CompletedNCT01211145TEENZUpdated May 18, 2016Results posted

Zomig - Treatment of Acute Migraine Headache in Adolescents

A Phase 4 interventional study of Placebo and Zolmitriptan in Migraine Headache, sponsored by AstraZeneca. Completed at 74 sites in 8 countries. Open to participants aged 12 Years to 17 Years. Per ClinicalTrials.gov, last updated 2016-05-18.

Sponsored by AstraZeneca · Phase 4, Interventional, and Treatment

Phase: Phase 4
Study type: Interventional
Enrollment: 1,653
Allocation: Randomized
Ages: 12 Years to 17 Years
Sex: All

Study summary

The purpose of this study is to investigate if Zomig® Nasal Spray will help children (age 12-17 years) with migraine headaches feel better. This will be done by comparing 3 different doses of Zomig Nasal Spray with placebo nasal spray (inactive treatment).

Conditions studied

Migraine Headache

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Keywords

Migraine
Headache
Pain
Efficacy
Adolescents

In context

Migraine Disorders

1,528 studies on the registry are indexed under Migraine Disorders; 299 are open to participants now.

This study's enrollment of 1,653 is above the median of 80 across 1,175 interventional studies indexed under Migraine Disorders.

Browse Migraine Disorders studies →

Lead sponsor

AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.

Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 12 Years to 17 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Provision of written informed consent by parent or legal guardian, and written assent provided by patient prior to any study specific procedures.
Established diagnosis of migraine.
History of a minimum of 2 migraine attacks (moderately or severely disabling)per month.

Exclusion criteria

Exclusion Criteria:

Any medical condition that may put the patient at increased risk with exposure to zolmitriptan or that may interfere with the safety or efficacy assessments.
A history of basilar, ophthalmoplegic, or hemiplegic migraine headache or any potentially serious neurological condition that is associated with headache.
Have had an unacceptable adverse experience following previous use of any 5HT1B/1D agonist drug.

Study design

Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 1,653 participants (actual)

Study arms

Placebo comparator
1
Placebo
Drug: Placebo
Experimental
2
ZOMIG 0.5 mg
Drug: Zolmitriptan
Experimental
3
ZOMIG 2.5 mg
Drug: Zolmitriptan
Experimental
4
ZOMIG 5.0 mg
Drug: Zolmitriptan

Interventions

DrugPlacebo
Placebo nasal spray
DrugZolmitriptan
0.5 mg nasal spray
Also known as: Zomig® Nasal Spray
DrugZolmitriptan
2.5 mg nasal spray
Also known as: Zomig® Nasal Spray
DrugZolmitriptan
5.0 mg nasal spray
Also known as: Zomig® Nasal Spray

What researchers measure

Primary outcomes

Pain-free Status at 2 Hours Post-treatment
Time frame: 2 hours post-treatment.

Secondary outcomes

Pain-free Status at 24 Hours Post-treatment
Time frame: 24 hours post-treatment
Headache Response at 2 Hours Post-treatment
Headache response is a binary response variable derived from the headache intensities recorded in the patient diary. Headache response is defined as a reduction in headache pain intensity from severe or moderate to mild or none with no use of rescue medication prior to the assessment.
Time frame: 2 hours post-treatment
Headache Response at 24 Hours Post-treatment
Headache response is a binary response variable derived from the headache intensities recorded in the patient diary. Headache response is defined as a reduction in headache pain intensity from severe or moderate to mild or none with no use of rescue medication prior to the assessment.
Time frame: 24 hours post-treatment
Sustained Headache Response at 2 Hours
Sustained headache response at 2 hours is a binary response variable derived from the headache intensities recorded in the patient diary. Sustained headache response is defined as a reduction in migraine headache pain intensity from severe or moderate to mild or none a 1 hr. which is then maintained (without a return to moderate or severe pain) at 2 hrs. with no use of rescue medication prior to the 2 hr. assessment.
Time frame: Up to 2 hours post-treatment
Use of Rescue Medication During the First 24 Hours After Treatment
Time frame: 24 hours post-treatment.

Results

Posted Oct 24, 2014

Participant flow

This multicenter study was conducted between 7 October 2010 and 31 October 2013.

