Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT02451696 : A Pilot Study To Evaluate The Effects of Everolimus on Brain mTOR Activity and Cortical Hyperexcitability in TSC and FCD
PhasePhase 2
AgesMin: 2 Years Max: 40 Years
Eligibility
Inclusion Criteria

1. Patients: 1 year to 40 years. 2. Diagnosis: treatment resistant epilepsy due to
Tuberous Sclerosis Complex or Focal Cortical Dysplasia Inclusion Criteria (Concurrent
Comparison Group)

1. Patients: 1 year to 40 years. Matched for age (+/- 7 years) and sex of subjects in
the treatment group.

2. Diagnosis: treatment resistant due to TSC or FCD. Matched for diagnosis of TSC and
FCD.

3. Brain surgery for seizure control in which tissue is banked for research utilizing an
existing IRB-approved study.

Exclusion Criteria

1. Treatment with an mTOR inhibitor (everolimus, sirolimus) during the past four weeks.

2. Known hypersensitivity to an mTOR inhibitor (everolimus, sirolimus)

3. Failure to establish diagnosis of treatment resistant epilepsy (i.e., adequate trials
of two appropriately-chosen, tolerated and adequate trials of antiepileptic drugs)
[32].

4. Exposure to any investigational agent in the month prior to study entry.

5. History of malignancy patients who are receiving anti-cancer treatments, such as
radiation therapy and/or chemotherapy.

6. Patients with severe and/or uncontrolled medical conditions,

7. Patients on chronic corticosteroid therapy

8. A history of HIV seropositivity

9. Patients who have received live attenuated vaccines within 1 week of start of
everolimus and during the study;

10. Known impairment of gastrointestinal (GI) function or GI disease that may
significantly alter the absorption of oral everolimus;

11. Uncontrolled diabetes mellitus

12. Patients who have any severe and/or uncontrolled medical conditions

13. Known impairment of gastrointestinal (GI) function or GI disease that may
significantly alter the absorption of oral everolimus;
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT02451696      |      Link to official Clinicaltrials.gov listing
Locations



Home | Brain Tumor Guide | FAQs | Find A Treatment
Noteworthy Treatments | News | Virtual Trial | Videos | Novocure Optune® | Newsletter
Donations | Brain Tumor Centers | Survivor Stories | Temodar®
Fundraising For Research | Unsubscribe | Contact Us

Copyright (c) 1993 - 2019 by:
The Musella Foundation For Brain Tumor Research & Information, Inc
1100 Peninsula Blvd
Hewlett, NY 11557
888-295-4740