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    Summary
    EudraCT Number:2019-000740-10
    Sponsor's Protocol Code Number:901809
    National Competent Authority:Norway - NOMA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2019-11-05
    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 ConcernedNorway - NOMA
    A.2EudraCT number2019-000740-10
    A.3Full title of the trial
    Hyperbaric oxygen therapy after cerebral infarction
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Hyperbaric oxygen therapy after stroke
    A.4.1Sponsor's protocol code number901809
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04149379
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorNUI As
    B.1.3.4CountryNorway
    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 supportHordaland fylkeskommune
    B.4.2CountryNorway
    B.4.1Name of organisation providing supportForskningsrådet
    B.4.2CountryNorway
    B.4.1Name of organisation providing supportRepsol Norge As
    B.4.2CountryNorway
    B.4.1Name of organisation providing supportGassco As
    B.4.2CountryNorway
    B.4.1Name of organisation providing supportSpirit Energy As
    B.4.2CountryNorway
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationWestern Norway University of Applied Sciences
    B.5.2Functional name of contact pointTobba Therkildsen Sudmann
    B.5.3 Address:
    B.5.3.1Street AddressInndalsveien 28
    B.5.3.2Town/ cityBergen
    B.5.3.3Post code5063
    B.5.3.4CountryNorway
    B.5.4Telephone number4755585675
    B.5.6E-mailTobba.Therkildsen.Sudmann@hvl.no
    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 Yes
    D.2.1.1.1Trade name Medisinsk Oksygen Air Liquide 100%, medisinsk gass, komprimert English: Medical oxygen, 100%, compressed
    D.2.1.1.2Name of the Marketing Authorisation holderAir Liquide Norway
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameMedisinsk oksygen komprimert
    D.3.4Pharmaceutical form Inhalation vapour
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInhalation use
    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 Yes
    D.3.11.13.1Other medicinal product typeOxygen 100%
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Chronic physical and/or cognitive imparement after cerebral infarction.
    E.1.1.1Medical condition in easily understood language
    Patients with chronic physical and/or cognitive disability after going through stroke.
    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 21.1
    E.1.2Level PT
    E.1.2Classification code 10067056
    E.1.2Term Cognitive rehabilitation
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level SOC
    E.1.2Classification code 10029205
    E.1.2Term Nervous system disorders
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10057374
    E.1.2Term Rehabilitation therapy
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10076483
    E.1.2Term Neurological rehabilitation
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Establish more information about hyperbaric oxygen therapy for this
    group of patients. Can we find any indications that supports use of this
    therapy for patients suffering from chronic disability after cerebral
    infarction. Can we improve physical and cognitive function.
    E.2.2Secondary objectives of the trial
    This is a pilot project including 6 patients for one session of 20 HBO2
    treatments. The objective is to establish knowledge of HBO for this
    group of patients in a Norwegian context, so that we can prepare for the
    main study afterwards, including about 70 patients. We need to know
    how to optimize the administrative and technical systems for the larger
    study. We want to collect feedback from the patients undergoing the
    pilot study. We want more information about the treatment table, if 20
    treatments are enough, if 2,4 bar pressure is adequate. The treatment
    table is based on existing research, and is considered safe.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inlcution criteria:
    - No age restriction, other than women under 55 yeras of age, because of risk of pregnancy
    - Suffered from ischemic stroke (cerebral infarction) 6-12 months before inclusion.
    - Stable phase after standard rehabilitation (https://www.helsedirektoratet.no/pakkeforlop/hjerneslag/oppfolging-og-rehabilitering-ved-hjerneslag)
    - Measurable physical function failure and / or reduced ADL function.
    - Sufficient physical function / mobility to be able to move into / out of the pressure chamber with the help of only one person (Tender).
    E.4Principal exclusion criteria
    Patients to participate in the study must be physically, mentally and cognitively fit for pressure chamber treatment. They must be able to stand for their own help, move with support, and be able to follow instructions. This is ensured by discretionary assessment after observation and interview with the patient. Women in childbearing age (up to, and including 55 years old women) are excluded because the effect of hyperbaric oxygen on the fetus is not fully understood).

    Patients who have the following contraindications cannot participate in the study.
    - Claustrophobia
    - Psychosis, severe anxiety
    - Inability to equalize pressure in the middle ear
    - Severe COPD and asthma, pathological lung sounds
    - Hypertension (Blood pressure > 140/90 mmHg)
    - Epilepsy whith history of seizures
    - Pregnancy or the possibility for pregnancy
    - Hernia
    - Earlier fractures, or suspected fractures in the face
    - Ongoing chemotherapy
    - Ongoing treatment with Disulfiram
    - ongoing or previous treatment with Bleomycin
    - Aphasia that prevents necessary communication
    - Cognitive failure that prevents necessary co-operation in the pressure chamber.
    - Previous or current pneumothorax, other lung injury
    - Increased risk of pneumothorax
    --Known or suspected injury to the chest
    --Marfan syndrome
    --Homocystinuria
    --Family history of pneumothorax
    --Chronic lung disease (COPD, Emphysema, Asthma eller cystic fibrosis)
    --Tuberculosis
    - Illness in ears, nose or thorat, that could lead to problems during compression/decompression (chronic rhinitis, holes in the eardrum, laryngocele, vestibular syndrome, recent surgery on the middle ear)
    - Fever uncontrolled, temperature 38,5 Celcius and over.

    In the case of sudden and transient illness such as sinusitis and ear infections, NUI's physician assesses the risk of each patient before treatment can be given.
    E.5 End points
    E.5.1Primary end point(s)
    The treatment period is planned to be 7. Sept 2020, and will be ongoing until 2. Oct 2020.
    The patients will be followed up until 12 months after treatment, 1. Oct 2021.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Evaluation is an ongoing process, starting when treatment is ongoing. Final evaluation is planned 12 months after treatment is finished. Oct 2021.
    E.5.2Secondary end point(s)
    None
    E.5.2.1Timepoint(s) of evaluation of this end point
    None
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    SSDE – Singel Subject experimental design
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    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
    None
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    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: 3
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 3
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state6
    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 Decision2019-12-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-03-05
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2020-04-21
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