Restless Legs Syndrome (RLS)
Conditions
Interventions
Product Name: Ropinirole Tablets
Pharmaceutical Form: Tablet
INN or Proposed INN: Ropinirole
CAS Number: 91374-20-8
Current Sponsor code: SKF101468-A
Other descriptive name: Ropinirole hydrochloride
C
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 at the time of entry into the double-blind phase: 1. Male and female 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 suffering from augmentation and/ or ‘end of treatment’ rebound RLS symptoms at baseline (Day 0). 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 treatment’ rebound describes worsening of symptoms from baseline that occur after pharmacological treatment is stopped. 2. Subjects with a previous history of augmentation. 3. Subjects who have exhibited intolerance to ropinirole or any other dopamine agonist. 4. Subjects requiring treatment of daytime RLS symptoms (daytime defined as 10:00 hours until 17:00 hours). 5. Signs of secondary RLS (e.g., end stage renal disease, iron deficient anaemia or pregnancy at Baseline Visit). 6. Subjects with a serum ferritin level of < 10 mcg/L (ng/mL) at Screening Visit. 7. 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). 8. Subjects diagnosed with movement disorders (e.g., Parkinson’s Disease, dyskinesias, and dystonias). 9. Subjects who have medical conditions which could affect efficacy assessments or clinically significant or unstable medical conditions that present a safety concern. These may include, but are not limited to, the following disorders: diabetes, peripheral neuropathy, rheumatoid arthritis, fibromyalgia syndrome, symptomatic orthostatic hypotension, severe cardiovascular disease, hepatic or renal failure, pleuro-pulmonary fibrosis, major psychotic illness. 10. Subjects having a clinically significant abnormal laboratory value, ECG, or physical examination findings not resolved by the time of the baseline examinations (Day 0). Abnormal 12-lead ECG findings include, but are not limited to, the following: myocardial ischemia, clinically significant conduction abnormalities, or clinically significant arrhythmias. 11. Subjects with a diastolic blood pressure = 110mmHg or = 50mmHg or systolic blood pressure = 180mmHg or = 90mmHg at the Screening or Baseline Visit. 12. Subjects with a history of alcohol or substance abuse within the past year. 13. Subjects taking any medication known to induce drowsiness, affect RLS or sleep and which have not been discontinued prior to the Baseline Visit. These medications include the following: Atypical and typical antipsychotics, anticonvulsants, opioids (including propoxyphene and oxycodone), anxiolytics, all sedatives/hypnotics (including benzodiazepines), lithium, oral neuroloeptics, stimulants (including methylphenidate), dopamine agonists (including ropinirole), dopamine antagonists (e.g., typical neuroleptics, metoclopromide), levodopa/carbidopa, clonidine, and sedating antihistamines (e.g., chlorpheniramine, diphenhydramine, hydroxyzine) or any preparations containing these antihistamines. The minimum discontinuation period is generally 5 half lives or 7 consecutive evenings/nights medication free, prior to baseline, whichever is the longer period. Exceptions to this general rule are: fluoxetine, monoamine oxidase inhibitors: 4 weeks. For subjects entering the
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To evaluate the short term (12 weeks) efficacy of ropinirole in the treatment of adult subjects with moderate to severe RLS. • To evaluate the long term (26 weeks) efficacy of ropinirole in the treatment of adult subjects with moderate to severe RLS. • To assess the frequency of ‘clinically meaningful’ augmentation and ‘early morning rebound’ in adult subjects with moderate to severe RLS, as assessed and confirmed by the Adjudication Board. ;Secondary Objective: • To assess the frequency of augmentation in adult subjects with moderate to severe RLS, as assessed by the Adjudication Board. • To evaluate the safety and tolerability of ropinirole and subject reported outcomes in adult subjects with moderate to severe RLS. ;Primary end point(s): Primary Efficacy Variable: • Change from baseline in the International RLS (IRLS) Rating Scale total score at Week 12 Secondary Efficacy Variable in the Primary Inferential Set: • Change from baseline in the IRLS Rating Scale total score at Week 26. Primary Safety Variables: • Incidence of ‘clinically meaningful’ augmentation cases (overall, double-blind phase and open-label phase). • Incidence of early morning rebound (overall, double-blind phase and open-label phase). | — |
Countries
Czech Republic, Germany, Hungary, Italy, Portugal, Spain, Sweden
Outcome results
None listed