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Study of Zatolmilast (BPN14770) in Participants With PPP2R5D Neurodevelopmental Disorder (Jordan's Syndrome [JS])

Sponsored by Shionogi

About this trial

Last updated 7 months ago

Study ID

BPN14770-CNS-205

Status

Not yet recruiting

Type

Interventional

Phase

Phase 2

Placebo

Yes

Accepting

18-75 Years
9 to 45 Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Started 6 months ago

What is this trial about?

The primary objective of this study is to assess the safety and tolerability of BPN14770 in participants aged 9 to 45 years with JS.

What are the participation requirements?

Yes

Inclusion Criteria

1. Participant is aged 9 to 45 years, inclusive.

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.

No

Exclusion Criteria

1. Participant has body weight less than 25 kilograms (kg).

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.

Locations

Location

Status