Trial · NCT03649477
Phase 3 Study of Intranasal Carbetocin (LV-101) in Patients With Prader-Willi Syndrome
NCT03649477, Phase 3, Completed, Levo Therapeutics, Inc.; results first posted 2021-11-17
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Phase 3 Study of Intranasal Carbetocin (LV-101) in Patients With Prader-Willi Syndrome. Trials, record NCT03649477. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03649477
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase 3 Study of Intranasal Carbetocin (LV-101) in Patients With Prader-Willi Syndrome
- NCT number
- NCT03649477
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 130 participants, actual
- Lead sponsor
- Levo Therapeutics, Inc.
- Conditions
- Prader-Willi Syndrome
- Interventions
- 3.2 mg intranasal carbetocin, 9.6 mg intranasal carbetocin, placebo
- First posted
- 2018-08-28
- Last updated
- 2022-07-26
- Results first posted
- 2021-11-17
- Limitations and caveats
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.
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Hyperphagia Behavior | 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. |
| Primary | Obsessive and Compulsive Behaviors | 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. |
| Secondary | Anxiety | Baseline to Week 8 | 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. |
| Secondary | Global Impression | Week 8 | 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. |
| Secondary | Hyperphagia Behavior (Subset) | Baseline to Week 8 | 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. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Hyperphagia Behavior | Baseline to Week 8 | 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. | score on a scale | LEAST_SQUARES_MEAN |
| PRIMARY | Obsessive and Compulsive Behaviors | baseline to Week 8 | 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. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Anxiety | Baseline to Week 8 | 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. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Global Impression | Week 8 | 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. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Hyperphagia Behavior (Subset) | Baseline to Week 8 | 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. | score on a scale | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group15
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Hyperphagia Behavior | 9.6 mg of LV-101 | -3.439 | 95% Confidence Interval -5.304 to -1.575 | score on a scale | |
| Hyperphagia Behavior | 3.2 mg of LV-101 | -5.372 | 95% Confidence Interval -7.259 to -3.486 | score on a scale | |
| Hyperphagia Behavior | Placebo | -2.237 | 95% Confidence Interval -4.095 to -0.378 | score on a scale | |
| Obsessive and Compulsive Behaviors | 9.6 mg of LV-101 | -2.968 | 95% Confidence Interval -4.667 to -1.268 | score on a scale | |
| Obsessive and Compulsive Behaviors | 3.2 mg of LV-101 | -3.123 | 95% Confidence Interval -4.843 to -1.403 | score on a scale | |
| Obsessive and Compulsive Behaviors | Placebo | -2.360 | 95% Confidence Interval -4.046 to -0.674 | score on a scale | |
| Anxiety | 9.6 mg of LV-101 | -4.306 | 95% Confidence Interval -6.797 to -1.815 | score on a scale | |
| Anxiety | 3.2 mg of LV-101 | -8.301 | 95% Confidence Interval -10.790 to -5.811 | score on a scale | |
| Anxiety | Placebo | -4.489 | 95% Confidence Interval -6.942 to -2.037 | score on a scale | |
| Global Impression | 9.6 mg of LV-101 | 3.582 | 95% Confidence Interval 3.250 to 3.913 | score on a scale |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | 9.6 mg of LV-101 | 44 | |
| Overall Study | STARTED | 3.2 mg of LV-101 | 43 | |
| Overall Study | STARTED | Placebo | 43 | |
| Overall Study | COMPLETED | 9.6 mg of LV-101 | 42 | |
| Overall Study | COMPLETED | 3.2 mg of LV-101 | 43 | |
| Overall Study | COMPLETED | Placebo | 43 | |
| Overall Study | NOT COMPLETED | 9.6 mg of LV-101 | 2 | |
| Overall Study | NOT COMPLETED | 3.2 mg of LV-101 | 0 | |
| Overall Study | NOT COMPLETED | Placebo | 0 |
Source ClinicalTrials.gov
Adverse events24
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhea | Gastrointestinal disorders | 9.6 mg of LV-101 | 2 | 44 | 2 |
| other | Diarrhea | Gastrointestinal disorders | 3.2 mg of LV-101 | 4 | 43 | 5 |
| other | Diarrhea | Gastrointestinal disorders | Placebo | 1 | 43 | 1 |
| other | Pyrexia | General disorders | 9.6 mg of LV-101 | 0 | 44 | 0 |
| other | Pyrexia | General disorders | 3.2 mg of LV-101 | 3 | 43 | 3 |
| other | Pyrexia | General disorders | Placebo | 0 | 43 | 0 |
| other | Upper respiratory tract infection | General disorders | 9.6 mg of LV-101 | 2 | 44 | 2 |
| other | Upper respiratory tract infection | General disorders | 3.2 mg of LV-101 | 3 | 43 | 4 |
| other | Upper respiratory tract infection | General disorders | Placebo | 2 | 43 | 2 |
| other | Headache | Nervous system disorders | 9.6 mg of LV-101 | 4 | 44 | 4 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 9.6 mg of LV-101 | 0 | 44 |
| Total, all-cause mortality | 3.2 mg of LV-101 | 0 | 43 |
| Total, all-cause mortality | Placebo | 0 | 43 |
| Total, other adverse events | 9.6 mg of LV-101 | 20 | 44 |
| Total, other adverse events | 3.2 mg of LV-101 | 19 | 43 |
| Total, other adverse events | Placebo | 10 | 43 |
| Total, serious adverse events | 9.6 mg of LV-101 | 0 | 44 |
| Total, serious adverse events | 3.2 mg of LV-101 | 0 | 43 |
| Total, serious adverse events | Placebo | 0 | 43 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03649477
GET https://conductscience.org/api/trials/v1/NCT03649477/events?page=2