Idiopathic Intracranial HypertensionPhase 3IIH EVOLVENCT05347147
A Trial to Determine the Efficacy and Safety of Presendin in IIH
A Phase 3 study testing Presendin in people with Idiopathic Intracranial Hypertension, run by Invex Therapeutics Ltd. at 24 sites in 6 countries.
Trial summary
Idiopathic intracranial hypertension (IIH) has significant associated morbidity and reduced quality of life. There is a significant risk of visual loss and patients also typically suffer with chronic disabling headaches. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Idiopathic Intracranial Hypertension
- What is being tested?
- Presendin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 24 sitesin 6 countries
- Study dates
- 18 Nov 2022to 20 Oct 2023
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years at the time of consent.
- Diagnosis of new IIH by consensus criteria, including normal structural brain imaging (excluding features of raised ICP and incidentalomas), including either magnetic resonance venography or computed tomographic venography to exclude thrombosis and no evidence of a secondary causes of raised ICP.
- Newly diagnosed patients with screening commenced no more than 4 weeks after the diagnostic LP.
- Lumbar puncture opening pressure ≥25 cm cerebrospinal fluid (CSF) at diagnosis.
- Presence of bilateral papilloedema (Frisén grade ≥1). Verification of papilloedema by the OCT Reading Centre. Where there is uncertainty fundus photography and/or ultrasound scan (B scan) of the optic nerves should be conducted for evaluation by the Independent Adjudication Committee (IAC).
- Perimetric Mean Deviation defined as between -2 to -7 decibels (dB) in at least one eye. Eyes meeting this criterion will defined as 'study eyes'.
Show all 11Show fewer
- Reproducible visual loss present on automated perimetry including no more than 15% false positive responses (reliability confirmed by the Visual Field Reading Centre) in study eyes.
- Two or more headache days over the 7-day period prior to screening and also the patient must meet this criterion during the 7-day screening period.
- Females of childbearing potential must have a negative pregnancy test and must agree to use a highly effective birth control method (failure rate less than 1% per year when used consistently and correctly) during the whole trial duration including the last follow-up visit (12 weeks after ceasing drug). Female patients who are lactating must agree to stop breast-feeding OR Female patients of non-childbearing potential (defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or post-menopausal females defined as 12 months of amenorrhoea [in questionable cases a blood sample with simultaneous follicle stimulation hormone 25-140 IE/L and oestradiol <200 pmol/L is confirmatory]).
- Male patients with a female partner of childbearing potential must commit to practice methods of contraception (e.g., condom, vasectomy) and abstain from sperm donation during the trial including the last follow-up visit (12 weeks after ceasing drug). Their partners, if they are women of childbearing potential, must agree to practice contraception and to use a highly effective method of contraception during the trial, including the last follow-up visit (12 weeks after ceasing drug).
- Able to provide written informed consent.
Who cannot join
- IIH-related exclusion criteria:
- Presence of venous sinus thrombosis on brain imaging by either magnetic resonance or computerised tomographic venography.
- Previous IIH surgery including CSF shunt, optic nerve sheath fenestration or dural venous sinus stent or sub-temporal decompression.
- Previous bariatric surgery within the last 3 months or intention during the trial.
- Abnormal neurological examination (aside from papilloedema and consequent visual loss or sixth or seventh nerve palsy or palsies).
- Treatment to lower ICP within 1 week prior to screening visit (e.g., acetazolamide, topiramate [including if used as a migraine preventative], diuretics, glucocorticoids [I.V., injectable steroids or oral (including dexamethasone and prednisolone)]). Nasal, inhaled, or topical steroids are allowed.
Show all 31Show fewer
- Use of any drugs known to cause intracranial hypertension, including exposure to fluoroquinolones, lithium, vitamin A, or tetracyclines within 2 months prior to diagnostic LP.
- Vision-related exclusion criteria:
- Any disease other than refractive error that causes visual loss in the study eyes. Where there is uncertainty this would be determined by the IAC.
- Refractive error worse than +/- 6.00 sphere or worse than +/- 3.00 cylinder in study eyes. In addition, participants with myopia of worse than -6.00 D sphere but less than or equal to -8.00 D sphere are eligible if the subject wears a contact lens for all perimetry examinations with the appropriate correction.
- Inability to perform a reliable visual field examination as deemed by the Visual Field Reading Centre in the study eyes. Where there is uncertainty this would be evaluated by the IAC.
- Headache-related exclusion criteria:
- Does not complete ≥6 days of electronic/paper trial diary during the 7-day screening period.
- Other exclusion criteria:
- Untreated previously diagnosed obstructive sleep apnoea with historically recorded apnoea-hypopnea index greater than 15.
- Glucagon like peptide-1 receptor agonist within last 4 weeks prior to screening.
- COVID-19 vaccine within 2 weeks prior to screening.
- Allergy/known hypersensitivity to the active substance and/or excipients of the investigational product.
- Has known contraindications to glucagon like peptide-1 (GLP-1) receptor agonists (e.g., ketoacidosis, severe gastrointestinal disease, pancreatitis, renal impairment) which may affect the safety of the patient.
- Using any glucose-lowering medication.
- Currently taking warfarin.
- Alanine transaminase (ALT) or aspartate transaminase (AST) ≥2x the upper limit of normal (ULN), total bilirubin ≥1.5x ULN, or alkaline phosphatase (ALP) ≥1.5 ULN at screening. Note - patients with elevated total bilirubin are not excluded if they meet criteria for Gilbert's syndrome, including: bilirubin is predominantly indirect (with normal direct bilirubin level); and ALT, AST and ALP ≤1x ULN).
- Kidney disease (as defined by serum cystatin C-based estimated glomerular filtration rate <55 mL/min/1.73 m², calculated at investigator site).
- Any of the following abnormalities in clinical laboratory tests at screening, as assessed by the central laboratory and confirmed by a single repeat, if deemed necessary: Haemoglobin <10 g/dL (<100 g/L); Platelet count <75 x 10⁹/L (<75,000/mm³).
- Using recreational or illicit drugs at the time of signing the informed consent, or recent history (within the last year) of drug or alcohol abuse or dependence according to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition criteria, that in the opinion of the investigator puts the patient at risk.
- Is unable to self-administer the trial medication (or unable to administer trial medication with support) after receiving training during the screening period.
- History of any clinically significant disease or disorder that, in the opinion of the investigator, may either put the patient at risk because of participation in the trial or influence the results or the patient's ability to participate in the trial.
- Any contraindication to lumbar puncture procedure in the opinion of the investigator.
- Has participated in any other interventional trial within 1 month prior to the screening visit.
- Is pregnant or breastfeeding.
- Note: Use of headache preventative medication is allowed at enrolment (except for topiramate). Changes to headache preventative medication during the trial should be made in consultation with the IAC.
Trial locations and contacts
24 sites in 6 countries.
24 sites in 6 countries
United States7 sites
UCHealth Sue Anschutz-Rodgers Eye Center - Anschutz Medical Campus
Aurora, Colorado, 80045
The University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Neuro-Eye Clinical Trials, Inc
Houston, Texas, 77074
University of Miami Leonard M. Miller School of Medicine (UMMSM) - Bascom Palmer Eye Institute
Miami, Florida, 33136
University of Minnesota Health
Minneapolis, Minnesota, 55455
Vanderbilt Eye Institute
Nashville, Tennessee, 37232
New York Eye and Ear Infirmary of Mount Sinai
New York, New York, 10075
Israel6 sites
Rambam Medical Center
Haifa, 3109601
Bnai Zion Medical Center
Haifa, 3339419
The Edith Wolfson Medical Center
Holon, 5822012
Shaare Zedek Medical Center
Jerusalem, 9103102
Hadassah Medical Center - Ein Karem
Jerusalem, 91120
Pade Medical Center (Poriya)
Tiberias, 1528001
Australia4 sites
Vision SA
Kent Town, South Australia, 5056
Liverpool Hospital
Liverpool, New South Wales, 2170
Alfred Health - The Alfred Centre
Melbourne, Victoria, 3004
Sydney Eye Hospital
Sydney, New South Wales, 2000
Germany4 sites
University Hospital Bonn
Bonn, 53105
Universitätsklinikum Freiburg
Freiburg im Breisgau, 79106
Universitaetsmedizin Mainz
Mainz, 55131
University Hospital Muenster, Department Ophthalmology Clinical Trials in Ophthalmology (CTO)
Münster, 48149
United Kingdom2 sites
University Hospitals Birmingham NHS Foundation Trust - Queen Elizabeth Hospital Birmingham
Birmingham, B15 2GW
Guy's and St Thomas' NHS Foundation Trust
London, SE1 7EH
About this study
Official title: A Phase III Randomised, Placebo-controlled, Double-blind, Multi-centre, Clinical Trial to Determine the Efficacy and Safety of Presendin in Idiopathic Intracranial Hypertension
Idiopathic intracranial hypertension (IIH) has significant associated morbidity and reduced quality of life. There is a significant risk of visual loss and patients also typically suffer with chronic disabling headaches.
