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    Summary
    EudraCT Number:2021-004110-20
    Sponsor's Protocol Code Number:78666
    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:2022-07-12
    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 number2021-004110-20
    A.3Full title of the trial
    Improving symptomatic treatment with pyridostigmine and amifampridine: a randomized double-blinded,
    placebo controlled crossover trial in patients with myasthenia gravis (IMPACT-MG)
    Verbeteren van de symptomatische behandeling met pyridostigmine en amifampridine: een
    gerandomiseerd, dubbelblind, placebo-gecontroleerd onderzoek bij patiënten met myasthenia gravis
    (IMPACT-MG)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Improving symptomatic treatment with pyridostigmine and amifampridine in patients with myasthenia gravis
    Verbeteren van de symptomatische behandeling met pyridostigmine en amifampridine bij patienten met myasthenia gravis.
    A.3.2Name or abbreviated title of the trial where available
    Pyridostigmine and amifampridine for myasthenia gravis
    Pyridostigmine en amifampridine bij patienten met myasthenia gravis
    A.4.1Sponsor's protocol code number78666
    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 SponsorLeiden University Medical Center
    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 supportLeiden University Medical Center
    B.4.2CountryNetherlands
    B.4.1Name of organisation providing supportNMD Pharma
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLeiden University Medical Center
    B.5.2Functional name of contact pointIMPACT-MG study contact
    B.5.3 Address:
    B.5.3.1Street AddressAlbinusdreef 2
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2333 ZA
    B.5.3.4CountryNetherlands
    B.5.4Telephone number0031715266523
    B.5.6E-mailmyasthenie@lumc.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.2.1.2Country 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.3.1Product nameAmifampridine
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral 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.IMP: 2
    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 Mestinon
    D.2.1.1.2Name of the Marketing Authorisation holderMylan Healthcare B.V.
    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.3.1Product namePyridostigmine
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPyridostigmine bromide
    D.3.9.1CAS number 155-97-5
    D.3.9.3Other descriptive namePYRIDOSTIGMINE
    D.3.9.4EV Substance CodeSUB15059MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number720
    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 placeboTablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Myasthenia Gravis
    Myasthenia Gravis
    E.1.1.1Medical condition in easily understood language
    Myasthenia Gravis
    Myasthenia Gravis
    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 24.0
    E.1.2Level LLT
    E.1.2Classification code 10085562
    E.1.2Term AChR myasthenia gravis
    E.1.2System Organ Class 100000004852
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    1. To determine the efficacy of pyridostigmine compared to placebo on MG symptoms in patients with AChR MG as measured by the MGII.
    2. To determine the efficacy of amifampridine compared to placebo on MG symptoms in patients with AChR MG using pyridostigmine as measured by the MGII.
    1. Het bepalen van de effectiviteit van pyridostigmine in vergelijking met placebo op de symptomen bij patiënten met AChR MG gemeten door middel van de MGII.
    2. Het bepalen van de effectiviteit van amifampridine in vergelijking met placebo op de symptomen bij patiënten met AChR MG die pyridostigmine gebruiken, gemeten door middel van de MGII.
    E.2.2Secondary objectives of the trial
    a) To assess patient satisfaction with pyridostigmine and add-on amifampridine as measured by TSQM-9.
    b) To determine the tolerability of pyridostigmine and add-on amifampridine as measured by a side effects questionnaire.
    c) To evaluate the impact of pyridostigmine and add-on amifampridine on quality of life as measured by the MG-QoL15r and EQ-5D-5L.
    d) To determine efficacy of pyridostigmine and amifampridine add-on compared to placebo on the QMG, MG-ADL and MGII ocular and general subscores.
    e) To evaluate the PK and PD of amifampridine (for those subjects in the PK/PD Substudy only).
    f) To evaluate the PK parameters of pyridostigmine when taking with and without amifampridine (for those subjects in the PK/PD Substudy).
    g) To assess cost-utility of amifampridine as add on in patients with AChR-MG.
    h) To determine whether long-term efficacy, patient satisfaction, tolerability and impact on quality of life is sustained over a six-month period.
    a) Beoordelen van patienttevredenheid van pyridostigmine en add-on amifampridine in vergelijking met placebo, d.m.v. de TSQM-9.
    b) De verdraagbaarheid van pyridostigmine en amifampridine als add-on, d.m.v een op maat gemaakte vragenlijst voor bijwerkingen.
    c) Evaluatie van de impact van pyridostigmine en add-on amifampridine in vergelijking met placebo op kwaliteit van leven d.m.v de MG-QoL15r en EQ-5D-5L.
    d) Bepalen van de werkzaamheid van pyridostigmine en amifampridine add-on in vergelijking met placebo op de QMG, MG-ADL en MGII oculaire en gegeneraliseerde subscores.
    e) Evalueren van PK en PD van amifampridine (voor proefpersonen in de PK/PD-substudie).
    f) Evalueren van PK-parameters van pyridostigmine bij inname met en zonder amifampridine (voor proefpersonen in de PK/PD-substudie).
    g) Beoordelen van kosten-utiliteit van amifampridine als add-on bij patienten met AChR-MG.
    h) Bepalen van lange-termijn-effect en de lange-termijn bijwerkingen van amifampridine na 6 maanden.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Patients will have the option to participate in a PK/PD Substudy. The purpose of the PK/PD Substudy is to characterize the PK and PD of amifampridine in AChR positive MG patients. Subjects enrolled in the Substudy will provide consent for additional blood samples for the purpose of PK/PD analyses.
