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Interventions for Reading Disabilities in NF1

StatusActive, Not Recruiting
PhasePhase 2
Started
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Record History

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  1. Minor Re-verified, no change to tracked fieldsv15
  2. Notable Primary completion date: May 2026 to Jan 2027
    • Trial status: Recruiting to Active, Not Recruiting
    • Study completion date: Jul 2026 to Jan 2027
    • Site details revised
    v14
  3. Notable Primary completion date: May 2024 to May 2026
    • Study completion date: Jul 2024 to Jul 2026
    v13
  4. Minor Re-verified, no change to tracked fieldsv12
  5. Notable Primary completion date: May 2022 to May 2024
    • Study completion date: Jul 2022 to Jul 2024
    v11
Show 9 earlier versionsHide 9 earlier versions
  1. Minor Re-verified, no change to tracked fieldsv10
  2. Notable Primary completion date: Nov 2020 to May 2022
    • Study completion date: Jun 2022 to Jul 2022
    v9
  3. Minor 2 versions Re-verified since Feb 21, 2019, no change to tracked fieldsv7-v8
  4. Minor Enrollment target: 99 to 120v6 Show 4 more changesShow less
    • Interventions: Lovastatin (Drug), Placebo Oral Tablet (Drug), reading tutoring intervention (Behavioral), sham tutoring (Behavioral) to Lovastatin (Drug), Other Academic "sham" tutoring (Behavioral), Placebo Oral Tablet (Drug), reading tutoring intervention (Behavioral)
    • Eligibility criteria expanded, about 11 words
    • Study description expanded, about 43 words
    • Study arms: 3 to 4
  5. Notable Primary endpoints: 12 to 10
    • Interventions: Lovastatin 20 MG (Drug), Lovastatin 40 MG (Drug), Placebo Oral Tablet (Drug), reading tutoring intervention (Behavioral), sham tutoring… to Lovastatin (Drug), Placebo Oral Tablet (Drug), reading tutoring intervention (Behavioral), sham tutoring (Behavioral)
    • Eligibility criteria shortened, about 1,026 words
    • Study title expanded, about 2 words
    v5
  6. Notable Primary completion date: Nov 2017 to Nov 2020
    • Study completion date: Jun 2018 to Jun 2022
    v4
  7. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Interventions: Lovastatin (Drug), Placebo Oral Tablet (Drug), reading tutoring intervention (Behavioral), sham tutoring (Behavioral) to Lovastatin 20 MG (Drug), Lovastatin 40 MG (Drug), Placebo Oral Tablet (Drug), reading tutoring intervention (Behavioral), sham tutoring…
    • Eligibility criteria expanded, about 686 words
    v3
  8. Minor Re-verified, no change to tracked fieldsv2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Neurofibromatosis Type 1 (NF1) is a common genetic disorder that is associated with a four times greater risk of learning disabilities, including reading disabilities, and a deficiency of neurofibromin - a protein important in a signaling pathway that regulates learning and memory. Our previous work (NS49096) demonstrated that school-age children with NF+RD can respond to standard phonologically-based reading tutoring originally developed to treat reading disability in the general population. Combining our work with that by other researchers suggesting that a medication (Lovastatin) may counteract the effects of the deficient neurofibromin, and possibly ameliorate learning disabilities in NF1, the investigator propose to examine the synergistic effects of medication plus reading tutoring.
Trial Details
NCT Number NCT02964884
Lead Sponsor Vanderbilt University
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions
(from sponsor)
Neurofibromatosis Type 1, Learning Disability, Reading Disability, NF1
Related terms Dyslexia, Learning Disabilities, Neurofibromatosis 1
Enrollment 120 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov