A study to compare Rizatriptan 10 mg and Meloxicam 20 mg orally disintegrating tablet ODT with Rizatriptan 10 mg tablet in adults with migraine with or without warning symptoms to see how well they relieve migraine attacks and how safe they are

Authors
Category Primary study
Registry of TrialsClinical Trials Registry - India
Year 2026
INTERVENTION: Intervention1: Rizatriptan 10mg and Meloxicam 20mg Orally Disintegrating Tablet: Subjects will be administered Rizatriptan and Meloxicam is one tablet containing 20 mg meloxicam and 10 mg rizatriptan orally after each episode of migraine attack for 12‐weeks (84 3 days) or until occurrence of migraine attack IV +2 Days) Control Intervention1: Rizatriptan 10mg Tablet: Subjects will be administered Rizatriptan containing 10 mg Rizatriptan tablet orally after each episode of migraine attack for 12‐weeks (84 3 days) or until occurrence of migraine attack IV +2 Days) CONDITION: Health Condition 1: G431‐ Migraine with aura PRIMARY OUTCOME: Proportion of subjects with headache pain freedom at Hour 2 with headache pain freedom defined ; as pain intensity none.Timepoint: Post dose Hour 2 SECONDARY OUTCOME: To assess the safety and tolerability of Rizatriptan 10 mg and Meloxicam 20 mg ODT in comparison to Rizatriptan 10 mg Tablet in patients with acute migraine with or without aura in adults. To evaluate the effect of treatment on migraine‐associated symptoms at 2 hours post‐dose.Timepoint: Hours 0.5, 1, 8, 24, and 48 INCLUSION CRITERIA: 1.Is male or female, 18 to 65 years of age, inclusive. 2.Is willing and able to provide written informed consent to participate in the study, and willing and able to understand and comply with the procedures and study requirements. 3.Has previously received Rizatriptan 10 mg or Rizatriptan 10 mg and Meloxicam 20 mg for the acute treatment of migraine either through participation in a clinical study or under routine medical care, and in the opinion of the investigator, is an appropriate candidate for continued treatment. 4.Patient with frequency of migraine attacks more than 2 in a month for 6 months prior to the start of the study, with at least 12 migraine attacks in total during the 6 months. 5.If female, is either not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile, bilateral tubal ligation, bilateral oophorectomy, or hysterectomy, or is nonlactating and nonpregnant, has negati
Epistemonikos ID: 3431ee5f09f174138c7a266ebcaa6d9610e8d2a3
First added on: Oct 08, 2026