Trial results
AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
According to the results reported on ClinicalTrials.gov, this trial looked at a medicine called everolimus in people with a condition called tuberous sclerosis complex, specifically examining its effect on brain growths known as subependymal giant cell astrocytomas (SEGAs — a type of slow-growing tumour that can form in the brain). The trial had two phases: a core period of 48 weeks where 78 people received everolimus and 39 received a placebo (a dummy treatment with no active ingredient), followed by an open-label extension period of up to four years where 111 people received everolimus. The trial's main goal was to measure how many participants had their SEGA growths shrink by at least half, confirmed by brain scans reviewed by an independent panel of radiologists. The reported data shows that during the core 48-week period, 34.6% of participants in the everolimus group met the criteria for a SEGA response (meaning their growths shrank by at least half and met other scan-based criteria), compared with 0.0% in the placebo group. During the longer extension period, the reported response rate rose to 57.7% among everolimus participants. The reported data also shows changes in seizure frequency (measured by brain-wave monitoring over 24 hours): the everolimus group in the core period showed an average change of −1.24 seizures per 24 hours from their starting point, compared with −0.24 in the placebo group; in the extension period, the reported average change was −6.07. For several other measures — including how long responses lasted and time to worsening — the data was not reported as a single median figure, either because too few events occurred or the milestone was not reached during the study period. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View full results on ClinicalTrials.gov ↗ · Read the linked publication on PubMed (PMID 30053159) ↗
These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.
Phase 3 Multiple Sclerosis Trial, Completed
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- People of any age are welcome to apply
- You must have a confirmed diagnosis of Tuberous Sclerosis based on established medical guidelines
- You must have at least one specific type of brain growth (called a Subependymal Giant Cell Astrocytoma) that is at least 1 cm in size
- There must be signs that this brain growth has been getting larger or worse compared to earlier brain scans
- Women who could become pregnant must agree to use birth control during the trial
- You must be willing and able to sign a consent form agreeing to take part
Who may not be able to join:
- People whose doctors believe they will likely need surgery related to their brain growth in the near future
- People who have recently had a heart attack, chest pain related to the heart, or a stroke
- People with seriously reduced lung function
- People with severe liver problems
- People with severe kidney problems
- People who are pregnant or currently breastfeeding
- People who currently have an active infection
- People who have previously had an organ transplant
- People who have had surgery within the two months before joining the study
- People who have previously taken a medication from the same drug family as Everolimus (confirm with trial site)
- People with uncontrolled high cholesterol
- People with uncontrolled diabetes
- People who have HIV
- People who have metal implants in their body that would prevent them from having an MRI scan
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: Novartis Pharmaceuticlas, Novartis Pharmaceuticals
Australian sites
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
1 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Percentage of Participants With Best Overall Subependymal Giant Cell Astrocytomas (SEGA) Response
Can't join this trial?
Data last synced from ClinicalTrials.gov: 8 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.