Restless Legs Syndrome (RLS)
Conditions
Interventions
Product Name: Ropinirole XR Tablets
Pharmaceutical Form: Tablet
INN or Proposed INN: Ropinirole
CAS Number: 91374-20-8
Current Sponsor code: SKF101468-A
Other descriptive name: Ropinirole hydrochlorid
Sponsors
GlaxoSmithKline Research & Development Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: A subject will be eligible for inclusion in this study only if all of the following criteria apply: 1. Subjects with a diagnosis of RLS using the RLS Diagnostic Clinical Interview and the IRLSSG Diagnostic Criteria at the Screening Visit. 2. Subjects =18 years and =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: A subject will not be eligible for inclusion in this study if any of the following criteria applies: 1. Subjects requiring treatment of daytime RLS symptoms (daytime defined as 07:00 hours until 17:00 hours). 2. Subjects with signs of secondary RLS (e.g., end stage renal disease, iron deficient anemia or pregnancy at the Baseline Visit). 3. Subjects with a serum ferritin level of <10 mcg/L (ng/mL) that has not resolved by the time of the Baseline Visit. 4. Subjects who suffer from a primary sleep disorder other than RLS that may significantly affect the symptoms of RLS (e.g., narcolepsy, sleep terror disorder, sleepwalking disorder, breathing-related sleep disorder). 5. Subjects diagnosed with movement disorders (e.g., Parkinson’s Disease, dyskinesias, and dystonias). 6. Subjects who have medical conditions which could affect efficacy assessments or clinically significant or unstable medical conditions that present a safety concern. See Protocol for full details. 7. Subjects with augmentation and/or end-of-dose rebound symptoms with recent treatment. Augmentation is defined as RLS symptoms that occurred while on treatment and occur earlier in the afternoon/evening than they did before, symptoms which are more severe than when not treated, symptoms which start after less time at rest than they did before treatment, or symptoms which involve other parts of the body, such as the arms or trunk. End-of-dose rebound is defined as a re-emergence/recurrence of RLS symptoms while on treatment in the early morning the day after taking the dose of RLS medication. 8. Subjects with a history of alcohol or substance abuse within the past year. 9. Subjects with a diastolic blood pressure =110mmHg or =50mmHg or a systolic blood pressure =180mmHg or =90mmHg at the Screening or Baseline Visit. Orthostatic blood pressure: Subjects with a decrease in the diastolic blood pressure that is =10mmHg or the systolic blood pressure that is =20mgHg. 10. Subjects taking any medication known to induce drowsiness, affect RLS or sleep and which have not been discontinued prior to the Baseline Visit. The minimum discontinuation period is generally 5 half lives or 7 consecutive evening/nights medication free, prior to the Baseline Visit, whichever is the longer period. Exceptions to this general rule are as follows: fluoxetine and monoamine oxidase inhibitors: 4 weeks; depot neuroleptics: 12 weeks. SSRI, norepinephrine-serotonin uptake inhibitors and norepinephrine reuptake inhibitors antidepressants may be allowed during the study provided that certain criteria are met. 11. Withdrawal, introduction, or change in dose of hormone replacement therapy (HRT) and/or any drug known to substantially inhibit CYP1A2 (e.g., ciprofloxacin, cimetidine, fluvoxamine, HRT) or induce CYP1A2 (e.g., tobacco, omeprazole) within 7 days prior to the Baseline Visit. Subjects already on these agents may be enrolled, but must remain on stable doses of the agents from 7 days prior to the Baseline Visit through to the follow-up visit at the end of the study. 12. Subjects who have exhibited intolerance to ropinirole or any other dopamine agonist, or to dopamine antagonists, levodopa/carbidopa. 13. Subjects taking domperidone or any other dopamine antagonist which has not been discontinued prior to the Baseline Visit. Subjects currently taking stable doses (at least one month prior to screening) of medications to treat nausea or other gastrointestinal conditions, including proton pum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the superior tolerability of ropinirole XR compared to ropinirole IR in adult subjects with RLS requiring evening and night-time coverage of RLS symptoms.;Secondary Objective: To compare the safety profile of ropinirole XR with ropinirole IR in subjects with RLS. To evaluate clinical benefits of ropinirole XR compared to ropinirole IR as assessed by efficacy endpoints and patient-reported outcomes in subjects with RLS. ;Primary end point(s): Incidence of nausea adverse event during the first 3 weeks fixed dose titration of ropinirole XR and ropinirole IR. | — |
Countries
Denmark, Germany, Italy, Spain, Sweden, United Kingdom
Outcome results
None listed