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NCT01713946 · OUTCOME

Core Phase: Impact of Everolimus on Anti-epileptic Drugs (AEDs) Concentrations

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
GEOMETRIC_MEAN
Unit
ng/mL
Interval / dispersion
90% Confidence Interval
Time frame
Baseline, Weeks 1 & 3

What was measured

Impact of everolimus on AED concentrations at trough. Pre-dose plasma samples to measure AED concentrations were measured at at Visits 1 (Screening), 2 (Baseline), 3, and 5. Effects of everolimus on the exposure of antiepileptic drugs was assessed by comparing the anti-epileptic drug concentrations at Visits 1 and 2 (AEDs alone) and at Visits 3 and 5 (AEDs plus everolimus).

Analysis population: Confirmed PK Sample Set from all everolimus-treated patients in the Safety Set and Long-term Evaluation (LTE) Safety Set was defined as: Cmin collected prior to dose administration on the same treatment day and 20-28 hours after the previous dose, at steady state, and with no evidence of vomiting within 4 hours of the previous dose.

Groups in this outcome

Valporic Acid

Antiepileptic drug

Carbamazepine

antiepileptic drug

Clobazam

antiepileptic drug

N-desmethylclobazam

antiepileptic drug

Topiramate

antiepileptic drug

TRI477

antiepileptic drug

TRI476

antiepileptic drug

Clonazepam

antiepileptic drug

Zonisamide

antiepileptic drug

Phenobarbital

antiepileptic drug

Phenytoin

antiepileptic drug

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

Analysis denominator · Participants

GroupSource count
Valporic Acid86
Carbamazepine34
Clobazam37
N-desmethylclobazam37
Topiramate34
TRI47731
TRI47631
Clonazepam17
Zonisamide12
Phenobarbital11
Phenytoin7

Reported measurements

Source class 1
Values in ng/mL · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
Valporic Acid0.962Not reported0.9131.014Not reported
Carbamazepine1.108Not reported1.0161.208Not reported
Clobazam1.093Not reported1.0371.153Not reported
N-desmethylclobazam1.071Not reported1.0171.127Not reported
Topiramate0.983Not reported0.8721.108Not reported
TRI4771.086Not reported0.9131.291Not reported
TRI4761.194Not reported0.9361.523Not reported
Clonazepam1.065Not reported0.9741.163Not reported
Zonisamide1.028Not reported0.9711.089Not reported
Phenobarbital0.957Not reported0.8861.034Not reported
Phenytoin1.020Not reported0.8741.190Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.913
        upper Limit
        1.014
        value
        0.962
      2. group Id
        OG001
        lower Limit
        1.016
        upper Limit
        1.208
        value
        1.108
      3. group Id
        OG002
        lower Limit
        1.037
        upper Limit
        1.153
        value
        1.093
      4. group Id
        OG003
        lower Limit
        1.017
        upper Limit
        1.127
        value
        1.071
      5. group Id
        OG004
        lower Limit
        0.872
        upper Limit
        1.108
        value
        0.983
      6. group Id
        OG005
        lower Limit
        0.913
        upper Limit
        1.291
        value
        1.086
      7. group Id
        OG006
        lower Limit
        0.936
        upper Limit
        1.523
        value
        1.194
      8. group Id
        OG007
        lower Limit
        0.974
        upper Limit
        1.163
        value
        1.065
      9. group Id
        OG008
        lower Limit
        0.971
        upper Limit
        1.089
        value
        1.028
      10. group Id
        OG009
        lower Limit
        0.886
        upper Limit
        1.034
        value
        0.957
      11. group Id
        OG010
        lower Limit
        0.874
        upper Limit
        1.190
        value
        1.020
denoms
  1. counts
    1. group Id
      OG000
      value
      86
    2. group Id
      OG001
      value
      34
    3. group Id
      OG002
      value
      37
    4. group Id
      OG003
      value
      37
    5. group Id
      OG004
      value
      34
    6. group Id
      OG005
      value
      31
    7. group Id
      OG006
      value
      31
    8. group Id
      OG007
      value
      17
    9. group Id
      OG008
      value
      12
    10. group Id
      OG009
      value
      11
    11. group Id
      OG010
      value
      7
    units
    Participants
description
Impact of everolimus on AED concentrations at trough. Pre-dose plasma samples to measure AED concentrations were measured at at Visits 1 (Screening), 2 (Baseline), 3, and 5. Effects of everolimus on the exposure of antiepileptic drugs was assessed by comparing the anti-epileptic drug concentrations at Visits 1 and 2 (AEDs alone) and at Visits 3 and 5 (AEDs plus everolimus).
dispersion Type
90% Confidence Interval
groups
  1. description
    Antiepileptic drug
    id
    OG000
    title
    Valporic Acid
  2. description
    antiepileptic drug
    id
    OG001
    title
    Carbamazepine
  3. description
    antiepileptic drug
    id
    OG002
    title
    Clobazam
  4. description
    antiepileptic drug
    id
    OG003
    title
    N-desmethylclobazam
  5. description
    antiepileptic drug
    id
    OG004
    title
    Topiramate
  6. description
    antiepileptic drug
    id
    OG005
    title
    TRI477
  7. description
    antiepileptic drug
    id
    OG006
    title
    TRI476
  8. description
    antiepileptic drug
    id
    OG007
    title
    Clonazepam
  9. description
    antiepileptic drug
    id
    OG008
    title
    Zonisamide
  10. description
    antiepileptic drug
    id
    OG009
    title
    Phenobarbital
  11. description
    antiepileptic drug
    id
    OG010
    title
    Phenytoin
param Type
GEOMETRIC_MEAN
population Description
Confirmed PK Sample Set from all everolimus-treated patients in the Safety Set and Long-term Evaluation (LTE) Safety Set was defined as: Cmin collected prior to dose administration on the same treatment day and 20-28 hours after the previous dose, at steady state, and with no evidence of vomiting within 4 hours of the previous dose.
reporting Status
POSTED
time Frame
Baseline, Weeks 1 & 3
title
Core Phase: Impact of Everolimus on Anti-epileptic Drugs (AEDs) Concentrations
type
SECONDARY
unit Of Measure
ng/mL

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Preserved source evidence · Not medical advice