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Phase 3 Study of Intranasal Carbetocin (LV-101) in Patients With Prader-Willi Syndrome
Phase 3 trial testing 3.2 mg intranasal carbetocin in Prader-Willi Syndrome in 130 participants. Completed in 9 July 2022.
| Lead sponsor | Levo Therapeutics, Inc. |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 130 |
| Start date | 20 November 2018 |
| Primary completion | 13 May 2020 |
| Estimated completion | 9 July 2022 |
| Sites | 24 locations across Canada, United States, Australia |
Levo Therapeutics, Inc. — full company profile →
Adults 7 to 18, any sex, with Prader-Willi Syndrome. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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.
| Group | Value | 95% CI |
|---|---|---|
| 9.6 mg of LV-101 | -3.439 | -5.304 – -1.575 |
| 3.2 mg of LV-101 | -5.372 | -7.259 – -3.486 |
| Placebo | -2.237 | -4.095 – -0.378 |
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.
| Group | Value | 95% CI |
|---|---|---|
| 9.6 mg of LV-101 | -2.968 | -4.667 – -1.268 |
| 3.2 mg of LV-101 | -3.123 | -4.843 – -1.403 |
| Placebo | -2.360 | -4.046 – -0.674 |
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.
| Group | Value | 95% CI |
|---|---|---|
| 9.6 mg of LV-101 | -4.306 | -6.797 – -1.815 |
| 3.2 mg of LV-101 | -8.301 | -10.790 – -5.811 |
| Placebo | -4.489 | -6.942 – -2.037 |
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.
| Group | Value | 95% CI |
|---|---|---|
| 9.6 mg of LV-101 | 3.582 | 3.250 – 3.913 |
| 3.2 mg of LV-101 | 3.395 | 3.057 – 3.733 |
| Placebo | 3.893 | 3.562 – 4.225 |
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.
| Group | Value | 95% CI |
|---|---|---|
| 9.6 mg of LV-101 | -3.295 | -4.667 – -1.922 |
| 3.2 mg of LV-101 | -4.621 | -6.010 – -3.233 |
| Placebo | -2.209 | -3.577 – -0.841 |
Time frame: 8-week placebo-controlled period. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | 9.6 mg of LV-101 | 3.2 mg of LV-101 | Placebo |
|---|---|---|---|---|
| Flushing | Vascular disorders | — | — | — |
| Headache | Nervous system disorders | — | — | — |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | — | — | — |
| Diarrhea | Gastrointestinal disorders | — | — | — |
| Pyrexia | General disorders | — | — | — |
| Upper respiratory tract infection | General disorders | — | — | — |
| Nasal discomfort | Respiratory, thoracic and mediastinal disorders | — | — | — |
| Nasopharyngitis | Infections and infestations | — | — | — |
Data from ClinicalTrials.gov NCT03649477 adverse events section.
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.
8 peer-reviewed publications reference this trial (live from Europe PMC):
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