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    Summary
    EudraCT Number:2017-001357-14
    Sponsor's Protocol Code Number:KUM_PSY_2017_1
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2017-07-27
    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 ConcernedGermany - BfArM
    A.2EudraCT number2017-001357-14
    A.3Full title of the trial
    Randomized, doubleblind, 4-arms, monocentric, interventinal Study for enhancing the efficacy of tDCS across from single intervention or Placebo by nicotinergic stimulation in schizophrenia.
    Randomisierte, doppelblinde, 4-armige, monozentrische Interventionsstudie zum Nachweis der Überlegenheit der kombinierten Stimulation mittels Vareniclin und tDCS gegenüber den Einzelinterventionen oder Placebo (NicStim)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Randomized, doubleblind, 4-arms, monocentric, interventinal Study for enhancing the efficacy of tDCS across from single intervention or Placebo by nicotinergic stimulation in schizophrenia.
    Verbesserung der klinischen Effekte der tDCS durch nikotinerger Stimulation bei Patienten mit einer Schizophrenie
    A.4.1Sponsor's protocol code numberKUM_PSY_2017_1
    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 SponsorKlinikum der Universität München - AöR verteten durch den Vorstand des Bereiches Humanmedizin
    B.1.3.4CountryGermany
    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 supportDeutsche Forschungsgemeinschaft (DFG) Förderkennzeichen HA 6091/5-1
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationTechnische Universität München Fakultät für Medizin Münchner Studienzentrum
    B.5.2Functional name of contact pointBeate Schossow
    B.5.3 Address:
    B.5.3.1Street AddressIsmaningerstr. 22
    B.5.3.2Town/ cityMünchen
    B.5.3.3Post code81675
    B.5.3.4CountryGermany
    B.5.4Telephone number00498941406469
    B.5.5Fax number00498941406322
    B.5.6E-mailbeate.schossow@mri.tum.de
    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 Champix
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameChampix
    D.3.4Pharmaceutical form Capsule, hard
    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 INNVARENICLINE
    D.3.9.1CAS number 249296-44-4
    D.3.9.4EV Substance CodeSUB25195
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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 Yes
    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 placeboCapsule, hard
    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
    Schizophrenia
    Schizophrenie
    E.1.1.1Medical condition in easily understood language
    Schizophrenia
    Schizophrenie
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Mental Disorders [F03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10040707
    E.1.2Term Simple type schizophrenia, chronic state
    E.1.2System Organ Class 100000004873
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate whether the improvement of cognitive functioning in schizophrenia via the combination of varenicline and trancranial direct current stimulation is superior to the stimulation with varenicline or tDCS alone.
    Evaluation, ob bei Patienten mit einer Schizophrenie die Kombination aus transkranieller Gleichstromstimulation (tDCS) und nikotinerger Stimulation durch Vareniclin (Partialagonist an α4β2 Nikotinrezeptoren) effektiver in der Verbesserung kognitiver Funktionen als die tDCS oder Vareniclin alleine ist.
    E.2.2Secondary objectives of the trial
    To evaluate whether the improvement of cognitive functioning in schizophrenia via the combination of varenicline and trancranial direct current stimulation is superior to the stimulation with varenicline or tDCS alone.
    Evaluation, ob bei Patienten mit einer Schizophrenie die Kombination aus transkranieller Gleichstromstimulation (tDCS) und nikotinerger Stimulation durch Vareniclin (Partialagonist an α4β2 Nikotinrezeptoren) effektiver in der Verbesserung kognitiver Funktionen als die tDCS oder Vareniclin alleine ist.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Male and female (with contraception) patients with schizophrenia (ICD-10 Criteria), age 18 to 65 being diagnosed according to the “Statistical Classification of Diseases and Related Health Problems (ICD-10)“. Diagnosis will be confirmed via the MINI interview.
