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Oxytocin Analog

3.2 mg intranasal carbetocin for Prader-Willi Syndrome (CARE-PWS Trial)

Phase 3
Waitlist Available
Research Sponsored by Levo Therapeutics, 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 8
Awards & highlights

CARE-PWS Trial Summary

This study is evaluating whether a drug called carbetocin can help people with Prader-Willi syndrome.

Eligible Conditions
  • Prader-Willi Syndrome

CARE-PWS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 8
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 8 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Hyperphagia Behavior
Obsessive and Compulsive Behaviors
Secondary outcome measures
Anxiety
Global Impression
Hyperphagia Behavior (Subset)

Side effects data

From 2022 Phase 3 trial • 130 Patients • NCT03649477
16%
Headache
14%
Flushing
9%
Diarrhea
7%
Upper respiratory tract infection
7%
Pyrexia
7%
Nasal discomfort
2%
Epistaxis
100%
80%
60%
40%
20%
0%
Study treatment Arm
3.2 mg of LV-101
9.6 mg of LV-101
Placebo

CARE-PWS Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: 9.6 mg of LV-101Experimental Treatment1 Intervention
9.6 mg of LV-101 during first 8-weeks; remain on same dose during 56-week follow-up and optional extension periods
Group II: 3.2 mg of LV-101Experimental Treatment1 Intervention
3.2 mg of LV-101 during first 8-weeks; remain on same dose during 56-week follow-up and optional extension periods
Group III: PlaceboPlacebo Group1 Intervention
matched placebo during first 8-weeks; prospectively randomized 1:1 to either one of the two doses of carbetocin during 56-week follow-up and optional extension periods
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
3.2 mg intranasal carbetocin
2018
Completed Phase 3
~130
9.6 mg intranasal carbetocin
2018
Completed Phase 3
~130

Find a Location

Who is running the clinical trial?

Levo Therapeutics, Inc.Lead Sponsor

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Phase 3 Study of Intranasal Carbetocin (LV-101) in Patients With Prader-Willi Syndrome
2018. "Phase 3 Study of Intranasal Carbetocin (LV-101) in Patients With Prader-Willi Syndrome". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03649477.
~20 spots leftby Apr 2025
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