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    Summary
    EudraCT Number:2010-022033-28
    Sponsor's Protocol Code Number:CHDR1015
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-10-26
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2010-022033-28
    A.3Full title of the trial
    A two-phased, randomized, double blind, placebo-controlled study of ECP002A (Δ9-THC) to determine safety, tolerability and efficacy in Multiple Sclerosis patients suffering from spasticity and pain.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study investigating safety, tolerability and efficacy of ECP002A (Δ9-THC) in Multiple Sclerosis patients suffering from spasticity and pain.
    A.3.2Name or abbreviated title of the trial where available
    ECP002A (Δ9-THC) in MS patients
    A.4.1Sponsor's protocol code numberCHDR1015
    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 SponsorEcho Pharmaceuticals B.V.
    B.1.3.4CountryNetherlands
    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 supportEcho Pharmaceuticals B.V.
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationEcho Pharmaceuticals B.V.
    B.5.2Functional name of contact pointClinical Research Centre
    B.5.3 Address:
    B.5.3.1Street AddressJonkerbosplein 52
    B.5.3.2Town/ cityNijmegen
    B.5.3.3Post code6534 AB
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+31294457353
    B.5.5Fax number+31294457353
    B.5.6E-mailinfo@echo-pharma.com
    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 nameNamisol
    D.3.2Product code ECP002A
    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 INNdronabinol
    D.3.9.1CAS number 1972-08-03
    D.3.9.2Current sponsor codeECP002A
    D.3.9.3Other descriptive nameNamisol
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number1.5 to 5.0
    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 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 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
    Multiple Sclerosis
    E.1.1.1Medical condition in easily understood language
    Multiple Sclerosis
    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 14.1
    E.1.2Level PT
    E.1.2Classification code 10028245
    E.1.2Term Multiple sclerosis
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluation of the efficacy of ECP002A (Δ9-THC) on spasticity in patients with MS
    E.2.2Secondary objectives of the trial
    Evaluation of the efficacy of ECP002A (Δ9-THC) on pain in patients with MS;
    Evaluation of the tolerability of ECP002A (Δ9-THC) in patients with MS;
    Establishment of a PK-PD model for the effect of ECP002A (Δ9-THC) on spasticity in patients with MS
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subject is legally competent;
    2. Subject is eighteen years of age or older;
    3. Subject is able to speak, read and understand the local language of the investigational site, is familiar with the procedures of the study, and agrees to participate in the study program by giving oral and written informed consent prior to screening evaluations;
    4. Subject has a diagnosis of progressive (primary or secondary) Multiple Sclerosis according to the revised McDonald criteria;
    5. Subject has a disease duration of more than 1 year as defined by a diagnosis of MS at least one year prior to inclusion in the trial;
    6. Subject has clinically stable disease > 30 days.
    E.4Principal exclusion criteria
    1. Baseline Expanded Disability Status Scale (EDSS) score < 4.5 or > 7.5;
    2. Subject does not have spasticity in at least one of the lower limbs as defined by an Ashworth score ≥ 2;
    3. Subject has a body mass index (BMI) below 18 or above 28.5 kg/m2;
    4. Subject has a presence or a significant history of any cardiac or vascular disorder, asthma or other pulmonary disease, major gastrointestinal abnormalities, peptic ulceration, hepatic, psychiatric, haematological (including bleeding disorders), endocrine, renal, or major genitourinary disease or neurological disease other than MS or uses any kind of concomitant medication that - in the opinion of the investigator - may interfere with the study;
    5. Subject has a (history of) a significant medical disorder that may pose a risk for the subject or jeopardize the aims of the study, based on medical history, physical examination, ECG and safety laboratory parameters;
    6. Subject has a presence or history of clinically significant psychiatric illness in first degree relatives;
    7. History of sensitivity / idiosyncrasy to THC, compounds chemically related to these compounds, or excipients which may be employed in the study or to any other drug used in the past;
    8. Irregular use of any drug or substance that is known to induce or inhibit (study) drug-metabolizing enzymes within one month prior to the first dose;
    9. Subject is currently a regular user (including “recreational uses”) of any illicit drugs, except for cannabis, or has (a history of) drug or alcohol abuse (alcohol consumption > 40 grams/day or 4 units/day);
    10. Subject smokes more than 10 cigarettes or 2 cigars or 2 pipes per day and/or not able or not willing to refrain from smoking on study days;
    11. Subject is a habitual and heavy consumer of caffeinated beverages (more than 6 cups of coffee or equivalent/day) at the time of the study and/or is not able to refrain from use of (methyl) xanthines (e.g. coffee, tea, cola, chocolate) from 12 hours prior to dosing until the end of the study day;
    12. Unable/unwilling to refrain from all use of grapefruit from 2 weeks prior to the first dose until the last study day and/or unable/unwilling to refrain from all use of quinine containing products from 2 days prior to the first dose until discharge;
    13. Positive alcohol breath test at screening or admission and/or unable/unwilling to refrain from alcohol use from 48 hours before each study day until the last blood sample has been drawn;
    14. Positive urine screen at screening for other drugs than THC, i.e., cocaine, opioids, MDMA, methamphetamine and amphetamines;
    15. Positive urine drug test, including THC prior to first dosing;
    16. Positive test result on hepatitis B surface antigen, hepatitis C antibody or HIV antibody test;
    17. Participation in an investigational drug study within 90 days prior to the first dose and during the entire study period;
    18. Donation of blood/plasma outside limits of Sanquin Blood Supply Foundation guidelines;
    19. Premenopausal women not using one of the monophasic oral contraceptives (including Diane-35), who are unable or unwilling to also skip the pill/ring-free week, from the screening until the end of the first study phase and during the second study phase;
    20. Pregnant and/or breastfeeding subjects;
    21. Clinically significant history of use of CNS medication as judged by the investigator.
    22. Unable to stay in the Netherlands for more than four weeks.
    E.5 End points
    E.5.1Primary end point(s)
    The difference in the severity of spasticity: defined by the H-reflex/M-wave amplitude ratio.
    E.5.1.1Timepoint(s) of evaluation of this end point
    o Dose finding phase - day 1 (T=-30 min, T=100 min, T=200 min, T=300 min)
    o Dose finding phase - day 15 (T=-30 min, T=100 min, T=200 min, T=300 min)

