Skip to content
Triangle logo TriangleGet started
← Full study record

NCT01713946 · OUTCOME

Core Phase: Percentage of Patients With at Least a 25% Reduction in Seizure Frequency

A Placebo-controlled Study of Efficacy & Safety of 2 Trough-ranges of Everolimus as Adjunctive Therapy in Patients With Tuberous Sclerosis Complex (TSC) & Refractory Partial-onset Seizures · Source last updated 2018-11-07

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
NUMBER
Unit
Percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
Baseline (8-week period before randomization), Week 7 to 18 (12-week maintenance period of the core phase)

What was measured

Comparison of percentage of patients with at least ≥ 25% reduction in seizure frequency in the everolimus low-trough treatment arm (3-7 ng/mL), high-trough treatment arm (9-15 ng/mL) and placebo arm during maintenance period of the core phase. At least 25% reduction from baseline in partial-onset seizure frequency during maintenance period of the core phase.

Analysis population: The Full Analysis Set (FAS) comprised all patients to whom study treatment was assigned by randomization

Groups in this outcome

Everolimus LT Target of 3 to 7 ng/mL

Participants were randomized to receive everolimus dispersible tablets for oral suspension with titration to a low trough (LT) range of 3 to 7 ng/mL

Everolimus HT Target of 9 to 15 ng/mL

Participants were randomized to receive everolimus dispersible tablets for oral suspension with titration to a high trough (HT) range of 9 to 15 ng/mL

Placebo

Participants were randomized to receive placebo dispersible tablets for oral suspension.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Everolimus LT Target of 3 to 7 ng/mL117
Everolimus HT Target of 9 to 15 ng/mL130
Placebo119

Reported measurements

Source class 1
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Everolimus LT Target of 3 to 7 ng/mL52.1Not reported42.761.5Not reported
Everolimus HT Target of 9 to 15 ng/mL70.0Not reported61.377.7Not reported
Placebo37.8Not reported29.147.2Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Lower Limit
    1.05
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    2.97
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY
    param Type
    Odds Ratio (OR)
    param Value
    1.77
  2. ci Lower Limit
    2.25
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    6.48
    group Ids
    1. OG001
    2. OG002
    non Inferiority Type
    SUPERIORITY
    param Type
    Odds Ratio (OR)
    param Value
    3.82
Complete source fields
analyses
  1. ci Lower Limit
    1.05
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    2.97
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY
    param Type
    Odds Ratio (OR)
    param Value
    1.77
  2. ci Lower Limit
    2.25
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    6.48
    group Ids
    1. OG001
    2. OG002
    non Inferiority Type
    SUPERIORITY
    param Type
    Odds Ratio (OR)
    param Value
    3.82
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        42.7
        upper Limit
        61.5
        value
        52.1
      2. group Id
        OG001
        lower Limit
        61.3
        upper Limit
        77.7
        value
        70.0
      3. group Id
        OG002
        lower Limit
        29.1
        upper Limit
        47.2
        value
        37.8
denoms
  1. counts
    1. group Id
      OG000
      value
      117
    2. group Id
      OG001
      value
      130
    3. group Id
      OG002
      value
      119
    units
    Participants
description
Comparison of percentage of patients with at least ≥ 25% reduction in seizure frequency in the everolimus low-trough treatment arm (3-7 ng/mL), high-trough treatment arm (9-15 ng/mL) and placebo arm during maintenance period of the core phase. At least 25% reduction from baseline in partial-onset seizure frequency during maintenance period of the core phase.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants were randomized to receive everolimus dispersible tablets for oral suspension with titration to a low trough (LT) range of 3 to 7 ng/mL
    id
    OG000
    title
    Everolimus LT Target of 3 to 7 ng/mL
  2. description
    Participants were randomized to receive everolimus dispersible tablets for oral suspension with titration to a high trough (HT) range of 9 to 15 ng/mL
    id
    OG001
    title
    Everolimus HT Target of 9 to 15 ng/mL
  3. description
    Participants were randomized to receive placebo dispersible tablets for oral suspension.
    id
    OG002
    title
    Placebo
param Type
NUMBER
population Description
The Full Analysis Set (FAS) comprised all patients to whom study treatment was assigned by randomization
reporting Status
POSTED
time Frame
Baseline (8-week period before randomization), Week 7 to 18 (12-week maintenance period of the core phase)
title
Core Phase: Percentage of Patients With at Least a 25% Reduction in Seizure Frequency
type
SECONDARY
unit Of Measure
Percentage of participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice