not applicable MedDRA version: 14.1 Level: SOC Classification code 10029205 Term: Nervous system disorders System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Trade Name: RIZATRIPTAN BENZOATE (MAXALT)
Pharmaceutical Form: Oral lyophilisate
INN or Proposed INN: Rizatriptan
Concentration unit: mg milligram(s)
Concentration number: 10-
Pharmaceutical form of t
Sponsors
CASA DI CURA PRIVATA S.RAFFAELE - PISANA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: A patient will be eligible to participate in this study if all of the following criteria apply: a. Patient is =18 years of age at screening. b. Patient has had a history of migraine with or without aura > 1 year with =1 and =8 moderate or severe migraine attacks per month in the 2 months prior to screening that typically last longer than 2 hours13. c. During the migraine attack (if untreated) patient has every time at least 1 of the following symptoms due to the activation of the trigeminal-autonomic reflex (UAs): unilateral conjunctival injection and/or lacrimation and/or nasal congestion/rhinorrhea and/or ptosis and/or eyelid oedema and/or forehead/facial sweating d. A patient who is of reproductive potential agrees to remain abstinent or use (or have their partner use) 2 acceptable methods of birth control within the projected duration of the study (intrauterine device (IUD), diaphragm with spermicide, contraceptive sponge, condoms, vasectomy) e. Patient is: (a) male or (b) female and not of reproductive potential is eligible without requiring the use of contraception. f. Patient is judged to be in satisfactory health in the opinion of the investigator based on screening assessment including medical history, physical examination, and laboratory testing carried out within ~2 months prior to study treatment. g. Patient understands the study procedures and voluntarily agrees to participate by giving written informed consent. h. Patient is able to complete the study questionnaire(s) and paper diary. Are the trial subjects under 18? no Number of subjects for this age range: 0 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) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: A patient will not be eligible to participate in this study if any of the following criteria apply: a. Patient is pregnant or breast-feeding, or expecting to conceive within the projected duration of the study. b. Patient has difficulty distinguishing his/her migraine attacks from tension or interval headaches. c. Patient has a history of predominantly mild migraine attacks or migraines usually resolved spontaneously in less than 2 hours. d. Patient has basilar or hemiplegic migraine headache. e. Patient has more than 15 headache-days per month or has taken medication for acute headache on more than 10 days per month in any of the 3 months prior to screening. f. Patient is taking migraine Propranolol or has discontinued it from less than 14 days g. Patient is taking migraine prophylactic medication where the prescribed daily dose has changed during the 3 months prior to screening. h. Patient was > 50 years old at age of migraine onset. i. Patient has a recent history (within the past 5 years) or current evidence of drug or alcohol abuse or is a “recreational user” of illicit drugs. j. Patient has a concomitant use of propranolol, ergot derivatives, methysergide or MAO inhibitors k. Patient has a demonstrated hypersensitivity to any marketed 5HT1B/1D receptor agonist. l. 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. m. Patient has clinical, laboratory, or ECG evidence of uncontrolled hypertension, uncontrolled diabetes, or significant pulmonary, renal, hepatic, endocrine, or other systemic disease in the opinion of the investigator. n. Patient has, in the opinion of the investigator, other confounding pain syndromes, psychiatric conditions such as uncontrolled major depression based on criteria such as DSM-IV, dementia or significant neurological disorders other than migraine. o. Patient has a history of neoplastic disease = 5 years prior to signing informed consent. p. Patient has a history of gastric or small intestinal surgery (including gastric bypass surgery or banding), or has a disease that causes malabsorption. q. Patient has a history or current evidence of any clinically significant disease that according to the investigator might confound the results of the study, complicate the interpretation of the study results, interfere with the patient’s participation for the full duration of the study, or pose an additional undue risk to the patient.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate of efficacy of rizatriptan 10 mg lyophilized wafer (MLT) compared to placebo in the treatment of acute migraine in patients with unilateral autonimic symptoms (UAs: unilaterl lacrimation, eye redness, eyelid oedema, nasal congestion or rhinorrehoea, miosis or ptosis, forehead or facial sweating) during the attack.;Secondary Objective: a. The rizatriptan treatment group is superior to placebo, as measured by the percentage of patients who have pain freedom at 2 hours postdose. b. The rizatriptan treatment group is superior to placebo, as measured by the percentage of patients who have pain relief at 2 hours postdose. c. The rizatriptan treatment group is superior to placebo, as measured by the percentage of patients free of nausea at 2 hours. a. The rizatriptan treatment group is superior to placebo, as measured by the percentage of patients free of photophobia at 2 hours. b. The rizatriptan treatment group is superior to placebo, as measured by the percentage of patients free of phonophobia at 2 hours. c. The rizatriptan treatment group is superior to placebo, as measured by the percentage of patients who have sustained pain freedom 2–24 hours postdose. d. The rizatriptan treatment group is superior to placebo, as measured by the percentage of patients who have sustained pain relief 2–24 hours postdose.;Primary end point(s): Primary Measure: a. Rating of headache severity at baseline and 2 hours postdose. Headache severity will be measured on the following verbal scale: 0 = no pain; 1 = mild pain; 2 = moderate pain; 3 = severe pain. Timing of all efficacy measurements is relative to the first dose of study medication. Secondary and Exploratory Measures: a. Rating of headache severity at 0.5, 1, 1.5, 2, 3, 4, and 24 hours post dose. b. Presence or absence of associated symptoms (nausea, vomiting, photophobia, or phonophobia) at the same time points as headache severity ratings. c. Rating of functional disability at the | — |
Countries
Italy
Outcome results
None listed