Trial record 2 of 4 for:
zolmitriptan | Child
Zomig - Treatment of Acute Migraine Headache in Adolescents (TEENZ)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT01211145 |
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Recruitment Status :
Completed
First Posted : September 29, 2010
Results First Posted : October 24, 2014
Last Update Posted : May 18, 2016
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Sponsor:
AstraZeneca
Information provided by (Responsible Party):
AstraZeneca
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Brief 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).
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Migraine Headache | Drug: Placebo Drug: Zolmitriptan | Phase 4 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 1653 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| 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 |
| Study Start Date : | September 2010 |
| Actual Primary Completion Date : | October 2013 |
| Actual Study Completion Date : | October 2013 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Migraine
Drug Information available for:
Zolmitriptan
| Arm | Intervention/treatment |
|---|---|
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Placebo Comparator: 1
Placebo
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Drug: Placebo
Placebo nasal spray |
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Experimental: 2
ZOMIG 0.5 mg
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Drug: Zolmitriptan
0.5 mg nasal spray
Other Name: Zomig® Nasal Spray |
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Experimental: 3
ZOMIG 2.5 mg
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Drug: Zolmitriptan
2.5 mg nasal spray
Other Name: Zomig® Nasal Spray |
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Experimental: 4
ZOMIG 5.0 mg
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Drug: Zolmitriptan
5.0 mg nasal spray
Other Name: Zomig® Nasal Spray |
Primary Outcome Measures :
- Pain-free Status at 2 Hours Post-treatment [ Time Frame: 2 hours post-treatment. ]
Secondary Outcome Measures :
- 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 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.
- Headache Response at 24 Hours Post-treatment [ Time Frame: 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.
- Sustained Headache Response at 2 Hours [ Time Frame: Up to 2 hours post-treatment ]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.
- Use of Rescue Medication During the First 24 Hours After Treatment [ Time Frame: 24 hours post-treatment. ]
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| Ages Eligible for Study: | 12 Years to 17 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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:
- 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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01211145
Locations
Show 74 study locations
Sponsors and Collaborators
AstraZeneca
Investigators
| Study Director: | Rohini Chitra | AZ Pharmaceuticals, US | |
| Principal Investigator: | Paul Winner | Children's Hospital of The King's Daughters |
Additional Information:
| Responsible Party: | AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT01211145 |
| Other Study ID Numbers: |
D1220C00001 |
| First Posted: | September 29, 2010 Key Record Dates |
| Results First Posted: | October 24, 2014 |
| Last Update Posted: | May 18, 2016 |
| Last Verified: | April 2016 |
Keywords provided by AstraZeneca:
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Migraine Headache Pain Efficacy Adolescents |
Additional relevant MeSH terms:
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Zolmitriptan Migraine Disorders Headache Headache Disorders, Primary Headache Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Pain Neurologic Manifestations |
Oxazolidinones Serotonin 5-HT1 Receptor Agonists Serotonin Receptor Agonists Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Anti-Infective Agents Protein Synthesis Inhibitors Enzyme Inhibitors |