Intranasal zolmitriptan is effective and well tolerated in acute cluster headache
| ISRCTN | ISRCTN27362692 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN27362692 |
| Secondary identifying numbers | ZINCH-1 |
- Submission date
- 14/02/2006
- Registration date
- 23/02/2006
- Last edited
- 06/08/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Peter Goadsby
Scientific
Scientific
Institute of Neurology
University College London
London
WC1N 3BG
United Kingdom
Study information
| 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 |
| 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 |
| 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 |
| Completion date | 01/01/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 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 |
Locations
Countries of recruitment
- England
- Germany
- Italy
- United Kingdom
Study participating centre
Institute of Neurology
London
WC1N 3BG
United Kingdom
WC1N 3BG
United Kingdom
Sponsor information
AstraZeneca (UK)
Industry
Industry
Alderley Park
Macclesfield
SK10 2NA
United Kingdom
"ROR" |
https://ror.org/04r9x1a08 |
|---|
Funders
Funder type
Industry
AstraZeneca (UK)
Government organisation / For-profit companies (industry)
Government organisation / For-profit companies (industry)
- Alternative name(s)
- AstraZeneca PLC, Pearl Therapeutics
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Results | 01/11/2006 | Yes | No |
