E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Migraine in Pediatric Population (12-17 year olds, inclusive) |
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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 |
The objective of this study are to evaluate the efficacy of 2 dosages of topiramate, 50 and 100 mg/day, compared with placebo in the prevention of migraine attacks in subjects 12 to 17 years of age, as assessed by the percent reduction in the frequency of monthly migraine attacks over the last 12 weeks of the double-blind phase compared with baseline
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E.2.2 | Secondary objectives of the trial |
To evaluate the safety of 2 dosages of topiramate, 50 and 100 mg/day, in subjects 12 to 17 years of age with migraine
To document exposure to topiramate by estimating the trough plasma topiramate concentrations
To explore the effect of 2 dosages of topiramate, 50 and 100 mg/day, on the physical, emotional, social, home, and school functioning of subjects 12 to 17 years of age with migraine.
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
Males and females between 12 and 17 years of age, inclusive, with a history consistent with migraine with or without aura conforming to IHS criteria for pediatric subjects for at least 6 months prior to screening
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E.4 | Principal exclusion criteria |
Previously failed therapy with topiramate for migraine prophylaxis or discontinued due to adverse events
Currently taking topiramate
Has mixed headaches and is unable to distinguish migraines from other headache types (Note: Episodic tension or sinus headaches will not be considered exclusionary unless they contribute to the total number of headache days exceeding 14 per month during the 3 months before Visit 1 or during the prospective baseline period.)
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary efficacy end point (i.e., percent reduction in frequency of monthly [28 day] migraine attack, using the 48-hour rule, from the prospective baseline period to the last 12 weeks of the double-blind phase) will be analyzed using an ANCOVA model and the last-observation-carried-forward (LOCF) method. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | Yes |
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 | Yes |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
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.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
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.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |