Trial Review

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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12625000401459
Ethics application status
Approved
Date submitted
15/04/2025
Date registered
2/05/2025
Date last updated
2/05/2025
Date data sharing statement initially provided
2/05/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Pilot study of medication repurposing for idiopathic intracranial hypertension
Scientific title
A phase 2 randomised, placebo-controlled, double-blind pilot trial of drug repurposing in idiopathic intracranial hypertension in adult women.
Secondary ID [1] 314280 0
IIH Repurposing
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Idiopathic intracranial hypertension 337102 0
Condition category
Condition code
Neurological 333522 333522 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Empagliflozin 25mg daily for 12 weeks administered as an oral tablet.
Adherence will be monitored based on drug tablet return.
Intervention code [1] 330809 0
Treatment: Drugs
Comparator / control treatment
The control group will receive a placebo tablet composed of prosolv (silicified microcrystalline cellulose)
Control group
Placebo

Outcomes
Primary outcome [1] 341098 0
Intracranial pressure measured by lumbar puncture opening pressure
Timepoint [1] 341098 0
At 12 weeks post intervention commencement
Secondary outcome [1] 446221 0
Feasibility
Timepoint [1] 446221 0
At study completion
Secondary outcome [2] 446222 0
Neurological symptoms - headache and vision
Timepoint [2] 446222 0
Every 4 weeks during 12 week intervention period
Secondary outcome [3] 446223 0
Quality of life
Timepoint [3] 446223 0
At randomisation and at 12 weeks post intervention commencement
Secondary outcome [4] 446224 0
Metabolic parameters
Timepoint [4] 446224 0
Pre-intervention and 12 weeks post-intervention
Secondary outcome [5] 446663 0
Safety endpoint - blood tests
Timepoint [5] 446663 0
4-weekly during intervention
Secondary outcome [6] 446769 0
Safety endpoint
Timepoint [6] 446769 0
4-weekly during intervention

Eligibility
Key inclusion criteria
Women aged 18 years or older
Diagnosis of IIH by consensus criteria
Bilateral papilloedema
Lumbar puncture opening greater than or equal to 25cm cerebrospinal fluid (CSF) at diagnosis
New diagnosis of IIH (screening commenced no more than 8 weeks after diagnostic LP)
Body mass index 27-58 kg/m2
Women of childbearing potential must have a negative pregnancy test and must agree to use a highly effective contraception method for the duration of the study
Able to provide written informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Medical treatment to lower ICP within 1 week prior to screening
Prior surgical treatment to lower ICP
Use of drugs known to affect ICP
Bariatric surgery
Contraindication to SGLT2i use (e.g. Type 1 diabetes)
Pregnancy or positive urine dipstick pregnancy test
Breastfeeding

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
6/05/2025
Actual
Date of last participant enrolment
Anticipated
12/05/2026
Actual
Date of last data collection
Anticipated
31/12/2026
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 318720 0
University
Name [1] 318720 0
Monash University
Country [1] 318720 0
Australia
Primary sponsor type
Hospital
Name
Alfred Hospital
Address
Country
Australia
Secondary sponsor category [1] 321155 0
None
Name [1] 321155 0
Address [1] 321155 0
Country [1] 321155 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317331 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 317331 0
Ethics committee country [1] 317331 0
Australia
Date submitted for ethics approval [1] 317331 0
26/09/2024
Approval date [1] 317331 0
13/12/2024
Ethics approval number [1] 317331 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 140710 0
A/Prof Priya Sumithran
Address 140710 0
Monash University, Level 6, 99 Commercial Road, Melbourne VIC 3004
Country 140710 0
Australia
Phone 140710 0
+61 0399038939
Fax 140710 0
Email 140710 0
[email protected]
Contact person for public queries
Name 140711 0
Damien Qi
Address 140711 0
Monash University, Level 6, 99 Commercial Road, Melbourne VIC 3004
Country 140711 0
Australia
Phone 140711 0
+610399030555
Fax 140711 0
Email 140711 0
[email protected]
Contact person for scientific queries
Name 140712 0
Priya Sumithran
Address 140712 0
Monash University, Level 6, 99 Commercial Road, Melbourne VIC 3004
Country 140712 0
Australia
Phone 140712 0
+61 0399038939
Fax 140712 0
Email 140712 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• Yes, conditions apply:
• Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
• Requires a scientifically sound proposal or protocol
• Requires approval by an ethics committee
• Requires a data sharing agreement between data requester and trial custodian or sponsor
What individual participant data might be shared?
• All de-identified individual participant data
What types of analyses could be done with individual participant data?
• Systematic reviews and meta-analyses
• Studies exploring new research questions
• Studies testing whether findings can be repeated or confirmed
When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
Not yet decided
Where can requests to access individual participant data be made, or data be obtained directly?
• TBC - email to principal investigator ([email protected])

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.