Intranasal zolmitriptan is effective and well tolerated in acute cluster headache

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Prof Peter Goadsby
Scientific

Institute of Neurology
University College London
London
WC1N 3BG
United Kingdom

Primary study design	Interventional
Study design	Randomised, placebo-controlled, double-blind cross-over trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	ZINCH
Study objectives	Zolmitriptan intranasal is more effective than placebo in the treatment of acute cluster headache.
Ethics approval(s)	Ethics approval received from the National Hospital for Neurology and Neurosurgery Ethics Committee on the 8th May 2003 (ref: 02/N031).
Health condition(s) or problem(s) studied	Cluster headache
Intervention	Zolmitriptan nasal spray versus placebo.
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Zolmitriptan
Primary outcome measure(s)	Proportion of patients who have taken active drug with headache relief at 30 minutes.
Key secondary outcome measure(s)	Pain free at 30 minutes.
Completion date	01/01/2005

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	90
Key inclusion criteria	Cluster headache with attacks longer than 45 minutes.
Key exclusion criteria	Contraindications to zolmitriptan in participating countries.
Date of first enrolment	01/09/2003
Date of final enrolment	01/01/2005

Institute of Neurology

London
WC1N 3BG
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	Results	01/11/2006		Yes	No