DIalysis Symptom COntrol-Restless Legs Syndrome Trial

NCT03806530 | Completed Phase 3

• 1 other identifier: DISCO_RLS_001
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

End Stage Renal Disease; Restless Legs Syndrome

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (4)

• Restless Legs Syndrome-6 Scale (RLS-6)

  18 weeks (Baseline, Run-In, Follow-up)

• Patient Global Impressions (PGI)

  18 weeks (Baseline, Run-In, Follow-up)

• Euro-Quality of Life Scale (EQ-5D-5L)

  18 weeks (Baseline, Run-In, Follow-up)

• Incidence of falls, fractures and hospitalizations/emergency room visits due to altered level of consciousness.

  18 weeks (Baseline, Run-In, Follow-up)

Study Arms (4)

Gabapentin + Ropinirole

ACTIVE COMPARATOR

Gabapentin 100 mg capsule, once daily for 4 weeks. Ropinirole 0.50 mg capsule, once daily for 4 weeks.

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.

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.

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.

Drug: Placebo Gabapentin; Drug: Placebo Ropinirole

Interventions

Gabapentin DRUG

100 mg capsule

Also known as: GD-Gabapentin

Gabapentin + Placebo Ropinirole; Gabapentin + Ropinirole

Ropinirole DRUG

0.50 mg capsule

Also known as: pms-Ropinirole

Gabapentin + Ropinirole; Ropinirole + Placebo Gabapentin

Placebo Gabapentin DRUG

Placebo capsule

Also known as: Placebo

Placebo Gabapentin + Placebo Ropinirole; Ropinirole + Placebo Gabapentin

Placebo Ropinirole DRUG

Placebo capsule

Also known as: Placebo

Gabapentin + Placebo Ropinirole; Placebo Gabapentin + Placebo Ropinirole

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Population Health Research Institute: lead

Study Sites (3)

Nova Scotia Health Authority

Halifax, Nova Scotia, B3H 2Y9, Canada

Location

St. Joseph's Hamilton Healthcare

Hamilton, Ontario, L8N 4A6, Canada

Location

The Ottawa Hospital

Ottawa, Ontario, K1H 7W9, Canada

Location

Related Publications (1)

• 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.

  PMID: 33294203 DERIVED

MeSH Terms

Conditions

Kidney Failure, Chronic; Restless Legs Syndrome

Interventions

Gabapentin; ropinirole

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Parasomnias; Mental Disorders

Intervention Hierarchy (Ancestors)

Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Dr. Michael Walsh, PhD,FRCPC(C)

  Population Health Research Institute, McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The study interventions will be blinded.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: January 14, 2019
• First Posted: January 16, 2019
• Study Start: May 1, 2019
• Primary Completion: December 14, 2021
• Study Completion: July 19, 2022
• Last Updated: September 21, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (3)