Randomised open label cross-over study into the efficacy of RApamycin in children with Tuberous sclerosis complex with intractable Epilepsy (RATE-trial) - RATE

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-022655-29-NL

Enrollment

Registered

2010-10-22

Start date

2011-05-30

Completion date

Unknown

Last updated

2025-01-07

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

Conditions

Epilepsy in children with Tuberous Sclerosis Complex

Interventions

Trade Name: Rapamune Pharmaceutical Form: Oral solution

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Children with definite TSC older than 3 months, up to 12 yrs old, with catastrophic epilepsy (West syndrome or intractable epilepsy defined as 1 or more seizures/week despite two adequate trials of anti-epileptic drug regimens). Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Renal dysfunction, surgery during 6wk before inclusion, current infection.

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the efficacy of rapamycin (Sirolimus) on intractable epilepsy in children with Tuberous Sclerosis Complex.;Secondary Objective: To evaluate tolerability of rapamycin (Sirolimus) in children with TSC.;Primary end point(s): Seizure frequency during the last month of treatment versus baseline (percentage change).	—

Countries

Netherlands

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026