Restless Legs SyndromePhase 3NCT01537042
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
A Phase 3 study testing Rotigotine in people with Restless Legs Syndrome and End-Stage Renal Disease, run by UCB BIOSCIENCES GmbH at 15 sites in 6 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Restless Legs Syndrome, End-Stage Renal Disease
- What is being tested?
- Rotigotine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 15 sitesin 6 countries
- Study dates
- Apr 2012to Oct 2013
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
15 sites in 6 countries.
15 sites in 6 countries
United States6 sites
601
Austin, Texas
606
Brandon, Florida
607
Dublin, Ohio
604
Newton, Massachusetts
605
West Chester, Pennsylvania
603
West Seneca, New York
About this study
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
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
- Being tested
- Rotigotine, Placebo
- Keywords
- Rotigotine, Neupro, Restless Legs Syndrome, RLS, End-Stage Renal Disease
- Medical subject headings
- Restless Legs Syndrome, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RotigotineDrug
Also called Neupro
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.
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Rotigotine | Experimental | 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. Receives: Drug: Rotigotine |
| Placebo | Placebo comparator | Transdermal patch matched according to patch size and appearance. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ratio From Baseline to the End of the 2-week Maintenance Period in Periodic Limb Movement Index (PLMI)
The PLMI is defined as Periodic Limb Movements (PLMs)/ total time in bed in hours. PLMs are measured by Polysomnography (PSG).
The reduction of the PLMI is reflected in terms of the ratio from Baseline to the end of the Maintenance Period and was calculated as [PLMI at end of Maintenance Period (MP)] / [PLMI at Baseline].
A PLMI Ratio <1 indicates an improvement from Baseline to the end of the 2-week MP.
Measured: From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period
Secondary outcomes (14)
Change From Baseline in the Periodic Limb Movements Index (PLMI) to the End of the Maintenance Period
The PLMI is defined as Periodic Limb Movements (PLMs)/ total time in bed in hours. PLMs are measured by Polysomnography (PSG). A negative value in change from Baseline indicates an improvement from Baseline to the end of the Maintenance Period.
Measured: From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period
Change From Baseline in the International Restless Legs Syndrome Study Group Rating Scale (IRLS) Sum Score to the End of the Maintenance Period
The IRLS is a subject based scale that consists of 10 items to evaluate the severity of major RLS symptoms and the impact of the disease on subjects' functioning in daytime activities. Each of the 10 items is measured on a scale that ranges from 0 (not present) to 4 (severe). A sum score between 0 (no RLS symptoms present at all) and 40 (maximum severity in all symptoms) across all 10 items will be calculated.
A negative value in Change from Baseline indicates an improvement from Baseline in IRLS.
Measured: From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period
Change From Baseline in Clinical Global Impressions (CGI) Item 1 Score
The CGI Item 1 score measures the severity of illness on a scale that ranges from 0 (Not assessed) to 7 (Among the most extremely ill).
Measured: Visit 2 (Baseline); Visit 6 (End of Maintence Period)
Change From Baseline in the Restless Legs-6 (RLS-6) Rating Scale 1 to the End of the Maintenance Period
The RLS-6 consists of six scales of which four scales are designed to assess severity of RLS and two scales cover sleep and daytime tiredness.
Scale 1 measures satisfaction with sleep during the last seven nights on an 11-point scale that ranges between 0 (completely satisfied) to 10 (completely dissatisfied). The ratings are given by the subjects.
A negative value in Change from Baseline indicates an improvement from Baseline.
Measured: From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period
Change From Baseline in the Restless Legs-6 (RLS-6) Rating Scale 2 to the End of the Maintenance Period
The RLS-6 consists of six scales of which four scales are designed to assess severity of RLS and two scales cover sleep and daytime tiredness.
Scale 2 measures the severity of RLS symptoms during the last 7 nights in the situation of falling asleep. This is measured on an 11-point scale that ranges between 0 (none) to 10 (very severe). The ratings are given by the subjects.
A negative value in Change from Baseline indicates an improvement from Baseline.
Measured: From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period
Change From Baseline in the Restless Legs-6 (RLS-6) Rating Scale 3 to the End of the Maintenance Period
The RLS-6 consists of six scales of which four scales are designed to assess severity of RLS and two scales cover sleep and daytime tiredness.
Scale 3 measures the severity of RLS symptoms during the last seven nights on an 11-point scale that ranges between 0 (none) to 10 (very severe). The ratings are given by the subjects.
A negative value in Change from Baseline indicates an improvement from Baseline.
Measured: From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period
Change From Baseline in the Restless Legs-6 (RLS-6) Rating Scale 4 to the End of the Maintenance Period
The RLS-6 consists of six scales of which four scales are designed to assess severity of RLS and two scales cover sleep and daytime tiredness.
