Study of Zatolmilast (BPN14770) in Participants With PPP2R5D Neurodevelopmental Disorder (Jordan's Syndrome [JS])
NCT ID: NCT06717438
Last Updated: 2026-01-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
30 participants
INTERVENTIONAL
2025-05-13
2030-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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BPN14770
Participants will receive a weight adjusted dose of BPN14770 twice daily (BID) during the 24-week Double-blind Period.
Participants in the BPN14770 arm who complete the Double-blind Period will have the opportunity to continue in the Open-label Extension Period. Participants will receive a weight adjusted dose of BPN14770 BID during the 24-week Open-label Extension Period.
BPN14770
Capsules for oral administration
Placebo
Participants will receive BPN14770 matching placebo BID during the 24-week Double-blind Period.
Participants in the placebo arm who complete the Double-blind Period will have the opportunity to continue in the Open-label Extension Period. Participants will receive a weight adjusted dose of BPN14770 BID during the 24-week Open-label Extension Period.
BPN14770
Capsules for oral administration
Placebo
Capsules for oral administration
Interventions
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BPN14770
Capsules for oral administration
Placebo
Capsules for oral administration
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Participant has confirmed/documented history of PPP2R5D Neurodevelopmental Disorder.
3. Current treatment with no more than 3 prescribed psychotropic medications.
4. Participant has a parent, legal authorized guardian or consistent caregiver.
Exclusion Criteria
2. Clinically significant abnormalities, in the investigator's judgment, in safety laboratory tests, vital signs, or electrocardiogram (ECG), as measured during Screening.
3. Concurrent major psychiatric condition (e.g., Major Depressive Disorder, Schizophrenia or Bipolar Disorder) as diagnosed by the investigator. Participants with additional diagnosis of Autism Spectrum Disorder or Anxiety Disorder will be allowed.
4. Participant is planning to commence psychotherapy or cognitive behavior therapy (CBT) during the period of the study or had begun psychotherapy or CBT within 4 weeks prior to Screening.
9 Years
45 Years
ALL
No
Sponsors
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Shionogi
INDUSTRY
Responsible Party
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Locations
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Rush University Medical Center
Chicago, Illinois, United States
Boston Children's Hospital
Boston, Massachusetts, United States
Seattle Children's Hospital
Seattle, Washington, United States
Countries
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Other Identifiers
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BPN14770-CNS-205
Identifier Type: -
Identifier Source: org_study_id
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