Phase 3 Study of Intranasal Carbetocin (LV-101) in Patients With Prader-Willi Syndrome

Completed · Phase 3 · Has a placebo group

Conditions studied: Prader-Willi Syndrome

In brief

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.

Key facts

Study ID

NCT03649477

Run by

Levo Therapeutics, Inc.

People needed

130

Starts

2018-11-20

Expected to finish

2022-07-09

Last updated by the study team

2022-07-26

Who can join

Age: 7 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Phoenix Children's Hospital — Phoenix, Arizona, United States
• Children's Hospital of Los Angeles (USC) — Los Angeles, California, United States
• Rady Children's Hospital San Diego — San Diego, California, United States
• Children's Hospital Colorado — Aurora, Colorado, United States
• Children's National — Washington D.C., District of Columbia, United States
• University of Florida — Gainesville, Florida, United States
• Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago, Illinois, United States
• Kansas University Medical Center — Kansas City, Kansas, United States
• University of Harvard Boston Children's Hospital — Boston, Massachusetts, United States
• Children's Hospitals and Clinics of Minnesota — Saint Paul, Minnesota, United States
• Cardinal Glennon Children's Medical Center — St Louis, Missouri, United States
• Nationwide Children's Hospital — Columbus, Ohio, United States
• University of Oklahoma Health Sciences Center — Tulsa, Oklahoma, United States
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• Vanderbilt University School of Medicine — Nashville, Tennessee, United States
• Texas Children's Hospital — Houston, Texas, United States
• Children's Hospital of San Antonio — San Antonio, Texas, United States
• University of Utah — Salt Lake City, Utah, United States
• Queensland Children's Hospital — South Brisbane, Queensland, Australia
• University of Alberta — Edmonton, Alberta, Canada
• British Columbia Children's Hospital — Vancouver, British Columbia, Canada
• Toronto Hospital for Sick Kids — Toronto, Ontario, Canada
• CHU Ste Justine — Montreal, Quebec, Canada

Full record on ClinicalTrials.gov

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