An open-label, multi-center long-term safety roll-over study in patients with tuberous sclerosis complex (TSC) and refractory seizures who are judged by the Investigator to benefit from continued treatment with everolimus after completion of Study CRAD001M2304 (EXIST-3)

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-516746-19-00

Acronym

CRAD001M2X02B

Enrollment

Registered

2024-11-18

Start date

2017-08-30

Completion date

2025-05-14

Last updated

2025-02-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Refractory seizures associated with tuberous sclerosis complex

Brief summary

Frequency and severity of AEs/SAEs

Detailed description

Proportion of patients with clinical benefit as assessed by the Investigator at scheduled visits

Interventions

DRUGEVEROLIMUS

Eligibility

Sex/Gender

All

Age

0 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
Frequency and severity of AEs/SAEs	—

Secondary

Measure	Time frame
Proportion of patients with clinical benefit as assessed by the Investigator at scheduled visits	—

Countries

Poland

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026