A pragmatic randomised controlled trial of treatments for Idiopathic Intracranial Hypertension
| ISRCTN | ISRCTN84867253 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN84867253 |
| Protocol serial number | N/A |
| Sponsor | University of Birmingham (UK) |
| Funders | Unrestricted grants from pharmaceutical industry., Internal research funds. |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/05/2002 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| 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
- United Kingdom
- England
Study participating centre
Department of Neurology
Birmingham
B18 7QH
United Kingdom
B18 7QH
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 |
