Efficacy and Tolerability of Zolmitriptan Nasal Spray

Overview

The purpose of this study is to evaluate the effectiveness and tolerability (the ability not to experience ill effects from the study drug) of a zolmitriptan nasal spray, 5.0 mg, compared with placebo (inactive drug) for 2 migraine headaches for up to 12 weeks in adult subjects with migraine headaches

Full Title of Study: “A Multicenter, Randomized, Placebo-Controlled, Double-Blind, Parallel Group Trial to Evaluate Early Efficacy and Tolerability of Zolmitriptan (ZOMIG) Nasal Spray in the Acute Treatment of Adult Subjects With Migraine.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Investigator)

Interventions

  • Drug: Zolmitriptan
    • 5mg Nasal Spray
  • Drug: Placebo

Arms, Groups and Cohorts

  • Experimental: 1
  • Placebo Comparator: 2

Clinical Trial Outcome Measures

Primary Measures

  • Improvement in migraine headache pain from severe or moderate to mild or none
    • Time Frame: 15 minutes after the initial dose of trial treatment

Secondary Measures

  • Headache response rate
    • Time Frame: 30 minutes and 1, 2 and 4 hours after dosing

Participating in This Clinical Trial

Inclusion Criteria

  • Subject has an established diagnosis of migraine headache, with or without aura – Subject has a medical history indicating the presence of migraine attacks for at least 1 year before the start of the trial or a minimum of 2 and maximum of 6 migraine attacks per month on average for 3 months preceding the study – Subject has non migraine headaches on fewer than 6 days each month for 3 months preceding the study Exclusion Criteria:

  • Subject has history of basilar, ophthalmoplegic or hemiplegic migraine or serious neurologic condition associated with headache – Subject has used a MAOI within 2 weeks of randomisation or has been given SSRI therapy or migraine prophylactic agent within 3 months of randomisation. Subject requires treatment with propranolol or cimetidine or has had an intolerable or serious adverse event while using another triptan – Subject has a history or symptoms suggestive of ischemic heart disease, coronary artery vasospasm or other significant underlying cardiovascular disease or clinically significant abnormalities seen on an ECG or uncontrolled hypertension

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • AstraZeneca

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