Loading clinical trials...

An Initial Study of AZD7325 in Adults With Fragile X Syndrome | Clinical Trials | Clareo Health

COMPLETEDPHASE1

An Initial Study of AZD7325 in Adults With Fragile X Syndrome

An Initial Double-Blind, Placebo-Controlled Two-Dose Crossover Study of AZD7325 in Adults With Fragile X Syndrome

NCT03140813•Children's Hospital Medical Center, Cincinnati

Summary

This study will investigate the safety, tolerability and blood pharmacodynamics of treatment with oral administration of AZD7325 at 5 mg BID, 15 mg BID, and placebo BID, in adults with Fragile X Syndrome. The study also will also investigate measures of efficacy and biomarkers during treatment.

Eligibility

Age

18 - 50 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Diagnostic confirmation of full mutation FXS
•50 ≥ Age ≥18 years. Males and Females included in study.
•General good health as determined by physical exam, medical history and laboratory work up.
•FXS genetic reports at screening
•IQ less than or equal to 80. Note: IQ cutoff is used as a means to exclude cases of females with FXS who have the full mutation, but may have neurotypical development (ie: do not have the full FXS phenotype despite positive FXS genetic testing) due to variability in X chromosome inactivation patterns.
•Male study participants who are sexually active with a female partner of childbearing potential must be surgically sterilized, practicing abstinence, or agree to use highly effective methods of birth control (defined in the list below), and not rely on barrier methods and spermicide alone, from the time of screening until 1 week after final dose of study drug. Male study participants must also not donate sperm from the time of screening until 1 week after final dose of study drug. Given that AZD7325 is not mutagenic, there is no mandatory requirement for condom use, either for avoidance of procreation or in the case of treated males with a pregnant partner.
•Women of childbearing potential may be included in the study provided they are established on, and continue to use, highly effective contraceptive methods from the time of screening until 1 week after the final dose of study drug. Highly effective methods of contraception associated with inhibition of ovulation (either oral, intravaginal or transdermal), progestin-only hormonal contraception associated with inhibition of ovulation (either oral \[specifically Micronor, Nor-QD or their generic equivalents\], injectable or implantable).
•Aberrant Behavior Checklist total score of 20 or higher at screening

Exclusion Criteria

•Concomitant use of modulators of GABA A neurotransmission. (examples)
•Use of more than three psychotropic drugs that do not directly impact GABA transmission, and/or unstable dosing of any psychotropic medication in the 4 weeks prior to baseline visit.
•Subjects are prohibited from use of strong and moderate modulators of CYP3A and CYP2C19 during the screening (at least 2 weeks before initiation of the study) and treatment periods of the study. Such prohibited drugs are outlined in http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm292362.pdf
•CNS-suppressing agents such as central analgesics, muscle relaxants, benzodiazepines, other sedatives, and should also limit alcohol intake to ≤1 alcoholic beverage per day.
•Unstable seizure disorder as defined by any seizure in the 6 months prior to baseline visit and/or a change in any anti-convulsant drug dosing in the 60 days prior to study entry.
•All patients with abnormal baseline safety lab assessments including, but not limited to ALT or AST greater than 1.5 the upper limit of normal, total bilirubin or creatinine greater than 1 time the upper limit of normal or other clinically relevant lab abnormality or abnormality in ECG, HR or BP at screening as judged by the investigator.
•Clinical relevant history or presence of any medical disorder judged by the investigator at potentially interfering with this trial.
•History of or current abuse of drugs or alcohol including prescription medication.
•For female subjects of child bearing potential (women 50 \& under is "amenorrhoeic for 12 months or more (following cessation of exogenous hormonal treatments - if these have been previously taken) and with luteinizing hormone (LH) and follicle stimulating hormone (FSH) levels in the post-menopausal range) a positive pregnancy test.

Locations (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Key Dates

Start Date

January 16, 2018

Primary Completion Date

June 18, 2020

Completion Date

June 18, 2020

Last Updated

February 8, 2021

Enrollment

ACTUAL participants

Conditions

Fragile X Syndrome

Interventions

AZD7325 (High-Dose)

DRUG

AZD7325 (Low-Dose)

DRUG

Placebo oral capsule

DRUG

Evaluating the Neurophysiologic and Clinical Effects of Single Dose Drug Challenge

NCT05418049

Fragile X Syndrome

View study

NOT_YET_RECRUITINGPHASE2/PHASE3

A Study to Investigate the Effects and Safety of SPG601 for the Treatment of Fragile X Syndrome in Male Participants

NCT07439510

Fragile X Syndrome (FXS)

View study

NOT_YET_RECRUITINGPHASE2

Effect of CANnabidiol on Anxiety and GABAergic Function in Individuals with Fragile-X Syndrome

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 8, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

An Initial Study of AZD7325 in Adults With Fragile X Syndrome

Inclusion Criteria

Exclusion Criteria

Evaluating the Neurophysiologic and Clinical Effects of Single Dose Drug Challenge

A Study to Investigate the Effects and Safety of SPG601 for the Treatment of Fragile X Syndrome in Male Participants

Effect of CANnabidiol on Anxiety and GABAergic Function in Individuals with Fragile-X Syndrome

Study of SPG601 in Adult Men With Fragile X Syndrome

An Investigation of Psilocybin on Behavioural and Cognitive Symptoms of Adults With Fragile X Syndrome

Pediatric Exploratory Research Study of EGCG Use and Safety (PERSEUS)