Restless Legs SyndromePhase 2NCT00498186
Long-term Open-label Trial in Idiopathic Restless Legs Syndrome (RLS)
A Phase 2 study testing Rotigotine in people with Restless Legs Syndrome, run by UCB Pharma at 24 sites in 3 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Restless Legs Syndrome
- What is being tested?
- Rotigotine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 295 participants
- Where
- 24 sitesin 3 countries
- Study dates
- Jul 2003to Apr 2009
- Phase
- Phase 2
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject has completed the preceding trial SP709 (NCT00243217)
Who cannot join
- 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
Show all 19Show fewer
- 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)
Trial locations and contacts
24 sites in 3 countries.
24 sites in 3 countries
Germany20 sites
Study site
Bamberg
Study site
Berlin
Study site
Bielefeld
Study site
Gelsenkirchen
Study site
Gera
Study site
Halle
Study site
Jena
Study site
Kassel
Study site
Köthen
Study site
Marburg, 35039
Study site
Mittweida
Study site
München
Study site
Neubrandenburg
Study site
Oldenburg
Study site
Regensburg
Study site
Schwalmstadt-Treysa
Study site
Schwerin
Study site
Tuttlingen
Study site
Ulm
Study site
Unterhaching
About this study
Official title: An Open-label Extension Trial to Determine Safety and Tolerability of Long-term Transdermal Application of Rotigotine in Subjects With Idiopathic Restless Legs Syndrome
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).
- Conditions
- Restless Legs Syndrome
- Being tested
- Rotigotine
- Keywords
- Rotigotine, Neupro®
- Medical subject headings
- Restless Legs Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RotigotineDrug
Also called Neupro®
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)
| Study group | Role | What they receive |
|---|---|---|
| Rotigotine | Experimental | Rotigotine trans-dermal patch Receives: Drug: Rotigotine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2007 (estimated)
- Study startJul 2003
- Primary completionApr 2009
- Study completionApr 2009
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.
- Publications (5)Papers the sponsor has linked to this study.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 295 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCB Pharma
- 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
- NCT00498186
- Sponsor's protocol ID
- SP0710
- Status last verified
- Oct 2011
- First submitted
- 6 Jul 2007
- Last updated
- 2 Oct 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
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 18753003Hogl 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 20920156Oertel 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 21705273Dohin 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 23256574Hogl 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
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Extension Trial to Determine Safety and Tolerability of Long-term Transdermal Application of Rotigotine in Subjects With Idiopathic Restless Legs Syndrome
- ClinicalTrials.gov ID
- NCT00498186
- Acronym / sponsor ID
- SP0710
- Conditions
- Restless Legs Syndrome
- Keywords
- Rotigotine, Neupro®
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 295 participants (actual)
- Lead sponsor
- UCB PharmaIndustry (pharma, biotech, devices)
- Study start
- Jul 2003
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 9 Jul 2007 (estimated)
- Results
- Posted 13 Apr 2010
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 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rotigotine | Experimental | Drug: RotigotineRotigotine trans-dermal patch |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subject has completed the preceding trial SP709 (NCT00243217)
Key exclusion criteria (19 listed)
- 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
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: Neupro®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) | Drug | Rotigotine |
Primary outcome
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.
Time frame: Up to five years
Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.
1 secondary outcome
Number of Subjects Who Withdrew From the Trial Due to an Adverse Event During the 5-year Open Label Extension
Time frame: Up to five years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 18753003Oertel 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.
- Results publication: PubMed 20920156Hogl 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.
- Results publication: PubMed 21705273Oertel 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.
- Derived from this study: PubMed 23256574Dohin 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.
- Derived from this study: PubMed 23009552Hogl 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.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
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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)
24 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Rotigotine in people with Restless Legs Syndrome, run by UCB Pharma at 24 sites in 3 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 1 inclusion and 19 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 2 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in Germany, Spain, Austria. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 13 Apr 2010). 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?
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. (time frame: Up to five years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00498186, which also lists 5 linked publications.
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 2 Oct 2014.