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



Status:Recruiting
Conditions:Women's Studies
Therapuetic Areas:Reproductive
Healthy:No
Age Range:7 - 18
Updated:4/6/2019
Start Date:November 20, 2018
End Date:December 2020
Contact:Levo MedInfo
Email:contactus@levotx.com
Phone:847-901-9260

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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)

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.

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 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.

After the 8-week placebo-controlled period, there will be 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.

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
We found this trial at
20
sites
Nashville, Tennessee 37232
Principal Investigator: Ronald Cowan, MD
Phone: 615-343-0915
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
Principal Investigator: Hussein Abdul-Latif, MD
Phone: 205-638-6452
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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700 Childrens Drive
Columbus, Ohio 43205
(616) 722-2000
Principal Investigator: Kathryn Obrynba, MD
Nationwide Children's Hospital At Nationwide Children’s, we are creating the future of pediatric health care....
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Gainesville, Florida 32610
(352) 392-3261
Principal Investigator: Jennifer Miller, MD
Phone: 352-294-5280
University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
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South 34th Street
Philadelphia, Pennsylvania 19104
 215-590-1000
Principal Investigator: Shana McCormack, MD
Phone: 267-426-8724
Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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201 Presidents Circle
Salt Lake City, Utah 84108
801) 581-7200
Principal Investigator: David Viskochil, MD
Phone: 801-587-3605
University of Utah Research is a major component in the life of the U benefiting...
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3020 Childrens way
San Diego, California 92123
(858) 576-1700
Principal Investigator: Lynne Bird, MD
Phone: 858-966-8453
Rady Children's Hospital - San Diego Rady Children's Hospital-San Diego is the region’s pediatric medical...
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13123 E 16th Ave
Aurora, Colorado 80045
(720) 777-1234
Principal Investigator: Shawn McCandless, MD
Phone: 720-777-5001
Children's Hospital Colorado At Children's Hospital Colorado, we see more, treat more and heal more...
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Boston, Massachusetts 02115
Principal Investigator: Amy Fleischman, MD
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225 E Chicago Ave
Chicago, Illinois 60611
(312) 227-4000
Principal Investigator: Laura Torchen, MD
Phone: 312-227-4177
Ann & Robert H. Lurie Children's Hospital of Chicago Ann & Robert H. Lurie Children
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Cleveland, Ohio 44012
Principal Investigator: Ryan Farrell, MD
Phone: 216-844-7124
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Edmonton, Alberta T6G 2J2
Principal Investigator: Andrea Haqq, MD
Phone: 780-248-1770
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6621 Fannin St
Houston, Texas 77030
(832) 824-1000
Principal Investigator: Christopher Williams, MD
Texas Children's Hospital Texas Children's Hospital, located in Houston, Texas, is a not-for-profit organization whose...
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Kansas City, Kansas
Principal Investigator: Merlin Butler, MD
Phone: 913-574-0302
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Los Angeles, California 90027
Principal Investigator: Alaina Vidmar, MD
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1919 E Thomas Rd
Phoenix, Arizona 85006
(602) 933-1000
Principal Investigator: Oliver Oatman, MD
Phone: 602-933-4112
Phoenix Children's Hospital Phoenix Children's Hospital has provided hope, healing, and the best healthcare for...
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Saint Louis, Missouri 63104
Principal Investigator: Susan Myers, MD
Phone: 314-268-4027
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Saint Paul, Minnesota 55102
Principal Investigator: Melinda Pierce, MD
Phone: 651-220-5730
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San Antonio, Texas 78207
Principal Investigator: Elizabeth Roeder, MD
Phone: 210-704-4755
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Washington, District of Columbia 20010
Principal Investigator: Tamanna Ratti Roshan Lal, MD
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