Trial · NCT01981941
Post-marketing Study of Gabapentin Enacarbil to Evaluate the Effect in Restless Leg Syndrome (RLS) Patients With Moderate Renal Impairment
NCT01981941, Phase 4, Completed, Astellas Pharma Inc
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Post-marketing Study of Gabapentin Enacarbil to Evaluate the Effect in Restless Leg Syndrome (RLS) Patients With Moderate Renal Impairment. Trials, record NCT01981941. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01981941
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Post-marketing Study of Gabapentin Enacarbil to Evaluate the Effect in Restless Leg Syndrome (RLS) Patients With Moderate Renal Impairment
- NCT number
- NCT01981941
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 19 participants, actual
- Lead sponsor
- Astellas Pharma Inc
- Conditions
- Restless Legs Syndrome (RLS)
- Interventions
- Gabapentin enacarbil
- First posted
- 2013-11-13
- Last updated
- 2024-11-08
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in International Restless Leg Syndrome (IRLS) rating scale score | Baseline and at 4 week of the treatment (or at discontinuation) | |
| Secondary | Change in Investigator-rated clinical global impression (ICGI) score | Baseline and at 4 week of the treatment (or at discontinuation) | |
| Secondary | Change in Patient-related clinical global impression (PCGI) score | Baseline and at 4 week of the treatment (or at discontinuation) | Baseline and at 4 week of the treatment (or at discontinuation) |
| Secondary | Safety assessed by the incidence of adverse events, vital signs, labo-tests, body weight and Epworth sleepiness scale | Up to 5 weeks | |
| Secondary | Plasma gabapentin concentration | Up to 5 weeks |
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/NCT01981941
GET https://conductscience.org/api/trials/v1/NCT01981941/registered