Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
ZINCH-1
Study information
Scientific title
Acronym
ZINCH
Study hypothesis
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).
Study design
Randomised, placebo-controlled, double-blind cross-over trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Not specified
Study type
Treatment
Patient information sheet
Condition
Cluster headache
Intervention
Zolmitriptan nasal spray versus placebo.
Intervention type
Drug
Pharmaceutical study type(s)
Phase
Not Specified
Drug/device/biological/vaccine name(s)
Zolmitriptan
Primary outcome measure
Proportion of patients who have taken active drug with headache relief at 30 minutes.
Secondary outcome measures
Pain free at 30 minutes.
Overall study start date
01/09/2003
Overall study end date
01/01/2005
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Cluster headache with attacks longer than 45 minutes.
Participant type(s)
Patient
Age group
Adult
Sex
Both
Target number of participants
90
Participant exclusion criteria
Contraindications to zolmitriptan in participating countries.
Recruitment start date
01/09/2003
Recruitment end date
01/01/2005
Locations
Countries of recruitment
England, Germany, Italy, United Kingdom
Study participating centre
Institute of Neurology
London
WC1N 3BG
United Kingdom
Sponsor information
Organisation
AstraZeneca (UK)
Sponsor details
Alderley Park
Macclesfield
SK10 2NA
United Kingdom
Sponsor type
Industry
Website
ROR
Funders
Funder type
Industry
Funder name
AstraZeneca (UK)
Alternative name(s)
AstraZeneca PLC, Pearl Therapeutics
Funding Body Type
government organisation
Funding Body Subtype
For-profit companies (industry)
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Results | 01/11/2006 | Yes | No |