Trial · NCT03053427
A Study of Oral Dosing of Gabapentin Enacarbil in Japanese Restless Legs Syndrome Patients
NCT03053427, Phase 4, Completed, Astellas Pharma Inc; results first posted 2019-07-10
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Oral Dosing of Gabapentin Enacarbil in Japanese Restless Legs Syndrome Patients. Trials, record NCT03053427. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03053427
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Oral Dosing of Gabapentin Enacarbil in Japanese Restless Legs Syndrome Patients
- NCT number
- NCT03053427
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 375 participants, actual
- Lead sponsor
- Astellas Pharma Inc
- Conditions
- Restless Legs Syndrome (RLS)
- Interventions
- Placebo, Gabapentin enacarbil
- First posted
- 2017-02-15
- Last updated
- 2024-12-12
- Results first posted
- 2019-07-10
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in International Restless Legs Syndrome Rating Scale (IRLS) Score at Week 12 | Baseline and week 12 | The IRLS consisted of 10-item scale for assessing severity of restless legs syndrome (RLS) with each item ranging from 0 (no symptoms) to 4 (very severe symptoms). The total IRLS score ranges from 0 to 40. Higher IRLS score indicated greater disease activity. Mixed Model of Repeated Measurements (MMRM) model with compound symmetry as a covariance structure was used. The explanatory variables of the model included treatment group, IRLS score at baseline, age category, estimated creatinine clearance category, time point, and interaction of treatment group and time point. |
| Secondary | Change From Baseline in IRLS Score at Each Time Point | Baseline and weeks 1, 2, 4, 6, 8, 10, 12 and EoT (week 12) | ANCOVA model with the baseline value as a covariate was used. |
| Secondary | Percentage of Participants With an Investigator-rated Clinical Global Impression (ICGI) Response | EoT (week 12) | ICGI was assessed by 7-point ordinate scale. Participants who were "Very much improved" or "Much improved" were defined as responders. |
| Secondary | Percentage of Participants With a Patient-rated Clinical Global Impression (PCGI) Response | EoT (week 12) | PCGI was assessed by 7-point ordinate scale. Participants who were "Very much improved" or "Much improved" were defined as responders. |
| Secondary | Change From Baseline in Pittsburgh Sleep Quality Index Total Score (PSQI) | Baseline and EoT (week 12) | The self-rated items of the PSQI generate seven component scores (range of subscale scores, 0-3). The sum of these seven component scores yielded one global score of subjective sleep quality (range, 0-21). Higher scores represent poorer subjective sleep. ANCOVA model with the baseline value as a covariate was used. |
| Secondary | Change From Baseline in Athens Insomnia Scale | Baseline and EoT (week 12) | Athens Insomnia Scale consisted of 8-item scale (range of subscale scores, 0-3). The scale range of Athens Insomnia was 0-24. Higher scores represent poorer sleep quality. ANCOVA model with the baseline value as a covariate was used. |
| Secondary | Change From Baseline in Restless Legs Syndrome (RLS) Pain Score | Baseline and EoT (week 12) | The scale range of RLS pain score was 0-10. Higher scores represent greater RLS pain intensity. ANCOVA model with the baseline value as a covariate was used. |
| Secondary | Change From Baseline in Health Status Score of EuroQol-5 Dimension-5 Level (EQ-5D-5L) | Baseline and EoT (week 12) | Health status was assessed by general visual analog scale (VAS). The VAS ranges from 0 (worst health status) and 100 (best health status). |
| Secondary | Number of Participants With Adverse Events | From first dose of study drug up to week 13 | Treatment-emergent adverse events (TEAE) was defined as an adverse event (AE) with onset after the start of the run-in period. A drug-related TEAE was a TEAE with at least a possible relationship to the study drug as assessed by the investigator. Serious TEAE was an AE considered serious. |
Source ClinicalTrials.gov
Outcomes9
