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Clinical Trials/EUCTR2021-006664-24-DE
EUCTR2021-006664-24-DEActive, not recruitingPhase 1

A Phase III randomised, placebo-controlled, double-blind, multi-centre, clinical trial to determine the efficacy and safety of Presendin in idiopathic intracranial hypertension - IIH EVOLVE

Invex Therapeutics Ltd.0 sites240 target enrollmentStarted: December 22, 2022Last updated:
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Conditions

Trial Snapshot

Phase
Phase 1
Status
Active, not recruiting
Enrollment
240
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

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.
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1.2 Adults (18-64 years) yes
  • •F.1.2.1 Number of subjects for this age range 235
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range 5

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
  • •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

Investigators

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