Scale 4 measures the severity of RLS symptoms during the last seven days at rest on an 11-point scale that ranges between 0 (none) to 10 (very severe). The ratings are given by the subjects.
A negative value in Change from Baseline indicates an improvement from Baseline.
Measured: From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period
Change From Baseline in the Restless Legs-6 (RLS-6) Rating Scale 5 to the End of the Maintenance Period
The RLS-6 consists of six scales of which four scales are designed to assess severity of RLS and two scales cover sleep and daytime tiredness.
Scale 5 measures the severity of RLS symptoms during the last seven days engaged in activities on an 11-point scale that ranges between 0 (none) to 10 (very severe). The ratings are given by the subjects.
A negative value in Change from Baseline indicates an improvement from Baseline.
Measured: From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period
Change From Baseline in the Restless Legs-6 (RLS-6) Rating Scale 6 to the End of the Maintenance Period
The RLS-6 consists of six scales of which four scales are designed to assess severity of RLS and two scales cover sleep and daytime tiredness.
Scale 6 measures the severity of daytime tiredness/ sleepiness on an 11-point scale that ranges between 0 (not at all) to 10 (very severe). The ratings are given by the subjects.
A negative value in Change from Baseline indicates an improvement from Baseline.
Measured: From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period
Change From Baseline in the Periodic Limb Movement During Sleep Arousal Index (PLMSAI) to the End of the Maintenance Period
The Periodic Limb Movement during Sleep Arousal Index (PLMSAI) reflects the influence of the PLM on subject's sleep. Arousal is defined as sudden change in the Electroencephalogram (EEG) activity and the index illustrates to what degree the PLMs contribute to arousal from sleep.
A negative value in Change from Baseline indicates an improvement from Baseline.
Measured: From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period
Change From Baseline in Sleep Efficiency to the End of the Maintenance Period
Sleep stages and time spent in each sleep stage are determined from Electroencephalogram (EEG) readings. Sleep stage data will be used to calculate sleep efficiency. Sleep efficiency will be presented as percentages. Sleep efficiency is the percentage of time in bed spent asleep.
A postive value in Change from Baseline indicates an improvement from Baseline.
Measured: From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period
Change From Baseline in the Restless Legs-Quality of Life (RLS-QoL) Total Score to the End of the Maintenance Period
The RLS-QoL is a disease-specific questionnaire to evaluate quality of life. It consists of 12 items. A total score will be calculated from all of the 12 items. The overall sum score can be from 0 (highest QoL) to 60 (lowest QoL).
A negative value in Change from Baseline indicates an improvement from Baseline.
Measured: From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period
Change From Baseline in the Short-Form-36 (SF-36) Item Questionnaire Mental Component Summary (MCS) to the End of the Maintenance Period
The SF-36 is a 36 item generic human research quality of life instrument that uses a recall period of 4 weeks. Items are grouped into 8 domains as follows: Physical Functioning (10 items), Role Physical (4 items), Bodily Pain (2 items), General Health (5 items), Vitality (4 items), Social Functioning (2 items), Role Emotional (3 items), Mental Health (5 items), and a further unscaled single item (question 2) for perceived stability or change in health (Health Transition) during the last year. The norm based scores (based on the US general population) were used for analysis. For the MCS, the lowest and highest possible scores are -9 and 82 (rounded).
The SF-36 domains (subscores) are scored so that a higher score indicates a better health state.
Measured: From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period
Change From Baseline in the Short-Form-36 (SF-36) Item Questionnaire Physical Component Summary (PCS) to the End of the Maintenance Period
The SF-36 is a 36 item generic human research quality of life instrument that uses a recall period of 4 weeks. Items are grouped into 8 domains as follows: Physical Functioning (10 items), Role Physical (4 items), Bodily Pain (2 items), General Health (5 items), Vitality (4 items), Social Functioning (2 items), Role Emotional (3 items), Mental Health (5 items), and a further unscaled single item (question 2) for perceived stability or change in health (Health Transition) during the last year. The norm-based scores (based on the US general population) were used for analysis. For the PCS, the lowest and highest possible scores are 1 and 81 (rounded).
The SF-36 domains (subscores) are scored so that a higher score indicates a better health state.
Measured: From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2012 (estimated)
- Study startApr 2012
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Restless Legs SyndromeStudies 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCB BIOSCIENCES GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- UCB Clinical Trial Call Center, Study director, +1 877 822 9493 (UCB)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01537042
- Sponsor's protocol ID
- SP0934
- Other IDs
- 2011-003486-15
- Status last verified
- Oct 2014
- First submitted
- 16 Feb 2012
- Last updated
- 3 Nov 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01537042
- Acronym / sponsor ID
- SP0934
- Conditions
- Restless Legs Syndrome, End-Stage Renal Disease
- Keywords
- Rotigotine, Neupro, Restless Legs Syndrome, RLS, End-Stage Renal Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- UCB BIOSCIENCES GmbHIndustry (pharma, biotech, devices)
- Study start
- Apr 2012
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 22 Feb 2012 (estimated)
- Results
- Posted 3 Nov 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rotigotine | Experimental | Drug: RotigotineRotigotine 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. |
| Placebo | Placebo comparator | Drug: PlaceboTransdermal patch matched according to patch size and appearance. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (16 listed)
- 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)
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 |
|---|---|---|
| RotigotineAlso: NeuproTransdermal 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. | Drug | Rotigotine |
| PlaceboTransdermal 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. | Drug | Placebo |
Primary outcome
Ratio From Baseline to the End of the 2-week Maintenance Period in Periodic Limb Movement Index (PLMI)
Time frame: From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period
The PLMI is defined as Periodic Limb Movements (PLMs)/ total time in bed in hours. PLMs are measured by Polysomnography (PSG). The reduction of the PLMI is reflected in terms of the ratio from Baseline to the end of the Maintenance Period and was calculated as [PLMI at end of Maintenance Period (MP)] / [PLMI at Baseline]. A PLMI Ratio <1 indicates an improvement from Baseline to the end of the 2-week MP.
14 secondary outcomes
Change From Baseline in the Periodic Limb Movements Index (PLMI) to the End of the Maintenance Period
Time frame: From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period
Change From Baseline in the International Restless Legs Syndrome Study Group Rating Scale (IRLS) Sum Score to the End of the Maintenance Period
Time frame: From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period
Change From Baseline in Clinical Global Impressions (CGI) Item 1 Score
Time frame: Visit 2 (Baseline); Visit 6 (End of Maintence Period)
Change From Baseline in the Restless Legs-6 (RLS-6) Rating Scale 1 to the End of the Maintenance Period
Time frame: From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period
Change From Baseline in the Restless Legs-6 (RLS-6) Rating Scale 2 to the End of the Maintenance Period
Time frame: From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period
Change From Baseline in the Restless Legs-6 (RLS-6) Rating Scale 3 to the End of the Maintenance Period
Time frame: From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period
Change From Baseline in the Restless Legs-6 (RLS-6) Rating Scale 4 to the End of the Maintenance Period
Time frame: From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period
Change From Baseline in the Restless Legs-6 (RLS-6) Rating Scale 5 to the End of the Maintenance Period
Time frame: From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period
Change From Baseline in the Restless Legs-6 (RLS-6) Rating Scale 6 to the End of the Maintenance Period
Time frame: From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period
Change From Baseline in the Periodic Limb Movement During Sleep Arousal Index (PLMSAI) to the End of the Maintenance Period
Time frame: From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period
Change From Baseline in Sleep Efficiency to the End of the Maintenance Period
Time frame: From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period
Change From Baseline in the Restless Legs-Quality of Life (RLS-QoL) Total Score to the End of the Maintenance Period
Time frame: From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period
Change From Baseline in the Short-Form-36 (SF-36) Item Questionnaire Mental Component Summary (MCS) to the End of the Maintenance Period
Time frame: From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period
Change From Baseline in the Short-Form-36 (SF-36) Item Questionnaire Physical Component Summary (PCS) to the End of the Maintenance Period
Time frame: From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Restless Legs Syndrome
RecruitingObservational study
Lemborexant vs Clonidine vs Sedatives to Treat Insomnia in Chronic Pain Patients
Chronic Insomnia, Chronic Pain
Not yet recruiting
Neuromodulation to Overcome Severe Restless Legs Syndrome
Restless Leg Syndrome (RLS), Spinal Cord Stimulation (SCS)
Not yet recruitingPhase 2
Tolerability and Efficacy of CBD Extract for RLS Treatment
Restless Leg Syndrome
Recruiting
Functional Connectivity of the Interoceptive Network in RLS
Restless Legs Syndrome
Not yet recruitingPhase 2
Intravenous Iron in the Management of Drug-resistant Restless Legs syndromeI
Restless Legs Syndrome (RLS)
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.
UCB Clinical Trial Call Center study director
+1 877 822 9493 (UCB)
15 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Rotigotine in people with Restless Legs Syndrome and End-Stage Renal Disease, run by UCB BIOSCIENCES GmbH at 15 sites in 6 countries.
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 8 inclusion and 16 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 3 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States, Germany, Finland, France, Austria and 1 more country. 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?
Yes. Results are posted in the registry (first posted 3 Nov 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Ratio From Baseline to the End of the 2-week Maintenance Period in Periodic Limb Movement Index (PLMI) (time frame: From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Nov 2014.