Study Purpose
Carbetocin (LV-101) is an investigational drug that was created to have effects in the body like oxytocin. Carbetocin is not approved in the United States, but is approved in some other countries for treatment of women with excessive bleeding after giving birth via caesarean section. This Phase 3 study of intranasal carbetocin (LV-101) is a randomized, double-blind study with an 8-week, placebo controlled period, followed by a long-term follow-up period of 56 weeks during which all participants will receive active treatment with LV-101. 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.
A webinar sharing details on this study was recorded March, 2019. You can watch the webinar below or read a transcription of the webinar on our blog.
Recruitment Criteria
Study Type: Interventional
Eligible Ages: 7-18 years
Other Criteria: PWS Nutritional Phase 3
Trial Details
Trial Id: NCT03649477
Phase: 3
Duration: 8 weeks of double blind, placebo controlled study, followed by 56 weeks of open label treatment
Status: recruiting
Lead Sponsor: Levo
Countries: United States
Additional Details: Outcome measures include changes in hyperphagia behavior, obsessive and compulsive behaviors, anxiety and global impression
Eligibility Criteria
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Inclusion Criteria:
- Genetically-confirmed Prader-Willi syndrome
- Provide voluntary, written informed consent (parent(s) / legal guardian(s) of participant); provide voluntary, written assent (participants, as appropriate)
- PWS Nutritional Phase 3 (hyperphagic, rarely feels full)
Exclusion Criteria:
- Living in a group home
- Genetically diagnosed Schaaf-Yang syndrome or other genetic, hormonal, or chromosomal cognitive impairment
- New food-related interventions, including environment or dietary restrictions, within 1 month of screening
- Dose of any allowed chronic concomitant medications or supplements that have not been stable for ≥3 months prior to the study or is not expected to remain stable while participating in the study; adjustments in growth hormone dose ≤10% are not exclusionary
- Presence of cardiovascular disorders, epilepsy, frequent migraines, or severe asthma
- More than 3 episodes of sinusitis in the 12 months prior to Screening Visit or presence of nasal diseases that may affect deposition of intranasal medication
- Unwilling to abstain from nasal saline, other nasal irrigation, or other intranasal medications for 2 weeks prior to the Baseline visit and during the 8-week, placebo-controlled period of the study
- Use of weight loss medication, oxytocin, carbetocin, or vasopressin in the 6 months prior to screening
- Participation in an interventional research study involving another investigational medication or device in the 6 months prior to screening or during the study
- Based on the judgment of the Investigator, is unsuitable for the study for any reason, including but not limited to unstable medical condition, inability to comply with the protocol, or other risk to subject or to the integrity of the study
This study will be available at the following sites:
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
Contact: Jacob Orr 205-638-6452 jorr@peds.uab.edu
Principal Investigator: Hussein Abdul-Latif, MD
United States, Arizona
Phoenix Children's Hospital
Phoenix, Arizona, United States, 85006
Contact: Kiri Olsen 602-933-4112 kolsen1@phoenixchildrens.com
Principal Investigator: Oliver Oatman, MD
United States, California
Children's Hospital of Los Angeles (USC)
Los Angeles, California, United States, 90027
Contact: Janelle Gonzalez janGonzalez@chla.usc.edu
Principal Investigator: Alaina Vidmar, MD
Stanford Children's Health
Palo Alto, California, United States, 94304
Contact: Jake Urbassik 650-497-7528 jake.urbassik@stanford.edu
Principal Investigator: Diane Stafford, MD
Rady Children's Hospital San Diego
San Diego, California, United States, 92123
Contact: Michael Farrell, RN 858-966-8453 mfarrell@rchsd.org
Principal Investigator: Lynne Bird, MD
United States, Colorado
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
Contact: Julia Smith 720-777-4030 julia.smith@childrenscolorado.org
Principal Investigator: Shawn McCandless, MD
United States, District of Columbia
Children's National
Washington, District of Columbia, United States, 20010
Contact: Jin Zhang jzhang2@childrensnational.org
Principal Investigator: Tamanna Ratti Roshan Lal, MD
Sub-Investigator: Kenneth Rosenbaum, MD
United States, Florida
University of Florida
Gainesville, Florida, United States, 32608
Contact: Beverly Giordano 352-294-5280 bgiordano@peds.ufl.edu
Principal Investigator: Jennifer Miller, MD
United States, Illinois
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States, 60611
Contact: Amanda Barkho 312-503-7016 abarkho@luriechildrens.org
Principal Investigator: Laura Torchen, MD
United States, Kansas
Kansas University Medical Center
Kansas City, Kansas, United States, 66160
Contact: Yolanda Harness 913-574-0302 yharness@kumc.edu
Principal Investigator: Merlin Butler, MD
United States, Massachusetts
University of Harvard Boston Children's Hospital
Boston, Massachusetts, United States, 02115
Contact: Jasmina Cesko, RN 617-919-7555 Jasmina.Cesko@childrens.harvard.edu
Principal Investigator: Charumathi Baskaran, MD
United States, Minnesota
Children's Hospitals and Clinics of Minnesota
Saint Paul, Minnesota, United States, 55102
Contact: Brittany Machus 651-220-5730 brittany.machus@childrensmn.org
Principal Investigator: Melinda Pierce, MD
United States, Missouri
Cardinal Glennon Children's Medical Center
Saint Louis, Missouri, United States, 63104
Contact: Barbara Whitman, PhD 314-268-4027 barbara.whitman@health.slu.edu
Principal Investigator: Susan Myers, MD
United States, Ohio
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44106
Contact: Ryan Ferrell 216-844-3661 ryan.farrell@UHhospitals.org
Principal Investigator: Ryan Farrell, MD
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Contact: Emily Viall 614-722-2630 Emily.Viall@nationwidechildrens.org
Principal Investigator: Kathryn Obrynba, MD
United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19107
Contact: Kristin Wade 267-426-8724 WadeKL@email.chop.edu
Contact: Anna DeDio 215-425-1998 dedioa@email.chop.edu
Principal Investigator: Shana McCormack, MD
United States, Tennessee
Vanderbilt University School of Medicine
Nashville, Tennessee, United States, 37212
Contact: Hailee Hunt 615-343-0915 hailee.m.hunt@vanderbilt.edu
Principal Investigator: Ronald Cowan, MD
Sub-Investigator: Elizabeth Roof
United States, Texas
Texas Children's Hospital
Houston, Texas, United States, 77030
Contact: Andrew Meddaugh 832-824-1640 axmeddau@texaschildrens.org
Contact: Stanley Osegha sxosegha@texaschildrens.org
Principal Investigator: Laurel Williams, MD
Children's Hospital of San Antonio
San Antonio, Texas, United States, 78207
Contact: Katrina Roberts 210-704-4755 katrina.roberts@christushealth.org
Principal Investigator: Elizabeth Roeder, MD
United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84108
Contact: Carrie Bailey, BS, CCRC 801-587-3605 carrie.bailey@hsc.utah.edu
Principal Investigator: David Viskochil, MD
Australia, New South Wales
Sydney Children's Hospital
Randwick, New South Wales, Australia, 2031
Contact Petrina Hetherrington +61 (0) 2 9382 5537 Patrina.Hetherington@health.nsw.gov.au
Principal Investigator: Ohn Nyunt, MD
The Children's Hopital at Westmead
Westmead, New South Wales, Australia, 2145
Contact: Amy Bruce +61 (0) 2 9845 1320 amy.bruce@health.nsw.gov.au
Principal Investigator: Yoon Hi Cho, MD
Australia Queensland
Queensland Children's Hospital
South Brisbane, Queensland, Australia 4101
Contact: Emma Brownrigg +61 (0) 7 3069 7505 emma.brownrigg@health.qld.gov.au
Principal Investigator: Diane Jensen, MD
Canada, Alberta
University of Alberta
Edmonton, Alberta, Canada, T6G 2E1
Contact: Caroline Lyster 780-248-1770 clyster@ualberta.ca
Principal Investigator: Andrea Haqq, MD
Canada, British Columbia
British Columbia Children's Hospital
Vancouver, British Columbia, Canada, V6H 3V4
Contact: Jennifer Kwan 604-875-2345 ext 5120 jkwan7@cw.bc.ca
Principal Investigator: Carol Lam, MD
Sub-Investigator: Laura Stewart, MD
Canada, Ontario
Toronto Hospital for Sick Kids
Toronto, Ontario, Canada, M5G 1X8
Contact: Kate Hamilton 416-813-7654 ext 201931 Katharine.hamilton@sickkids.ca
Principal Investigator: Jill Hamilton, MD
Canada, Quebec
CHU Ste Justine
Montréal, Quebec, Canada, H3T 1C5
Contact: Christine Massicotte, RN 514-345-4931 ext 3209 christine.massicotte@recherche-ste-justine.qc.ca
Principal Investigator: Cheri Deal, MD
Questions?
Contact: Levo MedInfo | 847-901-9260 | contactus@levotx.com |