Participant flow — Overall Study
Milestone	Placebo	ZOMIG 0.5 mg	ZOMIG 2.5 mg	ZOMIG 5 mg
Started	296	115	99	288
Completed	270	98	86	268
Not completed	26	17	13	20
Withdrew: Reason not specified	3	2	2	1
Withdrew: Lost to follow-up	3	2	1	2
Withdrew: Study-specific withdrawal criteria	1	0	0	0
Withdrew: Severe noncompliance to protocol	1	0	0	0
Withdrew: Eligibility criteria not fulfilled	16	12	10	15
Withdrew: Patient decision	2	1	0	2

Outcome measures

PrimaryPain-free Status at 2 Hours Post-treatment

Time frame:: 2 hours post-treatment.
Reported as:: Number · Participants

Pain-free Status at 2 Hours Post-treatment
Participants	Placebo	ZOMIG 0.5 mg	ZOMIG 2.5 mg	ZOMIG 5 mg
Yes	42	20	20	68
No	211	71	61	161

Statistical analysis

Placebo vs ZOMIG 0.5 mg · Regression, Logistic · p = .312 (Unadjusted) · Odds ratio (or): 1.37 · 95% CI 0.75 to 2.50ZOMIG 0.5 mg/Placebo
Placebo vs ZOMIG 2.5 mg · Regression, Logistic · p = .071 (Unadjusted) · Odds ratio (or): 1.76 · 95% CI 0.95 to 3.26ZOMIG 2.5 mg/Placebo
Placebo vs ZOMIG 5 mg · Regression, Logistic · p = <.001 (Unadjusted) · Odds ratio (or): 2.18 · 95% CI 1.40 to 3.39ZOMIG 5.0 mg/Placebo

SecondaryPain-free Status at 24 Hours Post-treatment

Time frame:: 24 hours post-treatment
Reported as:: Number · Participants

Pain-free Status at 24 Hours Post-treatment
Participants	Placebo	ZOMIG 0.5 mg	ZOMIG 2.5 mg	ZOMIG 5 mg
Yes	155	59	60	155
No	96	32	20	72

Statistical analysis

Placebo vs ZOMIG 0.5 mg · Regression, Logistic · p = .575 (Unadjusted) · Odds ratio (or): 1.15 · 95% CI 0.70 to 1.91ZOMIG 0.5 mg/Placebo
Placebo vs ZOMIG 2.5 mg · Regression, Logistic · p = .032 (Unadjusted) · Odds ratio (or): 1.87 · 95% CI 1.06 to 3.31ZOMIG 2.5 mg/Placebo
Placebo vs ZOMIG 5 mg · Regression, Logistic · p = .137 (Unadjusted) · Odds ratio (or): 1.33 · 95% CI 0.91 to 1.95ZOMIG 5.0 mg/Placebo

SecondaryHeadache Response at 2 Hours Post-treatment

Headache response is a binary response variable derived from the headache intensities recorded in the patient diary. Headache response is defined as a reduction in headache pain intensity from severe or moderate to mild or none with no use of rescue medication prior to the assessment.

Time frame:: 2 hours post-treatment
Reported as:: Number · Participants

Headache Response at 2 Hours Post-treatment
Participants	Placebo	ZOMIG 0.5 mg	ZOMIG 2.5 mg	ZOMIG 5 mg
Yes	99	40	43	116
No	154	51	38	113

Statistical analysis

Placebo vs ZOMIG 0.5 mg · Regression, Logistic · p = .458 (Unadjusted) · Odds ratio (or): 1.20 · 95% CI 0.74 to 1.96ZOMIG 0.5 mg/Placebo
Placebo vs ZOMIG 2.5 mg · Regression, Logistic · p = .021 (Unadjusted) · Odds ratio (or): 1.82 · 95% CI 1.09 to 3.03ZOMIG 2.5 mg/Placebo
Placebo vs ZOMIG 5 mg · Regression, Logistic · p = .010 (Unadjusted) · Odds ratio (or): 1.61 · 95% CI 1.12 to 2.32ZOMIG 5.0 mg/Placebo

SecondaryHeadache Response at 24 Hours Post-treatment

Time frame:: 24 hours post-treatment
Reported as:: Number · Participants

Headache Response at 24 Hours Post-treatment
Participants	Placebo	ZOMIG 0.5 mg	ZOMIG 2.5 mg	ZOMIG 5 mg
Yes	170	63	61	168
No	81	28	19	59

