A 2-Period Crossover Study of BPN14770 in Adults Males With Fragile X

Status Completed

Clinical Trial 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.

Clinical Trial Description

A total of 30 subjects will be enrolled. The study consists of a screening period of up to 28 days prior to initial treatment, followed by two double-blind treatment periods, each 12 weeks long. A final follow-up visit or phone contact for safety is planned one week after the conclusion of Period 2. Eligible subjects will be randomized in a blinded, balanced (1:1) fashion to receive either 25 mg BPN14770 capsules or matching placebo capsules during Period 1, followed by the opposite treatment during Period 2. One capsule will be taken twice daily during both double-blind periods. Subjects will return to the clinic at the end of Weeks 2, 6, and 12 of each study period. Cognitive and behavioral evaluations will be repeated at Weeks 6 and 12 of each Period. Additionally, patients will be monitored for adverse events via a telephone call at the end of Week 1 of each Period, and one week following completion of Period 2 or following early discontinuation. During clinic visits, adverse effects will be assessed, and laboratory measures, vital signs, and ECGs will be performed. Suicidality risk will also be evaluated at each clinic visit; if a concern is detected, the subject will be referred for further evaluation and treatment. Cognitive and behavioral assessments will be performed during each clinic visit. Pharmacodynamic measures of CNS function will be obtained to evaluated effects of the drug in the brain. Pharmacokinetic samples will be collected to confirm that study drug is present and to estimate plasma exposure at Week 12 of each Period. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03569631
Study type	Interventional
Source	Tetra Discovery Partners
Contact
Status	Completed
Phase	Phase 2
Start date	July 9, 2018
Completion date	July 31, 2020

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05418049` - Evaluating the Neurophysiologic and Clinical Effects of Single Dose Drug Challenge	Phase 2
Enrolling by invitation	`NCT01364818` - Brain Connectivity in Neurodevelopmental Disorders in Response to Treatment	N/A
Completed	`NCT00965432` - A Single-Dose Study in Normal Volunteers to Assess the Safety, Tolerability and Pharmacokinetics of STX107	Phase 1
Completed	`NCT01120626` - Randomized Controlled Study of Donepezil in Fragile X Syndrome	Phase 2
Completed	`NCT01204151` - Teaching Math Skills to Individuals With Fragile X Syndrome	N/A
Active, not recruiting	`NCT00334971` - Aromatase Activity and Ovarian Growth Factors in African-American Versus Caucasian Women	N/A
Enrolling by invitation	`NCT06139172` - Promoting Prosocial Behavior in Syndromic Intellectual and Developmental Disabilities	N/A
Recruiting	`NCT04977986` - Clinical Study of Cannabidiol in Children, Adolescents, and Young Adults With Fragile X Syndrome	Phase 3
Active, not recruiting	`NCT04698551` - NIPD on cffDNA for Triplet Repeat Diseases
Completed	`NCT03722290` - Metformin in Children and Adults With Fragile X Syndrome	Phase 2
Completed	`NCT05030129` - Single Blind Study of Ergoloid Mesylates, 5-HTP and the Combination in Adult Males With Fragile X Syndrome	Phase 2
Recruiting	`NCT05957549` - Tracking Early Emergence of Sound Perception Impairments in FXS With Multimodal fNIRS/EEG	N/A
Recruiting	`NCT04141163` - Metformin in Patients With Fragile X	Phase 1/Phase 2
Not yet recruiting	`NCT06081348` - Sertraline vs. Placebo in the Treatment of Anxiety in Children and AdoLescents With NeurodevelopMental Disorders	Phase 2
Completed	`NCT00858689` - Add-on Pilot Trial of Minocycline to Treat Fragile X Syndrome	N/A
Enrolling by invitation	`NCT03655223` - Early Check: Expanded Screening in Newborns
Enrolling by invitation	`NCT03802799` - Open Label Extension to Assess the Long-Term Safety and Tolerability of ZYN002 in Children and Adolescents With FXS	Phase 2/Phase 3
Recruiting	`NCT05295277` - Validation of Optical Genome Mapping for the Identification of Constitutional Genomic Variants in a Postnatal Cohort
Enrolling by invitation	`NCT03836300` - Parent and Infant Inter(X)Action Intervention (PIXI)	N/A
Completed	`NCT01725152` - Ganaxolone Treatment in Children With Fragile X Syndrome	Phase 2

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

A 2-Period Crossover Study of BPN14770 in Adults Males With Fragile X Syndrome

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms