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The DISCO-RLS Trial is a randomized controlled trial to determine the safety and efficacy of pharmacologic therapy (ropinirole versus placebo and gabapentin versus placebo) for the treatment of Restless Legs Syndrome in patients with End Stage Renal Disease requiring hemodialysis.
The DISCO-RLS Trial is a randomized controlled trial to determine whether or not a fixed, low-dose therapy with ropinirole and/or gabapentin is safe and effective compared to either alone or placebo for the treatment of Restless Legs Syndrome in patients with End Stage Renal Disease receiving hemodialysis. DISCO-RLS will randomize a total of 80 participants. Participants will be randomized to 1 of 8 treatment sequences. Each sequence is composed of 4 periods and in each period participants will receive 1 of 4 possible combinations of study medications (gabapentin+ropinirole, gabapentin+placebo ropinirole, ropinirole+placebo gabapentin, placebo gabapentin+placebo ropinirole). Eligible participants will complete a 1-week Run-In period followed by 4 periods of 4 weeks each for a total of 16-week follow-up after randomization. A final study visit will be completed at the end of the 16 week follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gabapentin + Ropinirole | Active Comparator | Gabapentin 100 mg capsule, once daily for 4 weeks. Ropinirole 0.50 mg capsule, once daily for 4 weeks. |
|
| Gabapentin + Placebo Ropinirole | Placebo Comparator | Gabapentin 100 mg capsule, once daily for 4 weeks. Ropinirole placebo 0.50 mg capsule, once daily for 4 weeks. |
|
| Ropinirole + Placebo Gabapentin | Placebo Comparator | Gabapentin placebo 100 mg capsule, once daily for 4 weeks. Ropinirole 0.50 mg capsule, once daily for 4 weeks. |
|
| Placebo Gabapentin + Placebo Ropinirole | Placebo Comparator | Gabapentin placebo 100 mg capsule, once daily for 4 weeks. Ropinirole placebo 0.50 mg capsule, once daily for 4 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gabapentin | Drug | 100 mg capsule |
|
| Measure | Description | Time Frame |
|---|---|---|
| International Restless Legs Syndrome Study Group Rating Scale (IRLS) | The IRLS is a measure of severity of Restless Legs Syndrome. It includes 10 items, measured on a scale of 0-4. A score of 1-10 indicates mild severity, 11-20 indicates moderate severity, 21-30 is severe and 31-40 is very severe. Primary outcome is the difference in IRLS scores for each of the treatment regimens. | 18 weeks (Baseline, Run-In, Follow-up) |
| Measure | Description | Time Frame |
|---|---|---|
| Restless Legs Syndrome-6 Scale (RLS-6) | The RLS-6 is a measure of severity of Restless Legs Syndrome for the past week. It includes 6 items, measured on a scale of 0-10. Each item is measured from no symptoms (score of 0) to very severe symptoms (score of 10). Secondary outcome is the difference in RLS-6 scores for each of the treatment regimens. | 18 weeks (Baseline, Run-In, Follow-up) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dr. Michael Walsh, PhD,FRCPC(C) | Population Health Research Institute, McMaster University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nova Scotia Health Authority | Halifax | Nova Scotia | B3H 2Y9 | Canada | ||
| St. Joseph's Hamilton Healthcare |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33294203 | Derived | Collister D, Pohl K, Herrington G, Lee SF, Rabbat C, Tennankore K, Zimmermann D, Tangri N, Wald R, Manns B, Suri RS, Nadeau-Fredette AC, Goupil R, Silver SA, Walsh M. The DIalysis Symptom COntrol-Restless Legs Syndrome (DISCO-RLS) Trial: A Protocol for a Randomized, Crossover, Placebo-Controlled Blinded Trial. Can J Kidney Health Dis. 2020 Nov 26;7:2054358120968959. doi: 10.1177/2054358120968959. eCollection 2020. |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| D012148 | Restless Legs Syndrome |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| ID | Term |
|---|---|
| D000077206 | Gabapentin |
| C046649 | ropinirole |
| ID | Term |
|---|---|
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
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Participants will be randomly allocated to 1 of 8 treatment sequences. Each sequence is composed of 4 periods and in each period participants will receive 1 of 4 possible combinations of study medications (gabapentin+ropinirole, gabapentin+placebo ropinirole, ropinirole+placebo gabapentin, placebo gabapentin+placebo ropinirole).
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The study interventions will be blinded.
| Ropinirole | Drug | 0.50 mg capsule |
|
|
| Placebo Gabapentin | Drug | Placebo capsule |
|
|
| Placebo Ropinirole | Drug | Placebo capsule |
|
|
| Patient Global Impressions (PGI) | The PGI is a measure of Restless Legs Syndrome symptom severity. It includes 1 item, measured on a scale of 1-7. 1 indicates mild severity, 3 indicates moderate severity, 5 is severe and 7 is very severe. Secondary outcome is the difference in PGI scores for each of the treatment regimens | 18 weeks (Baseline, Run-In, Follow-up) |
| Euro-Quality of Life Scale (EQ-5D-5L) | The EQ-5D-5L is a measure of health status. It includes 5 dimensions (mobility, self care, usual activities, pain/discomfort, anxiety/depression) and a visual analogue scale of 0-100 (0 being worst health and 100 being best health). The scale is measured by levels. Level 1 indicating no problems, 2 indicating slight problems, 3 indicating moderate problems, 4 indicating severe problems and 5 indicating extreme problems. Secondary outcome is the difference in EQ-5D-5L scores for each of the treatment regimens | 18 weeks (Baseline, Run-In, Follow-up) |
| Incidence of falls, fractures and hospitalizations/emergency room visits due to altered level of consciousness. | The total number of falls, fractures, or hospitalization/emergency rooms visits due to confusion/delirium or altered mental state. | 18 weeks (Baseline, Run-In, Follow-up) |
| Hamilton |
| Ontario |
| L8N 4A6 |
| Canada |
| The Ottawa Hospital | Ottawa | Ontario | K1H 7W9 | Canada |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009422 | Nervous System Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D020447 | Parasomnias |
| D001523 | Mental Disorders |
| D002087 |
| Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |