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A Trial to Determine the Efficacy and Safety of Presendin in IIH (IIH EVOLVE)

Primary Purpose

Idiopathic Intracranial Hypertension

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Presendin
Placebo
Sponsored by
Invex Therapeutics Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Idiopathic Intracranial Hypertension focused on measuring Presendin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 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.
  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 defined as between -2 to -7 decibels (dB) in at least one eye. Eyes meeting this criterion will 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 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.

Exclusion Criteria:

IIH-related 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.

    Vision-related exclusion criteria:

  7. 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.
  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 uncertainty this would be evaluated by the IAC.

    Headache-related exclusion criteria:

  10. Does not complete ≥6 days of electronic/paper trial diary during the 7-day screening period.

    Other exclusion criteria:

  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. Using any glucose-lowering medication.
  17. Currently taking warfarin.
  18. 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).
  19. Kidney disease (as defined by serum cystatin C-based estimated glomerular filtration rate <55 mL/min/1.73 m², calculated at investigator site).
  20. 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).
  21. 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.
  22. Is unable to self-administer the trial medication (or unable to administer trial medication with support) after receiving training during the screening period.
  23. 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.
  24. Any contraindication to lumbar puncture procedure in the opinion of the investigator.
  25. Has participated in any other interventional trial within 1 month prior to the screening visit.
  26. 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.

Sites / Locations

  • UCHealth Sue Anschutz-Rodgers Eye Center - Anschutz Medical Campus
  • University of Miami Leonard M. Miller School of Medicine (UMMSM) - Bascom Palmer Eye Institute
  • University of Minnesota Health
  • New York Eye and Ear Infirmary of Mount Sinai
  • Vanderbilt Eye Institute
  • The University of Texas Southwestern Medical Center
  • Neuro-Eye Clinical Trials, Inc
  • Liverpool Hospital
  • Sydney Eye Hospital
  • Vision SA
  • Alfred Health - The Alfred Centre
  • University Hospital Bonn
  • Universitätsklinikum Freiburg
  • Universitaetsmedizin Mainz
  • University Hospital Muenster, Department Ophthalmology Clinical Trials in Ophthalmology (CTO)
  • Rambam Medical Center
  • Bnai Zion Medical Center
  • The Edith Wolfson Medical Center
  • Shaare Zedek Medical Center
  • Hadassah Medical Center - Ein Karem
  • Pade Medical Center (Poriya)
  • New Zealand Clinical Research (Aukland)
  • University Hospitals Birmingham NHS Foundation Trust - Queen Elizabeth Hospital Birmingham
  • Guy's and St Thomas' NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Presendin

Placebo

Arm Description

2.0 mg

Outcomes

Primary Outcome Measures

Change in ICP from baseline to Week 24 measured by lumbar puncture (LP), where a higher LP value indicates greater ICP

Secondary Outcome Measures

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
Papilloedema by change in retinal nerve fibre layer (RNFL) thickness, with a greater thickness of RNFL indicating greater swelling and greater extent of papilloedema
Papilloedema by 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
The number of monthly headache days (MHD)
Number of moderate to severe MHD
Responder rate MHD (defined as a ≥50% reduction in MHD)
Responder rate moderate to severe MHD (defined as a ≥50% reduction in moderate to severe MHD)
Headache severity
Headache severity will be 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
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.
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.

Full Information

First Posted
April 20, 2022
Last Updated
October 24, 2023
Sponsor
Invex Therapeutics Ltd.
Collaborators
Premier Research Group plc
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1. Study Identification

Unique Protocol Identification Number
NCT05347147
Brief Title
A Trial to Determine the Efficacy and Safety of Presendin in IIH
Acronym
IIH EVOLVE
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Terminated
Why 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.
Study Start Date
November 18, 2022 (Actual)
Primary Completion Date
September 18, 2023 (Actual)
Study Completion Date
October 20, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Invex Therapeutics Ltd.
Collaborators
Premier Research Group plc

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Intracranial Hypertension
Keywords
Presendin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
This will be a placebo-controlled, double-blind, multi-centre clinical trial in approximately 240 randomised patients with IIH.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Investigators and other site personnel, patients, contract research organisation and Sponsor personnel will be blinded regarding the treatment during the randomised period.
Allocation
Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Presendin
Arm Type
Experimental
Arm Description
2.0 mg
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Presendin
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
Title
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
Title
Papilloedema by 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
Title
The number of monthly headache days (MHD)
Time Frame
Baseline to Week 24
Title
Number of moderate to severe MHD
Time Frame
Baseline to Week 24
Title
Responder rate MHD (defined as a ≥50% reduction in MHD)
Time Frame
Baseline to Week 24
Title
Responder rate moderate to severe MHD (defined as a ≥50% reduction in moderate to severe MHD)
Time Frame
Baseline to Week 24
Title
Headache severity
Description
Headache severity will be assessed by 11-point Numeric Rating Scale (NRS), 0-10 where 0 = no pain and 10 = most severe pain).
Time Frame
Baseline to Week 24
Title
Use of acute headache analgesic medications (acute headache analgesics in days per month)
Time Frame
Baseline to Week 24
Title
Visual acuity
Description
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.
Time Frame
Baseline to Week 24
Title
Number of patients with treatment failure
Description
Treatment failure is defined as the initiation of either medical therapy or a surgical intervention to lower ICP during the study.
Time Frame
Baseline to Week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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'. 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. Exclusion Criteria: 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. 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.
Facility Information:
Facility Name
UCHealth Sue Anschutz-Rodgers Eye Center - Anschutz Medical Campus
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
University of Miami Leonard M. Miller School of Medicine (UMMSM) - Bascom Palmer Eye Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
University of Minnesota Health
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
New York Eye and Ear Infirmary of Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10075
Country
United States
Facility Name
Vanderbilt Eye Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
The University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Neuro-Eye Clinical Trials, Inc
City
Houston
State/Province
Texas
ZIP/Postal Code
77074
Country
United States
Facility Name
Liverpool Hospital
City
Liverpool
State/Province
New South Wales
ZIP/Postal Code
2170
Country
Australia
Facility Name
Sydney Eye Hospital
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2000
Country
Australia
Facility Name
Vision SA
City
Kent Town
State/Province
South Australia
ZIP/Postal Code
5056
Country
Australia
Facility Name
Alfred Health - The Alfred Centre
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Facility Name
University Hospital Bonn
City
Bonn
ZIP/Postal Code
53105
Country
Germany
Facility Name
Universitätsklinikum Freiburg
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Facility Name
Universitaetsmedizin Mainz
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
University Hospital Muenster, Department Ophthalmology Clinical Trials in Ophthalmology (CTO)
City
Münster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Rambam Medical Center
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Facility Name
Bnai Zion Medical Center
City
Haifa
ZIP/Postal Code
3339419
Country
Israel
Facility Name
The Edith Wolfson Medical Center
City
Holon
ZIP/Postal Code
5822012
Country
Israel
Facility Name
Shaare Zedek Medical Center
City
Jerusalem
ZIP/Postal Code
9103102
Country
Israel
Facility Name
Hadassah Medical Center - Ein Karem
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
Pade Medical Center (Poriya)
City
Tiberias
ZIP/Postal Code
1528001
Country
Israel
Facility Name
New Zealand Clinical Research (Aukland)
City
Auckland
ZIP/Postal Code
0624
Country
New Zealand
Facility Name
University Hospitals Birmingham NHS Foundation Trust - Queen Elizabeth Hospital Birmingham
City
Birmingham
ZIP/Postal Code
B15 2GW
Country
United Kingdom
Facility Name
Guy's and St Thomas' NHS Foundation Trust
City
London
ZIP/Postal Code
SE1 7EH
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Trial to Determine the Efficacy and Safety of Presendin in IIH

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