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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

February 6, 2008
April 3, 2009
September 2002
Not Provided
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 ]
Same as current
Complete list of historical versions of study NCT00617747 on ClinicalTrials.gov Archive Site
Headache response rate [ Time Frame: 30 minutes and 1, 2 and 4 hours after dosing ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Efficacy and Tolerability of Zolmitriptan Nasal Spray
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.

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

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Migraine
  • Drug: Zolmitriptan
    5mg Nasal Spray
    Other Name: Zomig
  • Drug: Placebo
  • Experimental: 1
    Intervention: Drug: Zolmitriptan
  • Placebo Comparator: 2
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2114
June 2003
Not Provided

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00617747
311CUS/0022, D1221L00001
No
Not Provided
AstraZeneca
Not Provided
Not Provided
AstraZeneca
April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP