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Fragile X Syndrome clinical trials

View clinical trials related to Fragile X Syndrome.

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NCT ID: NCT02680379 Completed - Fragile X Syndrome Clinical Trials

Combined Treatment of Minocycline and Lovastatin to Treat Individuals With Fragile X Syndrome

LovaMiX
Start date: March 2016
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine whether Lovastatin, Minocycline and the combination Lovastatin/Minocycline are effective in treating behavioral symptoms in Fragile X individuals.

NCT ID: NCT02642653 Completed - Fragile X Syndrome Clinical Trials

Combining Lovastatin and a Parent-Implemented Language Intervention for Fragile X Syndrome

Start date: January 2016
Phase: Phase 4
Study type: Interventional

The purpose of the study is to test the efficacy of a 20 week multi-modal treatment comprised of lovastatin or placebo, and the Parent-implemented Language Intervention (PILI) in children with fragile X syndrome (FXS). Children will be randomized to drug or placebo in a double-blind design with all participating in the PILI. The primary endpoint will be to measure improvements in spoken language and behavior among lovastatin-treated than placebo treated participants.

NCT ID: NCT02616796 Completed - Clinical trials for Intellectual Disability

Effects of Social Gaze Training on Brain and Behavior in Fragile X Syndrome

Start date: April 2015
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of the study is to evaluate a 2-3 day treatment probe targeted to improving social gaze behavior in children with fragile X syndrome (FXS). The investigators will use the principles of Applied Behavior Analysis (ABA) to shape appropriate social skills. Importantly, the investigators propose to examine the effects of this treatment probe on brain and behavior.

NCT ID: NCT02603926 Completed - Clinical trials for Fragile X-associated Tremor/Ataxia Syndrome

Treatment of Fragile-X Associated Tremor/Ataxia Syndrome (FXTAS) With Allopregnanolone

Start date: October 2015
Phase: Phase 2
Study type: Interventional

The purpose of this study is to examine the safety and efficacy of Allopregnanolone as a possible treatment for symptoms of Fragile X-associated Tremor/Ataxia Syndrome (FXTAS).

NCT ID: NCT02465931 Completed - Clinical trials for Fragile X Syndrome (FXS)

Decisional Capacity and Informed Consent in Fragile X Syndrome

Start date: March 14, 2016
Phase: N/A
Study type: Interventional

The Decisional Capacity and Informed Consent in Fragile X Syndrome (FXS) project is for the Eunice Kennedy Shriver National Institute of Child Health & Human Development, 1R01HD071987-01A1, and will provide the first comprehensive description of decisional capacity of individuals with FXS; identify individual, family, and experiential factors associated with variability in decisional capacity; determine the validity of caregiver and expert ratings; and develop evidence-based guidelines for categorizing decisional capacity of individuals with FXS. The researchers will develop a methodologically rigorous and conceptually grounded decision aid using digital technology to enhance participation of individuals with FXS in the consent process.

NCT ID: NCT02126995 Completed - Fragile X Syndrome Clinical Trials

A 6-week, Study of MG01CI Low Dose and High Dose Compared With Placebo in Adults and Adolescents With Fragile X Syndrome

Start date: June 2014
Phase: Phase 2
Study type: Interventional

This study is a multisite, randomized, double-blind, placebo-controlled, phase 2 study of MG01CI (low dose and high dose once daily) for 6 weeks compared with placebo in a 1:1 ratio of 60 adolescent and adult subjects with Fragile X Syndrome (FXS). Following Screening, subjects will be randomized to MG01CI or matching placebo at Baseline (Day 0) and the 6 week Double-blind Treatment Period will begin on Day 1. The first 4 weeks of the treatment period will be a dose-optimization period, All subjects will start with two daily tablets: low dose metadoxine or matching blinded placebo. At weekly visits/phone assessments, the investigator will evaluate the dose based upon the investigator's assessment of safety and tolerability. If the subject demonstrates safety or tolerability concerns with the low dose after 1 or 2 weeks of treatment, then the subject will be discontinued. If there are no concerns about safety and tolerability after 2 weeks of treatment, then the dose will be increased to high dose or placebo. If at the high dose there are concerns about safety and tolerability, then the dose will be either kept the same or reduced to low dose for the remainder of the treatment period. There will be a 2-week Follow-up Period after the last dose of study treatment or early termination.

NCT ID: NCT01911455 Completed - Fragile X Syndrome Clinical Trials

Study of Acamprosate in Fragile x Syndrome

Start date: August 27, 2013
Phase: Phase 1
Study type: Interventional

In this research study we want to understand the effectiveness of a drug treatment, acamprosate, for interfering symptoms (i.e., inattention/hyperactivity, social impairment) associated with Fragile X Syndrome (FXS).

NCT ID: NCT01894958 Completed - Fragile X Syndrome Clinical Trials

A Safety Study of NNZ-2566 in Patients With Fragile X Syndrome

Start date: January 2014
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine whether NNZ-2566 is safe and well tolerated in the treatment of Fragile X Syndrome in adolescent and adult males.

NCT ID: NCT01855971 Completed - Fragile X Syndrome Clinical Trials

"Using Epigallocatechin Gallate (EGCG) and Cognitive Training to Modulate Cognitive Performance in Patients With Fragile X Syndrome" (TESFX)

Start date: June 11, 2013
Phase: Phase 2
Study type: Interventional

Fragile X syndrome (FXS) presents alterations in synaptic plasticity that produce intellectual disability. can produce improvement. Estrogens (targeting Estrogen Receptors beta (ER-β) can act as neuroprotective agents, promoting synaptic plasticity and neurite outgrowth, and health benefits derived from flavonoids, as the flavonol epigallocatechin gallate (EGCG), phytoestrogens of natural origin are partially explained by their interaction with membrane ER. Selective ER-β flavonoids are thus good candidates for their therapeutic evaluation in intellectual disabilities. EGCG also targets central intracellular transduction signals altered in FXS and improves memory recognition in a FXS animal model(adenosine triphosphate (ATP)-inhibitor of phosphatidylinositol 3-kinase (PI3K)and mammalian target of rapamycin (mTOR) and extracellular signal-regulated kinase (ERK1/2). This study targets the synaptic plasticity alterations that underlie the learning and memory impairment but also the computational disability in FXS. The hypothesis is that EGCG can act by favoring the physiological processes involved in cognition.

NCT ID: NCT01750957 Completed - Fragile X Syndrome Clinical Trials

A Study of RO4917523 in Pediatric Patients With Fragile X Syndrome

Start date: February 2013
Phase: Phase 2
Study type: Interventional

This randomized, double-blind, placebo-controlled, parallel-arm study will evaluate the safety and exploratory efficacy and pharmacokinetics of RO4917523 in pediatric patients with fragile X syndrome. Patients will be randomized to receive one of 2 dose levels of RO4917523 or placebo orally daily for 12 weeks.