E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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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 |
Headache response measured on a one to four point scale (Glaxo scale) two hours after intake of Rizatriptan 10 mg RPD |
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E.2.2 | Secondary objectives of the trial |
Percentage of patients being headache free two hours after intake of study medication. Time of dosing to onset of headache relieve measured by stopwatch. Time of dosing to return to work/ social function (time points 0.5, 1, 1.5, 2, 4, 8, 12, 24 hours after drug intake). Relief of concomitant symptoms. Need of rescue medication. Percentage of patients with sustained pain relief (Improvement of pain from severe or moderate to mild or no headache without recurrence and need of rescue medication for the next 22 hours).
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
Subjects must fulfill the following conditions to qualifiy for enrollment into the trial:
4.1.1 18 to 65 years of age, both genders.
4.1.2 Willingness to comply with the investigators and protocol's instructions.
4.1.3 patient's signature on the informed consent document [each patient should be given ample time to read (or have read to them) the consent form, ask any questions they may have regarding the trial and have a clear understanding of the trial and the procedures involved prior to the signing of the consent form].
4.1.4 have a clinical diagnosis of migraine with or without aura according to IHS criteria at least one year prior to enrollment.
4.1.5 At screening at least two migraine attacks per month and no more than ten during the last three months prior to inclusion.
4.1.6 At screening a stable dose of prophylactic medication (including no prophylactic treatment) for at least two months and no change of prophylactic medication during active trial period.
4.1.7 Safe method of contraception. Oral contraception, double barrier method, IUP is considered safe as well as no active sexual behavior. Reliable means of birth control is defined as:
a) Female sterilization; or b) non-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is post menopausal (>1 year since last menstrual cycle); or c) Male partner(s) who is (are) sterile prior to the female subject´s entry into the study and is (are) the sole sexual partner(s) for that female subject; or d) Implants of levonorgestral within the lifetime of the implant; or e) Injectable progesterone; or f) Oral contraception (combined or progestogen only) started at least 2 months prior entry in the study; or g) Any intrauterine device (IUD) with published data showing that the highest expected failure rate is less than 1% per year; or h) Double barrier contraception (e.g., combination of physical and chemical methods, preferably a spermicide with either a condom or a diaphragm); or i) Any other method of contraception with data documented in the product labeling as approved by regulatory agencies, or in the absence of approved labeling, in peer reviewed studies, showing that the highest expected failure rate for that method is less than 1% per year.
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E.4 | Principal exclusion criteria |
patients with any of the following coonditions may not be enrolled into the trial:
4.2.1 Contraindication to triptans or Rizatriptan according to medical information sheet.
4.2.2. Patient has a history or clinical evidence of ischemic heart disease (e.g., angina pectoris of any type, history of myocardial infarction or documented silent ischemia) or symptoms or findings consistent with ischemic heart disease, coronary artery vasospasm (including Prinzmetal's variant angina), or other significant underlying cardiovascular disease. Patient has uncontrolled hypertension. Patient has either demonstrated hypersensitivity to or experienced a serious adverse event in response to Rizatriptan or any of its inactive ingredients.
4.2.3 History of treatment failure for more than one triptan for the treatment of acute migraine attacks.
4.2.4 Medical relevant diagnosis of internal, neurological or psychiatric disease.
4.2.5 Any other headache, except tension type headache on 5 or less days a month within three months prior to screening.
4.2.6 A history of drug induced headache, medication overuse headache or any other addiction.
4.2.7 Any history of allergic hypersensitivity or poor tolerance to any components of the preparations used in this trial.
4.2.8 Females of childbearing potential not using reliable means of birth control, pregnant or lactating females or expected/ planned pregnancy.
4.2.9. Participation (planned or current) in any investigational drug or device trial within the previous 30 days prior to screening visit.
4.2.10. Inability to understand the trial procedures, and thus inability to give informed consent. unwillinglingness to accept the risk of of participating in the trial 4.2.11 History of allergy to sulfa drugs 4.2.12 Patient is pregnant or a nursing mother
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E.5 End points |
E.5.1 | Primary end point(s) |
evaluate the efficacy of Rizatriptan in the treatment of acute migraine attacks in patients with documented self-reported unsatisfactory response to analgesics and / or one triptan prior to enrollment |
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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 | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
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) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
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) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
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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 | No |
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 | 1 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |