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    Summary
    EudraCT Number:2021-004994-30
    Sponsor's Protocol Code Number:NL68837.091.21
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-02-03
    Trial 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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2021-004994-30
    A.3Full title of the trial
    Pulmonary function and sleep related disorders during cervical admission of intrathecal baclofen in spinal cord injury; a safety study
    Longfunctie en slaapgerelateerde stoornissen tijdens cervicaal toegediende intrathecale baclofen bij patiënten met een dwarslaesie.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Pulmonary function and sleep related disorders during admission baclofen at the level of cervical spine in spinal cord injury; a safety study
    Longfunctie en slaapgerelateerde stoornissen tijdens toediening van baclofen rondom ruggemerg ter hoogte van de nek bij patiënten met een dwarslaesie.
    A.3.2Name or abbreviated title of the trial where available
    Safety of cervical intrathecal baclofen
    A.4.1Sponsor's protocol code numberNL68837.091.21
    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 SponsorRoessingh
    B.1.3.4CountryNetherlands
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportRoessingh
    B.4.2CountryNetherlands
    B.4.1Name of organisation providing supportMedtronic
    B.4.2CountryUnited States
    B.4.1Name of organisation providing supportStichting the Neurobionics Foundation
    B.4.2CountryNetherlands
    B.4.1Name of organisation providing supportBedrijf OSA-sense
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRoessingh
    B.5.2Functional name of contact pointWetenschapsraad Roessingh
    B.5.3 Address:
    B.5.3.1Street AddressRoessinghbleekweg 33
    B.5.3.2Town/ cityEnschede
    B.5.3.3Post code7522 AH
    B.5.3.4CountryNetherlands
    B.5.4Telephone number0031534875291
    B.5.6E-maile.maas@roessingh.nl
    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 Baclofen Sintetica Intrathecaal 0,5 mg/ml Werkzame stof: baclofen
    D.2.1.1.2Name of the Marketing Authorisation holderSintetica GmbH
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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.3.4Pharmaceutical form Solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntrathecal 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 No
    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
    Spasticity in patients with spinal cord injury
    spasticiteit bij patiënten met een dwarslaesie
    E.1.1.1Medical condition in easily understood language
    spasticity in spinal cord injury
    verhoogde spierspanning bij patiënten met een dwarslaesie
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Primary Objective:
    The primary goal of the study is to demonstrate that cervical admission of ITB is a safe treatment without deterioration of pulmonary and respiratory function and possible increased risk or increased severity of SAS.
    E.2.2Secondary objectives of the trial
    Secondary objective:
    Secondary goal of the study is to explore the effect of cervical admission of ITB on reduction of spasticity (both functional en satisfaction) and improvement at the level of patients functions and activities.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    In order to be eligible to participate in this study, a subject must meet all of the following criteria:
    • Cervical SCI neurological level C1-Th1,
    • Functionally hindering generalized spasticity of the upper extremities with insufficient effect or too many side effects of oral spasmolytics and/or local treatments
    • American Spinal Injury Association (ASIA) Impairment Scale: A,B,C,D
    • > 1 year after onset of SCI
    • Over 18 years old
    • No progressive disease
    • Stabile medical situation for undergoing the ITB-trial and a final implantation of a baclofen pump after positive test
    • No muscle or nerve blocks < 6 months for start of study
    E.4Principal exclusion criteria
    A potential subject who meets any of the following criteria will be excluded from participation in this study:
    • Pregnancy
    • Allergy baclofen
    • Contra indication ITB (increased bleeding tendency, increased intracranial pressure, severe pressure ulcer)
    • Oral anticoagulants
    • Severe depression
    • excessive alcohol use
    • Patients depending on ventilation
    • Not adequately treated SAS
    • PcCO2 > 6,5 KPa
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of the study is treatment safety, which is defined as PcCO2 between 4,7 kPa and 6,5 kPa and an AHI ( APNEU HYPOPNEU INDEX,) (< 15 without complaints of SAS (sleep apneu syndrom) in patients without SAS and an AHI < 5 in patients with treated SAS. If patients use a CPAP device, it may be adjusted to stay within the safe margin. This adjustment will be registered.

    Respiration: The quality of breathing is determined by means of a capillary blood gas.
    Sleep apnea: This involves the use of OSAsense and, if necessary, a poly-(somno)graphy.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Respiration: The quality of breathing is determined by means of a capillary blood gas.
    Sleep apnea: This involves the use of OSAsense and, if necessary, a poly-(somno)graphy.


    These endpoints are evaluated during the test phase in the hospital (4 moments) and after definitive implantation of a baclofen pump after 3, 6 and 12 months
    E.5.2Secondary end point(s)
    Secondary endpoints are the amount of spasticity, patients satisfaction and patients level of function and activities.

    Spasticity: This is measured by Perceived Resistance to Passive Movement (PRPM).
    Patient satisfaction: This is measured by Patient Global Impression of Change (PGIC).
    The following parameters are already usual care before, during and after ITB trial phase in Roessingh:
    Function level:
    • Muscle strength core muscles UE and LE by MRC scale.
    o Elbow flexion/extension
    o Wrist flexion/extension
    o Finger flexion/extension
    o Hipflexors
    o Knee extensors
    o Dorsal flexors
    o Extensor dig I
    o Plantar flexors
    • Passive range of motion (ROM) UE and LE in degrees
    o Elbow flexion/extension
    o Wrist flexion/extension
    o Finger flexion/extension
    o Hip flexion/extension
    o Hip abduction/adduction
    o Knee flexion/extension
    o Ankle flexion/extension
    Activity/participation level
    • COPM: Canadian Occupational Performance Measure
    • Time up and go test
    • 10 meter walking test


    We will add to this usual care for current study:
    Function level:
    • Force lateral and cylinder grasp
    • Respiration: The quality of breathing is determined by means of a capillary blood gas.
    • Sleep apnea: This involves the use of OSAsense and, if necessary, a poly-somnography.
    • Pulmonary function: The pulmonary function is determined by spirometry.

    Activity/participation level:
    • GRASPP: The Graded Redefined Assessment of Strength, Sensibility and Prehension
    • QIF-sf: Quadriplegia Index of Functions short form
    E.5.2.1Timepoint(s) of evaluation of this end point
    The spasticity and the patients satisfaction is evaluated at the same time points as the primary endpoints.

    Patients level of function and activity is evaluated 3, 6 and 12 month after defenitive implantation of a baclofen pump
    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 Yes
    E.6.5Efficacy Yes
    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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    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
    prospective intervention study
    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.8.3 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 concerned2
    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 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 years4
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    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: 5
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 6
    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 state11
    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
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2022-02-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-02-08
    P. End of Trial
    P.End of Trial StatusOngoing
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