    Patienten zullen de mogelijkheid hebben om deel te nemen aan een PK/PD-substudie. Het doel van de PK/PD-substudie is het karakteriseren van de PK en PD van amifampridine bij AChR-positieve MG-patiënten. Proefpersonen die deelnemen aan de Substudie zullen toestemming geven voor aanvullende bloedmonsters ten behoeve van PK/PD-analyses.
    E.3Principal inclusion criteria
    1. Age >18 years
    2. AChR positive myasthenia gravis (ocular or generalized)
    3. Current use of pyridostigmine
    4. MGFA Clinical Classification I-IV
    5. Receiving a stable dose of MG treatment (other than pyridostigmine). If applicable:
    a. A stable steroid regimen for 1 month
    b. Nonsteroidal immunosuppressants:
    i. Azathioprine, mycophenolate mofetil, cyclosporine or other nonsteroid immunosuppressive agents start > 3 months ago and a stable regimen for 1 month.
    ii. Rituximab, complement inhibitors and Fc receptor inhibitors start > 6 months ago and a stable regimen for 3 months.
    1. Leeftijd >18 jaar
    2. AChR positieve myasthenia gravis (oculair of gegeneraliseerd)
    3. Actueel gebruik van pyridostigmine
    4. MGFA klasse I-IV
    5. Stabiele dosering van MG behandeling (anders dan pyridostigmine). Indien van toepassing:
    a. Stabiele dosering steroiden gedurende 1 maand
    b. Immuuunsuppressiva anders dan steroiden:
    i. Azathioprine, mycophenolate mofetil, cyclosporine of andere immuunsuppressiva start > 3 maanden geleden en een stabiele dosering gedurende 1 maand.
    ii. Rituximab, complement inhibitors en Fc receptor inhibitors start > 6 maanden geleden en een stabiele dosering gedurende 3 maanden.
    E.4Principal exclusion criteria
    1. Use of intravenous immunoglobulin or plasma exchange <4 weeks
    2. Thymectomy < 6 months, or thymectomy (expected) to take place during the trial
    3. Use of other AChE inhibitors than pyridostigmine
    4. Pregnancy, lactation or intention to become pregnant during the study
    5. Treatment with amifampridine is contraindicated. Contraindications include a history of epilepsy, uncontrolled asthma, inherited QT syndrome / a prolonged QT interval (as indicated by ECG), any drug known to cause QTc-prolongation, concomitant use of sultopride, a known hypersensitivity reaction to the active substance or to any of the excipients.
    6. The patient is unable to fill out the study questionnaires or be interviewed in Dutch, or is unable to undergo the tests needed for the study, or is unable to give informed consent for participation in the study.
    7. The investigator can exclude patients for this trial which are deemed not suitable for any reason.
    1. Intraveneus immuunglobuline of plasmaferese <4 weken
    2. Thymectomie <6 maanden of thymectomie (verwacht) tjijdens het onderzoek
    3. Gebruik van AChE remmers anders dan pyridostigmine
    4. Zwangerschap, zwangerschapswens of borstvoeding gedurende het onderzoek.
    5. Behandeling met amifampridine is gecontra-indiceerd. Contra-indicaties zijn: voorgeschiedenis met epilepsie, ongecontroleerde astma, lange-QT-syndroom of verlengd QT-interval (vastgesteld door middel van ECG), gelijktijdig gebruik van sultopride, bekende overgevoeligheid voor één van de bestanddelen van amifampridine.
    6. De proefpersoon is niet in staat om een vragenlijst of interview in
    het Nederlands te voltooien of is niet in staat om informed consent te
    geven.
    7. De onderzoeker kan patiënten excluderen die niet geschikt lijken
    om een bepaalde reden.
    E.5 End points
    E.5.1Primary end point(s)
    A clinically relevant change in MGII compared to placebo; a change of ≥8 is considered clinically relevant
    Een klinisch relevant verschil in MGII in vergelijking met placebo; een verschil van ≥8 wordt klinisch significant geacht.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Weekly on D5 during part 1 and part 2 of the study
    In the observational open label extension phase outcome measures will be evaluated at 3 and 6 months after completion of part 2.
