Contact information
Type
Scientific
Primary contact
Dr Carl Clarke
ORCID ID
Contact details
Department of Neurology
City Hospital
Dudley Road
Birmingham
B18 7QH
United Kingdom
+44 (0)121 507 4073
c.e.clarke@bham.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
The IIH Trial
Study hypothesis
Not provided at time of registration
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Idiopathic Intracranial Hypertension
Intervention
1. Acetazolamide
2. Weight reduction
3. Optic nerve sheath fenestration
4. Ventriculo-peritoneal or lumbo-peritoneal shunts
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/04/2000
Overall trial end date
31/05/2002
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
Not provided at time of registration
Participant 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
Recruitment start date
01/04/2000
Recruitment end date
31/05/2002
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Neurology
Birmingham
B18 7QH
United Kingdom
Sponsor information
Organisation
University of Birmingham (UK)
Sponsor details
c/o Department of Pharmacology
University of Birmingham
Medical School
Edgbaston
Birmingham
B15 2TT
United Kingdom
+44 (0)121 414 2286
c.mcgarry@bham.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Industry
Funder name
Unrestricted grants from pharmaceutical industry.
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Internal research funds.
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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
2011 results in: http://www.ncbi.nlm.nih.gov/pubmed/21161260
Publication citations
-
Results
Ball AK, Howman A, Wheatley K, Burdon MA, Matthews T, Jacks AS, Lawden M, Sivaguru A, Furmston A, Howell S, Sharrack B, Davies MB, Sinclair AJ, Clarke CE, A randomised controlled trial of treatment for idiopathic intracranial hypertension., J. Neurol., 2011, 258, 5, 874-881, doi: 10.1007/s00415-010-5861-4.