Condition category
Circulatory System
Date applied
01/04/2004
Date assigned
23/04/2004
Last edited
29/11/2013
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

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

  1. 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.

Additional files

Editorial Notes