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.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00617747

Enrollment

2114

Registered

2008-02-18

Start date

2002-09-30

Completion date

2003-06-30

Last updated

2009-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Migraine

Keywords

Zolmitriptan, ZOMIG, migraine, headache response, headache, headache pain

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

Interventions

DRUGZolmitriptan

5mg Nasal Spray

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame
Improvement in migraine headache pain from severe or moderate to mild or none	15 minutes after the initial dose of trial treatment

Secondary

Measure	Time frame
Headache response rate	30 minutes and 1, 2 and 4 hours after dosing

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026