Carbetocin Nasal Spray for Prader-Willi Syndrome

Phase 3

Waitlist Available

Research Sponsored by ACADIA Pharmaceuticals Inc.

Eligibility Criteria Checklist

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

Must have

Be younger than 65 years old

Must not have

Active psychotic symptoms, a history of psychotic symptoms, or a psychotic disorder

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 36 months

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial will look at how safe and well-tolerated a nasal spray called carbetocin is in people with PWS over a long period of time.

Who is the study for?

This trial is for individuals with Prader-Willi Syndrome, particularly those who experience hyperphagia or binge eating. Specific eligibility criteria are not provided, but typically participants must meet certain health standards and may need to have a confirmed diagnosis of the condition.

What is being tested?

The study is testing the long-term safety and tolerability of a nasal spray containing carbetocin (3.2 mg taken three times daily) in subjects with Prader-Willi Syndrome to see if it can help manage their symptoms.

What are the potential side effects?

While specific side effects are not listed here, carbetocin could potentially cause nasal discomfort or irritation, headaches, nausea, or other reactions related to hormone changes since it's similar to oxytocin.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have had or currently have symptoms of a psychotic disorder.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 36 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 36 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 36 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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