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    Summary
    EudraCT Number:2014-005344-17
    Sponsor's Protocol Code Number:CBDV_2014
    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:2015-01-02
    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 number2014-005344-17
    A.3Full title of the trial
    Oral cannabidivarin (CBDV) solution for treatment of HIV-associated neuropathic pain – a randomized, double-blind, placebo-controlled phase II study.
    Orale Cannabidivarin (CBDV) Lösung zur Behandlung von HIV-assoziiertem neuropathischem Schmerz – eine randomisierte, doppelblinde, Placebo-kontrollierte Phase II Untersuchung.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A cannabis preparation for neuropathic pain.
    Eine Cannabiszubereitung zur Anwendung bei neuropathischem Schmerz.
    A.3.2Name or abbreviated title of the trial where available
    Cannabidivarin (CBDV) for neuropathic pain in HIV
    Cannabidivarin (CBDV) für neuropathischen Schmerz bei HIV
    A.4.1Sponsor's protocol code numberCBDV_2014
    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 SponsorDepartment of Anesthesiology and Operative Intensive Care Medicine, Charité (CBF)
    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 supportEU-commission
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDepartment of Anesthesiology and Operative Intensive Care Medicine, Charité (CBF)
    B.5.2Functional name of contact pointClinical trial information
    B.5.3 Address:
    B.5.3.1Street AddressHindenburgdamm 30
    B.5.3.2Town/ cityBerlin
    B.5.3.3Post code12203
    B.5.3.4CountryGermany
    B.5.6E-mailneuropathie-studie@charite.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 No
    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 nameCannabidivarin (CBDV)
    D.3.2Product code GWP42006
    D.3.4Pharmaceutical form Oral solution
    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 INNcannabidivarin
    D.3.9.2Current sponsor codeGWP42006
    D.3.9.3Other descriptive nameCANNABIDIVARIN
    D.3.9.4EV Substance CodeSUB26600
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product Yes
    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 placeboOral solution
    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
    Chronic painful HIV-associated neuropathy
    Chronisch schmerzhafte HIV-assoziierte Neuropathie
    E.1.1.1Medical condition in easily understood language
    Neuropathic pain in HIV
    Neuropathischer Schmerz bei HIV
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Pain reduction when using cannabidivarin (CBDV) as compared to placebo
    Schmerzreduktion unter der Einnahme von Cannabidivarin (CBDV) im Vergleich zu Placebo
    E.2.2Secondary objectives of the trial
    •Does CBDV have any effects on special pain characteristics?
    •Is rescue medication needed?
    •Is CBDV sufficiently safe?
    •Does CBDV have an effect on physical and mental functions?
    •Does patients' expectation have any influence on the effect of CBDV and placebo?
    •Does CBDV have any influence on patients' acute subjective response?
    •Does CBDV have an impact on the quality of life and sleep?
    •Is a response to the therapy with CBDV associated with the genotype of the patient?
    •Zeigt CBDV Wirkungen auf spezielle Schmerzeigenschaften?
    •Werden zusätzliche Schmerzmittel gebraucht?
    •Ist CBDV ausreichend sicher?
    •Hat CBDV Einfluss auf physische und psychische Funktionen?
    •Hat die Erwartung der Patienten Einfluss auf den Effekt von CBDV und Placebo?
    •Hat CBDV Einfluss auf das akute subjektive Befinden der Patienten?
    •Hat CBDV Einfluss auf die Lebens- und Schlafqualität?
    •Ist ein Ansprechen („response“) auf die CBDV-Therapie assoziiert mit dem Genotyp der Patienten?
