Trial · NCT06173531
Study of Carbetocin Nasal Spray for the Treatment of Hyperphagia in Prader-Willi Syndrome
NCT06173531, Phase 3, Completed, ACADIA Pharmaceuticals Inc.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of Carbetocin Nasal Spray for the Treatment of Hyperphagia in Prader-Willi Syndrome. Trials, record NCT06173531. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06173531
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Carbetocin Nasal Spray for the Treatment of Hyperphagia in Prader-Willi Syndrome
- NCT number
- NCT06173531
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 175 participants, actual
- Lead sponsor
- ACADIA Pharmaceuticals Inc.
- Conditions
- Hyperphagia in Prader-Willi Syndrome
- Interventions
- Carbetocin, Placebo
- First posted
- 2023-12-15
- Last updated
- 2026-10-15
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline at Week 12 in Hyperphagia Questionnaire for Clinical Trials (HQ-CT) Score | Baseline to Week 12 | The HQ-CT is a caregiver-reported, 9-item assessment of observable hyperphagia-related behaviors in participants with PWS. The questionnaire is administered to the caregiver by a trained rater using standardized prompts, and the same caregiver is expected to complete the assessment throughout the study whenever possible. Each item is scored from 0 to 4, resulting in a total score ranging from 0 to 36, with higher scores indicating greater severity of hyperphagia. A decrease from baseline reflects improvement, and a reduction of 7.7 points has been identified as a clinically meaningful within-participant improvement. |
| Secondary | Change From Baseline at Week 12 in Clinical Global Impression of Severity (CGI-S) for PWS Score | Baseline to Week 12 | The CGI-S for PWS is a clinician-rated assessment of the overall severity of PWS symptoms at the time of evaluation. The CGI-S is rated on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most severely ill participants), with higher scores indicating greater illness severity. The assessment is performed by the Investigator or a trained, qualified designee, and the same rater is expected to evaluate a given participant throughout the study whenever possible to maintain rating consistency. |
| Secondary | Clinical Global Impression of Change (CGI-C) for PWS Score at Week 12 | Week 12 | The CGI-C for PWS is a clinician-rated assessment of change in the overall severity of PWS symptoms relative to Baseline. The CGI-C is rated on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse), with lower scores indicating greater improvement from Baseline. The assessment is performed by the Investigator or a trained, qualified designee, and the same rater is expected to evaluate a given participant throughout the study whenever possible to maintain rating consistency. |
| Secondary | Percentage of Subjects With Treatment Response at Week 12 (Defined as Improvement From Baseline ≥8 Points) Based on the HQ-CT Score at Week 12 | Week 12 | Treatment response was defined as an improvement from Baseline of at least 8 points in the HQ-CT total score at Week 12. The HQ-CT is a caregiver-reported, 9-item assessment of observable hyperphagia-related behaviors in participants with PWS. Total scores range from 0 to 36, with higher scores indicating greater severity of hyperphagia. Participants meeting the ≥8-point improvement threshold were classified as responders. |
| Secondary | Change From Baseline at Week 12 in CGI-S for Hyperphagia in PWS Score | Baseline to Week 12 | The CGI-S for PWS is a clinician-rated assessment of the overall severity of PWS symptoms at the time of evaluation. The CGI-S is rated on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most severely ill participants), with higher scores indicating greater illness severity. The assessment is performed by the Investigator or a trained, qualified designee, and the same rater is expected to evaluate a given participant throughout the study whenever possible to maintain rating consistency. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 42486751 | DERIVED |
Source PubMed
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/NCT06173531
GET https://conductscience.org/api/trials/v1/NCT06173531/registered