A Phase 2 Study to Evaluate Efficacy, Safety, and Pharmacokinetics of PBF-999 in the Treatment of Patients with Prader-Willi Syndrome.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2022-501462-22-00

Acronym

PBF-999CT-04

Enrollment

Registered

2022-12-01

Start date

2023-02-22

Completion date

Unknown

Last updated

2025-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prader-Willi Syndrome

Brief summary

Treatment-emergent adverse events.

Detailed description

Post-treatment HQ-CT questionnaire total score, CGIC questionnaire score., PBF-999 PK parameters: AUC0-3h; Cmax., Physical and biological markers.

Interventions

DRUGThis is a placebo formulation of PBF-999 capsules. It is registered at eXEVMPD with EV code PRD9864516

Eligibility

Sex/Gender

All

Age

0 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
Treatment-emergent adverse events.	—

Secondary

Measure	Time frame
Post-treatment HQ-CT questionnaire total score, CGIC questionnaire score., PBF-999 PK parameters: AUC0-3h; Cmax., Physical and biological markers.	—

Countries

Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026