Trial · NCT03708237
Effectiveness of Ropinirole and Gabapentin for the Treatment of RLS in Patients on Maintenance HD
NCT03708237, Phase 2, Terminated, University of Alberta
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Effectiveness of Ropinirole and Gabapentin for the Treatment of RLS in Patients on Maintenance HD. Trials, record NCT03708237. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03708237
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effectiveness of Ropinirole and Gabapentin for the Treatment of RLS in Patients on Maintenance HD
- NCT number
- NCT03708237
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 3 participants, actual
- Lead sponsor
- University of Alberta
- Conditions
- Restless Legs Syndrome, End Stage Renal Disease
- Interventions
- Ropinirole, Gabapentin, Placebos
- First posted
- 2018-10-17
- Last updated
- 2022-07-12
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Evaluate the effectiveness of ropinirole and gabapentin on the severity of RLS symptoms in the hemodialysis population. | up to 4 & 6 months after start of intervention. | The International Restless Legs Syndrome Study Group (IRLS) rating scale was developed to measure the severity of RLS symptoms over the preceding seven days. The rating scale takes approximately 10 minutes to complete and consists of 10 questions rated from 0 - 4 (0 = none, 4 = very severe). The scale includes diagnostic features and questions to evaluate the intensity/frequency of RLS, associated sleep problems and impact of symptoms on mood and daily functioning. The total score ranges from 0 to 40; mild (1 - 10), moderate (11 - 20), severe (21 - 30) and very severe (31 - 40). |
| Secondary | Evaluate the impact of ropinirole and gabapentin on the quality of life. | EQ-5D-5L collected at baseline, and 1, 2, 4 & 6 months after start of intervention. | The EQ-5D-5L is a two part standardized health status instrument used to measure quality of life over the previous four weeks. The questionnaire contains five, five-point Likert scale (1 = no problems, 5 = extreme problems) questions to evaluate mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The questionnaire also contains a 20 cm vertical visual analogue scale numbered 0 (worst health you can imagine) to 100 (best health you can imagine). This instrument is currently already in use within Alberta Health Services' (AHS) Northern Alberta Renal Program (NARP) for hemodialysis patients. |
| Secondary | Evaluate the impact of ropinirole and gabapentin on the quality of sleep. | MOSS-SS collected at baseline, and 1, 2, 4 & 6 months after start of intervention. | The Medical Outcomes Study Sleep Scale (MOS-SS) is used to evaluate six sleep parameter dimensions: sleep initiation, maintenance, respiratory problems quantity, perceived adequacy and somnolence over the past four weeks. Ten of the scale's 12 items are scored using a six-point Likert scale, one uses a five-point Likert scale, and one item is open-ended to record the average amount of hours slept. The scale takes less than five minutes to complete. |
| Secondary | Evaluate the impact of ropinirole and gabapentin on the symptom burden. | The 10 item ESAS-r: Renal collected at baseline, and 1, 2, 4 & 6 months after start of intervention. | The validated Edmonton Symptom Assessment System Revised Renal (ESAS-r: Renal) consists of 10 visual analogue scales with a superimposed zero to 10 severity scale for pain, activity, nausea, pruritus, depression, anxiety, drowsiness, appetite, well-being, and shortness of breath over the preceding 7 days. The scale for each symptom is anchored by the words 'No' and 'Severe' at zero and 10, respectively. Moderate intensity of any symptom is defined as 4 -6 and severe as 7 - 10 on the Likert scale. A total symptom distress score is calculated by summing of the scores for all 10 symptoms on the ESAS (ranges from 0 to 100). |
| Secondary | Validate the addition of RLS and difficulty sleeping items on the Edmonton Symptom Assessment System Revised: Renal (ESAS-r: Renal). | The restless legs and difficulty sleeping items added to the ESAR-r: renal will be collected at baseline, and 1, 2, 4 & 6 months after start of intervention. | The bi-monthly use of a modified 12 item ESAS-r: Renal has been implemented in to routine clinical care in Alberta Health Services' (AHS) Northern Alberta Renal Program (NARP) to assess patient symptom burden. The assessment used by clinicians includes two additional items scored from 0 to 10: sleep difficulties and restless legs. As a result of the additions, the total symptom distress score ranges from 0-120 for the ESAS version used in the NARP. |
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.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone 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/NCT03708237
GET https://conductscience.org/api/trials/v1/NCT03708237/registered