OLE Study of Carbetocin Nasal Spray for the Treatment of Hyperphagia in Prader-Willi Syndrome

Conditions

• Hyperphagia in Prader-Willi Syndrome

Eligibility Criteria

Sex

ALL

Age

5 Years - 30 Years

Healthy Volunteers

Not accepted

Interventions

• Carbetocin — DRUG
  Carbetocin nasal spray 3.2 mg three times daily (TID)

Study Details

To evaluate long-term safety and tolerability of carbetocin nasal spray (3.2 mg TID) in subjects with PWS

Key Dates

Start date

Mar 11, 2024

Status verified

Dec 2025

Primary completion

May 31, 2029

Completion

Jun 30, 2029

Study Design

Enrollment

160 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Drug: Carbetocin
  Carbetocin nasal spray 3.2 mg three times daily (TID)

Primary Outcome Measure

Treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), withdrawals due to adverse events (AEs), potentially clinically important changes in other safety assessments, device incidents or device malfunctions [ Time Frame: Baseline to 36 months ]

Locations (19)

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