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Efficacy and Tolerability of Zolmitriptan Nasal Spray

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ClinicalTrials.gov Identifier: NCT00617747
Recruitment Status : Completed
First Posted : February 18, 2008
Last Update Posted : April 6, 2009
Sponsor:
Information provided by:
AstraZeneca

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

Condition or disease Intervention/treatment Phase
Migraine Drug: Zolmitriptan Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2114 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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 Start Date : September 2002
Actual Study Completion Date : June 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache Migraine
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1 Drug: Zolmitriptan
5mg Nasal Spray
Other Name: Zomig
Placebo Comparator: 2 Drug: Placebo



Primary Outcome Measures :
  1. 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 Measures :
  1. Headache response rate [ Time Frame: 30 minutes and 1, 2 and 4 hours after dosing ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

ClinicalTrials.gov Identifier: NCT00617747     History of Changes
Other Study ID Numbers: 311CUS/0022
D1221L00001
First Posted: February 18, 2008    Key Record Dates
Last Update Posted: April 6, 2009
Last Verified: April 2009

Keywords provided by AstraZeneca:
Zolmitriptan
ZOMIG
migraine
headache response
headache
headache pain

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Zolmitriptan
Oxazolidinones
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors