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Intranasal zolmitriptan is effective and well tolerated in acute cluster headache
ISRCTN ISRCTN27362692
DOI 10.1186/ISRCTN27362692
ClinicalTrials.gov identifier
EudraCT number
Public title Intranasal zolmitriptan is effective and well tolerated in acute cluster headache
Scientific title
Acronym ZINCH
Serial number at source ZINCH-1
Study hypothesis Zolmitriptan intranasal is more effective than placebo in the treatment of acute cluster headache.
Lay summary
Ethics approval Ethics approval received from the National Hospital for Neurology and Neurosurgery Ethics Committee on the 8th May 2003 (ref: 02/N031).
Study design Randomised, placebo-controlled, double-blind cross-over trial
Countries of recruitment Germany, Italy, United Kingdom
Disease/condition/study domain Cluster headache
Participants - inclusion criteria Cluster headache with attacks longer than 45 minutes.
Participants - exclusion criteria Contraindications to zolmitriptan in participating countries.
Anticipated start date 01/09/2003
Anticipated end date 01/01/2005
Status of trial Completed
Patient information material
Target number of participants 90
Interventions Zolmitriptan nasal spray versus placebo.
Primary outcome measure(s) Proportion of patients who have taken active drug with headache relief at 30 minutes.
Secondary outcome measure(s) Pain free at 30 minutes.
Sources of funding AstraZeneca (UK)
Trial website
Publications Results in http://www.ncbi.nlm.nih.gov/pubmed/16966497
Contact name Prof  Peter  Goadsby
  Address Institute of Neurology
University College London
  City/town London
  Zip/Postcode WC1N 3BG
  Country United Kingdom
Sponsor AstraZeneca (UK)
  Address Alderley Park
  City/town Macclesfield
  Zip/Postcode SK10 2NA
  Country United Kingdom
Date applied 14/02/2006
Last edited 06/08/2008
Date ISRCTN assigned 23/02/2006
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