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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

StatusActive, Not Recruiting
PhasePhase 3
Primary completion (estimated)

At risk: Primary completion moved 58 days later.

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Record History

The 50 most recent of 58 versions: 27 with changes below, 23 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Eligibility criteria expanded, about 8 words
    • Primary and study completion pushed from Dec 30, 2026 to Feb 26, 2027
    • Study sites: 67 to 68
    • Secondary endpoints: details revised at 1 of 1 entry
  2. Start date: Jun 8, 2017 to Aug 23, 2017
    • Primary and study completion dates moved earlier to Dec 30, 2026
    • Study sites: 68 to 67
    v57
  3. Site details revised at 2 of 68 sitesv56
  4. Site details revised at 17 of 68 sitesv55
  5. Study sites revised (68)v53
Show 22 earlier versionsHide 22 earlier versions
  1. Study sites revised (68)v51
  2. Start date: Apr 2, 2017 to Jun 8, 2017
    • Study completion date: Aug 4, 2027 to Aug 13, 2027
    • Study sites revised (68)
    v50
  3. Site details revised at 1 of 68 sitesv45
  4. Primary completion date: Nov 28, 2018 to Aug 4, 2027v38
  5. Primary completion date changed from estimate of Aug 4, 2027 to Nov 28, 2018v35
  6. Primary completion date: Nov 28, 2018 to Aug 4, 2027v34
  7. Primary completion date changed from estimate of Aug 4, 2027 to Nov 28, 2018v30
  8. Primary completion date: Nov 28, 2018 to Aug 4, 2027v29
  9. Study completion date: Jul 8, 2027 to Aug 4, 2027v28
  10. Primary completion date changed from estimate of Jul 8, 2027 to Nov 28, 2018v26
  11. Site details revised at 1 of 68 sitesv23
  12. Primary completion date: Nov 28, 2018 to Jul 8, 2027v20
  13. Site details revised at 1 of 68 sitesv18
  14. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 218 to confirmed 206
    • Site details revised at 68 of 68 sites
    v17
  15. Site details revised at 3 of 68 sitesv16
  16. Site details revised at 1 of 68 sitesv15
  17. Site details revised at 4 of 68 sitesv14
  18. Primary completion date changed from estimate of Feb 27, 2019 to Nov 28, 2018
    • Site contacts updated at 1 of 68 sites
    v13
  19. Study sites revised (68)v12
  20. Site details revised at 4 of 68 sitesv11
  21. Study sites: 67 to 68
    • Start date: Jun 8, 2017 to Apr 2, 2017
    v10
  22. Primary completion date: Apr 2, 2027 to Feb 27, 2019
    • Study sites: 36 to 67
    • Study completion date: Jan 5, 2028 to Jul 8, 2027
    v9
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Occurances of adverse events and serious adverse events
Timeframe: Day 1 up to approximately 10 years

Secondary (1)

Percentage of patients with clinical benefit

Arms and interventions

everolimusExperimental

everolimus, 2mg dispersible tablets

Drugs: everolimus

Sites

68 sites in 18 countries

United States 14, United Kingdom 8, Spain 6, France 5, Italy 5, Belgium 4, Japan 4, Russia 4, South Korea 3, Taiwan 3, Thailand 3, Australia 2, Turkey (Türkiye) 2, Canada 1, Colombia 1, Hungary 1, Mexico 1, Poland 1