    o Treatment phase - Baseline (T=100 min)
    o Treatment phase - 14 days post start treatment (T=100 min)
    o Treatment phase - 28 days post start treatment (T=100 min)
    E.5.2Secondary end point(s)
    Dose Finding
    - Pharmacokinetics:
    o Cmax, AUC0-last, AUC0-, tmax, t1/2β
    - Pharmacodynamics:
    o severity of spasticity on numerical rating scale (NRS)
    o visual analogue scale (VAS) as described by Bowdle (feeling high, internal perceptions, external perceptions)
    o VAS as described by Bond & Lader (alertness, mood and calmness)
    o body sway
    o heart rate

    Treatment phase:
    o the difference in the severity of spasticity based on a daily diary assessment by the subject on a spasticity numerical rating scale (NRS), between the subjects who received ECP002A (Δ9-THC) and the subjects who received placebo
    o the difference in the severity of spasticity as measured by the modified Ashworth scale in lower limb muscles affected by spasticity between the subjects who received ECP002A (Δ9-THC) and the subjects who received placebo
    o the difference in the severity of patient disability in multiple sclerosis as measured by the Kurtzke expanded disability status scale (EDSS), between the subjects who received ECP002A (Δ9-THC) and the subjects who received placebo
    o the difference in the severity of spasms based on a daily diary assessment by the subject on a spasm frequency scale, between the subjects who received ECP002A (Δ9-THC) and the subjects who received placebo
    o the difference in the severity of pain based on the short form McGill pain questionnaire (SF-MPQ), between the subjects who received ECP002A (Δ9-THC) and the subjects who received placebo
    o the difference in the patient’s global impression of change (PGIC) in their disease between the subjects who received ECP002A (Δ9-THC) and the subjects who received placebo
    o the difference in the quality of sleep as determined by the Pittsburgh sleep quality index (PSQI), between the subjects who received ECP002A (Δ9-THC) and the subjects who received placebo
    o the difference in the walking distance as determined by the timed 25 feet walk test (T25FW) between the subjects who received ECP002A (Δ9-THC) and the subjects who received placebo
    o the difference in attention span as determined by the SDST test, between the subjects who received ECP002A (Δ9-THC) and the subjects who received placebo
    o the difference in level of fatigue as determined by the fatigue severity scale (FSS), between the subjects who received ECP002A (Δ9-THC) and the subjects who received placebo
    o the difference in the level of disability as determined by Guy’s neurological disability scale (GNDS) between the subjects who received ECP002A (Δ9-THC) and the subjects who received placebo
    o the difference in inflammatory state as defined by inflammatory disease markers IL-10, TNF-β, TIMP-1, and MMP-9 between the subjects who received ECP002A (Δ9-THC) and the subjects who received placebo
    o population pharmacokinetics sampling (POP-PK) to establish the pharmacokinetic parameters at steady state in this patient population
    o visual analogue scale (VAS) as described by Bowdle (feeling high, internal perceptions, external perceptions)
    o VAS as described by Bond & Lader (alertness, mood and calmness)
    o body sway
    o heart rate
    o The difference in level of neurodegeneration as defined by change from baseline of level of neurofilaments between subjects who received ECP002A (Delta9-THC) and subjects who received placebo.
    o inflammatory disease markers: MMP-8, MMP-9, TIMP-1, IL-12p40, IL-23, IL-17a, IL-10, IL-6 and TNFα
    o the difference in the severity of spasticity: defined by the RM test between the subjects who received ECP002A (Δ9-THC) and the subjects who received placebo.


    PK-PD
    o establishment of a PK-PD model for the effect of THC on spasticity.
    E.5.2.1Timepoint(s) of evaluation of this end point
    o Dose finding phase - day 1 (Repeated measures throughout day)
    o Dose finding phase - day 14 (Repeated measures throughout day)

    o Treatment phase - Baseline (Repeated measures throughout day)
    o Treatment phase - 14 days post start treatment (Repeated measures throughout day)
    o Treatment phase - 28 days post start treatment (Repeated measures throughout day)
    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 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) 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 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 Information not present in EudraCT
    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
    last visit of the last subject undergoing the trial
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial 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: 24
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 24
    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)
    Not different from normal treatment for Multiple Sclerosis.
    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 Decision2010-11-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-01-10
    P. End of Trial
    P.End of Trial StatusCompleted
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