Trial · NCT02424695
Effects of Gabapentin Enacarbil on Arousals, Heart Rate, Blood Pressure and PLMs in Restless Legs Syndrome
NCT02424695, Phase 4, Unknown, Cleveland Sleep Research Center
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Effects of Gabapentin Enacarbil on Arousals, Heart Rate, Blood Pressure and PLMs in Restless Legs Syndrome. Trials, record NCT02424695. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02424695
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effects of Gabapentin Enacarbil on Arousals, Heart Rate, Blood Pressure and PLMs in Restless Legs Syndrome
- NCT number
- NCT02424695
- Status
- Unknown
- Phases
- Phase 4
- Enrollment
- 20 participants, estimated
- Lead sponsor
- Cleveland Sleep Research Center
- Conditions
- Restless Legs Syndrome
- Interventions
- Gabapentin Enacarbil (GEn), Placebo
- First posted
- 2015-04-23
- Last updated
- 2015-04-23
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The mean change from baseline to week 4 in intensity of cortical arousals associated with periodic limb movements (PLMs) | 4 weeks | Cortical EEG arousals will be scored using wavelet analysis of C3/A2 and C4/A1 EEG signals. Arousals scored in NREM sleep will be assigned a score from 0-9. This arousal scaling is entirely subjective. Wavelet analysis will be performed on each of the scaled arousals using wavelet features that correlate with arousal intensity. The arousal intensity will be measured using Wavelet Transform which is superior for analyzing signals such as EEG. |
| Secondary | The mean change from baseline to week 4 in heart rate variability associated with arousals secondary to periodic limb movements (PLMs) | 4 weeks | Beat to beat heart rate measurement will identify the highest value in the interval 2-12 seconds preceding each arousal which will be used as a baseline heart rate. The highest heart rate in the interval between arousal and at 8 seconds after its end, and the difference from baseline will represent the change in heart rate associated with the arousal. |
| Secondary | The mean change from baseline to week 4 in blood pressure associated with arousals secondary to periodic limb movements (PLMs) | 4 weeks | Blood pressure changes will be identified using the same technique as the heart rate changes. Continuous blood pressure will be monitored using Somnotouch RESP. Using the 2-12 seconds preceding each arousal, any identified change between onset of arousal and at 8 seconds after its end will represent the change in blood pressure. |
| Secondary | The mean change from baseline to week 4 in periodic limb movement (PLM) intensity | 4 weeks | Periodic limb movement (PLM) intensity will be derived by measuring the highest anterior tibialis EMG amplitude during the 2-12 seconds prior to arousal onset and comparing to maximum EMG amplitude during PLMs with or without associated arousal. |
| Secondary | The mean change from Baseline to week 4 in Rechtschaffen and Kales polysomnography parameters | 4 weeks | Polysomnography (PSG) studies will be recorded for 8 hours using standard techniques described by Rechtschaffen and Kales (R\&K). The R\&K standard PSG parameters include: Total sleep time (TST), wake after sleep onset (WASO), latency to persistent sleep (LPS 10), sleep efficiency (SE), number of awakenings per hour of sleep (Awakenings Index), arousals index (AI), sleep stage percentages, periodic limb movements per hour (PLMI), and periodic limb movements associated with arousal per hour (PLMAI). |
| Secondary | The mean change from baseline to week 4 in International Restless Legs Syndrome (IRLS) Rating Scale total score | 4 weeks | |
| Secondary | The mean change from Baseline to week 4 in proportion of responders ("much"/ "very much" improved) on the investigator-rated Clinical Global Impression-Improvement (CGI-I) scale | 4 weeks | |
| Secondary | The mean change from Baseline to week 4 in proportion of responders ("moderately better" to "a great deal better") on the patient Global Impression of Change (PGIC) scale | 4 weeks | |
| Secondary | The mean change from Baseline to week 4 in Post Sleep Questionnaire (PSQ)scores | 4 weeks | |
| Secondary | The mean change from Baseline to week 4 in Subjective Sleep Questionnaire (SSQ) scores | 4 weeks |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 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.
Papers5
The papers the trial lists on ClinicalTrials.gov.
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/NCT02424695
GET https://conductscience.org/api/trials/v1/NCT02424695/registered