    - Antipsychotic monotherapy or a maximum combination of two antipsychotics with a maximum dosage of 1000 mg CPZ equivalents (using the minimum effective dose method)
    - Non-smoking status: defined as those patients who did not have any history of smoking on a regular or an occasional basis during the past 5 years (measured by CO and cotinine levels)
    - Being no longer in the acute phase of illness defined as (PANSS Total ≤ 75, CGI ≤ 4). No relevant depressive symptoms (CDSS < 8)
    - Female patients of childbearing potential: use of a proper method of contraception (according to the CTFG guideline) and negative pregnancy test before study inclusion
    - Männlich und weibliche einwilligungsfähige Teilnehmer im Alter von 18-65 Jahren die, die diagnostischen Kriterien einer Schizophrenie nach dem “Statistical Classification of Diseases and Related Health Problems (ICD-10)“ erfüllen. Die Diagnose erfolgt über ein „Mini-International Neuropsychiatric Interview - PLUS“, (Sheehan, Lecrubier et al. 1998), welches im Rahmen des Patientenscreenings durchgeführt wird.
    - Kontinuierliche antipsychotische Behandlung in Monotherapie nach aktuellen Leitlinien oder bei klinischer Notwendigkeit eine Kombinationsbehandlung mit maximal 2 Antipsychotika (dann maximal 1000 mg CPZ Äquivalente)
    - Nichtraucher Status (seit fünf Jahren keine regelmäßiger Konsum von Tabakprodukte), Feststellung des Nichtraucher Status durch Carbon Monoxid (CO) Level und durch Cotinin Messungen
    - Zum Zeitpunkt des Studieneinschlusses eine mittlere Schwere der Psychopathologie (PANSS Gesamtscore ≤ 75) aufweisen. Keine relevanten depressiven Symptome (CDSS < 8).
    - Männliche Teilnehmer und weibliche Teilnehmer, die nicht gebärfähig sind oder eine adäquate medizinisch Empfängnisverhütung (nach CTFG Leitlinie, siehe Haupttext für detaillierte Aufstellung) anwenden im Alter von 18 bis 65 Jahren, die die diagnostischen Kriterien einer Schizophrenie nach dem “Statistical Classification of Diseases and Related Health Problems (ICD-10)“ erfüllen. Die Diagnose erfolgt über ein „Mini-International Neuropsychiatric Interview - PLUS“, (Sheehan, Lecrubier et al. 1998), welches im Rahmen des Patientenscreenings durchgeführt wird.
    - Bei weiblichen Teilnehmern: negativer Schwangerschaftstest (Urin-Schwangerschaftstest), sichere Verhütungsmethode nach der CTFG Leitlinie Recommendations related to contraception and pregnancy testing in clinical trials (CTFG 2014):
    E.4Principal exclusion criteria
    - Lacking capacity to give informed consent or involuntary treatment
    - Pregnancy or lactation
    - Current suicidality as well as the risk to injure others
    - Treatment resistance or Treatment with Clozapin
    - Never treated schizophrenia or documented non-compliance
    - Lacking german language skills
    - Start of antidepressants or mood stabilizers during the 1-week intervention phase. Previous treatment can be continued in unaltered dosages.
    - Alcohol- or substance abuse during the last 6 months before inclusion into study except for Coffein and Nicotin (smoker), no narcotic drugs may be taken during the 1-week intervention phase
    - Detection of active substance abuse by positive D-Urin or CDT test before start of the intervention
    - Epileptic seizures in the anamnesis
    - Epileptic potentials in EEG
    - Proof of active substances by positve results in D-urine or CDT.
    - Moderate kidney insufficiency (creatinine-clearance: 30–50 ml/min) or severe kidney insufficiency (< 30 ml/min)
    - Known intolerance to the study medication (Vareniclin) or to tDCS
    - Clinically relevant interaction between clinically necessary per-medication and investigational medicinal product (to be tested by medic software
    - Known intolerance to the study medications or to tDCS
    -Bei weiblichen Teilnehmern bestehende Schwangerschaft.
    -Gegenwärtige Suizidalität sowie Fremdgefährdung.
    -Schwere neurologische und internistische Komorbiditäten
    -Behandlungsresistente Schizophrenie.
    -Bekannte oder vermutete non-compliance hinsichtlich der Medikamenteneinnahme.
    -Eindosierung von Stimmungsstabilisatoren, Benzodiazepine oder Antidepressiva während der 1-wöchigen Interventionsphase. Eine vorher bestehende Therapie kann in unveränderter Dosis fortgesetzt werden.
