Condition category
Signs and Symptoms
Date applied
14/02/2006
Date assigned
23/02/2006
Last edited
06/08/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Peter Goadsby

ORCID ID

Contact details

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

Additional identifiers

EudraCT 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

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

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Cluster headache

Intervention

Zolmitriptan nasal spray versus placebo.

Intervention type

Drug

Phase

Not Specified

Drug names

Zolmitriptan

Primary outcome measures

Proportion of patients who have taken active drug with headache relief at 30 minutes.

Secondary outcome measures

Pain free at 30 minutes.

Overall trial start date

01/09/2003

Overall trial end date

01/01/2005

Reason abandoned

Eligibility

Participant inclusion criteria

Cluster headache with attacks longer than 45 minutes.

Participant type

Patient

Age group

Adult

Gender

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

Germany, Italy, United Kingdom

Trial 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

Funders

Funder type

Industry

Funder name

AstraZeneca (UK)

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

corporate

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Results in http://www.ncbi.nlm.nih.gov/pubmed/16966497

Publication citations

  1. Results

    Cittadini E, May A, Straube A, Evers S, Bussone G, Goadsby PJ, Effectiveness of intranasal zolmitriptan in acute cluster headache: a randomized, placebo-controlled, double-blind crossover study., Arch. Neurol., 2006, 63, 11, 1537-1542, doi: 10.1001/archneur.63.11.nct60002.

Additional files

Editorial Notes