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Fragile X Syndrome clinical trials

View clinical trials related to Fragile X Syndrome.

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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.

NCT ID: NCT01725152 Completed - Fragile x Syndrome Clinical Trials

Ganaxolone Treatment in Children With Fragile X Syndrome

Start date: November 2012
Phase: Phase 2
Study type: Interventional

This Phase 2 proof-of-concept study is a double-blind, randomized, placebo-controlled, crossover study to investigate ganaxolone treatment in children with fragile x syndrome (FXS). The objective of the study is to assess the safety, tolerability and efficacy of ganaxolone in the treatment of anxiety and attention in subjects with FXS.

NCT ID: NCT01517698 Completed - Fragile X Syndrome Clinical Trials

A Study of RO4917523 in Patients With Fragile X Syndrome

Start date: May 2012
Phase: Phase 2
Study type: Interventional

This multi-center, randomized, double-blind, placebo-controlled, parallel-group study will investigate the efficacy and safety of RO4917523 in adolescent and adult patients with fragile X syndrome. Patients will be randomized to receive oral doses of 0.5 mg or 1.5 mg of RO4917523, or matching placebo once daily. The anticipated time on study treatment is 12 weeks.

NCT ID: NCT01482143 Completed - Fragile X Syndrome Clinical Trials

Clinical Study to Assess the Pharmacokinetics, Safety and Tolerability of Single and Multiple Oral Doses of AFQ056 in Children With Fragile X Syndrome (FXS)

Start date: March 2012
Phase: Phase 1
Study type: Interventional

The aim of this study is to characterize the pharmacokinetics and safety/tolerability of AFQ056 in children with Fragile X Syndrome(FXS)

NCT ID: NCT01474746 Completed - Fragile X Syndrome Clinical Trials

Trial of Sertraline to Treat Children With Fragile X Syndrome

Start date: January 2012
Phase: Phase 2
Study type: Interventional

This study is a control trial of sertraline (Zoloft) in fragile X syndrome children aged 2 years to 5 years 8 months old. The trial is six months long, and each participant will receive a series of tests at both the beginning and end of the study. The researchers hope to show improvements in language and a decrease in autistic symptoms.

NCT ID: NCT01357239 Completed - Fragile X Syndrome Clinical Trials

Safety and Efficacy of AFQ056 in Adolescent Patients With Fragile X Syndrome

Start date: May 2011
Phase: Phase 2
Study type: Interventional

This Phase IIb study is designed to assess whether 3 doses of AFQ056 are safe and effective in treating the behavioral symptoms of Fragile X Syndrome.