A Multicenter, Randomized, Double-Blind, Placebo-Controlled,

Authors
Category Primary study
Registry of TrialsEU Clinical Trials Register
Year 2008
INTERVENTION: 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 Concentration number: 10 ‐ Pharmaceutical form of the placebo: Orodispersible tablet Route of administration of the placebo: Oral use CONDITION: Treatment of Acute Migraine when pain severity is mild. ; MedDRA version: 9.1 Level: LLT Classification code 10066635 Term: Acute migraine PRIMARY OUTCOME: 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 Primary end point(s): 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. 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
Epistemonikos ID: 8737796fcf43fcd02bd6b0876821319ca256f8e8
First added on: Aug 21, 2024