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Phosphodiesterase-4D (PDE4D) Inhibitor
BPN14770 for Fragile X Syndrome
Phase 3
Recruiting
Led By Elizabeth Berry-Kravis, MD
Research Sponsored by Tetra Discovery Partners
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subject has FXS with a molecular genetic confirmation of the full fragile X mental retardation-1 (FMR1) mutation (≥200 CGG repetitions)
Male subject aged 18 to 45 years at screening visit
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 13 weeks
Awards & highlights
Study Summary
This trial tested a new drug in men with Fragile X Syndrome to see if it helps their symptoms.
Who is the study for?
This trial is for male adults aged 18 to 45 with Fragile X Syndrome who can swallow capsules and have stable medication regimens. They must not be participating in other trials, have significant diseases or impairments that could affect results, or a history of substance abuse within the last year. If sexually active, they should use barrier contraception.Check my eligibility
What is being tested?
The study tests BPN14770 (zatolmilast), comparing it against a placebo in a randomized, double-blind setup. Participants won't know if they're getting the actual drug or a dummy pill as researchers observe its effects on males with Fragile X Syndrome.See study design
What are the potential side effects?
While specific side effects are not listed here, participants will be monitored for any adverse reactions to BPN14770 compared to those taking the placebo. Side effects may include typical drug responses such as digestive issues, headaches, dizziness or allergic reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have Fragile X Syndrome confirmed by a genetic test.
Select...
I am a man aged between 18 and 45.
Select...
I have been seizure-free for 3 months on medication or 2 years without medication.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 13 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~13 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
National Institutes of Health Toolbox Cognitive Battery cognition crystallized composite score (NIH-TCB CCC)
Secondary outcome measures
Aberrant Behavior Checklist (ABC) scores
Anxiety, Depression, and Mood Scale (ADAMS) scores
Caregiver Global Impression of Improvement (CaGI-I)
+5 moreTrial Design
2Treatment groups
Active Control
Placebo Group
Group I: Study DrugActive Control1 Intervention
25mg BID BPN14770
Group II: PlaceboPlacebo Group1 Intervention
Placebo
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Who is running the clinical trial?
Tetra Discovery PartnersLead Sponsor
8 Previous Clinical Trials
882 Total Patients Enrolled
3 Trials studying Fragile X Syndrome
480 Patients Enrolled for Fragile X Syndrome
Elizabeth Berry-Kravis, MDPrincipal InvestigatorRush Medical Center
2 Previous Clinical Trials
346 Total Patients Enrolled
2 Trials studying Fragile X Syndrome
346 Patients Enrolled for Fragile X Syndrome
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am starting or have recently started psychotherapy or cognitive behavior therapy.I do not have active conditions like AIDS, hepatitis B, hepatitis C, or tuberculosis.I have Fragile X Syndrome confirmed by a genetic test.My liver tests are more than twice the normal limit.You have used drugs or alcohol excessively in the past year, as determined by the study team.You currently have a serious mental health condition like depression, schizophrenia, or bipolar disorder, as diagnosed by the doctor. However, if you have autism spectrum disorder or anxiety disorder in addition to these conditions, you may still be able to participate.My BMI is either below 18 or above 36.I am a man aged between 18 and 45.My non-drug treatments have been stable for the last 4 weeks.I can swallow pills.I don't have any major health issues that could affect the study.I can understand and sign the consent form for the study on my own.My epilepsy medication dose has been stable for the last 12 weeks.I can agree to join the study if I understand it, even if I'm not my own legal guardian.Your lab tests, vital signs, or ECG results show significant abnormalities that may affect your safety, according to the doctor.My kidney function is impaired with high creatinine levels.My guardian can sign the consent for me to join the study.My mental health medication doses have been stable for at least 4 weeks.You have trouble hearing or seeing that might make it hard for you to do the tests.You have tested positive for COVID-19 during the screening process.I am currently taking 3 or fewer medications for mental health, excluding seizure medications.I have been seizure-free for 3 months on medication or 2 years without medication.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: Study Drug
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Can adults aged 18 and older participate in this inquiry?
"As depicted in the study's eligibility criteria, participants must be between 18 and 45 years old."
Answered by AI
Who meets the criteria to be enrolled in this medical experiment?
"This trial requires 150 participants who have fragile x syndrome and are situated between the ages of 18-45."
Answered by AI
Are there multiple locations in the US where this experiment is being conducted?
"The study is currently inviting patients from CHOC Thompson Autism Center in Orange, California, UC Davis in Sacramento, Colorado and Children's Hospital Colorado in Denver. Additionally 13 other sites are participating."
Answered by AI
To what degree could Study Drug be detrimental to human health?
"The safety of Study Drug is considered to be highly reliable, and thus was given a score of 3. This assessment comes from the fact that this medical trial has already gone through Phase 3 clinical trials with data indicating its efficacy as well as multiple rounds proving it safe."
Answered by AI
Are there any vacancies available to participants in this clinical research?
"Affirmative. According to clinicaltrials.gov, the trial posted on November 1st 2022 is currently recruiting up to 150 participants from 13 medical centres. Last updated on February 17th 2023, this study seeks volunteers for further testing and analysis."
Answered by AI
What is the largest number of participants involved in this experiment?
"The trial sponsors, Tetra Discovery Partners, will be enrolling a total of 150 participants that meet their condtion-specific criteria across two sites: CHOC Thompson Autism Center in Orange, California and UC Davis in Sacramento."
Answered by AI
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