Trial · NCT02810483
Study of the Efficacy of Topiramate in Patients With Prader Willi Syndrome Over 8 Weeks
NCT02810483, Phase 3, Terminated, Assistance Publique - Hôpitaux de Paris
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of the Efficacy of Topiramate in Patients With Prader Willi Syndrome Over 8 Weeks. Trials, record NCT02810483. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02810483
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of the Efficacy of Topiramate in Patients With Prader Willi Syndrome Over 8 Weeks
- NCT number
- NCT02810483
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 69 participants, actual
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Conditions
- Prader-Willi Syndrome
- Interventions
- Topiramate, Placebo Comparator
- First posted
- 2016-06-23
- Last updated
- 2018-04-11
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Clinical Global Impression Improvement | at 8 weeks (endpoint) | Endpoint CGI score at 1 or 2 will make consider the patient as a responder. A 7 items scale will be used |
| Secondary | Weight and size | at 8 weeks (endpoint) | Weight and size (BMI in kg/m2) |
| Secondary | Self-Injury Behavior Scale ECAHA, | at 8 weeks (endpoint) | Comparison between baseline score and endpoint score |
| Secondary | Self-Injury Behavior, CONNERS Impulsivity | at 8 weeks (endpoint) | CONNERS Impulsivity comparison between baseline score and endpoint score |
| Secondary | Self-Injury Behavior,Dickens | at 8 weeks (endpoint) | Dickens comparison between baseline score and endpoint score |
| Secondary | C-SHARP (Chid and Adolescent), appearance of positive suicide item response | at 8 weeks (endpoint) | |
| Secondary | A-SHARP (Adult), appearance of positive suicide item response | at 8 weeks (endpoint) | A-SHARP (Adult), appearance of positive suicide item response |
| Secondary | Safety Assessment | at 8 weeks (endpoint) | The proportion of patients stopped the treatment, of patients with adverse events and prematurely discontinued treatment due to an adverse event will be estimated. |
| Secondary | Biological assessment | at 8 weeks (endpoint) | The number of patients with abnormal values and / or modified from the baseline values will be evaluated |
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.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT02810483
GET https://conductscience.org/api/trials/v1/NCT02810483/registered