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    Summary
    EudraCT Number:2006-004255-38
    Sponsor's Protocol Code Number:cnp-MS-0601 / MC-2006-01
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-02-20
    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 ConcernedGermany - BfArM
    A.2EudraCT number2006-004255-38
    A.3Full title of the trial
    Multi-centre, randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of the pain relieving effect of Dronabinol in patients with multiple sclerosis associated with central neuropathic pain
    A.4.1Sponsor's protocol code numbercnp-MS-0601 / MC-2006-01
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorBionorica research GmbH
    B.1.3.4CountryAustria
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 namedronabinol
    D.3.2Product code cnp-MS-0601
    D.3.4Pharmaceutical form Oral solution
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNdronabinol
    D.3.9.1CAS number 1972-08-3
    D.3.9.2Current sponsor codecnp-MS-0601
    D.3.9.3Other descriptive name(-)-trans-delta-9-Tetrahydrocannabinol
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 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
    Patients with multiple sclerosis associated with central neuropathic pain
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level LLT
    E.1.2Classification code 10054095
    E.1.2Term Neuropathic pain
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The objective of this study is to examine whether the long-term administration of dronabinol leads to a statistically and clinically significant reduction of the chronic pain in patients with MS associated with central neuropathic pain.
    E.2.2Secondary objectives of the trial
    • Distribution of frequency, duration, and intensity of episodes with acute pain attacks
    • Distribution of responder at visits E6, E7, E8 and E9
    • Distribution of responder at visits E6, E7, E8 and E9 by dosage group
    • NRS pain relief
    • Pain- related sleep interference
    • Length of treatment period
    • Time to first response
    • SF-36 (QOL-questionnaire)
    • Clinical global impression
    • Intake of rescue medication
    • Adverse Events
    • Safety laboratory parameters
    • Vital parameters / weigh

    Criteria in follow-up phase 3:
    • Retrospective pain assessment for the past 4 weeks (11-NRS)
    • Pain-related sleep interference
    • SF-36 (QOL-questionnaire)
    • CGI, Item A
    • Adverse events
    • Assessment of dependence
    • Safety laboratory
    • Vital parameters
    • Global assessment of tolerability
    • ECG
    • EDSS
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Outpatients aged 18 to 70 years
    • Patients who meet the McDonald diagnostic criteria for definite MS
    • Patients with an EDSS score ≥3 and ≤8
    • Patients who are in a stable phase of MS
    • Patients with MS associated with central neuropathic pain for at least 3 months
    • Patients with central neuropathic pain characterized by pain in a body territory with abnormal sensation to pinprick, touch, or temperature evaluated by the bedside
    • Patients with moderate to severe pain (= pain intensity score of at least 4 on the 11-point Likert Numerical Rating Scale (NRS) at the maximal pain site)

    Inclusion criteria for follow-up phase 3:
    • Complete participation in main study, from visit E1 to visit E20
    • Termination of study phase 2 with visit E20a taking place not more than 7 days later.
    Exception for all patients with E20 before implementation of Amendment No 11: Termination of study phase 2 with visit E20a taking place not more than 1 month later
    Exception for all patients with E20 taking place after 31.07.2008 and E20a taking place between December 1st and December 17th, 2008.
    • Treatment is still indicated as per the investigator’s discretion
    • Negative pregnancy test for female patients of childbearing potential at visit E20 or E20a respectively
    • Willingness and capability to pass all required examinations over the entire time of the follow-up phase 3
    E.4Principal exclusion criteria
    • Patients experiencing a relapse
    ─ within 30 days prior to screening, or
    ─ during the run-in phase, or
    ─ at randomization
    • Patients with mania or bipolar affective disorder
    • Schizoid symptoms or history of schizophrenia or schizophrenia in the family anamneses
    • Patients with epilepsy
    • Patients with trigeminal neuralgia
    • Patients with severe cardiac diseases
    • Advanced renal insufficiency (creatinine >2,2mg/100ml)
    • Advanced hepatic insufficiency (SGOT/ASAT; SGPT/ALAT >2,5 x upper normal value)
    • Treatment with dronabinol within the last 12 months
    • Use of marihuana within the last 4 weeks and unwillingness to abstain from the use of marihuana for the duration of the study
    • Known hypersensitivity to tramadol and excipients of Tramal® (in Germany and Austria) or Nobligan® (in Denmark) capsules

    Exclusion criteria for follow-up phase 3:
    • Critical adverse events during time interval between E20 and E20a including:
    ─ Schizoid symptoms
    ─ Mania or bipolar affective disorder
    ─ Epilepsy
    • Abuse of or dependence on Dronabinol
    • Reevaluation of main criteria such as
    ─ Advanced renal insufficiency (creatinine >2,2mg/100ml)
    ─ Advanced hepatic insuffiency (SGOT/ASAT; SGPT/ALAT >2,5 x upper normal value)
    ─ Known severe cardiac diseases (e.g. cardiac insufficiency NYHA IV, severe arrhythmia, severe CHD, myocardial infarction within the last 6 months)
    ─ Known HIV-infection
    ─ Known alcohol, narcotics or drug abuse
    ─ Unwillingness to abstain from use of marihuana
    ─ Concurrent participation in other studies
    ─ Patients with major peripheral pain syndromes
    ─ Legal incompetence or limited legal competence
    ─ Patients who do not sign a consent form after thorough medical consultation
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of efficacy will be the mean change of baseline pain severity score taken from the initial patient assessment and the daily patient recordings of his/her average chronic pain on the 11-point NRS within a maximum of 16 weeks
    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 Yes
    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) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    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 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 concerned30
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA40
    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 Information not present in EudraCT
    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
    Last patient out
    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 months9
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months9
    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.1.3Elderly (>=65 years) Yes
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2007-02-20. Yes
    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 state200
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 240
    F.4.2.2In the whole clinical trial 240
    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)
    For patients who have finished the study and for all patients who drop out prematurely, it is the responsibility of the investigator to choose adequate therpeutic measurements. As no alternative treatments do exist, the investigators are informed that they may prescribe dronabinol on special individual prescriptions.
    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 Decision2007-01-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-12-19
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-03-24
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