Efficacy and Tolerability of Zolmitriptan Nasal Spray - Full Text View

Purpose

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	Intervention	Phase
Migraine	Drug: Zolmitriptan Drug: Placebo	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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.

Resource links provided by NLM:

Genetics Home Reference related topics: familial hemiplegic migraine

MedlinePlus related topics: Headache Migraine

Drug Information available for: Zolmitriptan

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Headache response rate [ Time Frame: 30 minutes and 1, 2 and 4 hours after dosing ] [ Designated as safety issue: No ]

Enrollment:	2114
Study Start Date:	September 2002
Study Completion Date:	June 2003

Arms	Assigned Interventions
Experimental: 1	Drug: Zolmitriptan 5mg Nasal Spray Other Name: Zomig
Placebo Comparator: 2	Drug: Placebo

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
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

Contacts and Locations

No Contacts or Locations Provided

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00617747 History of Changes
Other Study ID Numbers:	311CUS/0022, D1221L00001
Study First Received:	February 6, 2008
Last Updated:	April 3, 2009
Health Authority:	United States: Food and Drug Administration

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
Pharmacologic Actions
Physiological Effects of Drugs
Anti-Infective Agents
Therapeutic Uses
Protein Synthesis Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on May 22, 2013