weeks after stopping study medication. Males also should not father a child in this period. A condom is also required to be used by vasectomized men to prevent delivery of the drug via seminal fluid
- Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
- Thailand
- United States
- Canada
- Colombia
- Turkey
- Japan
- Russian Federation
- Australia
- Korea, Republic of
- Mexico
- Taiwan
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, 18-64 years, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom; Thailand; United States; Canada; Colombia; Turkey and 6 more location(s). Enter your location above to see the nearest site and check your eligibility.
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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.