Trial · NCT01968187
Treatment of Hyperphagia Behavioral Symptoms in Children and Adults Diagnosed With Prader-Willi Syndrome
NCT01968187, Phase 2, Completed, Ferring Pharmaceuticals; results first posted 2025-03-27
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Treatment of Hyperphagia Behavioral Symptoms in Children and Adults Diagnosed With Prader-Willi Syndrome. Trials, record NCT01968187. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01968187
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Treatment of Hyperphagia Behavioral Symptoms in Children and Adults Diagnosed With Prader-Willi Syndrome
- NCT number
- NCT01968187
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 38 participants, actual
- Lead sponsor
- Ferring Pharmaceuticals
- Conditions
- Hyperphagia in Prader-Willi Syndrome
- Interventions
- FE 992097, Placebo
- First posted
- 2013-10-23
- Last updated
- 2025-03-27
- Results first posted
- 2025-03-27
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 in Hyperphagia in Prader-Willi Syndrome (PWS) Questionnaires- Responsiveness (HPWSQ-R) Total Score at End-of-treatment (Day 15) | From Day 1 (baseline) to Day 15 | The HPWSQ-R is an 11-item questionnaire examining the psychological, developmental, and neurobiological correlates of hyperphagia in PWS. The items are classified into 3 domains; behavior, drive, and severity with each item rated on a five-point scale (1: not at all/none of the time/extremely easy to 5: extremely/all of the time/extremely hard). The questionnaire was completed by the parent/caregiver using a 1-week recall period. Total score was the sum of all the items in the three domains and ranged from 11 (no hyperphagia behaviors) to 55 (most severe hyperphagia behaviors). Change from baseline in HPWSQ-R Total Score at Day 15 is presented for this outcome measure. |
| Secondary | Clinical Global Impression- Improvement After Treatment (CGI-I) Score at End-of-treatment (Day 15) | At Day 15 | The Clinical Global Impression (CGI) scale consists of a 7-point clinician rating of illness severity (1 = normal, not at all ill, 7 = among the most extremely ill patients), at the beginning of the trial (baseline) - Clinical Global Impression-Severity Rating (CGI-S) and a 7-point clinician rating of improvement of patient condition (1=very much improved since baseline/initiation of treatment, 7=very much worse from baseline), during and at the end of the trial (Day 15) - CGI-I. The CGI-I score at Day 15 is presented for this outcome measure. |
| Secondary | Change From Baseline in HPWSQ-R Domain Scores (Behavior, Drive and Severity) at End-of-treatment (Day 15) | From Day 1 (baseline) to Day 15 | The HPWSQ-R is an 11-item questionnaire examining the psychological, developmental, and neurobiological correlates of hyperphagia in PWS. The items were classified into 3 domains; behavior, drive, and severity with each item rated on a five-point score range from 1 (not at all/none of the time/extremely easy) to 5 (extremely/all of the time/extremely hard). The questionnaire was completed by the parent/caregiver using a 1-week recall period. Changes in the HPWSQ-R Total Score and in the Domain Scores (behavior, drive, and severity) at Day 15 is presented for this outcome measure. HPWSQ-R Behavior, Drive and Severity scores range from 5-25, 4-20, and 2-10, respectively, with higher scores indicating a worse outcome. Change from baseline is presented = (Day 15 score minus Baseline score). |
| Secondary | Change From Baseline in Children's Yale-Brown Obsessive Compulsive Scale Score (CY-BOCS) at End-of-treatment (Day 15) | From Day 1 (baseline) to Day 15 | The CY-BOCS is a clinician rated, semi-structured inventory of specific symptoms and symptom severity in pediatric obsessive-compulsive disorder (OCD). Total scores on the CY-BOCS are calculated using a symptom checklist and severity scale. The 10 severity items are summed to produce an Obsessions Severity Score (5 items), Compulsions Severity Score (5 items), and Total score (sum of all 10 severity items). The total score is calculated by summing the 10 individual scores and ranges from 0 (no obsessions or compulsions) to 40 (most severe OC). |