Statistical analysis

Placebo vs ZOMIG 0.5 mg · Regression, Logistic · p = .753 (Unadjusted) · Odds ratio (or): 1.09 · 95% CI 0.64 to 1.84ZOMIG 0.5 mg/Placebo
Placebo vs ZOMIG 2.5 mg · Regression, Logistic · p = .145 (Unadjusted) · Odds ratio (or): 1.55 · 95% CI 0.86 to 2.79ZOMIG 2.5 mg/Placebo
Placebo vs ZOMIG 5 mg · Regression, Logistic · p = .127 (Unadjusted) · Odds ratio (or): 1.37 · 95% CI 0.91 to 2.04ZOMIG 5.0 mg/Placebo

SecondarySustained Headache Response at 2 Hours

Sustained headache response at 2 hours is a binary response variable derived from the headache intensities recorded in the patient diary. Sustained headache response is defined as a reduction in migraine headache pain intensity from severe or moderate to mild or none a 1 hr. which is then maintained (without a return to moderate or severe pain) at 2 hrs. with no use of rescue medication prior to the 2 hr. assessment.

Time frame:: Up to 2 hours post-treatment
Reported as:: Number · Participants

Sustained Headache Response at 2 Hours
Participants	Placebo	ZOMIG 0.5 mg	ZOMIG 2.5 mg	ZOMIG 5 mg
Yes	59	27	27	66
No	192	64	54	158

Statistical analysis

Placebo vs ZOMIG 0.5 mg · Regression, Logistic · p = .274 (Unadjusted) · Odds ratio (or): 1.35 · 95% CI 0.79 to 2.32ZOMIG 0.5 mg/Placebo
Placebo vs ZOMIG 2.5 mg · Regression, Logistic · p = .067 (Unadjusted) · Odds ratio, log: 1.67 · 95% CI 0.96 to 2.91ZOMIG 2.5 mg/Placebo
Placebo vs ZOMIG 5 mg · Regression, Logistic · p = .127 (Unadjusted) · Odds ratio (or): 1.38 · 95% CI 0.91 to 2.08ZOMIG 5.0 mg/Placebo

SecondaryUse of Rescue Medication During the First 24 Hours After Treatment

Time frame:: 24 hours post-treatment.
Reported as:: Number · Participants

Use of Rescue Medication During the First 24 Hours After Treatment
Participants	Placebo	ZOMIG 0.5 mg	ZOMIG 2.5 mg	ZOMIG 5 mg
Yes	80	22	18	47
No	173	69	63	184

Statistical analysis

Placebo vs ZOMIG 0.5 mg · Regression, Logistic · p = .153 (Unadjusted) · Odds ratio (or): 0.67 · 95% CI 0.38 to 1.16ZOMIG 0.5 mg/Placebo
Placebo vs ZOMIG 2.5 mg · Regression, Logistic · p = .087 (Unadjusted) · Odds ratio (or): 0.59 · 95% CI 0.33 to 1.08ZOMIG 2.5 mg/Placebo
Placebo vs ZOMIG 5 mg · Regression, Logistic · p = .004 (Unadjusted) · Odds ratio (or): 0.54 · 95% CI 0.36 to 0.83ZOMIG 5.0 mg/Placebo

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Placebo	—	0/253 (0%)	25/253 (9.9%)
ZOMIG 0.5 mg	—	0/92 (0%)	14/92 (15.2%)
ZOMIG 2.5 mg	—	0/81 (0%)	9/81 (11.1%)
ZOMIG 5 mg	—	0/231 (0%)	59/231 (25.5%)

Most frequent other events

Showing 10 of 48

Most frequent other events
Event	Placebo	ZOMIG 0.5 mg	ZOMIG 2.5 mg	ZOMIG 5 mg
DysgeusiaNervous system disorders	3/253	6/92	5/81	29/231
Nasal discomfortRespiratory, thoracic and mediastinal disorders	4/253	1/92	2/81	7/231
Oropharyngeal painRespiratory, thoracic and mediastinal disorders	4/253	1/92	0/81	7/231
DizzinessNervous system disorders	2/253	1/92	0/81	6/231
NauseaGastrointestinal disorders	3/253	0/92	1/81	5/231
SomnolenceNervous system disorders	0/253	0/92	0/81	3/231
Throat irritationRespiratory, thoracic and mediastinal disorders	1/253	0/92	0/81	3/231
FatigueGeneral disorders	0/253	0/92	0/81	3/231
Abdominal pain upperGastrointestinal disorders	3/253	0/92	1/81	1/231
ParaesthesiaNervous system disorders	1/253	1/92	1/81	2/231

