A 2-Period Crossover Study of BPN14770 in Adults Males With Fragile X Syndrome (NCT03569631) | Clinical Trial Compass
CompletedPhase 2
A 2-Period Crossover Study of BPN14770 in Adults Males With Fragile X Syndrome
United States30 participantsStarted 2018-07-09
Plain-language summary
This is a single-center, randomized, double-blind, 2-period crossover study to explore the effects of BPN14770 on cognitive function and behavior in subjects with Fragile X Syndrome. Subjects will receive both active treatment with BPN14770 capsules and matching placebo capsules in the course of the study. One treatment will be administered during each of the 12-week study periods.
Who can participate
Age range18 Years – 45 Years
SexMALE
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Inclusion criteria
✓. Subject is male aged 18 to 45 years, inclusive.
✓. Subject has Fragile X Syndrome with a molecular genetic confirmation of the full Fragile X Mental Retardation (FMR1) mutation (≥200 CGG repetitions).
✓. Current treatment with no more than 3 prescribed psychotropic medications. Anti- epileptic medications are permitted and are not counted as psychotropic medications if they are used for treatment of seizures. Anti-epileptics for other indications, such as the treatment of mood disorders, count towards the limit of permitted medications.
✓. Permitted concomitant psychotropic medications must be at a stable dose and dosing regimen for at least 2 weeks prior to Screening and must remain stable during the period between Screening and the commencement of study medication.
✓. Anti-epileptic medications must be at a stable dose and dosing regimen for 12 weeks prior to Screening and must remain stable during the period between Screening and the commencement of study medication.
✓. Subjects with a history of seizure disorder who are currently receiving treatment with anti-epileptics must have been seizure-free for 3 months preceding Screening, or must be seizure-free for 3 years if not currently receiving anti-epileptics.
Exclusion criteria
✕. Subject must be willing to practice barrier methods of contraception while on study, if sexually active. Abstinence is also considered a reasonable form of birth control in this study population.
✕. Subject has a parent, legal authorized guardian or consistent caregiver.
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What they're measuring
1
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
0. Subject and caregiver are able to attend the clinic regularly and reliably.
✕1. Subject is able to swallow tablets and capsules.
✕2. For subjects who are not their own legal guardian, subject's parent/legal authorized guardian is able to understand and sign an informed consent form to participate in the study.
✕3. If subject is his/her own legal guardian, he/she can understand and sign informed consent to participate in the study.
✕4. If subject is not their own legal guardian, the subject provides assent for participation in the study, if the subject has the cognitive ability to provide assent.
✕. History of, or current cardiovascular, renal, hepatic, respiratory, gastrointestinal, psychiatric, neurologic, cerebrovascular, or other systemic disease that would place the subject at risk or potentially interfere with the interpretation of the safety, tolerability, or efficacy of the study medication. Common diseases such as mild hypertension, well-controlled type 2 diabetes mellitus (hemoglobin A1C \[Hgb A1C\] \<6.5%), etc. are allowed per the investigator's judgment as long as they are stable and controlled by medical therapy that is constant for at least 4 weeks before randomization.