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.
CARbetocin Efficacy and Safety Study in PWS
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.
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
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 www.clinicaltrials.gov (here) for up-to-date information regarding open study sites.
Rady Children’s Hospital San Diego
San Diego, California, United States, 92123
Contact: Rachel Winograd, RN 858-966-8453 email@example.com
Principal Investigator: Lynne Bird, MD
University of Florida
Gainesville, Florida, United States, 32608
Contact: Beverly Giordano 352-294-5280 firstname.lastname@example.org
Principal Investigator: Jennifer Miller, MD
Kansas University Medical Center
Kansas City, Kansas, United States, 66160
Contact: Yolanda Harness 913-574-0302 email@example.com
Principal Investigator: Merlin Butler, MD
Children’s Hospitals and Clinics of Minnesota
Saint Paul, Minnesota, United States, 55102
Contact: Brittany Machus 651-220-5730 firstname.lastname@example.org
Principal Investigator: Melinda Pierce, MD
Vanderbilt University School of Medicine
Nashville, Tennessee, United States, 37212
Contact: Hailee Hunt 615-343-0915 email@example.com
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 firstname.lastname@example.org
Principal Investigator: Elizabeth Roeder, MD
Texas Children’s Hospital
Houston, Texas, United States, 77030
Contact: Andrew Meddaugh 832-824-1640 email@example.com
Contact: Stanley Osegha firstname.lastname@example.org
Principal Investigator: Laurel Williams, MD
University of Alberta
Edmonton, Alberta, Canada, T6G 2E1
Contact: Caroline Lyster 780-248-1770 email@example.com
Principal Investigator: Andrea Haqq, MD
CHU Ste Justin
Montréal, Quebec, Canada, H3T 1C5
Contact: Christine Massicotte, RN 514-345-4931 Ext. 3209 firstname.lastname@example.org
Principal Investigator: Cheri Deal, MD