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New treatment option for Fragile X Syndrome (FXS)
Official title Optical Imaging in X-linked Disorders.
ClinicalTrials.gov ID: NCT06868979
What this study is testing
- What it's testing
- Fragile X syndrome (FXS, OMIM #300624) and Creatine Transporter Deficiency (CTD, #300352) are the two most common causes of X-linked intellectual disability. FXS and CTD affect hemizygous males and with highly variable severity heterozygous females.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 5 to 60. Healthy volunteers may be eligible.
You may be able to join if
- CTD male patients :
- male
- having a confirmed mutation in the SLC6A8 gene
- ≥ 5 to ≤ 35 years old
- whose maternal language is French,
You likely can't join if
- CTD male and female patients :
- Refusal of the subject and/or the subject's parents/legal guardian to sign the informed consent
- Refusal of the subject and/or the subject's parents/legal guardian to be informed of possible abnormalities detected during the neuropsychological...
- Refusal of the subject and/or the subject's parents/legal guardian to sign the informed consent
- Refusal of the subject and/or the subject's parents/legal guardian to be informed of possible abnormalities detected during the neuropsychological...
- Refusal of the subject and/or the subject's parents/legal guardian to sign the informed consent
See the full eligibility criteria
- CTD male patients :
- male
- having a confirmed mutation in the SLC6A8 gene
- ≥ 5 to ≤ 35 years old
- whose maternal language is French,
- having signed the informed consent and/or for whom parents (for children)/legal guardian (for protected adults) have signed the informed consent.
- affiliated to national Health Insurance system (sécurité sociale) or parents/legal guardian affiliated to national health insurance system CTD female patients :
- female CTD patients having a confirmed mutation in the SLC6A8 gene,
- aged \> 5 to \< 60 years,
- whose maternal language is French (for the patients included in France),
- having signed the informed consent and/or for whom parents (for children)/legal guardian (for protected adults) have signed the informed consent.
- affiliated to national Health Insurance system (sécurité sociale) or parents/legal guardian affiliated to national health insurance system FXS patients :
- male
- having a confirmed full mutation in the FMR1 gene (\>200 GCC repeats)
- ≥ 5 to ≤ 35 years old
- whose maternal language is French,
- having signed the informed consent and/or for whom parents (for children)/legal guardian (for protected adults) have signed the informed consent.
- affiliated to national Health Insurance system (sécurité sociale) or parents/legal guardian affiliated to national health insurance system Sex- and chronological age-matched male controls :
- male
- ≥ 5 to ≤ 35 years old
- whose maternal language is French,
- having signed the informed consent and/or for whom parents have signed the informed consent.
- affiliated to national Health Insurance system (sécurité sociale) or parents/legal guardian affiliated to national health insurance system Sex- and chronological age-matched female controls :
- female,
- aged \> 5 to \< 60 years
- whose maternal language is French (for the patients included in France),
- having signed the informed consent and/or for whom parents/legal guardian have signed the informed consent.
- affiliated to national Health Insurance system (sécurité sociale) or parents/legal guardian affiliated to national health insurance system. Each CTD patient will be matched to a sex- and chronological age-matched...
- CTD male and female patients :
- Refusal of the subject and/or the subject's parents/legal guardian to sign the informed consent
- Refusal of the subject and/or the subject's parents/legal guardian to be informed of possible abnormalities detected during the neuropsychological assessment. FXS patients :
- Refusal of the subject and/or the subject's parents/legal guardian to sign the informed consent
- Refusal of the subject and/or the subject's parents/legal guardian to be informed of possible abnormalities detected during the neuropsychological assessment. Sex- and chronological age-matched male and female controls :
- Refusal of the subject and/or the subject's parents/legal guardian to sign the informed consent
- Refusal of the subject and/or the subject's parents/legal guardian to be informed of possible abnormalities detected during the neuropsychological assessment.
- History of neurological or psychiatric disorder,
- Repetition of a grade,
- Learning disability requiring rehabilitation (speech therapy, psychomotor or oculomotor therapy).
The study team makes the final eligibility decision.
Where it's taking place
- Bron, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 5 years to 60 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bron, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.