This trial has been designed to evaluate the efficacy and safety of a new formulation of exenatide (Presendin) in the reduction of intracranial pressure (ICP) in patients with IIH.
Read the detailed description
Patients will be provided with training on the self-administration of the trial medication from the site trial co-ordinator.
A 1-week screening period will be followed by a 24-week randomised double-blind treatment period in which patients will be randomised (1:1) to receive a subcutaneous (SC) dose of either Presendin (containing 2 mg of exenatide [active group]) or matching placebo (placebo group), self-administered once weekly.
At the end of the randomised treatment period (Week 24), all patients will have an end-of-treatment clinic visit. Five weeks after the end-of-treatment visit, an end-of-trial safety follow-up telephone visit will be performed.
- Conditions
- Idiopathic Intracranial Hypertension
- Being tested
- Presendin, Placebo
- Keywords
- Presendin
- Medical subject headings
- Pseudotumor Cerebri
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PresendinDrug
Presendin is supplied as 2 parts, one vial consisting of a drug part (white or greyish white powder in a clear vial) and one pre-filled syringe containing the diluent part (colourless liquid). The drug part is suspended in the diluent part solution and administered SC as a suspension.
PlaceboDrug
Placebo is supplied as 2 parts (visually identical to the Presendin vial and pre-filled diluent syringe). The drug part will exclude the active pharmaceutical ingredient (exenatide acetate) and the diluent part will be the same as the active treatment diluent. The drug part is suspended in the diluent part solution and administered SC as a suspension.
| Study group | Role | What they receive |
|---|---|---|
| Presendin | Experimental | 2.0 mg Receives: Drug: Presendin |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in ICP From Baseline to Week 24 Measured by Lumbar Puncture (LP), Where a Higher LP Value Indicates Greater ICP
ICP was measured by LP (opening pressure) using an LP manometer; Baseline and Week 24 ICP values (measured in cm CSF) are presented for each subject. A standard operating procedure was followed by all study sites for all study-related ICP measurements by LP.
Measured: Baseline to Week 24
Secondary outcomes (11)
Change in Perimetric Mean Deviation (PMD), Measured by Humphrey Visual Field (HVF) Analysis (24-2 SITA-Standard), Where a Larger Negative Result Indicates Greater Visual Loss
Measured: Baseline to Week 24
Papilloedema by Change in Retinal Nerve Fibre Layer (RNFL) Thickness, With a Greater Thickness of RNFL Indicating Greater Swelling and Greater Extent of Papilloedema
Measured: Baseline to Week 24
Papilloedema by Percent Change in Optic Nerve Head Size, Measured by Optical Coherence Tomography (OCT), Where a Larger Optic Nerve Head Size Reflects Greater Swelling and a Greater Extent of Papilloedema
Measured: Baseline to Week 24
The Number of Monthly Headache Days (MHD)
Monthly headache days (according to daily headache diary) = number of days recorded in a 28-day window where data were collected on >7 days and where ≥1 headache on a day met the following criteria:
- Onset, continuation, or recurrence of headache
- Any severity or phenotype of headache
- Lasts at least 30 minutes
Baseline headache frequency was calculated over the 7 days prior to the randomization visit; ≥5 days of headache data were needed to obtain a valid baseline value. The number of headache days recorded for a period were linearly scaled by the total number of days of data collected in the period for each subject to give the MHD during the baseline period (linearly scaled to a maximum of 28 days) and the last 28-day period during which data were collected on >7 days for each subject prior to study completion or discontinuation.
