Trial · NCT02658188
Long-term Efficacy and Safety of Gabapentin Enacarbil in Japanese Restless Legs Syndrome Patients
NCT02658188, Phase 3, Completed, Astellas Pharma Inc
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Long-term Efficacy and Safety of Gabapentin Enacarbil in Japanese Restless Legs Syndrome Patients. Trials, record NCT02658188. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02658188
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Long-term Efficacy and Safety of Gabapentin Enacarbil in Japanese Restless Legs Syndrome Patients
- NCT number
- NCT02658188
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 182 participants, actual
- Lead sponsor
- Astellas Pharma Inc
- Conditions
- Restless Legs Syndrome
- Interventions
- ASP8825
- First posted
- 2016-01-18
- Last updated
- 2016-02-04
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change from baseline in IRLS score | Baseline to Week 52 | IRLS: International Restless Legs Syndrome Scale |
| Primary | Safety assessed by Vital signs | Up to Week 52 | Blood pressure and pulse rate |
| Primary | Safety assessed by Adverse Events | Up to Week 52 | |
| Primary | Safety assessed by Laboratory tests | Up to Week 52 | Hematology, blood biochemistry, thyroid function test and urinalysis |
| Primary | Safety assessed by 12-lead-electrocardiogram | Up to Week 52 | |
| Secondary | Proportion of responders on ICGl of improvement | Up to Week 52 | ICGI: Investigator-rated Clinical Global Impression of improvement |
| Secondary | Proportion of responders on PCGI of improvement | Up to Week 52 | PCGI: Patient-rated Clinical Global Impression |
| Secondary | Change from baseline in PSQI | Baseline to Week 52 | PSQI: Pittsburgh Sleep Quality Index |
| Secondary | Change from baseline in SF-36v2 | Baseline to Week 52 | SF-36v2: Medical Outcomes Study 36-Item Short-Form Health Survey version 2 |
| Secondary | Change from baseline in RLS-QOL | Baseline to Week 52 | RLS-QOL: Restless Legs Syndrome Quality of Life Questionnaire |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes0
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/NCT02658188
GET https://conductscience.org/api/trials/v1/NCT02658188/registered