Efficacy and Tolerability of Zolmitriptan Nasal Spray

This study has been completed.

Sponsor:

Information provided by:

AstraZeneca

ClinicalTrials.gov Identifier:

NCT00617747

First received: February 6, 2008

Last updated: April 3, 2009

Last verified: April 2009

History of Changes

Tracking Information
First Received Date ^ICMJE	February 6, 2008
Last Updated Date	April 3, 2009
Start Date ^ICMJE	September 2002
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE (submitted: February 6, 2008)	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 ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00617747 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: February 6, 2008)	Headache response rate [ Time Frame: 30 minutes and 1, 2 and 4 hours after dosing ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Efficacy and Tolerability of Zolmitriptan Nasal Spray
Official Title ^ICMJE	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.
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
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
Condition ^ICMJE	Migraine
Intervention ^ICMJE	Drug: Zolmitriptan 5mg Nasal Spray Other Name: Zomig Drug: Placebo
Study Arm (s)	Experimental: 1 Intervention: Drug: Zolmitriptan Placebo Comparator: 2 Intervention: Drug: Placebo
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	2114
Completion Date	June 2003
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	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	Both
Ages	18 Years to 65 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT00617747
Other Study ID Numbers ^ICMJE	311CUS/0022, D1221L00001
Has Data Monitoring Committee	No
Responsible Party	Not Provided
Study Sponsor ^ICMJE	AstraZeneca
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	AstraZeneca
Verification Date	April 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top