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Roll-over Study to Collect and Assess Long-term Safety of Everolimus in Patients With TSC and Refractory Seizures Who Have Completed the EXIST-3 Study [CRAD001M2304] and Who Are Benefitting From Continued Treatment
Roll-over Study to Collect and Assess Long-term Safety of Everolimus in Patients With TSC and Refractory Seizures Who Have Completed the EXIST-3 Study [CRAD001M2304] and Who Are Benefitting From Continued Treatment

NCT02962414

Active Not RecruitingPhase 3

Sponsor: Novartis Pharmaceuticals

Conditions: Tuberous Sclerosis Complex

Interventions: everolimus

Countries: United States, Australia, Belgium, Canada, Colombia, France, Hungary, Italy

The purpose of this study is to evaluate the long-term safety in patients with TSC and refractory seizures who are currently receiving everolimus treatment in the Novartis-sponsored EXIST-3 study and who are determined to be benefiting from continued treatment as judged by the investigator at the completion of EXIST-3

Eligibility overview

Sex: ALL

Age: 2 Years to 65 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Key Inclusion Criteria:

* 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.
* Patient is willing and able to comply with scheduled visits and treatment plans.
* Written informed consent/adolescent assent obtained prior to enrolling into the roll-over study.

Key Exclusion Criteria:

* Patient has been permanently discontinued from everolimus study treatment in EXIST-3 study
* Everolimus is approved for patients with TSC and refractory seizures and is reimbursed in the local country.
* Patients who are receiving everolimus in combination with unapproved or experimental treatments for seizure control Anti-epileptic drug (AEDs) are allowed for the purpose of seizure control.
Locations (67)
  • Phoenix, Arizona, United States
  • Los Angeles, California, United States
  • Oakland, California, United States
  • San Diego, California, United States
  • Aurora, Colorado, United States
  • Hartford, Connecticut, United States
  • Chicago, Illinois, United States
  • Saint Paul, Minnesota, United States
  • Morristown, New Jersey, United States
  • Cincinnati, Ohio, United States
  • Portland, Oregon, United States
  • Philadelphia, Pennsylvania, United States
  • Dallas, Texas, United States
  • Houston, Texas, United States
  • Sydney, New South Wales, Australia
  • Nedlands, Western Australia, Australia
  • Brussels, Belgium
  • Brussels, Belgium
  • Ghent, Belgium
  • Leuven, Belgium
  • Vancouver, British Columbia, Canada
  • Cali, Valle del Cauca Department, Colombia
  • Amiens, France
  • Bron, France
  • Lille, France
  • Marseille, France
  • Strasbourg, France
  • Budapest, Hungary
  • Bari, BA, Italy
  • Bologna, BO, Italy
  • + 37 more on CT.gov