Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44311   clinical trials with a EudraCT protocol, of which   7356   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2021-006664-24
    Sponsor's Protocol Code Number:INVEX-CLIN-IIH-301
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2022-12-22
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedFrance - ANSM
    A.2EudraCT number2021-006664-24
    A.3Full title of the trial
    A Phase III randomised, placebo-controlled, double-blind, multi-centre, clinical trial to determine the efficacy and safety of Presendin in idiopathic intracranial hypertension
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical trial to determine the efficacy and safety of Presendin in idiopathic intracranial hypertension
    A.3.2Name or abbreviated title of the trial where available
    IIH EVOLVE
    A.4.1Sponsor's protocol code numberINVEX-CLIN-IIH-301
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT05347147
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorInvex Therapeutics Ltd.
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportInvex Therapeutics Ltd.
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationInvex Therapeutics Ltd.
    B.5.2Functional name of contact pointClinical Operations Department
    B.5.3 Address:
    B.5.3.1Street AddressPO Box 406
    B.5.3.2Town/ cityKidlington
    B.5.3.3Post codeOX5 9FF
    B.5.3.4CountryUnited Kingdom
    B.5.6E-mailiihevolve@invextherapeutics.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/16/1629
    D.3 Description of the IMP
    D.3.1Product nameExenatide
    D.3.2Product code Presendin
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNExenatide acetate
    D.3.9.1CAS number 141758-74-9
    D.3.9.3Other descriptive namePT320, PT302 and YH14617
    D.3.9.4EV Substance CodeSUB21818
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.0
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSuspension for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Idiopathic intracranial hypertension
    E.1.1.1Medical condition in easily understood language
    intracranial hypertension with unknown cause
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.1
    E.1.2Level PT
    E.1.2Classification code 10078904
    E.1.2Term Idiopathic intracranial hypertension
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the efficacy of Presendin administered subcutaneously once weekly for 24 weeks to patients with IIH, as determined by change in ICP, as measured by LP at baseline and at 24 weeks.
    The baseline LP is the diagnostic LP.
    E.2.2Secondary objectives of the trial
    To determine the effect of Presendin on change in:
    Perimetric Mean Deviation as measured by Humphrey Visual Field analysis (24-2 SITA-Standard)
    • Papilloedema by change in optical coherence tomography (retinal nerve fibre layer (RNFL) thickness and optic nerve head size)
    • Monthly headache days (MHD)
    • Moderate to severe monthly headache days
    • Headache responder rate (≥50% reduction in monthly headache days)
    • Headache responder rate (≥50% reduction in moderate to severe monthly headache days)
    • Headache severity
    • Monthly use of acute headache analgesic medications
    • Visual acuity
    • Treatment failure
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age >18 years at the time of consent
    2. Diagnosis of new IIH by consensus criteria, including normal structural brain imaging (excluding features of raised intracranial pressure and incidentalomas), including either magnetic resonance venography or computed tomographic venography to exclude thrombosis and no evidence of a secondary causes of raised intracranial pressure
    3. Newly diagnosed patients with screening commenced no more than 4 weeks after the diagnostic LP
    4. Lumbar puncture opening pressure ≥ 25 cm cerebrospinal fluid (CSF) at diagnosis
    5. 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)
    6. Perimetric Mean Deviation (PMD) defined as between -2 to -7 decibels (dB) in at least one eye. Eyes meeting this criteria will be defined as ‘study eyes’
    7. 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
    8. 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
    9. 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 (FSH) 25-140 IE/L and oestradiol <200 pmol/L is confirmatory])
    10. 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)
    11. Able to provide written informed consent
    Note: This would restrict the ability of vulnerable patients, such as inmates of psychiatric wards, prison or state institutions, with commitment to an institution or a patient who is detained or committed to an institution by a law court or by legal authorities to be included on the grounds that informed consent could not be assumed.