Baseline characteristics

Age, Continuous
Age, Continuous(Years)	Placebo	ZOMIG 0.5 mg	ZOMIG 2.5 mg	ZOMIG 5 mg	Total
Mean	14.3 ± 1.67	14.5 ± 1.72	14.6 ± 1.77	14.5 ± 1.67	14.4 ± 1.69

Sex: Female, Male
Sex: Female, Male(Participants)	Placebo	ZOMIG 0.5 mg	ZOMIG 2.5 mg	ZOMIG 5 mg	Total
Female	188	71	62	172	493
Male	108	44	37	116	305

Study locations

74 sites

Research Site
Phoenix, Arizona, United States
Research Site
Fresno, California, United States
Research Site
Fullerton, California, United States
Research Site
Newport Beach, California, United States
Research Site
Sacramento, California, United States
Research Site
San Diego, California, United States
Research Site
San Francisco, California, United States
Research Site
Centennial, Colorado, United States
Research Site
Colorado Springs, Colorado, United States
Research Site
Thornton, Colorado, United States
Research Site
Fairfield, Connecticut, United States
Research Site
Boca Raton, Florida, United States
Research Site
Hallandale Beach, Florida, United States
Research Site
Miami Lakes, Florida, United States
Research Site
Miami, Florida, United States
Research Site
North Palm Beach, Florida, United States
Research Site
Orlando, Florida, United States
Research Site
Tampa, Florida, United States
Research Site
West Palm Beach, Florida, United States
Research Site
Owensboro, Kentucky, United States
Research Site
Worcester, Massachusetts, United States
Research Site
Ann Arbor, Michigan, United States
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Plymouth, Minnesota, United States
Research Site
Ocean Springs, Mississippi, United States
Research Site
Olive Branch, Mississippi, United States
Research Site
Columbia, Missouri, United States
Research Site
Springfield, Missouri, United States
Research Site
St Louis, Missouri, United States
Research Site
Bronx, New York, United States
Research Site
Cary, North Carolina, United States
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Hickory, North Carolina, United States
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Raleigh, North Carolina, United States
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Akron, Ohio, United States
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Cleveland, Ohio, United States
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Toledo, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Indiana, Pennsylvania, United States
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Jackson, Tennessee, United States
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Nashville, Tennessee, United States
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San Antonio, Texas, United States
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Spring, Texas, United States
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Salt Lake City, Utah, United States
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South Jordan, Utah, United States
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Charlottesville, Virginia, United States
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Norfolk, Virginia, United States
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Middleton, Wisconsin, United States
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Tallinn, Estonia
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Tartu, Estonia
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Helsinki, Finland
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Mikkeli, Finland
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Turku, Finland
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Budapest, Hungary
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Debrecen, Hungary
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Gyula, Hungary
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Miskolc, Hungary
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Nagykanizsa, Hungary
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Nyíregyháza, Hungary
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Pecs, Hungary
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Sopron, Hungary
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Szekszárd, Hungary
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Riga, Latvia
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Valmiera, Latvia
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Bialystok, Poland
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Bydgoszcz, Poland
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Elblag, Poland
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Gdansk, Poland
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Kielce, Poland
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Olsztyn, Poland
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Poznan, Poland
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Belgrade, Serbia
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Novi Sad, Serbia
Research Site
Dolny Kubin, Slovakia
Research Site
Nitra, Slovakia
Research Site
Zvolen, Slovakia

References and documents

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on May 18, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01211145
Lead sponsor: AstraZeneca
Responsible party: Sponsor
First posted: Sep 29, 2010
Start date: Sep 2010
Primary completion: Oct 2013
Completion: Oct 2013
Results posted: Oct 24, 2014
Last update: May 18, 2016

Study contacts

Rohini Chitra

study director · AZ Pharmaceuticals, US

Paul Winner

principal investigator · Children's Hospital of The King's Daughters

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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Zomig - Treatment of Acute Migraine Headache in Adolescents

Study summary

Conditions studied

Browse trials for

Keywords

In context

Migraine Disorders

Lead sponsor

Who can participate

✓Inclusion criteria

✕Exclusion criteria

Study design

Study arms

Interventions

What researchers measure

Primary outcomes

Secondary outcomes

Results

Participant flow

Outcome measures

Adverse events

Baseline characteristics

Study locations

References and documents

Related links

Updates

Registry details

Key details

Study contacts

Oversight

Not currently enrolling

Follow this study

Discussion

Other studies in this condition

Other studies from this sponsor

Inclusion criteria

Exclusion criteria