Restless Legs SyndromePhase 1NCT00140712
Ropinirole Tablets In Young Patients With Restless Legs Syndrome
A Phase 1 study testing Ropinirole Immediate Release in people with Restless Legs Syndrome, run by GlaxoSmithKline at 9 sites in 3 countries.
Trial summary
This is a two-period dose rising study of Ropinirole Immediate Release in adolescent patients with restless legs syndrome (RLS) in order to determine the starting dose for the ropinirole titration regimen for this age group. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Restless Legs Syndrome
- What is being tested?
- Ropinirole Immediate Release
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 9 sitesin 3 countries
- Study dates
- 10 Jun 2005to 28 Feb 2008
- Phase
- Phase 1
- 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 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Adolescent subjects diagnosed with probable or definite Restless Leg Syndrome (RLS).
Who cannot join
- Subjects who require RLS treatment during the daytime, suffer from other primary sleep disorders or are taking medication known to induce drowsiness, affect RLS or sleep, or to induce or treat alertness, including methylphenidate.
Trial locations and contacts
9 sites in 3 countries.
9 sites in 3 countries
United States7 sites
GSK Investigational Site
Chapel Hill, North Carolina, 27599
GSK Investigational Site
Chicago, Illinois, 60611
GSK Investigational Site
Edison, New Jersey, 08818
GSK Investigational Site
Kansas City, Missouri, 64108
GSK Investigational Site
Louisville, Kentucky, 40202
GSK Investigational Site
Macon, Georgia, 31201
GSK Investigational Site
Washington D.C., District of Columbia, 20010
About this study
Official title: A Study to Determine the Tolerability and Pharmacokinetics for Ropinirole in Paediatric / Adolescent Patients With RLS (Type 2)
This is a two-period dose rising study of Ropinirole Immediate Release in adolescent patients with restless legs syndrome (RLS) in order to determine the starting dose for the ropinirole titration regimen for this age group. Patients will receive two single doses unless poor tolerability is observed following the first dose.
- Conditions
- Restless Legs Syndrome
- Being tested
- Ropinirole Immediate Release
- Keywords
- RLS, PLMS, Adolescent, Periodic Limb Movements of Sleep, 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.
Ropinirole Immediate ReleaseDrug
Ropinirole Immediate Release
| Study group | Role | What they receive |
|---|---|---|
| Ropinirole | Experimental | single dose .25mg of IR formulation, .05mg of RLS controlled release Receives: Drug: Ropinirole Immediate Release |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC(0-8), Cmax. Safety (adverse events, vital signs, ECG, laboratory parameters), Change in BP, Incidence of adverse events. Number of periodic limb movements and Number of periodic limb movements per hour (as measured by actigraphy).
Measured: Up to 3 years
Secondary outcomes (1)
PK - tmax, t1/2, For SKF-89124 and SKF-104557 - ratio of metabolite AUC:ropinirole AUC. PD - Leg movement as measured by actigraphy.
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2005 (estimated)
- Study start10 Jun 2005
- Primary completion28 Feb 2008
- Study completion28 Feb 2008
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.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00140712
- Sponsor's protocol ID
- 101468/253
- Status last verified
- Sep 2017
- First submitted
- 31 Aug 2005
- Last updated
- 11 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Determine the Tolerability and Pharmacokinetics for Ropinirole in Paediatric / Adolescent Patients With RLS (Type 2)
- ClinicalTrials.gov ID
- NCT00140712
- Acronym / sponsor ID
- 101468/253
- Conditions
- Restless Legs Syndrome
- Keywords
- RLS, PLMS, Adolescent, Periodic Limb Movements of Sleep, Ropinirole
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 10 Jun 2005 (actual)
- Primary completion
- 28 Feb 2008 (actual)
- Study completion
- 28 Feb 2008 (actual)
- First posted
- 1 Sep 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 two-period dose rising study of Ropinirole Immediate Release in adolescent patients with restless legs syndrome (RLS) in order to determine the starting dose for the ropinirole titration regimen for this age group. Patients will receive two single doses unless poor tolerability is observed following the first dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ropinirole | Experimental | Drug: Ropinirole Immediate Releasesingle dose .25mg of IR formulation, .05mg of RLS controlled release |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Adolescent subjects diagnosed with probable or definite Restless Leg Syndrome (RLS).
Key exclusion criteria (1 listed)
- Subjects who require RLS treatment during the daytime, suffer from other primary sleep disorders or are taking medication known to induce drowsiness, affect RLS or sleep, or to induce or treat alertness, including methylphenidate.
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 |
|---|---|---|
| Ropinirole Immediate ReleaseRopinirole Immediate Release | Drug | Ropinirole |
Primary outcome
AUC(0-8), Cmax. Safety (adverse events, vital signs, ECG, laboratory parameters), Change in BP, Incidence of adverse events. Number of periodic limb movements and Number of periodic limb movements per hour (as measured by actigraphy).
Time frame: Up to 3 years
1 secondary outcome
PK - tmax, t1/2, For SKF-89124 and SKF-104557 - ratio of metabolite AUC:ropinirole AUC. PD - Leg movement as measured by actigraphy.
Time frame: Up to 3 years
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 11 Sep 2017.
- Results for study 101468/253 can be found on the GSK Clinical Study Register.Link provided by the sponsor.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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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.
GSK Clinical Trials study director
GlaxoSmithKline
9 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ropinirole Immediate Release in people with Restless Legs Syndrome, run by GlaxoSmithKline at 9 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 1 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 11 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States, Belgium, France. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
AUC(0-8), Cmax. Safety (adverse events, vital signs, ECG, laboratory parameters), Change in BP, Incidence of adverse events. Number of periodic limb movements and Number of periodic limb movements per hour (as measured by actigraphy). (time frame: Up to 3 years). 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 11 Sep 2017.