Period 1 = Weeks 1-4 Period 2 = Weeks 5-8 Period 3 = Weeks 9-12 Period 4 = Weeks 13-16 Period 5 = Weeks 17-20 Period 6 = Weeks 21-24
Measured: Baseline to Week 24
Number of Moderate to Severe MHD
Moderate to severe (m-s) MHD (according to daily headache diary) = number of days recorded in a 28-day window where data were collected on >7 days and where ≥1 headache on a day met the following criteria:
- Severity was of moderate or severe pain and lasted at least 4 hours or,
- Required acute headache analgesics
Baseline m-s headache frequency was calculated over the 7 days prior to the randomization visit; ≥5 days of headache data were needed to obtain a valid baseline value. The number of m-s headache days recorded for a period were linearly scaled by the total number of days of data collected in the period for each subject to give the m-s MHD during the baseline period (linearly scaled to a max 28 days) and the last 28-day period during which data were collected on >7 days for each subject prior to study completion or discontinuation.
Period 1 = Weeks 1-4 Period 2 = Weeks 5-8 Period 3 = Weeks 9-12 Period 4 = Weeks 13-16 Period 5 = Weeks 17-20 Period 6 = Weeks 21-24
Measured: Baseline to Week 24
Number of MHD Responders (Defined as a ≥50% Reduction in MHD)
A subject was considered a responder if they had at least a 50% reduction in MHD from baseline to Week 24. Subjects who dropped out prior to Week 24 were considered non-responders.
Measured: Baseline to Week 24
Number of Moderate to Severe MHD Responders (Defined as a ≥50% Reduction in Moderate to Severe MHD)
A subject was considered a responder if they had at least a 50% reduction in moderate to severe MHD from baseline to Week 24. Subjects who dropped out prior to Week 24 were considered non-responders.
Measured: Baseline to Week 24
Headache Severity
Headache severity was assessed by a 10-point Numeric Rating Scale (NRS), 0-10 where 0 = no pain and 10 = most severe pain. Severity of headaches was assessed on days where a headache occurred. Headache free days were not counted. Baseline headache severity was calculated over the 7 days prior to the randomization visit; at least 5 of 7 days of headache severity data had to be recorded by the subject to obtain a valid baseline value.
- 28-day period 1 = Weeks 1-4
- 28-day period 2 = Weeks 5-8
- 28-day period 3 = Weeks 9-12
- 28-day period 4 = Weeks 13-16
- 28-day period 5 = Weeks 17-20
- 28-day period 6 = Weeks 21-24
Measured: Baseline to Week 24
Use of Acute Headache Analgesic Medications (Acute Headache Analgesics in Days Per Month)
Number of days recorded in a 28-day window, where at least one dose of an acute headache analgesic was recorded.
The baseline acute headache analgesic use was calculated over the 7 days prior to the randomization visit; at least 5 of 7 days had to be recorded by the subject to obtain a valid baseline value.
The number of acute headache analgesic use days was linearly scaled for each subject to give the number of acute headache analgesic use days during the baseline period and the last 28-day period during which headache data were collected on more than 7 days for each subject prior to study completion or discontinuation.
- 28-day period 1 = Weeks 1-4
- 28-day period 2 = Weeks 5-8
- 28-day period 3 = Weeks 9-12
- 28-day period 4 = Weeks 13-16
- 28-day period 5 = Weeks 17-20
- 28-day period 6 = Weeks 21-24
Measured: Baseline to Week 24
Visual Acuity
Corrected visual acuity will be recorded using a Logarithm of the Minimum Angle of Resolution (LogMAR) scoring chart, with a range of -0.3 to 1.00, where a lower score indicates better visual acuity.
Measured: Baseline to Week 24
Number of Patients With Treatment Failure
Treatment failure is defined as the initiation of either medical therapy or a surgical intervention to lower ICP during the study.
