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ACTIVE NOT RECRUITING Phase 2

Interventions for Reading Disabilities in NF1

NCT02964884 · View on ClinicalTrials.gov ↗

Study Summary

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.

Interventions

  • DRUG Placebo Oral Tablet
  • DRUG Lovastatin
  • BEHAVIORAL reading tutoring intervention
  • BEHAVIORAL Other Academic "sham" tutoring

Study Locations (1)

Tennessee

  • Vanderbilt University — Nashville

Trial Details

FieldValue
Enrollment Target 120 participants
Start Date 2016-11
Est. Completion 2027-01
Phase Phase 2

Sponsor

Vanderbilt University

194 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02964884

The ClinicalTrials.gov registry entry for NCT02964884 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Vanderbilt University, which has 194 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 4 conditions, with Neurofibromatosis Type 1 appearing as the primary indexed condition, and to 4 interventions — of which Placebo Oral Tablet is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT02964884 reports 1 study location spanning 1 distinct geographic area — top geographies include Tennessee. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT02964884 about?

NCT02964884 is a clinical study titled "Interventions for Reading Disabilities in NF1". 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...

What is the current status of trial NCT02964884?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 120 participants. The study started on 2016-11. Estimated completion is 2027-01.

What conditions does trial NCT02964884 study?

This clinical trial studies the following conditions: Neurofibromatosis Type 1, NF1, Reading Disability, Learning Disability. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT02964884?

The interventions under investigation include: Placebo Oral Tablet (DRUG), Lovastatin (DRUG), reading tutoring intervention (BEHAVIORAL), Other Academic "sham" tutoring (BEHAVIORAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02964884?

This trial is sponsored by Vanderbilt University, which has 194 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT02964884 being conducted?

This trial has 1 study location across Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial