A Sleep Laboratory Study to Investigate the Safety and Efficacy of the Rotigotine Skin Patch in Subjects With Restless Legs Syndrome and End-Stage Renal Disease Requiring Hemodialysis

NCT ID: NCT01537042

Last Updated: 2014-11-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-04-30
• Study Completion Date: 2013-10-31

Brief Summary

This is a sleep laboratory study to evaluate the efficacy and safety of Rotigotine in subjects with Restless Legs Syndrome and End-Stage Renal Disease requiring hemodialysis.

The objectives are to demonstrate superiority of Rotigotine against Placebo as well as to investigate the effect of Rotigotine on quality of life and sleep.

Conditions

Restless Legs Syndrome; End-Stage Renal Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Rotigotine

Rotigotine Transdermal Patch

1 mg/24 h, 2 mg/24 h or 3 mg/24 h once daily depending on optimal dose; maximal dose is 3 mg/24 h.

Group Type: EXPERIMENTAL

Rotigotine

Intervention Type: DRUG

Transdermal patch; Dose: 1 mg/24 h, 2 mg/24 h or 3 mg/24 h once daily depending on optimal dose; maximal dose is 3 mg/24 h.

Subjects start with a Rotigotine dose of 1 mg/24 h for 1 week. The dose can be increased weekly during Up-Titration Period until either the optimal or the maximal dose of 3 mg/24 h has been reached. Subjects will maintain the optimal/maximal dose during the 2-week Maintenance Period. Following the Maintenance Period, subjects will be de-escalated from their optimal dose by decreasing the dose by 1 mg/24 h every other day during Taper Period until complete withdrawal.

Placebo

Transdermal patch matched according to patch size and appearance.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Transdermal patch; Patches matching to active treatment patches in size and appearance.

Up to 3 weeks of Titration,

2 weeks of Maintenance,

Up to 4 days of Taper Period.

Interventions

Rotigotine

Transdermal patch; Dose: 1 mg/24 h, 2 mg/24 h or 3 mg/24 h once daily depending on optimal dose; maximal dose is 3 mg/24 h.

Subjects start with a Rotigotine dose of 1 mg/24 h for 1 week. The dose can be increased weekly during Up-Titration Period until either the optimal or the maximal dose of 3 mg/24 h has been reached. Subjects will maintain the optimal/maximal dose during the 2-week Maintenance Period. Following the Maintenance Period, subjects will be de-escalated from their optimal dose by decreasing the dose by 1 mg/24 h every other day during Taper Period until complete withdrawal.

Intervention Type: DRUG

Placebo

Transdermal patch; Patches matching to active treatment patches in size and appearance.

Up to 3 weeks of Titration,

2 weeks of Maintenance,

Up to 4 days of Taper Period.

Intervention Type: DRUG

Other Intervention Names

Neupro

Eligibility Criteria

Inclusion Criteria

• End-Stage Renal Disease (ESRD) requiring hemodialysis and regular dialysis schedule
• Fulfillment of pre-defined criteria of hematology parameters
• Diagnosis of Restless Legs (RLS) based on the 4 cardinal diagnostic clinical features according to the International Restless Legs Syndrome Study Group
• Initial response to previous dopaminergic treatment for RLS, or has had no previous dopaminergic treatment (ie, de novo)
• Score of ≥ 15 points on the IRLS (indicating moderate to severe RLS) at Baseline
• Score of ≥ 11 points on the RLS-DI (Diagnostic Index) at Baseline
• Score of ≥ 4 points on the Clinical Global Impressions (CGI) Item 1 assessment (indicating moderately ill) at Baseline
• Scores ≥ 15 Periodic Limb Movements (PLMs) per hour on the Periodic Limb Movement Index (PLMI) based on Polysomnography (PSG) (recorded during the second night) as assessed by the investigator at Baseline

Exclusion Criteria

• Clinically relevant Polyneuropathy or Varicosis which cannot be clearly differentiated from RLS symptoms in the opinion of the investigator
• Clinically relevant concomitant diseases, such as Attention Deficit Hyperactivity Disorder, Painful Legs, and Moving Toes
• Other central nervous system diseases
• Evidence of an impulse control disorder according to the modified Minnesota Impulsive Disorders Interview (mMIDI)
• Lifetime history of suicide attempt (including an active attempt, interrupted attempt, or aborted attempt), or has suicidal ideation in the past 6 months as indicated by a positive response ('yes') to either Question 4 or Question 5 of the Columbia-Suicidality Severity Rating Scale (C-SSRS) at Screening (Visit 1) or Baseline (Visit 2)
• Prior history of psychotic episodes
• History of symptomatic (not asymptomatic) Orthostatic Hypotension
• Clinically relevant Cardiovascular Disease
• Clinically relevant Venous or Arterial Peripheral Vascular Disease
• Malignant Neoplastic Disease requiring therapy within 12 months prior to Screening (Visit 1)
• Treatment with any of the following drug classes: neuroleptics, norepinephrine and dopamine reuptake inhibitors (bupropion), gabapentin, budipine, dopamine antagonist antiemetics (except domperidone), opioids, monoamine oxidase (MAO) inhibitors, catechol-O-methyltransferase (COMT) inhibitors, or psychostimulants (eg, amphetamines)
• Subject is pregnant, nursing, or is a woman of childbearing potential who is not surgically sterile, 2 years postmenopausal, or does not consistently use 2 combined effective methods of contraception (including at least 1 barrier method), unless sexually abstinent
• Previous treatment with dopamine agonists within a period of 14 days prior to Baseline (Visit 2), or L-dopa within 7 days prior to Baseline (Visit 2)
• Medical history indicating intolerability to dopaminergic therapy (if pretreated) or has experienced Augmentation (Garcia-Borreguero and Williams, 2010) when previously treated with any dopaminergic agent
• Subject has received previous treatment with Rotigotine
• Known hypersensitivity to any of the components of the study medication, such as a history of significant Skin Hypersensitivity to adhesives, known Hypersensitivity to other transdermal medications, or unresolved Contact Dermatitis

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

UCB BIOSCIENCES GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

UCB Clinical Trial Call Center

Role: STUDY_DIRECTOR

+1 877 822 9493 (UCB)

Locations

606

Brandon, Florida, United States

604

Newton, Massachusetts, United States

603

West Seneca, New York, United States

607

Dublin, Ohio, United States

605

West Chester, Pennsylvania, United States

601

Austin, Texas, United States

101

Innsbruck, , Austria

201

Helsinki, , Finland

203

Tampere, , Finland

302

Bordeaux, , France

301

Montpellier Cédex 5, , France

404

Berlin, , Germany

401

Marburg, , Germany

402

Schwerin, , Germany

502

Pisa, , Italy

Countries

United States; Austria; Finland; France; Germany; Italy

Other Identifiers

2011-003486-15

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

SP0934

Identifier Type: -

Identifier Source: org_study_id