Clinical trial NCT01537042: 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
Official title: A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-group, Polysomnography Study to Investigate Safety and Efficacy of the Rotigotine Transdermal Patch in Subjects With Restless Legs Syndrome and End-Stage Renal Disease Requiring Hemodialysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Restless Legs Syndrome
End-Stage Renal Disease
Keywords: Rotigotine
Neupro
Restless Legs Syndrome
RLS
End-Stage Renal Disease
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2012-02-22
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Ratio From Baseline to the End of the 2-week Maintenance Period in Periodic Limb Movement Index (PLMI)
timeFrame: From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period
Secondary outcomes:
measure: Change From Baseline in the Periodic Limb Movements Index (PLMI) to the End of the Maintenance Period
timeFrame: From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period
measure: Change From Baseline in the International Restless Legs Syndrome Study Group Rating Scale (IRLS) Sum Score to the End of the Maintenance Period
timeFrame: From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period
measure: Change From Baseline in Clinical Global Impressions (CGI) Item 1 Score
timeFrame: Visit 2 (Baseline); Visit 6 (End of Maintence Period)
measure: Change From Baseline in the Restless Legs-6 (RLS-6) Rating Scale 1 to the End of the Maintenance Period
timeFrame: From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period
measure: Change From Baseline in the Restless Legs-6 (RLS-6) Rating Scale 2 to the End of the Maintenance Period
timeFrame: From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period
measure: Change From Baseline in the Restless Legs-6 (RLS-6) Rating Scale 3 to the End of the Maintenance Period
timeFrame: From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period
measure: Change From Baseline in the Restless Legs-6 (RLS-6) Rating Scale 4 to the End of the Maintenance Period
timeFrame: From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period
measure: Change From Baseline in the Restless Legs-6 (RLS-6) Rating Scale 5 to the End of the Maintenance Period
timeFrame: From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period
measure: Change From Baseline in the Restless Legs-6 (RLS-6) Rating Scale 6 to the End of the Maintenance Period
timeFrame: From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period
measure: Change From Baseline in the Periodic Limb Movement During Sleep Arousal Index (PLMSAI) to the End of the Maintenance Period
timeFrame: From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period
measure: Change From Baseline in Sleep Efficiency to the End of the Maintenance Period
timeFrame: From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period
measure: Change From Baseline in the Restless Legs-Quality of Life (RLS-QoL) Total Score to the End of the Maintenance Period
timeFrame: From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period
measure: Change From Baseline in the Short-Form-36 (SF-36) Item Questionnaire Mental Component Summary (MCS) to the End of the Maintenance Period
timeFrame: From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period
measure: Change From Baseline in the Short-Form-36 (SF-36) Item Questionnaire Physical Component Summary (PCS) to the End of the Maintenance Period
timeFrame: From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period
Other outcomes:
Locations:
city: Brandon
country: United States
facility: 606
state: Florida
city: Newton
country: United States
facility: 604
state: Massachusetts
city: West Seneca
country: United States
facility: 603
state: New York
city: Dublin
country: United States
facility: 607
state: Ohio
city: West Chester
country: United States
facility: 605
state: Pennsylvania
city: Austin
country: United States
facility: 601
state: Texas
city: Innsbruck
country: Austria
facility: 101
city: Helsinki
country: Finland
facility: 201
city: Tampere
country: Finland
facility: 203
city: Bordeaux Cedex
country: France
facility: 302
city: Montpellier Cédex 5
country: France
facility: 301
city: Berlin
country: Germany
facility: 404
city: Marburg
country: Germany
facility: 401
city: Schwerin
country: Germany
facility: 402
city: Pisa
country: Italy
facility: 502
Study officials:
affiliation: +1 877 822 9493 (UCB)
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References: