Prader-Willi SyndromePhase 3CARE-PWSNCT03649477

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

A Phase 3 study testing 3.2 mg intranasal carbetocin and 9.6 mg intranasal carbetocin in people with Prader-Willi Syndrome, run by Levo Therapeutics, Inc. at 24 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 7 to 18 years
Conditions the study is for: Prader-Willi Syndrome
What is being tested?: 3.2 mg intranasal carbetocin and 9.6 mg intranasal carbetocin
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 130 participants
Where: 24 sitesin 3 countries
Study dates: 20 Nov 2018to 9 Jul 2022
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 7 to 18 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

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)

Who cannot join

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

Show all 10Show fewer

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

Trial locations and contacts

24 sites in 3 countries.

Country

City, postcode or hospital

24 sites in 3 countries

United States19 sites

Children's Hospital Colorado
Aurora, Colorado, 80045
University of Alabama at Birmingham
Birmingham, Alabama, 35233
University of Harvard Boston Children's Hospital
Boston, Massachusetts, 02115
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
Nationwide Children's Hospital
Columbus, Ohio, 43205
University of Florida
Gainesville, Florida, 32608
Texas Children's Hospital
Houston, Texas, 77030
Kansas University Medical Center
Kansas City, Kansas, 66160
Children's Hospital of Los Angeles (USC)
Los Angeles, California, 90027
Vanderbilt University School of Medicine
Nashville, Tennessee, 37212
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19107
Phoenix Children's Hospital
Phoenix, Arizona, 85006
Children's Hospitals and Clinics of Minnesota
Saint Paul, Minnesota, 55102
University of Utah
Salt Lake City, Utah, 84108
Children's Hospital of San Antonio
San Antonio, Texas, 78207
Rady Children's Hospital San Diego
San Diego, California, 92123
Cardinal Glennon Children's Medical Center
St Louis, Missouri, 63104
University of Oklahoma Health Sciences Center
Tulsa, Oklahoma, 74135
Children's National
Washington D.C., District of Columbia, 20010

Other trials in United States

Canada4 sites

University of Alberta
Edmonton, Alberta, T6G 2E1
CHU Ste Justine
Montreal, Quebec, H3T 1C5
Toronto Hospital for Sick Kids
Toronto, Ontario, M5G 1X8
British Columbia Children's Hospital
Vancouver, British Columbia, V6H 3V4

Other trials in Canada

Australia1 site

Queensland Children's Hospital
South Brisbane, Queensland, 4101

Other trials in Australia

About this study

Official title: 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)

Read the detailed description

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 and an optional extension period after study week 64 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.

Conditions: Prader-Willi Syndrome
Being tested: 3.2 mg intranasal carbetocin, 9.6 mg intranasal carbetocin, placebo
Keywords: PWS, Prader-Willi syndrome, carbetocin
Medical subject headings: Prader-Willi Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

3.2 mg intranasal carbetocinDrug
Also called LV-101
three times per day with meals
9.6 mg intranasal carbetocinDrug
Also called LV-101
three times per day with meals
placeboDrug
three times per day with meals

Study groups in NCT03649477
Study group	Role	What they receive
Placebo	Placebo comparator	matched placebo during first 8-weeks; prospectively randomized 1:1 to either one of the two doses of carbetocin during 56-week follow-up and optional extension periods Receives: Drug: placebo
3.2 mg of LV-101	Experimental	3.2 mg of LV-101 during first 8-weeks; remain on same dose during 56-week follow-up and optional extension periods Receives: Drug: 3.2 mg intranasal carbetocin
9.6 mg of LV-101	Experimental	9.6 mg of LV-101 during first 8-weeks; remain on same dose during 56-week follow-up and optional extension periods Receives: Drug: 9.6 mg intranasal carbetocin

What is being measured

The primary outcome is the main question the study is designed to answer.

Hyperphagia Behavior
Change in hyperphagia (extreme hunger) as measured by the Hyperphagia Questionnaire for Clinical Trials (HQ-CT) Total Score versus placebo.
Score range: 0-36; higher scores mean a worse outcome. Reduction in score indicates improvement.
Measured: Baseline to Week 8
Obsessive and Compulsive Behaviors
Change in obsessive and compulsive behaviors as measured by the Children's Yale-Brown Obsessive-Compulsive Scale (CY-BOCS) Total Score versus placebo.
Score range: 0-40; higher scores mean a worse outcome. Reduction in score indicates improvement.
Measured: baseline to Week 8

Secondary outcomes (3)

Anxiety
Change in participant anxiety as measured by the PWS Anxiety and Distress Questionnaire (PADQ) Total Score versus placebo.
Score range: 0-56; higher scores mean a worse outcome. Reduction in score indicates improvement.
Measured: Baseline to Week 8
Global Impression
Clinical Global Impression of Change (CGI-C) score versus placebo. Score range: 1-7; higher scores mean a worse outcome. Reduction in score indicates improvement.
Measured: Week 8
Hyperphagia Behavior (Subset)
Change in hyperphagia as measured by the change in specified subsets of HQ-CT questions versus placebo.
Score range: 0-24; higher scores mean a worse outcome. Reduction in score indicates improvement.
Measured: Baseline to Week 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Nov 20189 Jul 2022

