Restless Legs Syndrome MedDRA version: 8.1 Level: LLT Classification code 10058920 Term: Restless legs syndrome
Conditions
Interventions
Product Name: Ropinirole CR-RLS
Product Code: Ropinirole CR-RLS
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Ropinirole
CAS Number: 91374-20-8
Current Sponsor code: SKF101468-A
Other d
Sponsors
GlaxoSmithKline Research & Development Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with a diagnosis of RLS using the RLS Diagnostic Clinical Interview and the International Restless Legs Syndrome Study Group (IRLSSG) Diagnostic Criteria at pre-study screening. Patients between 18 and 65 years of age inclusive. Body mass index of 18 to 32 kg/m2, with a body weight of at least 50 kg. Patients must have given written informed consent prior to admission to the study. Normal systolic (100-140mmHg) and diastolic (=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients who smoke = 20 cigarettes per day or patients who smoke less than 20 cigarettes per day but will not maintain a constant smoking habit for the duration of the study Patients with a history of postural hypotension or faints. Patients with signs of secondary RLS (e.g., end stage renal disease, iron deficiency anaemia or pregnancy at pre-study screening). Patients with a serum ferritin level of 450 msec. Patients with an orthostatic blood pressure drop of =10mmHg in the diastolic blood pressure or =20mmHg in the systolic blood pressure at pre-study screening. 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 prior to the first dose of study medication on Day 1. Patients already on these agents may be enrolled, but must remain on stable doses of the agents from 7 days prior to the first dose of study medication on Day 1 through to the follow-up visit at the end of the study. Patients who have exhibited intolerance to ropinirole or any other dopamine agonist, levodopa/carbidopa or to dopamine antagonists. Participation in any clinical drug or device trial within 90 days prior to the first dose of study medication on Day 1. Blood donation or blood loss of >200mL less than 90 days before the present study. Patients who, in the opinion of the investigator, would be non-compliant with the visit schedules or other study procedures. Women who have a positive pregnancy test or who are breast-feeding. Women of child-bearing potential who are not practising a clinically accepted method of contraception such as oral contraception, surgical sterilization, Intrauterine device (IUD), diaphragm in conjunction with spermicidal foam, condom on the male partner in conjunction with spermicidal foam or systemic contraception (e.g., Norplant). Male patients with female partners must also practice a clinically accepted method of contraception. Positive pre-study screening result for hepatitis B surface antigen, hepatitis C antibody or HIV-1/2 antibodies.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To determine the effect of food on absorption of ropinirole CR-RLS at 6mg (highest tablet strength) • To demonstrate the dose proportionality for ropinirole CR-RLS over the dose range 1-6mg • To determine the dosage strength equivalence for ropinirole CR-RLS as 1 x 6mg tablet compared with 2 x 3mg tablets;Secondary Objective: • To assess safety and tolerability of ropinirole CR-RLS;Primary end point(s): • Ropinirole AUC (0-t), the area under the plasma concentration-time curve over the dosing interval • Ropinirole Cmax, the maximum plasma concentration | — |
Countries
Germany
Outcome results
None listed