    Wekelijks op dag 5 (D5) gedurende deel 1 en deel 2 van het onderzoek
    In the observational open label extension phase outcome measures will be evaluated at 3 and 6 months after completion of part 2.
    E.5.2Secondary end point(s)
    a) Change on 9-item Treatment Satisfaction Questionnaire for Medication (TSQM-9) compared to placebo
    b) Change on MG-QoL15r compared to placebo
    c) Change on EQ-5D-5L compared to placebo
    d) A clinically relevant change in the clinical scores MG-ADL (≥2 points change) and QMG (≥3 points change) compared to placebo.
    e) Change on a global impression 10 point scale (VAS-score) to evaluate whether patients are feeling worse or better overall during treatment in comparison to placebo.
    f) To record side effects of either pyridostigmine and amifampridine a questionnaire will be obtained. The questionnaire is specifically developed for this purpose, which explores presence, duration and severity of symptoms that might be adverse effects of pyridostigmine or amifampridine treatment
    g) Number of patients not able to complete first wash-out period due to an increase in myasthenic symptoms.
    h) Number of times escape medication is used (including effect on symptoms)
    i) Serum concentrations of pyridostigmine
    j) For patients participating in the PK/PD substudy, the following endpoints will be included:
    a. Maximum concentration (Cmax, Cmax ss)
    b. Area under the concentration-time curve (AUC0-tau ss) at steady state
    c. Time of maximum concentration (Tmax, Tmax ss)
    d. Analyses will be performed to evaluate the dose response relationship between serum concentrations of amifampridine and iliopsoas and hand grip strength as measured with hand-held dynamometer.
    k) For the cost-utility analysis health care use and productivity will be assessed using the adapted iMCQ and iPCQ at baseline.
    a) Verandering op de 9-item tevredenheidsvragenlijst voor medicatie (TSQM-9) in vergelijking met placebo
    b) Verandering op MG-QoL15r vergeleken met placebo
    c) Verandering op EQ-5D-5L in vergelijking met placebo
    d) Een klinisch relevante verandering in de klinische scores MG-ADL (≥2 punten verandering) en QMG (≥3 punten verandering) vergeleken met placebo.
    e) Verandering op een globale indruk 10-puntsschaal (VAS-score) om te beoordelen of patiënten zich tijdens de behandeling slechter of beter voelen in vergelijking met placebo.
    f) Om bijwerkingen van pyridostigmine en amifampridine te registreren, zal een vragenlijst worden verkregen. De vragenlijst is speciaal voor dit doel ontwikkeld en onderzoekt de aanwezigheid, duur en ernst van symptomen die mogelijk nadelige effecten zijn van behandeling met pyridostigmine of amifampridine
    g) Aantal patiënten dat de eerste wash-outperiode niet kan voltooien vanwege een toename van myasthenische symptomen.
    h) Aantal keren dat escape-medicatie wordt gebruikt (inclusief effect op symptomen)
    i) Serumconcentraties van pyridostigmine
    j) Voor patiënten die deelnemen aan de PK/PD-substudie zullen de volgende eindpunten worden opgenomen:
    a. Maximale concentratie (Cmax, Cmax ss)
    b. Gebied onder de concentratie-tijdcurve (AUC0-tau ss) bij steady state
    c. Tijd van maximale concentratie (Tmax, Tmax ss)
    d. Er zullen analyses worden uitgevoerd om de dosis-responsrelatie tussen de serumconcentraties van amifampridine en iliopsoas en de handgreepsterkte te evalueren, zoals gemeten met een handdynamometer.
    k) Voor de kosten-utiliteitsanalyse zullen zorggebruik en productiviteit worden beoordeeld aan de hand van de aangepaste iMCQ en iPCQ bij baseline.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Weekly on D5 during part 1 and part 2 of the study.
    In the observational open label extension phase outcome measures will be evaluated at 3 and 6 months after completion of part 2.
    Wekelijks op dag 5 (D5) gedurende deel 1 en deel 2 van het onderzoek
    In de observationele open-label extensie fase worden de uitkomstmaten beoordeeld 3 en 6 maanden na afronding van deel 2.
    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 Yes
    E.6.7Pharmacodynamic Yes
    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) Yes
    E.7.4Therapeutic use (Phase IV) Yes
    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 No
    E.8.1.6Cross over Yes
    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 trial5
    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
    LVLS
    Laatste visite van de laatste patient
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    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: 17
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 7
    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 state24
    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)
    Patients can continue the use of amifampridine add-on after the trial has ended after consulting with their treating physician.
    Patienten mogen amifampridine add-on continueren na het beëindigen van het onderzoek in overleg met hun behandelend arts.
    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 Decision2022-07-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-10-12
    P. End of Trial
    P.End of Trial StatusOngoing
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    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
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