Trial · NCT02560766
An Efficacy and Safety Evaluation of HORIZANT in Adolescents With Moderate-to-Severe Primary RLS
NCT02560766, Phase 4, Unknown, XenoPort, Inc.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. An Efficacy and Safety Evaluation of HORIZANT in Adolescents With Moderate-to-Severe Primary RLS. Trials, record NCT02560766. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02560766
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- An Efficacy and Safety Evaluation of HORIZANT in Adolescents With Moderate-to-Severe Primary RLS
- NCT number
- NCT02560766
- Status
- Unknown
- Phases
- Phase 4
- Enrollment
- 132 participants, estimated
- Lead sponsor
- XenoPort, Inc.
- Conditions
- RLS
- Interventions
- HORIZANT 300 mg, HORIZANT 600 mg, Placebo
- First posted
- 2015-09-25
- Last updated
- 2021-06-09
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | the change on the IRLS rating scale from baseline to Week 12 | 12 weeks | IRLS rating change |
| Primary | the proportion of patients who are responders, assessed on the CGI-I scale as "much improved" or "very much improved" (CGI-I rating of 1 or 2, respectively) at Week 12 | 12 weeks | CGI-I scale |
| Secondary | IRLS total score, change from baseline to Weeks 4 and 8 | 4, 8 weeks | IRLS change |
| Secondary | CGI-I score at Weeks 4 and 8 | 4, 8 weeks | CGI-I score |
| Secondary | Proportions of patients by sleep parameters collected on the Post-Sleep questionnaire at baseline and Week 12 | Baseline to 12 weeks | sleep parameters on Post-Sleep questionnaire |
| Secondary | Proportions of patients by sleep parameters collected on the ESS-CHAD© total score and change from baseline to Week 12 | Baseline to 12 weeks | sleep parameters by ESS-CHAD© total score and change |
| Secondary | Proportions of patients with AEs, fatal serious adverse events (SAEs), non-fatal SAEs, and discontinuations due to AEs at all post-dose time points; and proportion of patients with neuropsychiatric AEs | 12 weeks | Adverse event proporations |
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/NCT02560766
GET https://conductscience.org/api/trials/v1/NCT02560766/registered