First posted28 Aug 2018
Study start20 Nov 2018
Primary completion13 May 2020
Study completion9 Jul 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Prader-Willi SyndromeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Three parallel groups (two different doses of carbetocin and placebo) for the first 8 weeks; two parallel groups (two different doses of carbetocin) during 56 weeks of follow-up and the optional extension period
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 130 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03649477
Sponsor's protocol ID: LV-101-3-01
Acronym: CARE-PWS
Status last verified: Aug 2021
First submitted: 24 Aug 2018
Last updated: 26 Jul 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Roof E, Strong TV, Stafford DEJ, Singh D, Roy SM, Doshi D, Zhang Y, Salvucci A, Youakim JM, McCandless SE; COMPASS PWS Investigators. Carbetocin Nasal Spray for the Treatment of Hyperphagia in Prader-Willi Syndrome: Results From the Randomized, Placebo-Controlled, Phase 3 Compass PWS Study. Clin Ther. 2026 Jul 22:S0149-2918(26)00234-1. doi: 10.1016/j.clinthera.2026.06.019. Online ahead of print.
PubMed 42486751
Roof E, Deal CL, McCandless SE, Cowan RL, Miller JL, Hamilton JK, Roeder ER, McCormack SE, Roshan Lal TR, Abdul-Latif HD, Haqq AM, Obrynba KS, Torchen LC, Vidmar AP, Viskochil DH, Chanoine JP, Lam CKL, Pierce MJ, Williams LL, Bird LM, Butler MG, Jensen DE, Myers SE, Oatman OJ, Baskaran C, Chalmers LJ, Fu C, Alos N, McLean SD, Shah A, Whitman BY, Blumenstein BA, Leonard SF, Ernest JP, Cormier JW, Cotter SP, Ryman DC. Intranasal Carbetocin Reduces Hyperphagia, Anxiousness, and Distress in Prader-Willi Syndrome: CARE-PWS Phase 3 Trial. J Clin Endocrinol Metab. 2023 Jun 16;108(7):1696-1708. doi: 10.1210/clinem/dgad015.
PubMed 36633570

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Prader-Willi Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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)
ClinicalTrials.gov ID: NCT03649477
Acronym / sponsor ID: CARE-PWS / LV-101-3-01
Conditions: Prader-Willi Syndrome
Keywords: PWS, Prader-Willi syndrome, carbetocin
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 130 participants (actual)
Lead sponsor: Levo Therapeutics, Inc.Industry (pharma, biotech, devices)
Study start: 20 Nov 2018 (actual)
Primary completion: 13 May 2020 (actual)
Study completion: 9 Jul 2022 (actual)
First posted: 28 Aug 2018 (actual)
Results: Posted 17 Nov 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3
Model description: Three parallel groups (two different doses of carbetocin and placebo) for the first 8 weeks; two parallel groups (two different doses of carbetocin) during 56 weeks of follow-up and the optional extension period

Arm	Type	Receives
Placebo	Placebo comparator	Drug: placebomatched placebo during first 8-weeks; prospectively randomized 1:1 to either one of the two doses of carbetocin during 56-week follow-up and optional extension periods
3.2 mg of LV-101	Experimental	Drug: 3.2 mg intranasal carbetocin3.2 mg of LV-101 during first 8-weeks; remain on same dose during 56-week follow-up and optional extension periods
9.6 mg of LV-101	Experimental	Drug: 9.6 mg intranasal carbetocin9.6 mg of LV-101 during first 8-weeks; remain on same dose during 56-week follow-up and optional extension periods

Who may qualify

Ages: 7 to 18 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (3 listed)

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)

Key exclusion criteria (10 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
3.2 mg intranasal carbetocinAlso: LV-101three times per day with meals	Drug	3.2 mg of LV-101
9.6 mg intranasal carbetocinAlso: LV-101three times per day with meals	Drug	9.6 mg of LV-101
placebothree times per day with meals	Drug	Placebo

Primary outcome

Hyperphagia Behavior
Time frame: Baseline to Week 8
Change in hyperphagia (extreme hunger) as measured by the Hyperphagia Questionnaire for Clinical Trials (HQ-CT) Total Score versus placebo. Score range: 0-36; higher scores mean a worse outcome. Reduction in score indicates improvement.
Obsessive and Compulsive Behaviors
Time frame: baseline to Week 8
Change in obsessive and compulsive behaviors as measured by the Children's Yale-Brown Obsessive-Compulsive Scale (CY-BOCS) Total Score versus placebo. Score range: 0-40; higher scores mean a worse outcome. Reduction in score indicates improvement.

