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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 18 January 2021
Main ID:  NCT02964884
Date of registration: 09/11/2016
Prospective Registration: Yes
Primary sponsor: Vanderbilt University
Public title: Interventions for Reading Disabilities in NF1
Scientific title: Neurobiology and Treatment of Reading Disability in NF1
Date of first enrolment: November 2016
Target sample size: 120
Recruitment status: Recruiting
URL:  https://clinicaltrials.gov/show/NCT02964884
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).  
Phase:  Phase 2
Countries of recruitment
United States
Contacts
Name:     Laura E. Cutting
Address: 
Telephone: 615-875-1054
Email:
Affiliation: 
Name:     Julie Delheimer, BS
Address: 
Telephone: 615-875-5534
Email: educationbrain@vanderbilt.edu
Affiliation: 
Name:     Laurie Cutting, PhD
Address: 
Telephone:
Email:
Affiliation:  Vanderbilt University Medical Center
Name:     Sheryl L. Rimrodt-Frierson, MD
Address: 
Telephone:
Email:
Affiliation:  Vanderbilt University Medical Center
Key inclusion & exclusion criteria

Inclusion Criteria:

This study will be open to all English speakers who meet eligibility criteria regardless of
race, gender, minority or socioeconomic status. Inclusion criteria to be met are listed
below:

1. Individuals ages 8-20 (all participants)

2. Documented NF-1 (NF patients only)

3. If female, participant is post-menarche (NF patients only)

4. If male, participant has reached Tanner Stage 2 (NF patients only)

5. Participant able to swallow capsule (NF patients only, may be confirmed via
swallowability test, described below)

6. Participant's English is sufficient for school (all participants)

7. Participant must either answer "yes" to question A, or answer "yes" to at least 2
items for questions B-D listed below:

A. Has your child ever been diagnosed with a reading disability? B. Did your child have
trouble learning how to "sound out" words? C. Have you (parent) ever been concerned about
your child's reading ability? D. Did the school or teacher ever express any concerns about
your child's reading ability? Swallowability Assessment: We may ask patients to perform a
capsule swallowability assessment prior to enrollment. We will ask subjects to attempt to
swallow an empty capsule, matching the same size of the Lovastatin 20mg and 40mg capsules
to be used in the study, to confirm swallowability. Patients will be provided with up to 2
capsules as needed to successfully perform the swallowability assessment. If the patient is
unable to swallow the capsule, enrollment in the study may deferred or declined.

A child will be excluded if he/she meets any of the following criteria, which will be
determined by initial telephone screening as well as review of medical/developmental
history prior to and during testing:

1. Child 7 years of age or less;

2. known uncorrectable visual impairment;

3. documented hearing impairment greater than or equal to a 25 dB loss;

4. medical contraindication to MRI procedures (e.g., metal devices);

5. any psychiatric, behavioral, or developmental disorder that would preclude active
participation in in-depth tutoring sessions

6. Pregnant at time of screening.

7. Known conditions which are contraindicated to Lovastatin

1. Hypersensitivity to the medication

2. Uncontrolled Epilepsy

3. Metabolic Syndrome X, High Blood Sugar,

4. Muscle Damage Due to Autoimmunity

5. Stroke caused by Bleeding in the Brain, Loss of Memory,

6. Severely Low Blood Pressure

7. Liver Problems including Abnormal Liver Function Tests

8. Severe Renal Impairment,

9. Serious Muscle Damage that may Lead to Kidney Failure,

10. Recent Operation or significant Injury

11. Muscle Pain or Tenderness with Increase Creatinine Kinase,

12. Habit of Drinking Too Much Alcohol

13. Pregnant or lactating. - Lovastatin is contraindicated during pregnancy and in
nursing mothers because it decreases synthesis of cholesterol and other products
of the cholesterol biosynthesis pathway that are essential components for fetal
development.

Children who meet criteria for ADHD, Oppositional Defiant Disorder, adjustment disorder,
and/or mild depression will be eligible as long as they are not taking psychotropic
medications, with the exception of stimulant medication for ADHD.

For pilot participants only:

Criteria for inclusion/exclusion for pilot participants is outlined below. Children who
meet criteria for ADHD, Oppositional Defiant Disorder, adjustment disorder, and/or mild
depression will be eligible as long as they are not taking psychotropic medications, with
the exception of stimulant medication for ADHD.

1. Children ages 8-17

2. Participant is a native English speaker

3. Participant must either answer "yes" to question A, or answer "yes" to at least 2
items for questions 2-4 listed below:

A. Has your child ever been diagnosed with a reading disability? B. Did your child have
trouble learning how to "sound out" words? C. Have you (parent) ever been concerned about
your child's reading ability? D. Did the school or teacher ever express any concerns about
your child's reading ability?

A child will be excluded if he/she meets any of the following criteria, which will be
determined by initial telephone screening as well as review of medical/developmental
history prior to and during testing:

1. Children 7 years of age or younger

2. previous diagnosis of Intellectual Disability;

3. known uncorrectable visual impairment;

4. documented hearing impairment greater than or equal to a 25 dB loss;

5. medical contraindication to MRI procedures (e.g., metal devices);

6. known IQ below 70;

7. a pervasive developmental disorder; and

8. any known neurologic pathology, including epilepsy, spina bifida, cerebral palsy,
traumatic brain injury, optic gliomas, and brain tumors (other than UBOs).

9. Comorbid severe psychiatric disorders will also be excluded.



Age minimum: 8 Years
Age maximum: 20 Years
Gender: All
Health Condition(s) or Problem(s) studied
Learning Disability
Neurofibromatosis Type 1
NF1
Reading Disability
Intervention(s)
Behavioral: Other Academic "sham" tutoring
Behavioral: reading tutoring intervention
Drug: Lovastatin
Drug: Placebo Oral Tablet
Primary Outcome(s)
Clinical Evaluation of Language Fundamentals-Fifth Edition [Time Frame: 24 weeks]
Comprehensive Test of Phonological Processing-2 [Time Frame: 24 weeks]
Delis Kaplan Executive Function System [Time Frame: 24 weeks]
Experimental Word and Pseudoword Lists [Time Frame: 24 weeks]
Test of Silent Contextual Reading Fluency-2 [Time Frame: 24 weeks]
Test of Word Reading Efficiency-2 [Time Frame: 24 weeks]
Visuospatial Learning and Memory, Judgment of Line Orientation [Time Frame: 24 weeks]
Visuospatial Learning and Memory, Morris Water Maze [Time Frame: 24 weeks]
Woodcock Johnson Tests of Achievement IV [Time Frame: 24 weeks]
Woodcock Reading Mastery Test-III [Time Frame: 24 weeks]
Secondary Outcome(s)
Secondary ID(s)
161159
1R01HD089474-01
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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