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Male and female patients with chronic, painful HIV-associated neuropathy (NRS-score ≥4); women who are post-menopausal for more than one year can participate in this study; female patients of child-bearing potential are allowed to participate in this study only if they are permanently sterilised (e.g. tubal occlusion, hysterectomy) or if they provide a negative pregnancy test and are willing to use a highly effective method of contraception (e.g. hormonal contraceptives) during the course of the study and for three months thereafter
    •Age: 18-65 years
    •Body mass index (BMI): 18-30 kg/m2
    •Sufficient knowledge of the German language
    •Signed written informed consent
    •Männer und Frauen mit chronischer, schmerzhafter HIV-assoziierter Neuropathie (NRS Score ≥4); Frauen, die seit mehr als einem Jahr postmenopausal sind, können an der klinischen Prüfung teilnehmen; Frauen im gebärfähigen Alter können nur an der klinischen Prüfung teilnehmen, wenn sie operativ steril sind (z.B. durch Tubenverschluss oder operative Entfernung der Gebärmutter) oder ein negativer Schwangerschaftstest vorliegt und sie bereit sind, eine zuverlässige Kontrazeptionsmethode (wie z.B. hormonelle Kontrazeptiva) während der klinischen Prüfung und bis zu drei Monate nach Ende der klinischen Prüfung zu benutzen
    •Alter: 18-65 Jahre
    •Body mass index (BMI) von 18-30 kg/m2
    •Patienten, die deutsch verstehen, sich klar verständigen können und die Bedeutung der klinischen Prüfung verstehen
    •Vorliegen der unterschriebenen und eigenhändig datierten Einwillligungserklärung
    E.4Principal exclusion criteria
    •Individuals dependent on the sponsor, the trial site or the investigator
    •Individuals housed in institutions due to official or judicial orders
    •Co-incident severe diseases of the central nervous system (e.g. dementia)
    •Co-incident major psychiatric conditions
    •Acute disorders with functional limitations and/or limitations of neurological assessment
    •Limited mental capacity or knowledge of the German language
    •Chronic or previous abuse of recreational drugs, drugs and/or alcohol
    •Pregnancy and lactation as well as planning pregnancy during the course of the study and for three months thereafter
    •Men and women of childbearing potential not using adequate contraception during the clinical trial and three months thereafter
    •Intolerance to the study medication or to one of the components of the study medication
    •Hepatic diseases where:
    - the level of ALT exceeds three times the upper limit of normal or the level of AST exceeds three times the upper limit of normal and the bilirubin exceeds two times the upper limit of normal or the INR exceeds 1,5 times the upper limit of normal
    - the levels of ALT or AST exceeds three times the upper limit of normal in combination with symptoms (fatigue, nausea, vomiting, pain or tenderness in the right upper quadrant of the abdomen, fever, rash, and/or eosinophilia)
    - the levels of ALT or AST alone exceed eight times the upper limit of normal
    - the levels of ALT or AST alone exceed five times the upper limit of normal longer than two weeks
    •Chronic renal insufficiency (with significant deviating levels of normal)
    •EKG-Parameters outside following reference ranges: PR-interval: 120 ms (lower limit), 220 ms (upper limit); QRS-duration: 0 ms (lower limit), 120 ms (upper limit); QT-interval: 0 ms (lower limit), 500 ms (upper limit); QTcF-Interval (males): 0 ms (lower limit), 430 ms (upper limit), QTcF (females): 0 ms (lower limit), 450 ms (upper limit)
    •Clinical significant cardiovascular or metabolic diseases: uncontrollable hypertension (lower limit: 90/40 mmHg, upper limit: 140/90 mmHg (18-45 years), 160/90 mmHg (>45 years)); severe heart insufficiency (NYHA ≥ III); abnormal heart rate (lower limit: 40 min-1 (18-45 years), 50 min-1 (>45 years), upper limit: 90 min-1); heart attack within the past 12 months
    •Active participation in other clinical trials three months before or within this clinical study
    •Personen, die vom Sponsor, der Prüfstelle oder vom Prüfer abhängig sind
    •Personen, die aufgrund behördlicher oder gerichtlicher Anordnung in einer Anstalt untergebracht sind
    •Zeitgleiche ernsthafte Erkrankung des Zentralnervensystems (z.B. Demenz)
    •Zeitgleiche ernsthafte psychische Erkrankung
    •Akute Erkrankungen mit funktionaler Einschränkung und/oder Einschränkung der neurologischen Beurteilbarkeit
    •Begrenzte Auffassungsgabe oder Deutschkenntnisse, die die Erfüllung der gestellten Aufgaben unmöglich machen
    •Chronischer oder früherer Drogen-, Medikamenten- und/oder Alkoholabusus
    •Schwangerschaft und Stillzeit sowie eine geplante Schwangerschaft während der klinischen Prüfung und drei Monate danach
    •Keine adäquate Kontrazeption während der Studie und drei Monate nach der letzten Studienmedikationsgabe
    •Überempfindlichkeit gegenüber dem Prüfpräparat oder einer der Komponenten des Prüfpräparates
    •Erkrankungen der Leber, bei denen:
    - die Alanin-Aminotransferase (ALT) >3-fach erhöht oder die Aspartat-Aminotransferase (AST) >3-fach erhöht und das Bilirubin >2-fach erhöht oder der INR >1.5 sind