    E.4Principal exclusion criteria
    1.Presence of venous sinus thrombosis on brain imaging by either magnetic resonance or computerised tomographic venography
    2. Previous IIH surgery including CSF shunt, optic nerve sheath fenestration or dural venous sinus stent or sub-temporal decompression
    3. Previous bariatric surgery within the last 3 months or intention during the trial
    4. Abnormal neurological examination (aside from papilloedema and consequent visual loss or sixth or seventh nerve palsy or palsies)
    5. 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)
    6. 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
    7.Any disease other than refractive error that causes visual loss in the study eyes. Where there is uncertainly this would be determined by the Independent Adjudication Committee [IAC]
    8. 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
    9. Inability to perform a reliable visual field examination as deemed by the Visual Field Reading Centre in the study eyes. Where there is uncertainly this would be evaluated by the Independent Adjudication Committee [IAC]
    10. Does not complete ≥6 days of electronic/paper trial diary during the 7-day screening period
    11. Untreated previously diagnosed obstructive sleep apnoea with historically recorded apnoea-hypopnea index greater than 15
    12. Glucagon like peptide-1 receptor agonist within last 4 weeks prior to screening
    13. COVID-19 vaccine within 2 weeks prior to screening
    14. Allergy/known hypersensitivity to the active substance and/or excipients of the investigational product
    15. 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
    16. History of drug-induced immune-mediated thrombocytopenia from exenatide products
    17. Personal or family history of medullary thyroid carcinoma or in patients with Multiple Endocrine Neoplasia syndrome type 2
    18. Using any glucose-lowering medication
    19. Currently taking warfarin
    20. 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)
    21. Kidney disease (as defined by serum cystatin C-based estimated glomerular filtration rate [eGFR] <55 mL/min/1.73 m2, calculated at investigator site)
    22. 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: Hemoglobin <10 g/dL (<100 g/L); Platelet count <75 x 109/L (<75,000/mm3)
    23. 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 DSM-5 criteria, that in the opinion of the investigator puts the patient at risk
    24. Is unable to self-administer the trial medication (or unable to administer trial
    medication with support) after receiving training during the Screening period
    25. 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
    26. Any contraindication to lumbar puncture procedure in the opinion of the investigator
    27. Has participated in any other interventional trial within 1 month prior to the screening visit.
    28. Is pregnant or breastfeeding
    E.5 End points
    E.5.1Primary end point(s)
    Change in ICP from baseline to Week 24 measured by LP.
    The baseline LP is the diagnostic LP.
    E.5.1.1Timepoint(s) of evaluation of this end point
    week 24
    E.5.2Secondary end point(s)
    • Perimetric Mean Deviation
    • Retinal nerve fibre layer (RNFL) thickness
    • Optic nerve head size
    • The number of monthly headache days (MHD). Monthly headache days will include all headache days, defined as those with an onset, continuation or recurrence, any severity or phenotype of headache, lasting at least 30 minutes or which require acute headache analgesia
    • Number of monthly moderate to severe headache days. A moderate/severe headache day will be defined as a day with moderate or severe pain that lasts at least 4 hours or that requires acute headache analgesic medications
    • Responder rate monthly headache days (defined as a ≥50% reduction)
    • Responder rate moderate to severe monthly headache days (defined as a ≥50% reduction)
    • Headache severity (assessed by 11-point Numeric Rating Scale [NRS], 0-10 where 0 = no pain and 10 = most severe pain)
    • Use of acute headache analgesic medications (acute headache analgesics in days per month)
    • Visual acuity, as measured by logarithm of the minimum angle or resolution (LogMAR) units
    • Treatment failure, defined as initiation of either medical therapy or a surgical intervention to lower ICP
    E.5.2.1Timepoint(s) of evaluation of this end point
    Refer to Trial assessments in protocol. Table 1
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA11
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Israel
    New Zealand
    United States
    France
    Germany
    United Kingdom
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months2
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 235
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 78
    F.4.2.2In the whole clinical trial 240
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2023-04-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-03-29
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2023-08-21
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA