Migraine HeadachePhase 4TEENZNCT01211145

Zomig - Treatment of Acute Migraine Headache in Adolescents

A Phase 4 study testing Zolmitriptan in people with Migraine Headache, run by AstraZeneca at 74 sites in 8 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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). Read more about this study

Who is it for?: Ages 12 to 17 years
Conditions the study is for: Migraine Headache
What is being tested?: Zolmitriptan
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 1,653 participants
Where: 74 sitesin 8 countries
Study dates: Sep 2010to Oct 2013
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 12 to 17 years
All sexes
No healthy volunteers
Child

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

74 sites in 8 countries.

Country

City, postcode or hospital

74 sites in 8 countries

United States46 sites

Research Site
Akron, Ohio
Research Site
Ann Arbor, Michigan
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Boca Raton, Florida
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Cary, North Carolina
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Centennial, Colorado
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Charlottesville, Virginia
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Cleveland, Ohio
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Colorado Springs, Colorado
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Columbia, Missouri
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Fairfield, Connecticut
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Fresno, California
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Fullerton, California
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Hallandale, Florida
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Hickory, North Carolina
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Indiana, Pennsylvania
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Jackson, Tennessee
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Miami, Florida
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Miami Lakes, Florida
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Middleton, Wisconsin
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Nashville, Tennessee
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Newport Beach, California
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Norfolk, Virginia
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North Palm Beach, Florida
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Ocean Springs, Mississippi
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Oklahoma City, Oklahoma
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Olive Branch, Mississippi
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Orlando, Florida
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Owensboro, Kentucky
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Phoenix, Arizona
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Plymouth, Minnesota
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Raleigh, North Carolina
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Sacramento, California
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Salt Lake City, Utah
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San Antonio, Texas
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San Diego, California
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San Francisco, California
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South Jordan, Utah
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Spring, Texas
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Springfield, Missouri
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St Louis, Missouri
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Tampa, Florida
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The Bronx, New York
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Thornton, Colorado
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Toledo, Ohio
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West Palm Beach, Florida
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Worcester, Massachusetts

Other trials in United States

Hungary9 sites

Research Site
Budapest
Research Site
Debrecen
Research Site
Gyula
Research Site
Miskolc
Research Site
Nagykanizsa
Research Site
Nyíregyháza
Research Site
Pécs
Research Site
Sopron
Research Site
Szekszárd

Other trials in Hungary

Poland7 sites

Research Site
Bialystok
Research Site
Bydgoszcz
Research Site
Elblag
Research Site
Gdansk
Research Site
Kielce
Research Site
Olsztyn
Research Site
Poznan

Other trials in Poland

Finland3 sites

Research Site
Helsinki
Research Site
Mikkeli
Research Site
Turku

Other trials in Finland

Slovakia3 sites

Research Site
Dolný Kubín
Research Site
Nitra
Research Site
Zvolen

Other trials in Slovakia

Estonia2 sites

Research Site
Tallinn
Research Site
Tartu

Other trials in Estonia

Latvia2 sites

Research Site
Riga
Research Site
Valmiera

Other trials in Latvia

Serbia2 sites

Research Site
Belgrade
Research Site
Novi Sad

Other trials in Serbia

About this study

Official title: A Multicenter, Double-blind, Randomized, Placebo-controlled, 4-Armed Parallel Group Study to Evaluate the Efficacy of Zolmitriptan 0.5-, 2.5- and 5-mg Nasal Spray in the Treatment of Acute Migraine Headache in Adolescents

Conditions: Migraine Headache
Being tested: Placebo, Zolmitriptan
Keywords: Migraine, Headache, Pain, Efficacy, Adolescents
Medical subject headings: Migraine Disorders, Headache, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PlaceboDrug
Placebo nasal spray
ZolmitriptanDrug
Also called Zomig® Nasal Spray
0.5 mg nasal spray
ZolmitriptanDrug
Also called Zomig® Nasal Spray
2.5 mg nasal spray
ZolmitriptanDrug
Also called Zomig® Nasal Spray
5.0 mg nasal spray

Study groups in NCT01211145
Study group	Role	What they receive
1	Placebo comparator	Placebo Receives: Drug: Placebo
2	Experimental	ZOMIG 0.5 mg Receives: Drug: Zolmitriptan
3	Experimental	ZOMIG 2.5 mg Receives: Drug: Zolmitriptan
4	Experimental	ZOMIG 5.0 mg Receives: Drug: Zolmitriptan

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (5)

Pain-free Status at 24 Hours Post-treatment
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 2 hours post-treatment
Use of Rescue Medication During the First 24 Hours After Treatment
Measured: 24 hours post-treatment.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2010Oct 2013

First posted29 Sep 2010 (estimated)
Study startSep 2010
Primary completionOct 2013
Study completionOct 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Migraine HeadacheStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 1,653 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01211145
Sponsor's protocol ID: D1220C00001
Acronym: TEENZ
Status last verified: Apr 2016
First submitted: 28 Sep 2010
Last updated: 18 May 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
App-Based Migraine Treatment: The Health enSuite Study
Migraine, Migraine With Aura
Enrolling by invitation
App-based Breathing Program for Migraine Relief
Migraine, Heart Rate Variability (HRV)
Recruiting
Headache Education and Awareness vs. Daily Mindfulness Strategies - Understanding Pain
Migraine, Migraine in Adolescence
Active, not recruiting
Intra-Nasal Mechanical Stimulation (INMEST) as a Potential Preventative Treatment for Migraine
Migraine
RecruitingPhase 3
Eary Infusion of Eptinezumab for TreatmEnt of ACute Post-Traumatic Headaches (ELITE-ACT)
Post Traumatic Headache

All Migraine Headache trials

Study at a glance

From the registry record, last updated by the sponsor on 18 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Double-blind, Randomized, Placebo-controlled, 4-Armed Parallel Group Study to Evaluate the Efficacy of Zolmitriptan 0.5-, 2.5- and 5-mg Nasal Spray in the Treatment of Acute Migraine Headache in Adolescents
ClinicalTrials.gov ID: NCT01211145
Acronym / sponsor ID: TEENZ / D1220C00001
Conditions: Migraine Headache
Keywords: Migraine, Headache, Pain, Efficacy, Adolescents
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,653 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Sep 2010
Primary completion: Oct 2013 (actual)
Study completion: Oct 2013 (actual)
First posted: 29 Sep 2010 (estimated)
Results: Posted 24 Oct 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
1	Placebo comparator	Drug: PlaceboPlacebo
2	Experimental	Drug: ZolmitriptanZOMIG 0.5 mg
3	Experimental	Drug: ZolmitriptanZOMIG 2.5 mg
4	Experimental	Drug: ZolmitriptanZOMIG 5.0 mg

Who may qualify

Ages: 12 to 17 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (3 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PlaceboPlacebo nasal spray	Drug	1
ZolmitriptanAlso: Zomig® Nasal Spray0.5 mg nasal spray	Drug	2
ZolmitriptanAlso: Zomig® Nasal Spray2.5 mg nasal spray	Drug	3
ZolmitriptanAlso: Zomig® Nasal Spray5.0 mg nasal spray	Drug	4

Primary outcome

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

5 secondary outcomes

Pain-free Status at 24 Hours Post-treatment
Time frame: 24 hours post-treatment
Headache Response at 2 Hours Post-treatment
Time frame: 2 hours post-treatment
Headache Response at 24 Hours Post-treatment
Time frame: 24 hours post-treatment
Sustained Headache Response at 2 Hours
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 and safety

Results posted to the registry on 24 Oct 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	296	270
ZOMIG 0.5 mg	115	98
ZOMIG 2.5 mg	99	86
ZOMIG 5 mg	288	268

Primary outcome: Pain-free Status at 2 Hours Post-treatment

Time frame: 2 hours post-treatment.. Number. Unit: Participants

Measure	Placebo n = 253	ZOMIG 0.5 mg n = 91	ZOMIG 2.5 mg n = 81	ZOMIG 5 mg n = 229
Yes	42	20	20	68
No	211	71	61	161

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

Population analysed: Full analysis set (last observation carried forward)

5 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 253 (0%)	25 of 253 (9.9%)	Not reported
ZOMIG 0.5 mg	0 of 92 (0%)	14 of 92 (15.2%)	Not reported
ZOMIG 2.5 mg	0 of 81 (0%)	9 of 81 (11.1%)	Not reported
ZOMIG 5 mg	0 of 231 (0%)	59 of 231 (25.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
D1220C00001 Clinical Study Report SynopsisLink provided by the sponsor.
D1220C00001 Revised CSP 3 RedactedLink provided by the sponsor.

Related trials for Migraine Headache

Active, not recruiting
App-Based Migraine Treatment: The Health enSuite Study
Migraine, Migraine With Aura
Enrolling by invitation
App-based Breathing Program for Migraine Relief
Migraine, Heart Rate Variability (HRV)
Recruiting
Headache Education and Awareness vs. Daily Mindfulness Strategies - Understanding Pain
Migraine, Migraine in Adolescence
Active, not recruiting
Intra-Nasal Mechanical Stimulation (INMEST) as a Potential Preventative Treatment for Migraine
Migraine
RecruitingPhase 3
Eary Infusion of Eptinezumab for TreatmEnt of ACute Post-Traumatic Headaches (ELITE-ACT)
Post Traumatic Headache

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Rohini Chitra study director

AZ Pharmaceuticals, US

Paul Winner principal investigator

Children's Hospital of The King's Daughters

74 sites in 8 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Zolmitriptan in people with Migraine Headache, run by AstraZeneca at 74 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 May 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 74 sites in United States, Hungary, Poland, Finland, Slovakia and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Oct 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain-free Status at 2 Hours Post-treatment (time frame: 2 hours post-treatment.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01211145.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2016.