Measured: Baseline to Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2022
- Study start18 Nov 2022
- Primary completion18 Sep 2023
- Study completion20 Oct 2023
Why it stopped: Following a strategic evaluation of its IIH EVOLVE Phase III clinical trial investigating Presendin™, the Invex Board has made the difficult decision that the continuation of the trial is not viable and therefore the trial has been terminated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Idiopathic Intracranial HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This will be a placebo-controlled, double-blind, multi-centre clinical trial in approximately 240 randomised patients with IIH.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Invex Therapeutics Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Premier Research, University Hospital Birmingham, University of Iowa
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05347147
- Sponsor's protocol ID
- INVEX-CLIN-IIH-301
- Acronym
- IIH EVOLVE
- Status last verified
- Mar 2024
- First submitted
- 20 Apr 2022
- Last updated
- 24 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Randomised, Placebo-controlled, Double-blind, Multi-centre, Clinical Trial to Determine the Efficacy and Safety of Presendin in Idiopathic Intracranial Hypertension
- ClinicalTrials.gov ID
- NCT05347147
- Acronym / sponsor ID
- IIH EVOLVE / INVEX-CLIN-IIH-301
- Conditions
- Idiopathic Intracranial Hypertension
- Keywords
- Presendin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Following a strategic evaluation of its IIH EVOLVE Phase III clinical trial investigating Presendin™, the Invex Board has made the difficult decision that the continuation of the trial is not viable and therefore the trial has been terminated.
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Invex Therapeutics Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Premier Research, University Hospital Birmingham, University of Iowa
- Study start
- 18 Nov 2022 (actual)
- Primary completion
- 18 Sep 2023 (actual)
- Study completion
- 20 Oct 2023 (actual)
- First posted
- 26 Apr 2022 (actual)
- Results
- Posted 24 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Idiopathic intracranial hypertension (IIH) has significant associated morbidity and reduced quality of life. There is a significant risk of visual loss and patients also typically suffer with chronic disabling headaches.
This trial has been designed to evaluate the efficacy and safety of a new formulation of exenatide (Presendin) in the reduction of intracranial pressure (ICP) in patients with IIH.
Detailed description
Patients will be provided with training on the self-administration of the trial medication from the site trial co-ordinator.
A 1-week screening period will be followed by a 24-week randomised double-blind treatment period in which patients will be randomised (1:1) to receive a subcutaneous (SC) dose of either Presendin (containing 2 mg of exenatide [active group]) or matching placebo (placebo group), self-administered once weekly.
At the end of the randomised treatment period (Week 24), all patients will have an end-of-treatment clinic visit. Five weeks after the end-of-treatment visit, an end-of-trial safety follow-up telephone visit will be performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This will be a placebo-controlled, double-blind, multi-centre clinical trial in approximately 240 randomised patients with IIH.
| Arm | Type | Receives |
|---|---|---|
| Presendin | Experimental | Drug: Presendin2.0 mg |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age ≥18 years at the time of consent.
- Diagnosis of new IIH by consensus criteria, including normal structural brain imaging (excluding features of raised ICP and incidentalomas), including either magnetic resonance venography or computed tomographic venography to exclude thrombosis and no evidence of a secondary causes of raised ICP.
- Newly diagnosed patients with screening commenced no more than 4 weeks after the diagnostic LP.
- Lumbar puncture opening pressure ≥25 cm cerebrospinal fluid (CSF) at diagnosis.
- Presence of bilateral papilloedema (Frisén grade ≥1). Verification of papilloedema by the OCT Reading Centre. Where there is uncertainty fundus photography and/or ultrasound scan (B scan) of the optic nerves should be conducted for evaluation by the Independent Adjudication Committee (IAC).
Key exclusion criteria (31 listed)
- Presence of venous sinus thrombosis on brain imaging by either magnetic resonance or computerised tomographic venography.
- Previous IIH surgery including CSF shunt, optic nerve sheath fenestration or dural venous sinus stent or sub-temporal decompression.
- Previous bariatric surgery within the last 3 months or intention during the trial.
- Abnormal neurological examination (aside from papilloedema and consequent visual loss or sixth or seventh nerve palsy or palsies).
