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
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 April 23, 2014