Phase 3 Study of Intranasal Carbetocin (LV-101) in Patients With Prader-Willi Syndrome
Public ClinicalTrials.gov record NCT03649477. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Phase 3, Randomized, Double-Blind, Placebo-Controlled, 8-week Clinical Study to Assess the Efficacy, Safety, and Tolerability, of Intranasal Carbetocin (LV-101) in Prader-Willi Syndrome (PWS) With Long Term Follow-Up (CARE-PWS)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This Phase 3 study is designed to test the effectiveness of intranasal carbetocin (LV-101) in participants with Prader-Willi syndrome (PWS). Carbetocin is an oxytocin analog (a man-made chemical that is like oxytocin). This study will also evaluate the safety and tolerability of LV-101.
Study identification
- NCT ID
- NCT03649477
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 130 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 7 Years to 18 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 20, 2018 (Actual)
- Primary completion
- May 13, 2020 (Actual)
- Completion
- Jul 9, 2022 (Actual)
- Last update posted
- Jul 26, 2022
2018 – 2022
United States locations
- U.S. sites
- 19
- U.S. states
- 17
- U.S. cities
- 19
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35233 | — |
| Phoenix Children's Hospital | Phoenix | Arizona | 85006 | — |
| Children's Hospital of Los Angeles (USC) | Los Angeles | California | 90027 | — |
| Rady Children's Hospital San Diego | San Diego | California | 92123 | — |
| Children's Hospital Colorado | Aurora | Colorado | 80045 | — |
| Children's National | Washington D.C. | District of Columbia | 20010 | — |
| University of Florida | Gainesville | Florida | 32608 | — |
| Ann & Robert H. Lurie Children's Hospital of Chicago | Chicago | Illinois | 60611 | — |
| Kansas University Medical Center | Kansas City | Kansas | 66160 | — |
| University of Harvard Boston Children's Hospital | Boston | Massachusetts | 02115 | — |
| Children's Hospitals and Clinics of Minnesota | Saint Paul | Minnesota | 55102 | — |
| Cardinal Glennon Children's Medical Center | St Louis | Missouri | 63104 | — |
| Nationwide Children's Hospital | Columbus | Ohio | 43205 | — |
| University of Oklahoma Health Sciences Center | Tulsa | Oklahoma | 74135 | — |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19107 | — |
| Vanderbilt University School of Medicine | Nashville | Tennessee | 37212 | — |
| Texas Children's Hospital | Houston | Texas | 77030 | — |
| Children's Hospital of San Antonio | San Antonio | Texas | 78207 | — |
| University of Utah | Salt Lake City | Utah | 84108 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 5 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03649477, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 26, 2022 · Synced Oct 24, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03649477 live on ClinicalTrials.gov.