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CompletedNCT00498186Updated Oct 2, 2014Results posted

Long-term Open-label Trial in Idiopathic Restless Legs Syndrome (RLS)

A Phase 2 interventional study of Rotigotine in Restless Legs Syndrome, sponsored by UCB Pharma. Completed at 24 sites in 3 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2014-10-02.

Sponsored by UCB Pharma · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
295
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study summary

This is a multi-center, open-label extension trial conducted at the same European sites that participated in trial SP 709 (NCT00243217). The trial is designed to collect long-term safety and tolerability, efficacy correlates, and quality of life data in subjects with idiopathic Restless Leg Syndrome (RLS). The duration of treatment is approximately 5 years. Subject will be up-titrated to their optimal dose (administration of 1 patch per day, 5 different doses and patch sizes).

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Conditions studied

  • Restless Legs Syndrome

Keywords

  • Rotigotine
  • Neupro®
03

In context

Psychomotor Agitation

500 studies on the registry are indexed under Psychomotor Agitation; 55 are open to participants now.

This study's enrollment of 295 is above the median of 90 across 413 interventional studies indexed under Psychomotor Agitation.

Browse Psychomotor Agitation studies →

Lead sponsor

UCB Pharma is the lead sponsor of 238 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Subject has completed the preceding trial SP709 (NCT00243217)

Exclusion criteria

Exclusion Criteria:

  • Subject did suffer from a serious adverse event during trial SP709 (NCT00243217) which is ongoing at the end of that trial and is assessed to be related to the study medication by the investigator and/or the Sponsor
  • Sleep disturbances
  • Further clinically relevant concomitant diseases such as polyneuropathy, akathisia, claudication, varicosis, muscle fasciculation, painful legs and moving toes, or radiculopathy
  • Other central nervous diseases
  • One psychotic episode since start of study SP709
  • Any medical or psychiatric condition, which in the opinion of the investigator can jeopardize or would compromise the subject's ability to participate in this trial
  • Clinically relevant cardiac dysfunction and arrhythmias
  • The subject has at entry in study SP710, a QTc interval ≥ 500 msec and/or a QTc interval which has increased by ≥ 60 msec as compared to the average baseline (Visit 2) QTc interval of study SP709
  • Subject has clinically relevant renal dysfunction (serum creatine ≥ 2.0 mg/dl)
  • Subject has clinically relevant hepatic dysfunction (total bilirubin > 2.0 mg/dl or ALT and/or AST greater than two times the upper limit of the reference range
  • Subject has a newly diagnosed or relapsing neoplastic disease since the start of study SP709
  • Subject has a known hypersensitivity to any components of the trial medication or comparative drugs as stated in this protocol
  • Subject needs drugs prohibited in the course of this trial: neuroleptics, bupidine, hypnotics, antidepressants, anxiolytic drugs, anticonvulsive therapy, psychostimulatory drugs, other L-Dopa or dopamine agonist therapy, opioids, benzodiazepines, MAO inhibitors, sedative antihistamines, amphetamines
  • Subject is abusing alcohol or drug since start of SP709
  • Subject is pregnant or nursing or woman of child-bearing potential who is not surgically sterile, two years postmenopausal, or does not practice two combined methods of contraception, unless sexually abstinent
  • Subject pursues shift work or is subject to other continuous non-disease-related life conditions which do not allow regular sleep at night
  • Subject has clinically relevant vasculopathies (eg, varix or arteriosclerosis)
  • Subject has significant skin hypersensitivity to adhesive or other transdermals or recent unresolved contact dermatitis
  • Subject has symptomatic orthostatic hypotension, or a systolic blood pressure (SBP) less tham 105mmHg and/or a drop in SBP of > 20mmHg or a drop of > 10mmHg in diastolic BP (DBP) on standing at baseline visit (Visit 1)
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Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
295 participants (actual)

Study arms

  • Experimental
    Rotigotine

    Rotigotine trans-dermal patch

    Drug: Rotigotine

Interventions

  • DrugRotigotine

    Rotigotine transdermal patches once daily: 2.5cm2 (0.5mg/24 hours) 5cm2 (1mg/24 hours) 10cm2 (2mg/24 hours) 15cm2 (3mg/24 hours) 20cm2 (4mg/24 hours)

    Also known as: Neupro®

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What researchers measure

Primary outcomes

  1. Number of Subjects With at Least One Adverse Event, as Reported Spontaneously by the Subject or Observed by the Investigator, During the 5-year Open-label Extension.

    Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.

    Time frame: Up to five years

Secondary outcomes

  1. Number of Subjects Who Withdrew From the Trial Due to an Adverse Event During the 5-year Open Label Extension

    Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.

    Time frame: Up to five years

07

Results

Posted Apr 13, 2010

Participant flow

A total of 295 subjects belong to the Enrolled Set (ES) and all of them received at least one dose of trial medication, so they all belong to the Safety Set (SS).

Participant flow — Overall Study
MilestoneRotigotine
Started295
Completed122
Not completed173
Withdrew: Protocol violation10
Withdrew: Lack of efficacy31
Withdrew: Adverse event89
Withdrew: Unsatisfactory compliance of subject12
Withdrew: Withdrawal by subject18
Withdrew: Lost to follow-up3
Withdrew: Other10

Outcome measures

PrimaryNumber of Subjects With at Least One Adverse Event, as Reported Spontaneously by the Subject or Observed by the Investigator, During the 5-year Open-label Extension.

Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.

Time frame:
Up to five years
Reported as:
Number · participants
Number of Subjects With at Least One Adverse Event, as Reported Spontaneously by the Subject or Observed by the Investigator, During the 5-year Open-label Extension.
participantsRotigotine
Number of Subjects With at Least One Adverse Event, as Reported Spontaneously by the Subject or Observed by the Investigator, During the 5-year Open-label Extension.273
SecondaryNumber of Subjects Who Withdrew From the Trial Due to an Adverse Event During the 5-year Open Label Extension

Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.

Time frame:
Up to five years
Reported as:
Number · participants
Number of Subjects Who Withdrew From the Trial Due to an Adverse Event During the 5-year Open Label Extension
participantsRotigotine
Number of Subjects Who Withdrew From the Trial Due to an Adverse Event During the 5-year Open Label Extension93

Adverse events

Collected over Adverse Events (AEs) were collected over the whole trial period up to 5 years from Visit 1 to the Safety Follow- up Visit.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Rotigotine—79/295 (26.8%)272/295 (92.2%)
Most frequent serious events
Showing 10 of 84
Most frequent serious events
EventRotigotine
OsteoarthritisMusculoskeletal and connective tissue disorders11/295
Myocardial infarctionCardiac disorders4/295
Toe deformityMusculoskeletal and connective tissue disorders4/295
Radius fractureInjury, poisoning and procedural complications3/295
Uterine leiomyomaNeoplasms benign, malignant and unspecified (incl cysts and polyps)3/295
SyncopeNervous system disorders3/295
Varicose veinVascular disorders3/295
Coronary artery diseaseCardiac disorders2/295
GoitreEndocrine disorders2/295
NauseaGastrointestinal disorders2/295
Most frequent other events
Showing 10 of 19
Most frequent other events
EventRotigotine
Application site erythemaGeneral disorders96/295
Application site reactionGeneral disorders74/295
NasopharyngitisInfections and infestations55/295
Application site pruritusGeneral disorders54/295
Back painMusculoskeletal and connective tissue disorders40/295
NauseaGastrointestinal disorders35/295
FatigueGeneral disorders31/295
HypertensionVascular disorders26/295
DepressionPsychiatric disorders22/295
ArthralgiaMusculoskeletal and connective tissue disorders21/295

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Rotigotine
<=18 years0
Between 18 and 65 years208
>=65 years87
Age, Continuous
Age, Continuous(years)Rotigotine
Mean58.3 ± 10.1
Sex: Female, Male
Sex: Female, Male(Participants)Rotigotine
Female196
Male99
Body Mass Index (BMI)
Body Mass Index (BMI)(kg/ m^2)Rotigotine
Mean26.37 ± 3.84
Height
Height(cm)Rotigotine
Mean167.5 ± 8.3
Weight
Weight(kilogram (kg))Rotigotine
Mean74.21 ± 13.19
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Study locations

24 sites
  • Innsbruck, Austria
  • Bamberg, Germany
  • Berlin, Germany
  • Bielefeld, Germany
  • Gelsenkirchen, Germany
  • Gera, Germany
  • Halle, Germany
  • Jena, Germany
  • Kassel, Germany
  • Köthen, Germany
  • Marburg, 35039, Germany
  • Mittweida, Germany
  • München, Germany
  • Neubrandenburg, Germany
  • Oldenburg, Germany
  • Regensburg, Germany
  • Schwalmstadt-Treysa, Germany
  • Schwerin, Germany
  • Tuttlingen, Germany
  • Ulm, Germany
  • Unterhaching, Germany
  • Alcira, Valencia, Spain
  • Barcelona, Spain
  • Madrid, Spain
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References and documents

Publications

  • Oertel WH, Benes H, Garcia-Borreguero D, Geisler P, Hogl B, Trenkwalder C, Tacken I, Schollmayer E, Kohnen R, Stiasny-Kolster K; Rotigotine SP710 Study Group. One year open-label safety and efficacy trial with rotigotine transdermal patch in moderate to severe idiopathic restless legs syndrome. Sleep Med. 2008 Dec;9(8):865-73. doi: 10.1016/j.sleep.2008.04.012. Epub 2008 Aug 26. PubMed 18753003 ↗
  • Hogl B, Oertel WH, Stiasny-Kolster K, Geisler P, Benes H, Garcia-Borreguero D, Trenkwalder C, Poewe W, Schollmayer E, Kohnen R. Treatment of moderate to severe restless legs syndrome: 2-year safety and efficacy of rotigotine transdermal patch. BMC Neurol. 2010 Sep 28;10:86. doi: 10.1186/1471-2377-10-86. PubMed 20920156 ↗
  • Oertel W, Trenkwalder C, Benes H, Ferini-Strambi L, Hogl B, Poewe W, Stiasny-Kolster K, Fichtner A, Schollmayer E, Kohnen R, Garcia-Borreguero D; SP710 study group. Long-term safety and efficacy of rotigotine transdermal patch for moderate-to-severe idiopathic restless legs syndrome: a 5-year open-label extension study. Lancet Neurol. 2011 Aug;10(8):710-20. doi: 10.1016/S1474-4422(11)70127-2. Epub 2011 Jun 24. PubMed 21705273 ↗
  • Dohin E, Hogl B, Ferini-Strambi L, Schollmayer E, Fichtner A, Bauer L, Garcia-Borreguero D. Safety and efficacy of rotigotine transdermal patch in patients with restless legs syndrome: a post-hoc analysis of patients taking 1 - 3 mg/24 h for up to 5 years. Expert Opin Pharmacother. 2013 Jan;14(1):15-25. doi: 10.1517/14656566.2013.758251. Epub 2012 Dec 21. PubMed 23256574 ↗
  • Hogl B, Oertel WH, Schollmayer E, Bauer L. Transdermal rotigotine for the perioperative management of restless legs syndrome. BMC Neurol. 2012 Sep 25;12:106. doi: 10.1186/1471-2377-12-106. PubMed 23009552 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 2, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00498186
Lead sponsor
UCB Pharma
Responsible party
Sponsor
First posted
Jul 9, 2007
Start date
Jul 2003
Primary completion
Apr 2009
Completion
Apr 2009
Results posted
Apr 13, 2010
Last update
Oct 2, 2014

Study contacts

UCB Clinical Trial Call Center
study director · +1 877 822 9493 (UCB)

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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