End Stage Renal DiseasePhase 3DISCO-RLSNCT03806530
DIalysis Symptom COntrol-Restless Legs Syndrome Trial
A Phase 3 study testing Gabapentin and Ropinirole in people with End Stage Renal Disease and Restless Legs Syndrome, run by Population Health Research Institute at 3 sites in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Disease, Restless Legs Syndrome
- What is being tested?
- Gabapentin and Ropinirole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 3 sitesCanada
- Study dates
- 1 May 2019to 19 Jul 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age greater or equal to 18 years
- Has received at least 90 days of in-center hemodialysis at a frequency at least 3 times weekly
- RLS defined by 2012 Revised International Restless Legs Syndrome Study Group (IRLSSG) Diagnostic Criteria for RLS and of moderate severity defined by an IRLS score greater or equal to 10 with symptoms more than 2 days per week (see IRLS question #7)
- Provides informed consent
Who cannot join
- Hemoglobin<80g/L in the previous 4 weeks
- Intolerance to a dopamine agonists (e.g. pramipexole or ropinirole) or alpha 2 delta ligands (e.g. gabapentin, Neurontin, pregabalin, or Lyrica)
- Change in medication to treat RLS in previous 4 weeks
- Current pregnancy
- Planned kidney transplantation, travel or relocation in the next 6 months
- Unable to complete RLS symptom and HRQOL measurements due to language barrier or cognitive impairment
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
Nova Scotia Health Authority
Halifax, Nova Scotia, B3H 2Y9
St. Joseph's Hamilton Healthcare
Hamilton, Ontario, L8N 4A6
The Ottawa Hospital
Ottawa, Ontario, K1H 7W9
About this study
Official title: DIalysis Symptom COntrol-Restless Legs Syndrome Trial (DISCO-RLS Trial): A Randomized Controlled Trial
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.
Read the detailed description
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.
- Conditions
- End Stage Renal Disease, Restless Legs Syndrome
- Being tested
- Gabapentin, Ropinirole, Placebo Gabapentin, Placebo Ropinirole
- Medical subject headings
- Kidney Failure, Chronic, Restless Legs Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GabapentinDrug
Also called GD-Gabapentin
100 mg capsule
RopiniroleDrug
Also called pms-Ropinirole
0.50 mg capsule
Placebo GabapentinDrug
Also called Placebo
Placebo capsule
Placebo RopiniroleDrug
Also called Placebo
Placebo capsule
| Study group | Role | What they receive |
|---|---|---|
| Gabapentin + Ropinirole | Active comparator | Gabapentin 100 mg capsule, once daily for 4 weeks. Ropinirole 0.50 mg capsule, once daily for 4 weeks. Receives: Drug: Gabapentin; Drug: Ropinirole |
| 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. Receives: Drug: Gabapentin; Drug: Placebo Ropinirole |
| 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. Receives: Drug: Ropinirole; Drug: Placebo Gabapentin |
| 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. Receives: Drug: Placebo Gabapentin; Drug: Placebo Ropinirole |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 18 weeks (Baseline, Run-In, Follow-up)
Secondary outcomes (4)
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.
Measured: 18 weeks (Baseline, Run-In, Follow-up)
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
Measured: 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
Measured: 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.
Measured: 18 weeks (Baseline, Run-In, Follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2019
- Study start1 May 2019
- Primary completion14 Dec 2021
- Study completion19 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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).
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Population Health Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr. Michael Walsh, PhD,FRCPC(C), Principal investigator, Population Health Research Institute, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03806530
- Sponsor's protocol ID
- DISCO_RLS_001
- Acronym
- DISCO-RLS
- Status last verified
- Sep 2022
- First submitted
- 14 Jan 2019
- Last updated
- 21 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33294203
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DIalysis Symptom COntrol-Restless Legs Syndrome Trial (DISCO-RLS Trial): A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03806530
- Acronym / sponsor ID
- DISCO-RLS / DISCO_RLS_001
- Conditions
- End Stage Renal Disease, Restless Legs Syndrome
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Population Health Research InstituteUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 14 Dec 2021 (actual)
- Study completion
- 19 Jul 2022 (actual)
- First posted
- 16 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Gabapentin + Ropinirole | Active comparator | Drug: Gabapentin, Drug: RopiniroleGabapentin 100 mg capsule, once daily for 4 weeks. Ropinirole 0.50 mg capsule, once daily for 4 weeks. |
| Gabapentin + Placebo Ropinirole | Placebo comparator | Drug: Gabapentin, Drug: Placebo RopiniroleGabapentin 100 mg capsule, once daily for 4 weeks. Ropinirole placebo 0.50 mg capsule, once daily for 4 weeks. |
| Ropinirole + Placebo Gabapentin | Placebo comparator | Drug: Ropinirole, Drug: Placebo GabapentinGabapentin 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 | Drug: Placebo Gabapentin, Drug: Placebo RopiniroleGabapentin placebo 100 mg capsule, once daily for 4 weeks. Ropinirole placebo 0.50 mg capsule, once daily for 4 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age greater or equal to 18 years
- Has received at least 90 days of in-center hemodialysis at a frequency at least 3 times weekly
- RLS defined by 2012 Revised International Restless Legs Syndrome Study Group (IRLSSG) Diagnostic Criteria for RLS and of moderate severity defined by an IRLS score greater or equal to 10 with symptoms more than 2 days per week (see IRLS question #7)
- Provides informed consent
Key exclusion criteria (6 listed)
- Hemoglobin<80g/L in the previous 4 weeks
- Intolerance to a dopamine agonists (e.g. pramipexole or ropinirole) or alpha 2 delta ligands (e.g. gabapentin, Neurontin, pregabalin, or Lyrica)
- Change in medication to treat RLS in previous 4 weeks
- Current pregnancy
- Planned kidney transplantation, travel or relocation in the next 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GabapentinAlso: GD-Gabapentin100 mg capsule | Drug | Gabapentin + Placebo Ropinirole, Gabapentin + Ropinirole |
| RopiniroleAlso: pms-Ropinirole0.50 mg capsule | Drug | Gabapentin + Ropinirole, Ropinirole + Placebo Gabapentin |
| Placebo GabapentinAlso: PlaceboPlacebo capsule | Drug | Placebo Gabapentin + Placebo Ropinirole, Ropinirole + Placebo Gabapentin |
| Placebo RopiniroleAlso: PlaceboPlacebo capsule | Drug | Gabapentin + Placebo Ropinirole, Placebo Gabapentin + Placebo Ropinirole |
Primary outcome
International Restless Legs Syndrome Study Group Rating Scale (IRLS)
Time frame: 18 weeks (Baseline, Run-In, Follow-up)
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.
4 secondary outcomes
Restless Legs Syndrome-6 Scale (RLS-6)
Time frame: 18 weeks (Baseline, Run-In, Follow-up)
Patient Global Impressions (PGI)
Time frame: 18 weeks (Baseline, Run-In, Follow-up)
Euro-Quality of Life Scale (EQ-5D-5L)
Time frame: 18 weeks (Baseline, Run-In, Follow-up)
Incidence of falls, fractures and hospitalizations/emergency room visits due to altered level of consciousness.
Time frame: 18 weeks (Baseline, Run-In, Follow-up)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2022.
- Derived from this study: PubMed 33294203Collister 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. Michael Walsh, PhD,FRCPC(C) principal investigator
Population Health Research Institute, McMaster University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Gabapentin and Ropinirole in people with End Stage Renal Disease and Restless Legs Syndrome, run by Population Health Research Institute at 3 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
International Restless Legs Syndrome Study Group Rating Scale (IRLS) (time frame: 18 weeks (Baseline, Run-In, Follow-up)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03806530, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2022.