An open label, repeat dose, dose escalation study conducted in RLS patients to characterize pharmacokinetics and food effect of ropinirole controlled release for RLS
- Conditions
- Restless Legs SyndromeMedDRA version: 8.1Level: LLTClassification code 10058920Term: Restless legs syndrome
- Registration Number
- EUCTR2006-002139-26-DE
- Lead Sponsor
- GlaxoSmithKline Research & Development Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 30
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 (<90 mmHg) blood pressure (supine)
at pre-study screening and prior to the first dose of study medication on Day 1.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
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 <10 mcg/L (ng/mL) that has not resolved prior
to the first dose of study medication on Day 1.
Patients 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).
Patients diagnosed with movement disorders (e.g., Parkinson’s disease, dyskinesias,
and dystonias).
Patients who have medical conditions that are clinically significant or have unstable
medical conditions that present a safety concern. These may include, but are not
limited to, the following disorders: diabetes, symptomatic orthostatic hypotension,
severe cardiovascular disease, hepatic or renal failure, pleuropulmonary fibrosis,
history of psychotic illness, compulsive behaviour.
Definite or suspected personal history or family history of adverse reactions or
hypersensitivity to the study drug or to drugs with a similar chemical structure.
Patients having a clinically significant abnormal laboratory value, ECG, or physical
examination finding not resolved prior to the first dose of study medication on Day
1. Abnormal 12-lead ECG findings include, but are not limited to, the following:
myocardial ischemia, clinically significant conduction abnormalities, clinically
significant arrhythmias or QTc > 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: • To determine the effect of food on absorption of ropinirole CR-RLS at 6mg<br>(highest tablet strength)<br>• To demonstrate the dose proportionality for ropinirole CR-RLS over the dose<br>range 1-6mg<br>• To determine the dosage strength equivalence for ropinirole CR-RLS as 1 x 6mg<br>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<br>the dosing interval<br>• Ropinirole Cmax, the maximum plasma concentration
- Secondary Outcome Measures
Name Time Method