3 secondary outcomes

Anxiety
Time frame: Baseline to Week 8
Global Impression
Time frame: Week 8
Hyperphagia Behavior (Subset)
Time frame: Baseline to Week 8

Results and safety

Results posted to the registry on 17 Nov 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
9.6 mg of LV-101	44	42
3.2 mg of LV-101	43	43
Placebo	43	43

Primary outcome: Hyperphagia Behavior

Time frame: Baseline to Week 8. Least squares mean (95% Confidence Interval). Unit: score on a scale

Measure	9.6 mg of LV-101 n = 40	3.2 mg of LV-101 n = 39	Placebo n = 40
Value	-3.439 (-5.304 to -1.575)	-5.372 (-7.259 to -3.486)	-2.237 (-4.095 to -0.378)

9.6 mg of LV-101 vs Placebo: Mean Difference (Net): -1.202 (95% CI -3.729 to 1.324), p = 0.3493, Mixed Models Analysis
3.2 mg of LV-101 vs Placebo: Mean Difference (Net): -3.136 (95% CI -5.685 to -0.586), p = 0.0162, Mixed Models Analysis

Population analysed: Primary Analysis Set: A subset of the Full Analysis Set that included all subjects with at least one post-Baseline visit (i.e., Week 2 or Week 8) completed prior to March 01, 2020 and excluded all efficacy data collected on or after March 01, 2020.

Primary outcome: Obsessive and Compulsive Behaviors

Time frame: baseline to Week 8. Least squares mean (95% Confidence Interval). Unit: score on a scale

Measure	9.6 mg of LV-101 n = 40	3.2 mg of LV-101 n = 39	Placebo n = 40
Value	-2.968 (-4.667 to -1.268)	-3.123 (-4.843 to -1.403)	-2.360 (-4.046 to -0.674)

9.6 mg of LV-101 vs Placebo: Mean Difference (Net): -0.608 (95% CI -2.890 to 1.674), p = 0.6001, Mixed Models Analysis
3.2 mg of LV-101 vs Placebo: Mean Difference (Net): -0.764 (95% CI -3.068 to 1.541), p = 0.5143, Mixed Models Analysis

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 8-week placebo-controlled period. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
9.6 mg of LV-101	0 of 44 (0%)	20 of 44 (45.5%)	0 of 44
3.2 mg of LV-101	0 of 43 (0%)	19 of 43 (44.2%)	0 of 43
Placebo	0 of 43 (0%)	10 of 43 (23.3%)	0 of 43

Limitations and caveats (from the sponsor): The COVID-19 pandemic began affecting this study in early March 2020 by substantially impacting the ability to safely enroll clinical study subjects, by requiring remote visits and monitoring, and by dramatically changing daily routines and social environments in this sensitive PWS population. Levo held new screening and enrollment in March 2020, and subsequently closed screening and enrollment in May 2020, resulting in the enrollment of 130 subjects instead of the 175 subjects planned.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 42486751Roof E, Strong TV, Stafford DEJ, Singh D, Roy SM, Doshi D, Zhang Y, Salvucci A, Youakim JM, McCandless SE; COMPASS PWS Investigators. Carbetocin Nasal Spray for the Treatment of Hyperphagia in Prader-Willi Syndrome: Results From the Randomized, Placebo-Controlled, Phase 3 Compass PWS Study. Clin Ther. 2026 Jul 22:S0149-2918(26)00234-1. doi: 10.1016/j.clinthera.2026.06.019. Online ahead of print.
Derived from this study: PubMed 36633570Roof E, Deal CL, McCandless SE, Cowan RL, Miller JL, Hamilton JK, Roeder ER, McCormack SE, Roshan Lal TR, Abdul-Latif HD, Haqq AM, Obrynba KS, Torchen LC, Vidmar AP, Viskochil DH, Chanoine JP, Lam CKL, Pierce MJ, Williams LL, Bird LM, Butler MG, Jensen DE, Myers SE, Oatman OJ, Baskaran C, Chalmers LJ, Fu C, Alos N, McLean SD, Shah A, Whitman BY, Blumenstein BA, Leonard SF, Ernest JP, Cormier JW, Cotter SP, Ryman DC. Intranasal Carbetocin Reduces Hyperphagia, Anxiousness, and Distress in Prader-Willi Syndrome: CARE-PWS Phase 3 Trial. J Clin Endocrinol Metab. 2023 Jun 16;108(7):1696-1708. doi: 10.1210/clinem/dgad015.
Individual participant dataSharing planned: No

Related trials for Prader-Willi Syndrome

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

24 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing 3.2 mg intranasal carbetocin and 9.6 mg intranasal carbetocin in people with Prader-Willi Syndrome, run by Levo Therapeutics, Inc. at 24 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in United States, Canada, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hyperphagia Behavior (time frame: Baseline to Week 8). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03649477, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2022.