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Medication + Reading Tutoring for Learning Disabilities in Neurofibromatosis Type 1
Study Summary
This trial will study whether the combination of a medication and reading tutoring can help improve learning disabilities in children with Neurofibromatosis Type 1.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- I had a stroke due to brain bleeding and have memory loss.You have a mental, behavioral, or developmental condition that would make it difficult for you to take part in detailed tutoring sessions.My child cannot take Lovastatin due to their condition.I speak English and am open to participating regardless of my background.I have muscle damage from an autoimmune condition.I have recently had surgery or a significant injury.I have severe kidney problems.I experience muscle pain and have high levels of creatinine kinase.My child is on medication for mental health issues.You are allergic to Lovastatin.My IQ is below 70.You have serious mental health conditions along with other health issues.I have Metabolic Syndrome X and high blood sugar.I am a female and have started menstruating.I have a confirmed diagnosis of Neurofibromatosis type 1.I am 7 years old or younger.I have a known neurological condition such as epilepsy or cerebral palsy.I have epilepsy that is not well-controlled.I have very low blood pressure.You have a vision problem that can't be fixed.I am a male with NF and have started puberty.I am a native English speaker.I have liver issues or abnormal liver test results.Participants must have specific requirements regarding difficulty with reading.I am between 8 and 20 years old.You have been diagnosed with intellectual disability in the past.I am between 8 and 17 years old.My child is 7 years old or younger.I have serious muscle damage that could cause kidney failure.I can swallow pills.You have a documented hearing loss of 25 decibels or more.You drink a lot of alcohol habitually.You have a developmental disorder that affects many areas of your life.
- Group 1: RD: Other Academic (sham) tutoring
- Group 2: NF1: Lovastatin + reading tutoring
- Group 3: NF1: Placebo + reading tutoring
- Group 4: RD: Reading tutoring
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
If I meet the requirements, can I sign up for this clinical trial?
"This study is recruiting 120 individuals aged 8-20 who have been diagnosed with learning disorders. To be eligible, participants must also meet the following criteria: - Be able to swallow a capsule (this will be confirmed via a swallowability test)- Have English skills that are sufficient for school- For parents: Has your child ever been diagnosed with a reading disability? Did your child have trouble learning how to "sound out" words? Have you (parent) ever been concerned about your child's reading ability? Did the school or teacher ever express any concerns about your child's reading ability? Child 7 years"
Does the combined treatment of lovastatin and reading tutoring present any health risks for patients?
"So far, the evidence suggests that NF1: Lovastatin + reading tutoring is safe but not necessarily effective. Our team gave it a safety score of 2."
What pediatric patients does the NF1: Lovastatin + reading tutoring intervention typically target?
"Coronary heart disease (CHD) is often treated with a combination of lovastatin and reading tutoring. This treatment approach can also help improve other conditions like dyslipidemias, coronary artery atherosclerosis, and apolipoprotein levels."
Are there many case studies of NF1 patients being helped by Lovastatin + reading tutoring?
"There are three ongoing clinical trials testing the efficacy of lovastatin + reading tutoring for NF1 patients. Of these, none have progressed to Phase 3 yet. The majority of these trials are being conducted in Beijing, but there are also three taking place in other locations."
Are patients able to enroll in this trial at this time?
"This clinical trial, which was first posted on November 1st 2016, is currently recruiting candidates. The last update to the listing on clinicaltrials.gov was on June 20th 2022."
Does this research allow octogenarians to participate?
"To participate in this trial, applicants must be between 8 and 20 years old. Out of the 106 total studies, 66 are for patients under 18 and 40 are for patients over 65."
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