CARbetocin Efficacy and Safety Study in PWS

Research is uncovering new approaches to treating the hallmark symptoms of Prader-Willi syndrome.  Levo Therapeutics is currently enrolling patients with PWS in our Phase 3 clinical trial investigating intranasal carbetocin (LV-101) in 7-18 year olds as a treatment for hyperphagia and behavior associated with Prader-Willi syndrome.

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About intranasal carbetocin (LV-101)

Intranasal carbetocin is similar to the naturally-occurring hormone oxytocin, but with greater selectivity for the effect of interest – stimulation of oxytocin receptors.  These receptors are involved in the regulation of both social-emotional and feeding behaviors.

About the study

This is a Phase 3 randomized, double-blind study with an 8-week, placebo-controlled period designed to test the effectiveness, safety, and tolerability of investigational LV-101 in participants with PWS.

Effectiveness will be measured using both caregiver-reported and clinician-reported measures of hyperphagia (extreme hunger), obsessive and compulsive behaviors, and anxiety. Safety and tolerability will be measured by adverse events, laboratory tests, and physical exams.

All participants will receive active treatment with LV-101 after the 8-week placebo-controlled period, during a long-term follow-up period of 56 weeks. At Week 8, participants who were randomized to placebo in the placebo-controlled period will be randomized to one of the two LV-101 doses, administered three times per day before meals.

Study endpoints

In this study, we are studying the effect of LV-101 on various hallmark features of PWS, specifically hyperphagia, obsessive and compulsive symptoms, and anxiety.  To measure hyperphagia, caregivers will be asked to complete the Hyperphagia Questionnaire for Clinical Trials (HQ-CT).  To measure obsessive and compulsive symptoms, study site professionals will ask caregivers about how these symptoms show up in their child with PWS.  To measure anxiety and distress in patients with PWS, caregivers will be asked to complete the PWS Anxiety and Distress Questionnaire (PADQ).

For more information about the CARE-PWS study, please view the trial listing at: NCT03649477

Study sites

Below is a listing of clinical study sites that are currently open and enrolling participants in the CARE-PWS study.  Please continue to come back to this website or to the trial listing on (here) for up-to-date information regarding open study sites.

United States

University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
Contact: Jacob Orr    205-638-6452
Principal Investigator: Hussein Abdul-Latif, MD

Phoenix Children’s Hospital
Phoenix, Arizona, United States, 85006
Contact: Kiri Olsen    602-933-4112
Principal Investigator: Oliver Oatman, MD

Rady Children’s Hospital San Diego
San Diego, California, United States, 92123
Contact: Michael Farrell, RN    858-966-8453
Principal Investigator: Lynne Bird, MD

Children’s Hospital of Los Angeles (USC)
Los Angeles, California, United States, 90027
Contact: Janelle Gonzalez   614-722-2630
Principal Investigator: Alaina Vidmar, MD

Children’s Hospital Colorado
Aurora, Colorado, United States, 80045
Contact: Julia Smith    720-777-4030
Principal Investigator: Shawn McCandless, MD

District of Columbia
Children’s National
Washington, District of Columbia, United States, 20010
Contact: Jin Zhang
Principal Investigator: Tamanna Ratti Roshan Lal, MD
Sub-Investigator: Kenneth Rosenbaum, MD

University of Florida
Gainesville, Florida, United States, 32608
Contact: Beverly Giordano    352-294-5280
Principal Investigator: Jennifer Miller, MD

Ann & Robert H. Lurie Children’s Hospital of Chicago
Chicago, Illinois, United States, 60611
Contact: Amanda Barkho    312-503-7016
Principal Investigator: Laura Torchen, MD

Kansas University Medical Center
Kansas City, Kansas, United States, 66160
Contact: Yolanda Harness   913-574-0302
Principal Investigator: Merlin Butler, MD

Boston Children’s Hospital
Boston, Massachusetts, United States, 02115
Contact: Andrea Hale, RN
Principal Investigator: Charumathi Baskaran, MD

Children’s Hospitals and Clinics of Minnesota
Saint Paul, Minnesota, United States, 55102
Contact: Brittany Machus   651-220-5730
Principal Investigator: Melinda Pierce, MD

Cardinal Glennon Children’s Medical Center
Saint Louis, Missouri, United States, 63104
Contact: Barbara Whitman, PhD    314-268-4027
Principal Investigator:  Susan Myers, MD

University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44106
Contact: Audrey Lynn, PhD    216-844-7124
Principal Investigator: Ryan Farrell, MD

Nationwide Children’s Hospital
Columbus, Ohio, United States, 43205
Contact: Emily Viall    614-722-2630
Principal Investigator: Kathryn Obrynba, MD

Children’s Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19107
Contact: Kristin Wade   267-426-8724
Contact: Anna DeDio   215-425-1998
Principal Investigator: Shana McCormack, MD

Vanderbilt University School of Medicine
Nashville, Tennessee, United States, 37212
Contact: Hailee Hunt    615-343-0915
Principal Investigator: Ronald Cowan, MD
Sub-Investigator: Elizabeth Roof

Children’s Hospital of San Antonio
San Antonio, Texas, United States, 78207
Contact: Katrina Roberts    210-704-4755
Principal Investigator: Elizabeth Roeder, MD

Texas Children’s Hospital
Houston, Texas, United States, 77030
Contact: Andrew Meddaugh   832-824-1640
Contact: Stanley Osegha
Principal Investigator: Laurel Williams, MD

University of Utah
Salt Lake City, Utah, United States, 84108
Contact: Carrie Bailey, BS, CCRC   801-587-3605
Principal Investigator: David Viskochil, MD


University of Alberta
Edmonton, Alberta, Canada, T6G 2E1
Contact: Caroline Lyster   780-248-1770
Principal Investigator: Andrea Haqq, MD

British Columbia
British Columbia Children’s Hospital
Vancouver, BC, Canada, V6H 3V4
Contact: Jennifer Kwan   604-875-2345 Ext. 5120
Principal Investigator: Carol Lam, MD
Sub-Investigator: Laura Stewart, MD

Toronto Hospital for Sick Kids
Toronto, Ontario, Canada, M5G 1X8
Contact: Kate Hamilton   416-813-7654 Ext. 201931
Principal Investigator: Jill Hamilton, MD

CHU Ste Justine
Montréal, Quebec, Canada, H3T 1C5
Contact: Christine Massicotte, RN   514-345-4931 Ext. 3209
Principal Investigator: Cheri Deal, MD

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