    -Alkohol- oder Substanzabhängigkeit innerhalb der letzten sechs Monate vor Studieneinschluss (überprüft durch Mini-International Neuropsychiatric Interview). Koffein ist hiervon ausgenommen. Während der einwöchigen Interventionsphase dürfen bis auf Koffein und Nikotin (Raucher)keinerlei Suchtstoffe eingenommen warden.
    - Nachweis von aktivem Substanzkonsum durch positive Befund im D-Urin oder im CDT vor Beginn der Intervention.
    - Epileptische Anfälle in der Anamnese.
    - Epilepsietypische Potentiale im EEG.
    - Kreatinin nicht im Normbereich
    - Bekannte Unverträglichkeit zu dem Studienmedikament (Vareniclin) oder zu der tDCS
    - Klinisch relevante Interaktion zwischen der klinisch notwendigen Vormedikation und der Prüfmedikation (zu prüfen mittels der mediq Software)
    - Bekannte Unverträglichkeit zu einem der Studienmedikamente oder tDCS.
    - Fehlende Einwilligungsfähigkeit oder Unterbringung gegen den Willen des Patienten.
    - Unzureichende Kenntnis der deutschen Sprache.
    - Zustand der Behandlungsresistenz oder noch nie behandelte Schizophrenie.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint will be change in working memory according to the n-back task.
    Verbesserung des Arbeitsgedächtnisses im n-back nach einer Woche.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 0 (V1), Day 5 (V2), Day 33 (V3), Day 61 (V4)
    Am Tag 0 (V1), Tag 5 (V2), Tag 33 (V3), Tag 61 (V4)
    E.5.2Secondary end point(s)
    Secondary endpoints will include several other measures of cognition (processing speed, verbal memory, and cognitive flexibility), psychopathology (Positive and Negative Syndrome Scale), depressive symptoms (Calgary Depression Scale for Schizophrenia), functioning (Global Assessment of Functioning) and disease severity (Clinical Global Impression). Physiological measures will (1) include EEG to investigate changes regional (below the stimulation electrodes) and remote electrical activity before after intervention9 and (2) motor-cortex excitability measures to investigate the impact of varenicline (steady state) on cortical excitability and plasticity.
    Verbesserung anderer neurokognitiver Funktionen nach einer, vier und acht Wochen (Verbales Gedächtnis, Arbeitsgeschwindigkeit), Veränderung in der Psychopathologie nach PANSS und CDSS, Veränderung im CGI und GAF, Auftreten von einzelnen Nebenwirkungen, Veränderung der kortikalen Erregbarkeit und Konnektivität
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 0 (V1), Day 5 (V2), Day 33 (V3), Day 61 (V4)
    PANSS and GAF

    Day 0 (V1), Day 33 (V3)
    CDSS and CGI
    Am Tag 0 (V1), Tag 5 (V2), Tag 33 (V3), Tag 61 (V4)
    PANSS und GAF

    Am Tag 0 (V1), Tag 33 (V3)
    CDSS und CGI
    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 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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    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 Yes
    E.8.1.6Cross over No
    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 Yes
    E.8.2.3.1Comparator description
    tDCS neuro / conn Gleichstromtherapie/ Vergleich mit oder ohne Strom
    tDCS Device neuro / conn / DC Therapy/Comparison with or without electricity
    E.8.2.4Number of treatment arms in the trial4
    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 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
    According to the start of the study is after 33 month LVLS
    Nach dem Beginn der Studie ist nach 33 Monaten LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months8
    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: 50
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state60
    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)
    After the end of the study patients regardless of wether the study end according to the protocol or early / non-terminated according to protocol, the Patient get the antipsychotic therapy which they had taken. Even switching to a different medication is possible.
    Nach Ende der Studie können Patienten unabhängig davon, ob die Studie protokollgemäß oder vorzeitig / nicht- protokollgemäß beendet wurde, mit demjenigen Antipsychotikum weiter behandelt werden, das sie eingenommen hatten. Auch eine Umstellung auf ein anderes Medikament ist möglich.
    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 Decision2017-09-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-08-16
    P. End of Trial
    P.End of Trial StatusOngoing
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