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 International Restless Legs Syndrome Rating Scale (IRLS) Score at Week 12 | Baseline and week 12 | Full Analysis Set (FAS) consisted of all participants who received the study drug for the treatment period and were evaluated for at least one efficacy (either primary or secondary) endpoint during the treatment period. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in IRLS Score at Each Time Point | Baseline and weeks 1, 2, 4, 6, 8, 10, 12 and EoT (week 12) | FAS. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants With an Investigator-rated Clinical Global Impression (ICGI) Response | EoT (week 12) | FAS. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With a Patient-rated Clinical Global Impression (PCGI) Response | EoT (week 12) | FAS. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Pittsburgh Sleep Quality Index Total Score (PSQI) | Baseline and EoT (week 12) | FAS | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Athens Insomnia Scale | Baseline and EoT (week 12) | FAS. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Restless Legs Syndrome (RLS) Pain Score | Baseline and EoT (week 12) | FAS. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Health Status Score of EuroQol-5 Dimension-5 Level (EQ-5D-5L) | Baseline and EoT (week 12) | FAS. | units on a scale | MEAN |
| SECONDARY | Number of Participants With Adverse Events | From first dose of study drug up to week 13 | Safety Analysis Set (SAF) consisted of all participants given at least one dose of the study drug for the treatment period. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group44
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 International Restless Legs Syndrome Rating Scale (IRLS) Score at Week 12 | Placebo | -10.5 | 95% Confidence Interval -11.4 to -9.5 | units on a scale | |
| Change From Baseline in International Restless Legs Syndrome Rating Scale (IRLS) Score at Week 12 | Gabapentin Enacarbil | -11.7 | 95% Confidence Interval -12.6 to -10.7 | units on a scale | |
| Change From Baseline in IRLS Score at Each Time Point | Placebo | Week 1 | -3.1 | 95% Confidence Interval -3.9 to -2.3 | units on a scale |
| Change From Baseline in IRLS Score at Each Time Point | Gabapentin Enacarbil | Week 1 | -4.2 | 95% Confidence Interval -5.0 to -3.4 | units on a scale |
| Change From Baseline in IRLS Score at Each Time Point | Placebo | Week 2 | -4.3 | 95% Confidence Interval -5.2 to -3.4 | units on a scale |
| Change From Baseline in IRLS Score at Each Time Point | Gabapentin Enacarbil | Week 2 | -5.8 | 95% Confidence Interval -6.7 to -4.9 | units on a scale |
| Change From Baseline in IRLS Score at Each Time Point | Placebo | Week 4 | -6.0 | 95% Confidence Interval -6.9 to -5.0 | units on a scale |
| Change From Baseline in IRLS Score at Each Time Point | Gabapentin Enacarbil | Week 4 | -7.5 | 95% Confidence Interval -8.4 to -6.5 | units on a scale |
| Change From Baseline in IRLS Score at Each Time Point | Placebo | Week 6 | -7.4 | 95% Confidence Interval -8.4 to -6.3 | units on a scale |
| Change From Baseline in IRLS Score at Each Time Point | Gabapentin Enacarbil | Week 6 | -8.8 | 95% Confidence Interval -9.9 to -7.8 | units on a scale |
1 to 10 of 44Source ClinicalTrials.gov
See all 44 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 186 | |
| Overall Study | STARTED | Gabapentin Enacarbil | 189 | |
| Overall Study | COMPLETED | Placebo | 173 | |
| Overall Study | COMPLETED | Gabapentin Enacarbil | 173 | |
| Overall Study | NOT COMPLETED | Placebo | 13 | |
| Overall Study | NOT COMPLETED | Gabapentin Enacarbil | 16 |
Source ClinicalTrials.gov
Adverse events12
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 | Nasopharyngitis | Infections and infestations | Placebo | 20 | 186 | 22 |
| other | Nasopharyngitis | Infections and infestations | Gabapentin Enacarbil | 24 | 189 | 26 |
| other | Somnolence neonatal | Nervous system disorders | Placebo | 13 | 186 | 13 |
| other | Somnolence neonatal | Nervous system disorders | Gabapentin Enacarbil | 25 | 189 | 26 |
| other | Dizziness | Nervous system disorders | Placebo | 0 | 186 | 0 |
| other | Dizziness | Nervous system disorders | Gabapentin Enacarbil | 20 | 189 | 21 |
| serious | Colitis ischaemic | Gastrointestinal disorders | Placebo | 0 | 186 | 0 |
| serious | Colitis ischaemic | Gastrointestinal disorders | Gabapentin Enacarbil | 1 | 189 | 1 |
| serious | Anaphylactic reaction | Immune system disorders | Placebo | 0 | 186 | 0 |
| serious | Anaphylactic reaction | Immune system disorders | Gabapentin Enacarbil | 1 | 189 | 1 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 186 |
| Total, all-cause mortality | Gabapentin Enacarbil | 0 | 189 |
| Total, other adverse events | Placebo | 32 | 186 |
| Total, other adverse events | Gabapentin Enacarbil | 59 | 189 |
| Total, serious adverse events | Placebo | 0 | 186 |
| Total, serious adverse events | Gabapentin Enacarbil | 3 | 189 |
Source ClinicalTrials.gov
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Gabapentin Enacarbil vs Placebo: deaths from any cause | Trial comparisons |
| Gabapentin Enacarbil 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/NCT03053427
GET https://conductscience.org/api/trials/v1/NCT03053427/results?page=2