    - die ALT oder die AST >3-fach erhöht, in Kombination mit Symptomen (Müdigkeit, Übelkeit, Erbrechen, Schmerzen oder Empfindlichkeit im rechten oberen Quadranten, Fieber, Ausschlag und/oder Eosinophilie)
    - die ALT oder die AST einzeln >8-fach erhöht ist
    - die ALT oder die AST >5-fach für länger als 2 Wochen erhöht ist
    •Vorliegen einer chronischen Niereninsuffizienz (mit signifikant von den Normwerten abweichenden Kreatinin-Werten)
    •EKG-Parameter außerhalb folgender Normbereiche: PR-Intervall: 120 ms (untere Grenze), 220 ms (obere Grenze); QRS-Dauer: 0 ms (untere Grenze), 120 ms (obere Grenze); QT-Intervall: 0 ms (untere Grenze), 500 ms (obere Grenze); QTcF-Intervall (Männer): 0 ms (untere Grenze), 430 ms (obere Grenze), QTcF (Frauen): 0 ms (untere Grenze), 450 ms (obere Grenze)
    •Vorliegen klinisch bedeutsamer kardiovaskulärer oder metabolischer Erkrankungen: unkontrollierbarer Bluthochdruck (untere Grenze: 90/40 mmHg, obere Grenze: 140/90 mmHg (18-45 Jahre), 160/90 mmHg (>45 Jahre)); schwere Herzinsuffizienz (NYHA ≥ III); abnorme Herzfrequenz (untere Grenze: 40 min-1 (18-45 Jahre), 50 min-1 (>45 Jahre), obere Grenze: 90 min-1); Herzinfarkt innerhalb der letzten 12 Monate
    •Teilnahme an anderen klinischen Prüfungen drei Monate vor oder während dieser klinischen Prüfung
    E.5 End points
    E.5.1Primary end point(s)
    Amelioration of pain intensity („baseline“) by 20%, measured based on the reduction of the total score on a 11-point numeric rating scale (NRS) after CBDV application as compared to placebo.
    Verbesserung der Schmerzintensität ("Baseline") um 20%, gemessen anhand der Reduktion des Gesamtscores auf einer 11-Punkte Numerischen Schmerzskala (NRS) nach CDBV-Applikation verglichen mit Placebo.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At the end of the treatment.
    Am Ende der Behandlung.
    E.5.2Secondary end point(s)
    •Analysis of specific pain parameters
    •Analysis of rescue medication
    •Analysis of side effects
    •Analysis of parameters of physical and mental functions
    •Analysis of patients’ expectation on the clinical effect
    •Analysis of patients' acute subjective response
    •Analysis of quality of life and sleep
    •Genotyping
    •Analyse spezifischer Schmerzparameter
    •Analyse des zusätzlichen Schmerzmittelverbrauchs
    •Analyse von Nebenwirkungen
    •Analyse physischer und psychischer Funktionsparameter
    •Analyse des Einflusses der Patientenerwartung auf den klinischen Effekt
    •Analyse des akuten subjektiven Befindens von Patienten
    •Analyse der Lebens- und Schlafqualität
    •Genotypisierung
    E.5.2.1Timepoint(s) of evaluation of this end point
    •Specific pain characters: at the beginning of the first, at the end of the second baseline and at the end of both treatment phases
    •Rescue medication: daily, throughout the whole clinical trial, during the follow-up period
    •Side effects: daily evaluation throughout both treatment phases, wash-out phase, the second baseline and the follow-up period
    •Physical and mental functions: at the beginning of the first baseline, at the end of the second baseline and at the end of both treatment phases
    •Patients' expectation: at the end of both treatment phases
    •Patients' acute subjective response: daily evaluation, within the first week of both treatment phases
    •Analysis of quality of life and sleep: at the end of first and second baseline, at the end of both treatment phases
    •Spezifische Schmerzparameter: zu Beginn der ersten, am Ende der zweiten Baseline, am Ende beider Behandlungsphasen
    •Zusätzlicher Schmerzmittelverbrauch: täglich, während der gesamten Studie, während der Nachbeobachtungszeit
    •Nebenwirkungen: täglich, während beider Behandlungsphasen, der Auswaschphase, der zweiten Baseline und der Nachbeobachtungszeit
    •Physische und psychische Funtionsparameter: zu Beginn der ersten Baseline, am Ende der zweiten Baseline und am Ende beider Behandlungsphasen
    •Patientenerwartung: am Ende beider Behandlungsphasen
    •Akutes subjektives Befinden: täglich, während der ersten Woche beider Behandlungsphasen
    •Analyse der Lebens- und Schlafqualität: am Ende beider Baselines, am Ende beider Behandlungsphasen
    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) 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 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 trial2
    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
    Letzte Visite des letzten Studienteilnehmers.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    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: 45
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 state50
    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 participation in the clinical trial, subjects will be treated with their medications prescribed by the referring physician.
    Die Studienteilnehmer werden nach Studienende mit Medikamenten versorgt, die sie von ihrem behandelnden (ambulanten) Arzt verschrieben bekommen.
    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 Decision2015-05-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-08-21
    P. End of Trial
    P.End of Trial StatusOngoing
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