| Secondary | Change From Baseline in the Food Domain Score of the Reiss Profile at End-of-treatment (Day 15) | From Day 1 (baseline) to Day 15 | The Food Domain Score of the Reiss Profile consisted of 7 questions that pertain to food seeking behavior. The questions were rated on a five point scale ranging from -2 (strongly disagree; this phrase is not at all characteristic of the person) to 2 (strongly agree; this phrase is definitely characteristic of the person). Total score was defined as the sum of all individual item scores. The total score ranged from -14 to 14 with higher scores indicating higher severity. Change from baseline in Food Domain of the Reiss Profile at Day 15 is presented for this outcome measure. |
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 | Change From Baseline in Hyperphagia in Prader-Willi Syndrome (PWS) Questionnaires- Responsiveness (HPWSQ-R) Total Score at End-of-treatment (Day 15) | From Day 1 (baseline) to Day 15 | The analysis population included the full analysis set (FAS) which consisted of all subjects in the safety population who had the primary efficacy endpoint measured (at baseline and phone call \[Day 8\] ±1 or Day 15). Analyses for the FAS were conducted according to the randomized treatment. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Clinical Global Impression- Improvement After Treatment (CGI-I) Score at End-of-treatment (Day 15) | At Day 15 | The analysis population included the full analysis set (FAS) which consisted of all subjects in the safety population who had the primary efficacy endpoint measured (at baseline and phone call \[Day 8\] ±1 or Day 15). Analyses for the FAS were conducted according to the randomized treatment.~Number of subjects analyzed signifies those subjects who were evaluable for this endpoint. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in HPWSQ-R Domain Scores (Behavior, Drive and Severity) at End-of-treatment (Day 15) | From Day 1 (baseline) to Day 15 | The analysis population included the FAS which consisted of all subjects in the safety population who had the primary efficacy endpoint measured (at baseline and phone call \[Day 8\] ±1 or Day 15). Analyses for the FAS were conducted according to the randomized treatment. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Children's Yale-Brown Obsessive Compulsive Scale Score (CY-BOCS) at End-of-treatment (Day 15) | From Day 1 (baseline) to Day 15 | The analysis population included the FAS which consisted of all subjects in the safety population who had the primary efficacy endpoint measured (at baseline and phone call \[Day 8\] ±1 or Day 15). Analyses for the FAS were conducted according to the randomized treatment.~Number of subjects analyzed signifies those subjects who were evaluable for this endpoint | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in the Food Domain Score of the Reiss Profile at End-of-treatment (Day 15) | From Day 1 (baseline) to Day 15 | The analysis population included the FAS which consisted of all subjects in the safety population who had the primary efficacy endpoint measured (at baseline and phone call \[Day 8\] ±1 or Day 15). Analyses for the FAS were conducted according to the randomized treatment.~Number of subjects analyzed signifies those subjects who were evaluable for this endpoint. | score on a scale | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Hyperphagia in Prader-Willi Syndrome (PWS) Questionnaires- Responsiveness (HPWSQ-R) Total Score at End-of-treatment (Day 15) | Carbetocin (FE 992097) | -15.6 | Standard Error 3.06 | score on a scale | |
