Skip to content
Triangle logo TriangleGet started
← Full study record

NCT01713946 · OUTCOME

Core Phase: Distribution of Reduction From Baseline 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
Not reported
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 in six categories of seizure reduction from baseline (≤ -25% (exacerbation); \> -25% to \< 25% (no change); ≥ 25% to \< 50%; ≥ 50% to \< 75%; ≥ 75% to \< 100%; 100% (seizure-freedom)) 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

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

100% (seizure free)
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Everolimus LT Target of 3 to 7 ng/mL5.1Not reportedNot reportedNot reportedNot reported
Everolimus HT Target of 9 to 15 ng/mL3.8Not reportedNot reportedNot reportedNot reported
Placebo0.8Not reportedNot reportedNot reportedNot reported
≥ 75 to <100 (75% responder)
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Everolimus LT Target of 3 to 7 ng/mL6.0Not reportedNot reportedNot reportedNot reported
Everolimus HT Target of 9 to 15 ng/mL15.4Not reportedNot reportedNot reportedNot reported
Placebo5.0Not reportedNot reportedNot reportedNot reported
≥ 50 to <75 (50% responder)
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Everolimus LT Target of 3 to 7 ng/mL17.1Not reportedNot reportedNot reportedNot reported
Everolimus HT Target of 9 to 15 ng/mL20.8Not reportedNot reportedNot reportedNot reported
Placebo9.2Not reportedNot reportedNot reportedNot reported
≥ 25 to <50 (25% responder)
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Everolimus LT Target of 3 to 7 ng/mL23.9Not reportedNot reportedNot reportedNot reported
Everolimus HT Target of 9 to 15 ng/mL30.0Not reportedNot reportedNot reportedNot reported
Placebo22.7Not reportedNot reportedNot reportedNot reported
>-25 to <25 (No change)
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Everolimus LT Target of 3 to 7 ng/mL35.0Not reportedNot reportedNot reportedNot reported
Everolimus HT Target of 9 to 15 ng/mL18.5Not reportedNot reportedNot reportedNot reported
Placebo41.2Not reportedNot reportedNot reportedNot reported
≤ -25 (Exacerbation)
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Everolimus LT Target of 3 to 7 ng/mL12.8Not reportedNot reportedNot reportedNot reported
Everolimus HT Target of 9 to 15 ng/mL11.5Not reportedNot reportedNot reportedNot reported
Placebo20.2Not reportedNot reportedNot reportedNot reported
Missing (missing)
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Everolimus LT Target of 3 to 7 ng/mL0.0Not reportedNot reportedNot reportedNot reported
Everolimus HT Target of 9 to 15 ng/mL0.0Not reportedNot reportedNot reportedNot reported
Placebo0.8Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        5.1
      2. group Id
        OG001
        value
        3.8
      3. group Id
        OG002
        value
        0.8
    title
    100% (seizure free)
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        6.0
      2. group Id
        OG001
        value
        15.4
      3. group Id
        OG002
        value
        5.0
    title
    ≥ 75 to <100 (75% responder)
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        17.1
      2. group Id
        OG001
        value
        20.8
      3. group Id
        OG002
        value
        9.2
    title
    ≥ 50 to <75 (50% responder)
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        23.9
      2. group Id
        OG001
        value
        30.0
      3. group Id
        OG002
        value
        22.7
    title
    ≥ 25 to <50 (25% responder)
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        35.0
      2. group Id
        OG001
        value
        18.5
      3. group Id
        OG002
        value
        41.2
    title
    >-25 to <25 (No change)
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        12.8
      2. group Id
        OG001
        value
        11.5
      3. group Id
        OG002
        value
        20.2
    title
    ≤ -25 (Exacerbation)
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        0.0
      2. group Id
        OG001
        value
        0.0
      3. group Id
        OG002
        value
        0.8
    title
    Missing (missing)
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 in six categories of seizure reduction from baseline (≤ -25% (exacerbation); \> -25% to \< 25% (no change); ≥ 25% to \< 50%; ≥ 50% to \< 75%; ≥ 75% to \< 100%; 100% (seizure-freedom)) 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
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: Distribution of Reduction From Baseline 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