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Active Not Recruiting NCT02962414

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

Conditions: Tuberous Sclerosis Complex

Sex: All
Ages: 2 Years – 65 Years
Healthy volunteers: No
Phase: PHASE3
Enrollment: 206
Sponsor: Novartis Pharmaceuticals

Location: TGen APNNA Phoenix Arizona

Summary

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 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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT02962414). StuddyBuddy aggregates publicly available trial information.