E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Restless Legs Syndrome (RLS) |
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E.1.1.1 | Medical condition in easily understood language |
Restless Legs Syndrome is characterized by unpleasant feelings in the legs and an uncontrolled desire to move the legs. It is a common condition also affecting school children and adolescents. |
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E.1.1.2 | Therapeutic area | Diseases [C] - Nervous System Diseases [C10] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To demonstrate the efficacy of rotigotine against placebo in adolescent subjects with idiopathic Restless Legs Syndrome (RLS) over a 12-week Maintenance Period |
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E.2.2 | Secondary objectives of the trial |
To investigate the safety and tolerability of rotigotine in adolescent subjects with idiopathic RLS |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Subject is male or female, and is >=13 and <18 years of age at Baseline - Subject’s Restless Legs Syndrome (RLS) symptoms cause significant daytime symptoms or significant distress or impairment in social, occupational, educational, or other important areas of functioning by the impact on sleep, energy/vitality, daily activities, behavior, cognition or mood - At Baseline, subject has a score of >=15 on the International Restless Legs Rating Scale (IRLS) (indicating moderate-to-severe RLS) - At Baseline, subject scores >=4 points on the Clinical Global Impressions (CGI) Item 1 assessment (indicating at least moderately ill) - Subjects who are receiving supplemental iron have been on a stable dose for at least 1 month prior to Screening - Female subjects must be surgically incapable of childbearing, or effectively practicing an acceptable method of contraception (oral/parenteral/implantable hormonal contraceptives, intrauterine device, or barrier and spermicide). Abstinence is an acceptable method. Subjects must agree to use adequate contraception during the study and for 4 weeks after their final dose of study medication |
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E.4 | Principal exclusion criteria |
- Subject has a serum ferritin level below the lower limit of normal at Visit 1/Screening - Subject has a hemoglobin level below the lower limit of normal at Visit 1/Screening - Subject has had previous treatment with dopamine agonists or L-dopa within 7 days prior to Visit 2/Baseline - Subject has any medical or psychiatric condition, which in the opinion of the investigator, would jeopardize or compromise the subject’s well-being or ability to participate in this study - Subject is pregnant or nursing - Subject is not willing to abstain from caffeine after 4 pm each evening within 7 days prior to Visit 2/Baseline and for the duration of the study - At Visit 1/Screening, subject has symptomatic orthostatic hypotension with a decrease of blood pressure (BP) from supine to standing position of >=20 mmHg in systolic blood pressure (SBP) or of >=10 mmHg in diastolic - Subject has secondary Restless Legs Syndrome (RLS) (eg, due to renal insufficiency [uremia], iron deficiency, or rheumatoid arthritis) - Subject has a lifetime history of suicide attempts (including actual attempt, interrupted attempt, or aborted attempt), or had suicidal ideation in the past 6 months as indicated by a positive response (“Yes”) to either Question 4 or Question 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS) at Screening (Visit 1) - Subject is taking a prohibited concomitant medication. Prohibited concomitant medication must have been discontinued at least 2 weeks prior to Screening (Visit 1) |
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E.5 End points |
E.5.1 | Primary end point(s) |
1. Change from Baseline to the end of the Maintenance Period in International Restless Legs Rating Scale (IRLS) sum score 2. Change from Baseline in Clinical Global Impressions (CGI) Item 1 to the end of the Maintenance Period 3. Percentage of participants with treatment-emergent adverse events (TEAEs) 4. Percentage of participants with treatment-emergent adverse events (TEAEs) leading to withdrawals |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
1.; 2. From Baseline to the end of the Maintenance Period (Day 78) 3.; 4. From Baseline to Safety Follow-Up (up to Week 20) |
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E.5.2 | Secondary end point(s) |
Change from Baseline in Restless Legs-6 Rating Scales (RLS-6) to the end of the Maintenance Period |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
From Baseline to the end of the Maintenance Period (Day 78) |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 3 |
E.8.3 |
Will this trial be conducted at a single site globally?
| Yes |
E.8.4 | Will this trial be conducted at multiple sites globally? | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.2 | Trial being conducted completely outside of the EEA | Yes |
E.8.6.3 | Specify the countries outside of the EEA in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.2 | In all countries concerned by the trial years | 4 |
E.8.9.2 | In all countries concerned by the trial months | 9 |
E.8.9.2 | In all countries concerned by the trial days | 20 |