search
Back to results

Efficacy and Tolerability of Zolmitriptan Nasal Spray

Primary Purpose

Migraine

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Zolmitriptan
Placebo
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine focused on measuring Zolmitriptan, ZOMIG, migraine, headache response, headache, headache pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    1

    2

    Arm Description

    Outcomes

    Primary Outcome Measures

    Improvement in migraine headache pain from severe or moderate to mild or none

    Secondary Outcome Measures

    Headache response rate

    Full Information

    First Posted
    February 6, 2008
    Last Updated
    April 3, 2009
    Sponsor
    AstraZeneca
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT00617747
    Brief Title
    Efficacy and Tolerability of Zolmitriptan Nasal Spray
    Official Title
    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
    Interventional

    2. Study Status

    Record Verification Date
    April 2009
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2002 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    June 2003 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    AstraZeneca

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Migraine
    Keywords
    Zolmitriptan, ZOMIG, migraine, headache response, headache, headache pain

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    2114 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Arm Title
    2
    Arm Type
    Placebo Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    Zolmitriptan
    Other Intervention Name(s)
    Zomig
    Intervention Description
    5mg Nasal Spray
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Primary Outcome Measure Information:
    Title
    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 Outcome Measure Information:
    Title
    Headache response rate
    Time Frame
    30 minutes and 1, 2 and 4 hours after dosing

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Learn more about this trial

    Efficacy and Tolerability of Zolmitriptan Nasal Spray

    We'll reach out to this number within 24 hrs