Treatment of Acute Migraine when pain severity is mild. MedDRA version: 9.1 Level: LLT Classification code 10066635 Term: Acute migraine
Conditions
Interventions
Trade Name: Maxalt lingua 10 mg
Pharmaceutical Form: Orodispersible tablet
INN or Proposed INN: rizatriptan
Current Sponsor code: MK-0462
Concentration unit: mg milligram(s)
Concentration type: equal
Sponsors
Merck & Co., Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female at least 18 years of age 2. At least a 1 year history of migraine with or without aura 3. A natural history that is typically mild at onset and progresses to moderate or severe 4. Typically, when the patient knows they are having a migraine, their headache pain is mild 5. Migraine frequency that is typically 1 to 4 attacks per month in the 2 months prior to Visit 1 6. Female patients of reproductive potential must agree to use acceptable method of birth control. 7. Understands study procedures, alternative treatments available and risks involved and voluntarily agrees to participate in the study. 8. Able to read, understand and complete questionnaires and diaries. 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. History of chronic-type tension headache 2. Difficulty in distinguishing migraine attacks from episodic tension type headaches 3. 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 Visit 1. 4. History of basilar or hemiplegic migraine 5. Use of monoamine oxidase inhibitors or propranolol within 1 months of Visit 1 6. Daily or near daily use of analgesics (> 3 days out of 7 days) 7. Prescribed daily dose of migraine prophylactic medication or SSRI/SNRI has changed within the 3 months prior to Visit 1 8. History or clinical evidence of stroke or transient ischemic attack, ischemic heart disease (angina pectoris, myocardial infarction or documented silent ischemia) or coronary artery vasospasm or peripheral vascular disease. 9. Uncontrolled hypertension, severe hepatic or renal insufficiency or any other history or concurrent condition, therapy, lab abnormality that might confound results or interfere with patient's participation in the study, such that it is not in the best interest of the patient to participate. 10. Hypersensitivity to rizatriptan or any of its inactive ingredients 11. Participation in a study with an investigational drug or device within 30 days of Visit 1.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of rizatriptan ODT/oral lyophilisate compared to placebo in the early treatment (while headache is mild) of acute migraine, as measured by pain freedom at 2 hours post-dose;Secondary Objective: (1) To evaluate the efficacy of rizatriptan ODT/oral lyophilisate compared to placebo in the early treatment (while headache is mild) of acute migraine, as measured: (a) by associated symptoms (phonophobia, photophobia, nausea & vomiting), functional disability and rescue medication use; (b) pain freedom at 30, 60 and 90 minutes post-dose; (c) 24-hours sustained pain freedom. (2) To assess the level of patient satisfaction with study medication; and, (3) to evaluate the tolerability of rizatriptan ODT/oral lyophilisate.;Primary end point(s): Pain freedom at 2 hours post-dose | — |
Countries
Germany
Outcome results
None listed