Restless Legs SyndromePhase 3NCT00367822
Transdermal Lisuride: a Trial for the Treatment of Patients With Restless Legs Syndrome (RLS)
A Phase 3 study testing Lisuride and Ropinirole in people with Restless Legs Syndrome, run by Axxonis Pharma AG at 1 site in Germany.
Trial summary
The objective of this trial is to compare an individually optimized dose of the lisuride TTS patch against placebo and against an individually optimized dose of oral ropinirole (active- and placebo-controlled design) in idiopathic and uremic RLS patients with regard to efficacy, safety, and quality of life. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Restless Legs Syndrome
- What is being tested?
- Lisuride and Ropinirole
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteGermany
- Study dates
- Start not givento not given
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Idiopathic or uremic RLS
- RLS Diagnostic Index (RLS-DI) > 10
- Total score in the IRLS Rating Scale ≥ 15 at baseline
- No previous treatment for RLS or insufficient current therapy
Who cannot join
- Secondary RLS, e.g. due to iron deficiency (exception: uremia)
- History or presence of sleep disorders other than RLS
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Transdermal Lisuride: a Double-blind, Randomized, Active- and Placebo-controlled Multi-centre Phase III Efficacy Trial for the Treatment of Patients With Restless Legs Syndrome (RLS)
The objective of this trial is to compare an individually optimized dose of the lisuride TTS patch against placebo and against an individually optimized dose of oral ropinirole (active- and placebo-controlled design) in idiopathic and uremic RLS patients with regard to efficacy, safety, and quality of life.
Read the detailed description
Approximately 300 patients will be randomized to receive either lisuride, ropinirole or placebo in a 2:1:1 fashion. After completion of 12 weeks of double-blind treatment, eligible patients will have the option to continue treatment with the lisuride patch for further 36 weeks in an open-label extension of the study.
Primary outcome: Changes in the total score of the International Restless Legs Severity Scale (IRLS) from baseline to end of double-blind treatment (12 weeks) will be used as primary efficacy outcome measure.
Secondary objectives are to evaluate quality of life, safety and tolerability. After the double-blind period, long-term efficacy of lisuride will be assessed for further 36 weeks in an open-label extension of the study.
- Conditions
- Restless Legs Syndrome
- Being tested
- Lisuride, Ropinirole, Placebo
- Keywords
- Restless Legs Syndrome, dopamine agonist, lisuride, ropinirole
- 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.
LisurideDrug
RopiniroleDrug
PlaceboDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
International Restless Legs Severity Scale (IRLS)
Secondary outcomes (2)
RLS-6 scales
CGI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2006 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Double blind
- Enrolment
- 300 participants
Sponsor and investigators
- Lead sponsor
- Axxonis Pharma AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Heike Benes, MD, Principal investigator, Somnibene GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00367822
- Sponsor's protocol ID
- Tulir 03/01
- Other IDs
- EudraCT No.: 2005-003549-16
- Status last verified
- Jan 2010
- First submitted
- 22 Aug 2006
- Last updated
- 7 Mar 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transdermal Lisuride: a Double-blind, Randomized, Active- and Placebo-controlled Multi-centre Phase III Efficacy Trial for the Treatment of Patients With Restless Legs Syndrome (RLS)
- ClinicalTrials.gov ID
- NCT00367822
- Acronym / sponsor ID
- Tulir 03/01
- Conditions
- Restless Legs Syndrome
- Keywords
- Restless Legs Syndrome, dopamine agonist, lisuride, ropinirole
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants
- Lead sponsor
- Axxonis Pharma AGIndustry (pharma, biotech, devices)
- First posted
- 23 Aug 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this trial is to compare an individually optimized dose of the lisuride TTS patch against placebo and against an individually optimized dose of oral ropinirole (active- and placebo-controlled design) in idiopathic and uremic RLS patients with regard to efficacy, safety, and quality of life.
Detailed description
Approximately 300 patients will be randomized to receive either lisuride, ropinirole or placebo in a 2:1:1 fashion. After completion of 12 weeks of double-blind treatment, eligible patients will have the option to continue treatment with the lisuride patch for further 36 weeks in an open-label extension of the study.
Primary outcome: Changes in the total score of the International Restless Legs Severity Scale (IRLS) from baseline to end of double-blind treatment (12 weeks) will be used as primary efficacy outcome measure.
Secondary objectives are to evaluate quality of life, safety and tolerability. After the double-blind period, long-term efficacy of lisuride will be assessed for further 36 weeks in an open-label extension of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Idiopathic or uremic RLS
- RLS Diagnostic Index (RLS-DI) > 10
- Total score in the IRLS Rating Scale ≥ 15 at baseline
- No previous treatment for RLS or insufficient current therapy
Key exclusion criteria (2 listed)
- Secondary RLS, e.g. due to iron deficiency (exception: uremia)
- History or presence of sleep disorders other than RLS
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 |
|---|---|---|
| Lisuride | Drug | – |
| Ropinirole | Drug | – |
| Placebo | Drug | – |
Primary outcome
International Restless Legs Severity Scale (IRLS)
2 secondary outcomes
RLS-6 scales
CGI
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2012.
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.
Heike Benes, MD principal investigator
Somnibene GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lisuride and Ropinirole in people with Restless Legs Syndrome, run by Axxonis Pharma AG at 1 site in Germany.
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 4 inclusion and 2 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 7 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
International Restless Legs Severity Scale (IRLS). 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 7 Mar 2012.