- Treatment to lower ICP within 1 week prior to screening visit (e.g., acetazolamide, topiramate [including if used as a migraine preventative], diuretics, glucocorticoids [I.V., injectable steroids or oral (including dexamethasone and prednisolone)]). Nasal, inhaled, or topical steroids are allowed.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PresendinPresendin is supplied as 2 parts, one vial consisting of a drug part (white or greyish white powder in a clear vial) and one pre-filled syringe containing the diluent part (colourless liquid). The drug part is suspended in the diluent part solution and administered SC as a suspension. | Drug | Presendin |
| PlaceboPlacebo is supplied as 2 parts (visually identical to the Presendin vial and pre-filled diluent syringe). The drug part will exclude the active pharmaceutical ingredient (exenatide acetate) and the diluent part will be the same as the active treatment diluent. The drug part is suspended in the diluent part solution and administered SC as a suspension. | Drug | Placebo |
Primary outcome
Change in ICP From Baseline to Week 24 Measured by Lumbar Puncture (LP), Where a Higher LP Value Indicates Greater ICP
Time frame: Baseline to Week 24
ICP was measured by LP (opening pressure) using an LP manometer; Baseline and Week 24 ICP values (measured in cm CSF) are presented for each subject. A standard operating procedure was followed by all study sites for all study-related ICP measurements by LP.
11 secondary outcomes
Change in Perimetric Mean Deviation (PMD), Measured by Humphrey Visual Field (HVF) Analysis (24-2 SITA-Standard), Where a Larger Negative Result Indicates Greater Visual Loss
Time frame: Baseline to Week 24
Papilloedema by Change in Retinal Nerve Fibre Layer (RNFL) Thickness, With a Greater Thickness of RNFL Indicating Greater Swelling and Greater Extent of Papilloedema
Time frame: Baseline to Week 24
Papilloedema by Percent Change in Optic Nerve Head Size, Measured by Optical Coherence Tomography (OCT), Where a Larger Optic Nerve Head Size Reflects Greater Swelling and a Greater Extent of Papilloedema
Time frame: Baseline to Week 24
The Number of Monthly Headache Days (MHD)
Time frame: Baseline to Week 24
Number of Moderate to Severe MHD
Time frame: Baseline to Week 24
Number of MHD Responders (Defined as a ≥50% Reduction in MHD)
Time frame: Baseline to Week 24
Number of Moderate to Severe MHD Responders (Defined as a ≥50% Reduction in Moderate to Severe MHD)
Time frame: Baseline to Week 24
Headache Severity
Time frame: Baseline to Week 24
Use of Acute Headache Analgesic Medications (Acute Headache Analgesics in Days Per Month)
Time frame: Baseline to Week 24
Visual Acuity
Time frame: Baseline to Week 24
Number of Patients With Treatment Failure
Time frame: Baseline to Week 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Idiopathic Intracranial Hypertension
Not yet recruitingObservational study
Multimodal MRI Assessment of Brain Fluid Circulation in Idiopathic Intracranial Hypertension
Idiopathic Intracranial Hypertension
RecruitingPhase 4
Tirzepatide in Idiopathic Intracranial Hypertension Trial
Idiopathic Intracranial Hypertension (IIH)
Active, not recruitingObservational study
Disease Biosignatures in ALS/FTD Spectrum: New Impactful Biological Perspectives Beyond Clinical Approaches
ALS (Amyotrophic Lateral Sclerosis), FTD
Active, not recruiting
Idiopathic Intracranial Hypertension: Prognostic Factors and Multidisciplinary Management
Idiopathic Intracranial Hypertension
Not yet recruitingPhase 3
Eptinezumab for Chronic Headache in Idiopathic Intracranial Hypertension
Idiopathic Intracranial Hypertension (IIH)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
24 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Presendin in people with Idiopathic Intracranial Hypertension, run by Invex Therapeutics Ltd. at 24 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in United States, Israel, Australia, Germany, United Kingdom and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in ICP From Baseline to Week 24 Measured by Lumbar Puncture (LP), Where a Higher LP Value Indicates Greater ICP (time frame: Baseline to Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2024.