A pragmatic randomised controlled trial of treatments for Idiopathic Intracranial Hypertension
| ISRCTN | ISRCTN84867253 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN84867253 |
| Secondary identifying numbers | N/A |
- Submission date
- 01/04/2004
- Registration date
- 23/04/2004
- Last edited
- 29/11/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Carl Clarke
Scientific
Scientific
Department of Neurology
City Hospital
Dudley Road
Birmingham
B18 7QH
United Kingdom
| Phone | +44 (0)121 507 4073 |
|---|---|
| c.e.clarke@bham.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Scientific title | |
| Study acronym | The IIH Trial |
| Study objectives | Not provided at time of registration |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Idiopathic Intracranial Hypertension |
| Intervention | 1. Acetazolamide 2. Weight reduction 3. Optic nerve sheath fenestration 4. Ventriculo-peritoneal or lumbo-peritoneal shunts |
| Intervention type | Other |
| Primary outcome measure | Not provided at time of registration |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/04/2000 |
| Completion date | 31/05/2002 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | Not provided at time of registration |
| Key inclusion criteria | 1. Diagnosis of Idiopathic Intracranial Hypertension (including that caused by medication such as tetracyclines) 2. Willing to give written informed consent 3. Able to complete trial documentation 4. Randomising clinician is uncertain about the treatment the patient should receive |
| Key exclusion criteria | 1. `Idiopathic¿ Intracranial Hypertension caused by cerebral venous sinus thrombosis or chronic neurological conditions (e.g. infections) 2. Contraindication to acetazolamide such as hypokalaemia, hyponatraemia, hyperchloraemic acidosis, severe hepatic impairment, renal impairment, sulphonamide sensitivity 3. Randomising clinician is certain about the treatment the patient should receive |
| Date of first enrolment | 01/04/2000 |
| Date of final enrolment | 31/05/2002 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Department of Neurology
Birmingham
B18 7QH
United Kingdom
B18 7QH
United Kingdom
Sponsor information
University of Birmingham (UK)
University/education
University/education
c/o Department of Pharmacology
University of Birmingham
Medical School
Edgbaston
Birmingham
B15 2TT
England
United Kingdom
| Phone | +44 (0)121 414 2286 |
|---|---|
| c.mcgarry@bham.ac.uk | |
"ROR" |
https://ror.org/03angcq70 |
Funders
Funder type
Industry
Unrestricted grants from pharmaceutical industry.
No information available
Internal research funds.
No information available
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 | 01/05/2011 | Yes | No |
