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Phosphodiesterase-4D (PDE4D) Inhibitor

BPN14770 for Fragile X Syndrome

Q: Is there an opportunity to partake in this clinical research?

This clinical trial is recruiting approximately 300 participants with fragile x syndrome aged 12 to 45.

Q: Does the age restriction of this medical trial exceed fifty years?

According to the inclusion criteria set forth by this medical study, patients must be between 12 and 45 years of age. Furthermore, there are 380 trials available for minors under 18 and 1005 studies open to seniors over 65.

Q: Has this therapy earned the endorsement of regulatory bodies?

Our team at Power has determined that this treatment presents a considerable degree of safety, awarding it with the highest rating available on our scale: 3. This is based off Phase 3 trial data which supports both its efficacy and safety.

Q: Are there any available slots remaining in the experiment?

Presently, this trial is not enrolling participants. Initially published on November 1st of 2022 and last updated on February 15th 2023, the medical study has no openings at present; however, there are currently 1438 other trials that are welcoming volunteers.

Q: Are there multiple sites in Canada where this research is being conducted?

Patients are welcome to apply at more than 10 sites, such as UC Davis in Sacramento, <a href="https://www.withpower.com/clinical-trials/california">California</a>, CHOC Thompson <a href="https://www.withpower.com/clinical-trials/autism">Autism</a> Center in Orange, <a href="https://www.withpower.com/clinical-trials/new-york">New york</a> and Seaver Autism Center for Research &#x26; Treatment at Mount Sinai in <a href="https://www.withpower.com/clinical-trials/maryland">Maryland</a>.

Phase 3

Waitlist Available

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

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

Study Summary

This trial extends 2 studies on BPN14770 in adult and adolescent males to observe effects over time.

Who is the study for?

This trial is for males with Fragile X Syndrome who completed a previous BPN14770 study. They must be able to consent or provide assent, use contraception if sexually active, have a caregiver, and attend regular clinic visits. Excluded are those with substance abuse, renal/hepatic impairment, significant lab/ECG abnormalities from the parent study, major psychiatric conditions (except autism or anxiety), certain diseases like AIDS or hepatitis, or participation in other trials within 30 days.Check my eligibility

What is being tested?

The trial tests Zatolmilast/BPN14770 as an ongoing treatment for subjects who've finished prior studies on it. It's an open-label extension meaning everyone gets the drug and there's no placebo group; participants know what they're taking.See study design

What are the potential side effects?

While specific side effects of Zatolmilast/BPN14770 aren't listed here, common ones may include gastrointestinal issues like nausea or diarrhea, headaches, dizziness and potential allergic reactions. Participants' health will be monitored closely throughout.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Safety and tolerability of BPN14770

Secondary outcome measures

Aberrant Behavior Checklist (ABC) scores

Anxiety, Depression, and Mood Scale (ADAMS) scores

Caregiver Global Impression of Improvement (CaGI-I) assessments

+5 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Study Drug (BPN14770)Experimental Treatment1 Intervention

25mg BID Study Drug BPN14770 (Adults) or 15mg BID Study Drug BPN14770 (Adolescents with body weight <43 kg)

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Tetra Discovery PartnersLead Sponsor

8 Previous Clinical Trials

732 Total Patients Enrolled

3 Trials studying Fragile X Syndrome

330 Patients Enrolled for Fragile X Syndrome

Elizabeth Berry-Kravis, MDPrincipal InvestigatorRush University Medical Center

2 Previous Clinical Trials

196 Total Patients Enrolled

2 Trials studying Fragile X Syndrome

196 Patients Enrolled for Fragile X Syndrome

Media Library

Zatolmilast/ BPN14770 (Phosphodiesterase-4D (PDE4D) Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05367960 — Phase 3

Fragile X Syndrome Research Study Groups: Study Drug (BPN14770)

Fragile X Syndrome Clinical Trial 2023: Zatolmilast/ BPN14770 Highlights & Side Effects. Trial Name: NCT05367960 — Phase 3

Zatolmilast/ BPN14770 (Phosphodiesterase-4D (PDE4D) Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05367960 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there an opportunity to partake in this clinical research?

"This clinical trial is recruiting approximately 300 participants with fragile x syndrome aged 12 to 45."

Answered by AI

Does the age restriction of this medical trial exceed fifty years?

"According to the inclusion criteria set forth by this medical study, patients must be between 12 and 45 years of age. Furthermore, there are 380 trials available for minors under 18 and 1005 studies open to seniors over 65."

Answered by AI

Has this therapy earned the endorsement of regulatory bodies?

"Our team at Power has determined that this treatment presents a considerable degree of safety, awarding it with the highest rating available on our scale: 3. This is based off Phase 3 trial data which supports both its efficacy and safety."

Answered by AI

Are there any available slots remaining in the experiment?

"Presently, this trial is not enrolling participants. Initially published on November 1st of 2022 and last updated on February 15th 2023, the medical study has no openings at present; however, there are currently 1438 other trials that are welcoming volunteers."

Answered by AI

Are there multiple sites in Canada where this research is being conducted?

"Patients are welcome to apply at more than 10 sites, such as UC Davis in Sacramento, California, CHOC Thompson Autism Center in Orange, New york and Seaver Autism Center for Research & Treatment at Mount Sinai in Maryland."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

An Open-Label Extension Study of BPN14770 in Subjects With Fragile X Syndrome

2022. "An Open-Label Extension Study of BPN14770 in Subjects With Fragile X Syndrome". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05367960.

All > Fragile X Syndrome