| Change From Baseline in Hyperphagia in Prader-Willi Syndrome (PWS) Questionnaires- Responsiveness (HPWSQ-R) Total Score at End-of-treatment (Day 15) | Placebo | -8.9 | Standard Error 2.61 | score on a scale | |
| Clinical Global Impression- Improvement After Treatment (CGI-I) Score at End-of-treatment (Day 15) | Carbetocin (FE 992097) | 2.7 | Standard Error 0.49 | score on a scale | |
| Clinical Global Impression- Improvement After Treatment (CGI-I) Score at End-of-treatment (Day 15) | Placebo | 3.6 | Standard Error 0.43 | score on a scale | |
| Change From Baseline in HPWSQ-R Domain Scores (Behavior, Drive and Severity) at End-of-treatment (Day 15) | Carbetocin (FE 992097) | Behavior | -5.9 | Full Range -16 to 3 | score on a scale |
| Change From Baseline in HPWSQ-R Domain Scores (Behavior, Drive and Severity) at End-of-treatment (Day 15) | Placebo | Behavior | -3.9 | Full Range -14 to 3 | score on a scale |
| Change From Baseline in HPWSQ-R Domain Scores (Behavior, Drive and Severity) at End-of-treatment (Day 15) | Carbetocin (FE 992097) | Drive | -4.5 | Full Range -13 to 3 | score on a scale |
| Change From Baseline in HPWSQ-R Domain Scores (Behavior, Drive and Severity) at End-of-treatment (Day 15) | Placebo | Drive | -2.9 | Full Range -16 to 3 | score on a scale |
| Change From Baseline in HPWSQ-R Domain Scores (Behavior, Drive and Severity) at End-of-treatment (Day 15) | Carbetocin (FE 992097) | Severity | -3.3 | Full Range -7 to 2 | score on a scale |
| Change From Baseline in HPWSQ-R Domain Scores (Behavior, Drive and Severity) at End-of-treatment (Day 15) | Placebo | Severity | -1.8 | Full Range -7 to 3 | score on a scale |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Carbetocin (FE 992097) | 18 | |
| Overall Study | STARTED | Placebo | 20 | |
| Overall Study | Treated | Carbetocin (FE 992097) | 17 | |
| Overall Study | Treated | Placebo | 20 | |
| Overall Study | COMPLETED | Carbetocin (FE 992097) | 17 | |
| Overall Study | COMPLETED | Placebo | 19 | |
| Overall Study | NOT COMPLETED | Carbetocin (FE 992097) | 1 | |
| Overall Study | NOT COMPLETED | Placebo | 1 |
Source ClinicalTrials.gov
Adverse events36
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 | Abdominal pain upper | Gastrointestinal disorders | Carbetocin (FE 992097) | 1 | 17 | 1 |
| other | Abdominal pain upper | Gastrointestinal disorders | Placebo | 1 | 20 | 1 |
| other | Diarrhea | Gastrointestinal disorders | Carbetocin (FE 992097) | 1 | 17 | 1 |
| other | Diarrhea | Gastrointestinal disorders | Placebo | 0 | 20 | 0 |
| other | Conjunctivitis infective | Infections and infestations | Carbetocin (FE 992097) | 1 | 17 | 1 |
| other | Conjunctivitis infective | Infections and infestations | Placebo | 0 | 20 | 0 |
| other | Sinusitis | Infections and infestations | Carbetocin (FE 992097) | 0 | 17 | 0 |
| other | Sinusitis | Infections and infestations | Placebo | 1 | 20 | 1 |
| other | Medication error | Injury, poisoning and procedural complications | Carbetocin (FE 992097) | 1 | 17 | 1 |
| other | Medication error | Injury, poisoning and procedural complications | Placebo | 2 | 20 | 2 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Carbetocin (FE 992097) | 0 | 17 |
| Total, all-cause mortality | Placebo | 0 | 20 |
| Total, other adverse events | Carbetocin (FE 992097) | 7 | 17 |
| Total, other adverse events | Placebo | 8 | 20 |
| Total, serious adverse events | Carbetocin (FE 992097) | 0 | 17 |
| Total, serious adverse events | Placebo | 0 | 20 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 29925684 | 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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Carbetocin (FE 992097) vs Placebo: deaths from any cause | Trial comparisons |
| Carbetocin (FE 992097) vs Placebo: serious adverse events | Trial comparisons |
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/NCT01968187
GET https://conductscience.org/api/trials/v1/NCT01968187/events?page=2