Restless Legs SyndromePhase 3NCT00263068
An Extension Trial to Investigate Long-Term Treatment With Transdermal Rotigotine in Idiopathic Restless Legs Syndrome
A Phase 3 study testing Rotigotine in people with Restless Legs Syndrome, run by UCB Pharma at 1 site in United States.
Trial summary
This is a multicenter, open-label trial to assess safety and tolerability of rotigotine (SPM 936) in subjects with idiopathic Restless Legs Syndrome (RLS), administered at an optimal dose for up to 1 year. Read more about this study
- Who is it for?
- Ages 18 years and older
- 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
- 279 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2005to Dec 2007
- 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 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- Idiopathic restless legs syndrome
Who cannot join
- Subject has an ongoing serious adverse event from SP792 that is assessed to be related to the trial medication by the investigator and/or the sponsor.
- Subject is pregnant, nursing, or is a woman of child-bearing 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.
- Subject has any medical or psychiatric condition that, in the opinion of the investigator, can jeopardize or would compromise the subject's ability to participate in this trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label Extension Trial to Investigate the Safety and Tolerability of Long-Term Treatment With Transdermal Rotigotine in Subjects With Idiopathic Restless Legs Syndrome
This is a multicenter, open-label trial to assess safety and tolerability of rotigotine (SPM 936) in subjects with idiopathic Restless Legs Syndrome (RLS), administered at an optimal dose for up to 1 year. Subjects who successfully completed the Maintenance Period and the Taper Period of SP792 are allowed to enroll in this trial.
All subjects will begin the Titration Period at a daily dosage of 1.125mg rotigotine (2.5cm2 patch). Subjects will be up-titrated at 7-day intervals in 1.125mg (2.5cm2 increments, initial titration step only) and 2.25mg intervals (5cm2) increments to a maximum dose of 6.75mg/day (15cm2) rotigotine. The maximum length of titration is 28 days (±3 days), although not all subjects will require 28 days to reach their optimal dose.
A subject's dose may be increased or decreased, as needed by the investigator to maintain a subject's effective dose during the Maintenance Period. A Taper Period is provided to allow for safe, gradual withdrawal from trial medication
- Conditions
- Restless Legs Syndrome
- Being tested
- Rotigotine
- Keywords
- IDIOPATHIC RESTLESS LEGS SYNDROME
- 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
Transdermal Patch 1 per day for 24 hours containing:
1.125mg/day 2.25mg/day 4.5mg/day 6.75mg/day
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Up to 6.75 mg/day (optimal dosing) Receives: Drug: Rotigotine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability will be assessed by adverse events, changes in laboratory tests, changes in vital signs, physical and neurological examination, changes in menstrual and sexual function, global subject rating
Measured: 1 year
Secondary outcomes (1)
To obtain data on changes in severity in RLS symptoms and quality of life over a one year maintenance period.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2005 (estimated)
- Study startDec 2005
- Primary completionDec 2007
- Study completionDec 2007
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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 279 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCB Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- UCB Clinical Trial Call Center, Study director, +1 877 822 9493 (UCB)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00263068
- Sponsor's protocol ID
- SP0793
- Status last verified
- Sep 2009
- First submitted
- 5 Dec 2005
- Last updated
- 25 Sep 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Extension Trial to Investigate the Safety and Tolerability of Long-Term Treatment With Transdermal Rotigotine in Subjects With Idiopathic Restless Legs Syndrome
- ClinicalTrials.gov ID
- NCT00263068
- Acronym / sponsor ID
- SP0793
- Conditions
- Restless Legs Syndrome
- Keywords
- IDIOPATHIC RESTLESS LEGS SYNDROME
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 279 participants (actual)
- Lead sponsor
- UCB PharmaIndustry (pharma, biotech, devices)
- Study start
- Dec 2005
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 7 Dec 2005 (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.
This is a multicenter, open-label trial to assess safety and tolerability of rotigotine (SPM 936) in subjects with idiopathic Restless Legs Syndrome (RLS), administered at an optimal dose for up to 1 year. Subjects who successfully completed the Maintenance Period and the Taper Period of SP792 are allowed to enroll in this trial.
All subjects will begin the Titration Period at a daily dosage of 1.125mg rotigotine (2.5cm2 patch). Subjects will be up-titrated at 7-day intervals in 1.125mg (2.5cm2 increments, initial titration step only) and 2.25mg intervals (5cm2) increments to a maximum dose of 6.75mg/day (15cm2) rotigotine. The maximum length of titration is 28 days (±3 days), although not all subjects will require 28 days to reach their optimal dose.
A subject's dose may be increased or decreased, as needed by the investigator to maintain a subject's effective dose during the Maintenance Period. A Taper Period is provided to allow for safe, gradual withdrawal from trial medication
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: RotigotineUp to 6.75 mg/day (optimal dosing) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Idiopathic restless legs syndrome
Key exclusion criteria (3 listed)
- Subject has an ongoing serious adverse event from SP792 that is assessed to be related to the trial medication by the investigator and/or the sponsor.
- Subject is pregnant, nursing, or is a woman of child-bearing 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.
- Subject has any medical or psychiatric condition that, in the opinion of the investigator, can jeopardize or would compromise the subject's ability to participate in this trial.
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 |
|---|---|---|
| RotigotineTransdermal Patch 1 per day for 24 hours containing: 1.125mg/day 2.25mg/day 4.5mg/day 6.75mg/day | Drug | 1 |
Primary outcome
Safety and tolerability will be assessed by adverse events, changes in laboratory tests, changes in vital signs, physical and neurological examination, changes in menstrual and sexual function, global subject rating
Time frame: 1 year
1 secondary outcome
To obtain data on changes in severity in RLS symptoms and quality of life over a one year maintenance period.
Time frame: 1 year
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 25 Sep 2014.
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)
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 Rotigotine in people with Restless Legs Syndrome, run by UCB Pharma at 1 site in United States.
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 3 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 25 Sep 2014. 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 United States. 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?
Safety and tolerability will be assessed by adverse events, changes in laboratory tests, changes in vital signs, physical and neurological examination, changes in menstrual and sexual function, global subject rating (time frame: 1 year). 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 25 Sep 2014.