Zomig - Treatment of Acute Migraine Headache in Adolescents (TEENZ)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01211145
First received: September 28, 2010
Last updated: February 13, 2014
Last verified: February 2014
  Purpose

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 Intervention Phase
Migraine Headache
Adolescents
Drug: Zolmitriptan
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Pain-free status at 2 hours post treatment based on headache intensities recorded in the patient diary. [ Time Frame: 2 hours post treatment. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pain-free status post treatment based on headache intensities recorded in the patient diary. [ Time Frame: 15 minutes post treatment ] [ Designated as safety issue: No ]
  • Pain-free status post treatment based on headache intensities recorded in the patient diary. [ Time Frame: 1 hour post treatment ] [ Designated as safety issue: No ]
  • Pain-free status post treatment based on headache intensities recorded in the patient diary. [ Time Frame: 3 hours post treatment ] [ Designated as safety issue: No ]
  • Pain-free status post treatment based on headache intensities recorded in the patient diary. [ Time Frame: 4 hours post treatment ] [ Designated as safety issue: No ]
  • Pain-free status post treatment based on headache intensities recorded in the patient diary. [ Time Frame: 24 hours post treatment ] [ Designated as safety issue: No ]
  • Headache response post treatment based on headache intensities recorded in the patient diary. [ Time Frame: 15 minutes hours post treatment ] [ Designated as safety issue: No ]
  • Headache response post treatment based on headache intensities recorded in the patient diary. [ Time Frame: 1 hour post treatment ] [ Designated as safety issue: No ]
  • Headache response post treatment based on headache intensities recorded in the patient diary. [ Time Frame: 3 hours post treatment ] [ Designated as safety issue: No ]
  • Headache response post treatment based on headache intensities recorded in the patient diary. [ Time Frame: 4 hours post treatment ] [ Designated as safety issue: No ]
  • Headache response post treatment based on headache intensities recorded in the patient diary. [ Time Frame: 24 hours post treatment ] [ Designated as safety issue: No ]
  • Sustained headache response at 2 hours subsequent to a 1-hour headache response, based on headache intensities recorded in the patient diary. [ Time Frame: up to 2 hours post treatment ] [ Designated as safety issue: No ]

Enrollment: 1653
Study Start Date: September 2010
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Zolmitriptan
0.5 mg nasal spray
Other Name: Zomig® Nasal Spray
Drug: Zolmitriptan
0.5 mg nasal spray
Other Name: Zomig® Nasal Spray
Drug: Zolmitriptan
0.5 mg nasal spray
Other Name: Zomig® Nasal Spray
Experimental: 2 Drug: Zolmitriptan
0.5 mg nasal spray
Other Name: Zomig® Nasal Spray
Drug: Zolmitriptan
0.5 mg nasal spray
Other Name: Zomig® Nasal Spray
Drug: Zolmitriptan
0.5 mg nasal spray
Other Name: Zomig® Nasal Spray
Experimental: 3 Drug: Zolmitriptan
0.5 mg nasal spray
Other Name: Zomig® Nasal Spray
Drug: Zolmitriptan
0.5 mg nasal spray
Other Name: Zomig® Nasal Spray
Drug: Zolmitriptan
0.5 mg nasal spray
Other Name: Zomig® Nasal Spray
Placebo Comparator: 4 Drug: Placebo
Nasal spray

  Eligibility

Ages Eligible for Study:   12 Years to 17 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01211145

  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
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01211145     History of Changes
Other Study ID Numbers: D1220C00001
Study First Received: September 28, 2010
Last Updated: February 13, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
Migraine
Headache
Pain
Efficacy
Adolescents

Additional relevant MeSH terms:
Headache
Migraine Disorders
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Zolmitriptan
Oxazolidinones
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Anti-Infective Agents
Therapeutic Uses
Protein Synthesis Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on July 26, 2014