Restless Legs Syndrom
Conditions
Interventions
Trade Name: Neupro 2mg/24h transdermal patch
Pharmaceutical Form: Transdermal patch
INN or Proposed INN: ROTIGOTINE
CAS Number: 99755-59-6
Concentration unit: mg/g milligram(s)/gram
Concentration type
Sponsors
Instituto de Investigaciones del Sueño
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Idiopathic restless legs syndrome (RLS), according to diagnostic criteria established by the International RLS Study Group (Allen et al.,2003). 2. If a previous PSG was performed, a PLMI>10. 3. A history (if currently controlled on medication) or the presence of RLS symptoms on 4 or more days per week for at least 6 months. 4. An IRLS score ?20 at baseline assessment (before dopaminergic treatment had been initiated). If not done at baseline, a retrospective evaluation upon the time before dopaminergic treatment was started shows a baseline value >20. 5. Having undergone treatment with pramipexole with 2 diary doses (p.ex 0.25 mg at 3PM; 0.25 mg at 11PM)for the last four previous weeks to study initiation. 6.An insufficient response to current dopaminergic treatment, defined by an IRLS score >15, 7. Not meeting during the clinical interview MPI diagnostic criteria for augmentation. 8. Aged 18 - 80 years. 9. Women of childbearing potential must have a negative pregnancy test at screen and must agree not to become pregnant. 10. Prior to any study-specific procedures, a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the trial. 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 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 14
Exclusion criteria
Exclusion criteria: 1. Any secondary forms of RLS. 2. History or current diagnosis of other clinically relevant diseases that may confound assessments or RLS symptoms. 3. Serum ferritin 5 half-lives. 5. Employed in shift work (for example, employment hours disruptive to the normal circadian sleep-wake cycle such as nighttime or variable rotating shifts) or irregular sleep-wake schedules. 6. Patients who require prescription medication for concurrent conditions which could interfere with efficacy assessments. 7- Medical disorder which could cause pain 8- Significant medical or psychiatric disorder. 9- Patients under treatment for concomitant diseases that may interfer with efficacy parameters. 10_ Any acute or chronic disease that may interfer with efficacy parameters. 11-Surgery within 180 days of baseline visit, which in the opinion of the investigator would negatively impact the patient's participation in the study. 12- Any other clinically significant condition or laboratory assay abnormality, which would interfere with the patient's ability to participate in the study. 13- Breastfeeding 14- Any known hypersensibility or intolerance to the study drug or similars. 15- Any significant renal disease that may interfer in completing the study or seric creatinine >1,5 the maximum of the normal range for the laboratory. 16- Severe alcoholism or drug addiction in the last 12 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate by m-SIT whether insufficient response to treatment with shorter-acting dopamine agonists is related to the presence of residual symptoms during the day in non-augmented RLS patients.;Secondary Objective: To investigate by m-SIT whether treatment of RLS with rotigotine also improves SPI symptoms in patients with an insufficient response to shorter-acting dopamine agonists.;Primary end point(s): The principal end point is based on m-SIT difference between mean value SIT-DI (M-SIT disturbance index) In visits 3 and 4 and mean value in visits1 and 2 will be assessed.;Timepoint(s) of evaluation of this end point: Week 4 after Rotigotine treatment, after treatment switch. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable | — |
Countries
Spain
Contacts
Public ContactDr. Diego García-Borreguero
Instituto de Investigaciones del Sueño
Outcome results
None listed