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NCT01713946 · FLOW

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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.

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
    FG000
    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
    FG001
    title
    Everolimus HT Target of 9 to 15 ng/mL
  3. description
    Participants who received placebo dispersible tablets for oral suspension at study start and switched to everolimus in Extension.
    id
    FG002
    title
    Placebo
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        2
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        19
      2. group Id
        FG001
        num Subjects
        14
      3. group Id
        FG002
        num Subjects
        13
      type
      Adverse Event
    3. reasons
      1. group Id
        FG000
        num Subjects
        12
      2. group Id
        FG001
        num Subjects
        12
      3. group Id
        FG002
        num Subjects
        8
      type
      Withdrawal by Subject
    4. reasons
      1. group Id
        FG000
        num Subjects
        8
      2. group Id
        FG001
        num Subjects
        8
      3. group Id
        FG002
        num Subjects
        14
      type
      Lack of Efficacy
    5. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        1
      type
      Protocol Violation
    6. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      type
      Lost to Follow-up
    7. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Administrative problems
    8. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        0
      type
      Did not continue in Ext
    9. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        0
      type
      Did not continue in Post-Ext. Phase
    10. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        5
      type
      Patients never switched to everolimus
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        117
      2. group Id
        FG001
        num Subjects
        130
      3. comment
        Of the 119 patients initially randomized to the Placebo arm, 5 patients never switched to everolimus
        group Id
        FG002
        num Subjects
        119
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        110
      2. group Id
        FG001
        num Subjects
        122
      3. group Id
        FG002
        num Subjects
        114
      type
      Completed Core Phase
    3. achievements
      1. group Id
        FG000
        num Subjects
        110
      2. group Id
        FG001
        num Subjects
        119
      3. group Id
        FG002
        num Subjects
        114
      type
      Continued in Ext. Phase
    4. achievements
      1. group Id
        FG000
        num Subjects
        79
      2. group Id
        FG001
        num Subjects
        92
      3. group Id
        FG002
        num Subjects
        81
      type
      Completed Ext. Phase
    5. achievements
      1. group Id
        FG000
        num Subjects
        78
      2. group Id
        FG001
        num Subjects
        90
      3. group Id
        FG002
        num Subjects
        81
      type
      Continued in Post-Ext. Phase
    6. achievements
      1. group Id
        FG000
        num Subjects
        74
      2. group Id
        FG001
        num Subjects
        85
      3. group Id
        FG002
        num Subjects
        75
      type
      Completed Post-Ext Phase
    7. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        0
      type
      Did Not Continue in Ext Phase
    8. achievements
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        0
      type
      Did Not Cont. in Post-Ext Phase
    9. achievements
      1. group Id
        FG000
        num Subjects
        74
      2. group Id
        FG001
        num Subjects
        85
      3. group Id
        FG002
        num Subjects
        75
      type
      COMPLETED
    10. achievements
      1. group Id
        FG000
        num Subjects
        43
      2. group Id
        FG001
        num Subjects
        45
      3. group Id
        FG002
        num Subjects
        44
      type
      NOT COMPLETED
    title
    Overall Study
recruitment Details
355 patients were planned to be enrolled and a total of 366 patients were randomized: 117 to the everolimus targeted low-trough arm (LT), 130 to the everolimus targeted high-trough (HT) arm, and 119 to treatment with placebo.
Complete source fields
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
    FG000
    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
    FG001
    title
    Everolimus HT Target of 9 to 15 ng/mL
  3. description
    Participants who received placebo dispersible tablets for oral suspension at study start and switched to everolimus in Extension.
    id
    FG002
    title
    Placebo
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        2
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        19
      2. group Id
        FG001
        num Subjects
        14
      3. group Id
        FG002
        num Subjects
        13
      type
      Adverse Event
    3. reasons
      1. group Id
        FG000
        num Subjects
        12
      2. group Id
        FG001
        num Subjects
        12
      3. group Id
        FG002
        num Subjects
        8
      type
      Withdrawal by Subject
    4. reasons
      1. group Id
        FG000
        num Subjects
        8
      2. group Id
        FG001
        num Subjects
        8
      3. group Id
        FG002
        num Subjects
        14
      type
      Lack of Efficacy
    5. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        1
      type
      Protocol Violation
    6. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      type
      Lost to Follow-up
    7. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Administrative problems
    8. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        0
      type
      Did not continue in Ext
    9. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        0
      type
      Did not continue in Post-Ext. Phase
    10. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        5
      type
      Patients never switched to everolimus
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        117
      2. group Id
        FG001
        num Subjects
        130
      3. comment
        Of the 119 patients initially randomized to the Placebo arm, 5 patients never switched to everolimus
        group Id
        FG002
        num Subjects
        119
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        110
      2. group Id
        FG001
        num Subjects
        122
      3. group Id
        FG002
        num Subjects
        114
      type
      Completed Core Phase
    3. achievements
      1. group Id
        FG000
        num Subjects
        110
      2. group Id
        FG001
        num Subjects
        119
      3. group Id
        FG002
        num Subjects
        114
      type
      Continued in Ext. Phase
    4. achievements
      1. group Id
        FG000
        num Subjects
        79
      2. group Id
        FG001
        num Subjects
        92
      3. group Id
        FG002
        num Subjects
        81
      type
      Completed Ext. Phase
    5. achievements
      1. group Id
        FG000
        num Subjects
        78
      2. group Id
        FG001
        num Subjects
        90
      3. group Id
        FG002
        num Subjects
        81
      type
      Continued in Post-Ext. Phase
    6. achievements
      1. group Id
        FG000
        num Subjects
        74
      2. group Id
        FG001
        num Subjects
        85
      3. group Id
        FG002
        num Subjects
        75
      type
      Completed Post-Ext Phase
    7. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        0
      type
      Did Not Continue in Ext Phase
    8. achievements
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        0
      type
      Did Not Cont. in Post-Ext Phase
    9. achievements
      1. group Id
        FG000
        num Subjects
        74
      2. group Id
        FG001
        num Subjects
        85
      3. group Id
        FG002
        num Subjects
        75
      type
      COMPLETED
    10. achievements
      1. group Id
        FG000
        num Subjects
        43
      2. group Id
        FG001
        num Subjects
        45
      3. group Id
        FG002
        num Subjects
        44
      type
      NOT COMPLETED
    title
    Overall Study
recruitment Details
355 patients were planned to be enrolled and a total of 366 patients were randomized: 117 to the everolimus targeted low-trough arm (LT), 130 to the everolimus targeted high-trough (HT) arm, and 119 to treatment with placebo.

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Preserved source evidence · Not medical advice