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Zatolmilast for Fragile X Syndrome

Q: Is this research project only enrolling those who are 25 years and younger?

This trial's age requirements for participants are between 12 and 18 years old.

Q: Would it be possible for me to join this research project?

This trial is meant for fraxa syndrome patients that are between the ages of 12-18. The clinical study will have a maximum of 150 enrollees.

Q: Are there any available openings for volunteers in this clinical research project?

This clinical trial, which was first posted on 3/29/2022 and last edited on 4/27/2022, is actively recruiting participants.

Q: Does this research represent a new frontier in medicine?

There is one ongoing clinical study for Low Dose Arm in 2 urban areas and 1 nation. The initial trial related to Low Dose Arm was in 2022. That particular trial, which was backed by Tetra Discovery Partners, included 150 individuals and completed its Phase 2 &#x26; 3 stages of drug approval. Since the year 2022, a total of 18291 trials have been conducted.

Q: Is the Low Dose Arm a new concept in medical research?

The Low Dose Arm was first studied in the year 2022 at Cincinatti Children's Hospital Medical Center. To date, there have been 18291 completed clinical trials. There is 1 actively recruiting clinical trial at the moment, with many of these trials taking place in Chicago, <a href="https://www.withpower.com/clinical-trials/illinois">Illinois</a>.

Phase 2 & 3

Recruiting

Research Sponsored by Tetra Discovery Partners

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Able to attend clinic regularly and reliably

Male adolescent aged 9 to < 18 years with FXS and molecular genetic confirmation of the full FMR1 mutation (≥ 200 CGG repetitions)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 13 weeks

Awards & highlights

Study Summary

This trial is testing a new drug for boys with fragile X syndrome. It will study how the boys' bodies process the drug and how well they tolerate it. The second part of the trial will be conducted with a placebo to compare the effects of the drug.

Who is the study for?

This trial is for male adolescents aged 12 to <18 with Fragile X Syndrome confirmed by genetic testing. They can be on up to three psychotropic medications (excluding anti-epileptics used for seizures), which must be stable in dose for four weeks prior. Participants should not have significant health issues, substance abuse history, or recent participation in other trials.Check my eligibility

What is being tested?

The study tests BPN14770's effects and how it's processed in the body compared to a placebo. Part 1 involves an open-label assessment of single doses, while Part 2 is double-blind and randomized between the drug and placebo groups.See study design

What are the potential side effects?

Potential side effects are not detailed here but may include reactions typical of pharmacological interventions such as gastrointestinal discomfort, headaches, or allergic responses. Specific side effects will depend on the study findings.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I can regularly and reliably go to the clinic for appointments.

Select...

I am a male aged 9-17 with Fragile X Syndrome confirmed by genetic testing.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 13 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~13 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 13 weeks for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

NIH Toolbox Cognitive Battery cognition crystallized composite score

Secondary outcome measures

CaGI-I for the general domain of Emotions/Behaviors

CaGI-I for the general domains of Daily Function, Language, and Academic Skills.

Investigator rated (CGI-I) for the general domains of Daily Function, Language, and Academic Skills

+5 more

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Study DrugActive Control1 Intervention

Subjects will receive 15 mg BID or 25mg BID dose of BPN14770

Group II: Placebo ArmPlacebo Group1 Intervention

Subjects will receive matching Placebo

0 / 2Eligibility criteria met

Find a Location

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

Media Library

BPN14770 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05163808 — Phase 2 & 3

Fragile X Syndrome Research Study Groups: Placebo Arm, Study Drug

Fragile X Syndrome Clinical Trial 2023: BPN14770 Highlights & Side Effects. Trial Name: NCT05163808 — Phase 2 & 3

BPN14770 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05163808 — Phase 2 & 3

Frequently Asked Questions

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

Is this research project only enrolling those who are 25 years and younger?

"This trial's age requirements for participants are between 12 and 18 years old."

Answered by AI

Would it be possible for me to join this research project?

"This trial is meant for fraxa syndrome patients that are between the ages of 12-18. The clinical study will have a maximum of 150 enrollees."

Answered by AI

Are there any available openings for volunteers in this clinical research project?

"This clinical trial, which was first posted on 3/29/2022 and last edited on 4/27/2022, is actively recruiting participants."

Answered by AI

Does this research represent a new frontier in medicine?

"There is one ongoing clinical study for Low Dose Arm in 2 urban areas and 1 nation. The initial trial related to Low Dose Arm was in 2022. That particular trial, which was backed by Tetra Discovery Partners, included 150 individuals and completed its Phase 2 & 3 stages of drug approval. Since the year 2022, a total of 18291 trials have been conducted."

Answered by AI

Is the Low Dose Arm a new concept in medical research?

"The Low Dose Arm was first studied in the year 2022 at Cincinatti Children's Hospital Medical Center. To date, there have been 18291 completed clinical trials. There is 1 actively recruiting clinical trial at the moment, with many of these trials taking place in Chicago, Illinois."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Randomized Study of BPN14770 in Male Adolescents (Aged 9 to < 18 Years) With Fragile X Syndrome

2022. "A Randomized Study of BPN14770 in Male Adolescents (Aged 9 to < 18 Years) With Fragile X Syndrome". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05163808.

All > Fragile X Syndrome