Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   38185   clinical trials with a EudraCT protocol, of which   6272   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2015-001431-20
    Sponsor's Protocol Code Number:CHDR1417
    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:2015-04-21
    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 number2015-001431-20
    A.3Full title of the trial
    A randomized, double blind, double-dummy placebo controlled, 3-way cross-over study to determine the test-retest reliability of, and the effect of oral retigabine and riluzole on, peripheral motor nerve excitability measurements in patients with ALS.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Trial to look at the nerve conductance in patients with ALS, with and without Riluzole or Retigabine.
    A.3.2Name or abbreviated title of the trial where available
    Peripheral motor nerve excitability study in patients with ALS
    A.4.1Sponsor's protocol code numberCHDR1417
    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 SponsorCentre for Human Drug Research
    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 supportCHDR
    B.4.2CountryNetherlands
    B.4.1Name of organisation providing supportBiogen Idec Ltd
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHDR
    B.5.2Functional name of contact pointResearch Director
    B.5.3 Address:
    B.5.3.1Street AddressZernikedreef 8
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2333 CL
    B.5.3.4CountryNetherlands
    B.5.6E-mailGGroeneveld@chdr.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.2.1.1.1Trade name Rilutek 50 mg film-coated tablets
    D.2.1.1.2Name of the Marketing Authorisation holderAventis Pharma S.A.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameRilutek
    D.3.4Pharmaceutical form Film-coated 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 INNRILUZOLE
    D.3.9.1CAS number 1744-22-5
    D.3.9.4EV Substance CodeSUB10319MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 Trobalt
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxo Group Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameTrobalt
    D.3.4Pharmaceutical form Film-coated 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 INNRETIGABINE
    D.3.9.1CAS number 150812-12-7
    D.3.9.4EV Substance CodeSUB10291MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    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 placeboCapsule
    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
    Amytrophic Lateral Sclerosis
    E.1.1.1Medical condition in easily understood language
    Neuromuscular disorder that involves death of neurons, leading to muscle weakness due to muscle wasting.
    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 18.1
    E.1.2Level PT
    E.1.2Classification code 10002026
    E.1.2Term Amyotrophic lateral 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
    To evaluate the test-retest reliability of nerve excitability threshold tracking in patients with ALS.
    E.2.2Secondary objectives of the trial
    • To investigate the ability of Strength Duration Time Constant (SDTC) to detect effects of retigabine and riluzole in patients with ALS.
    • To investigate the ability of Refractoriness at 2 ms to detect effects of retigabine and riluzole in patients with ALS.
    • To investigate the ability of Superexcitability to detect effects of retigabine and riluzole in patients with ALS.
    • To investigate the ability of depolarizing Threshold Electrotonus (40-60 ms)to detect effects of retigabine and riluzole in patients with ALS.
    • To investigate the ability of depolarizing Threshold Electrotonus (90-100 ms) to detect effects of retigabine and riluzole in patients with ALS.
    • To determine if there is a correlation between ALSFRS-R score at baseline and at 3 months and motor nerve excitability measures refractoriness at 2 ms, superexcitability, depolarizing Threshold Electrotonus (40-60 ms), depolarizing Threshold Electrotonus (90-100 ms) or Strength Duration time Constant at baseline on day 0.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Ability to understand the purpose and risks of the study and provide signed and dated informed consent.
    2. Aged 18 to 80 years old, inclusive, at the time of informed consent.
    3. Women of childbearing potential must practice effective contraception for the duration of the study.
    4. Willing to limit the intake of alcohol to no more than 2 units per day from the screening visit to the the last scheduled visit and to refrain from alcohol intake 48 hours prior to each study visit until their stay in the clinical research unit. One unit of alcohol is defined as 1 pint of beer (350 mL), 1 glass of wine (150 mL) or 1 shot of liquor (30 mL).
    5. Willing to refrain from marijuana use throughout the study.
    6. Willing to refrain from vigorous exercise within 48 hours prior to each study visit.
    7. Must have a diagnosis of “definite”, “probable”, or “probable laboratory-supported”, ALS according to the World Federation of Neurology El Escorial criteria (revised according to the Airlie House Conference 1998 [Brooks 1999]). \
    8. Fasciculations in the arms observed by the treating neurologist
    E.4Principal exclusion criteria
    1. History of diabetes or neuropathy.
    2. History of neuromuscular disorders (other than ALS) including but not limited to ALS mimic syndromes, myopathy, myasthenia gravis, and other motor neuron diseases.
    3. Median nerve CMAP less than 1 mV.
    4. Unstable cardiac, pulmonary, renal, hepatic disease or active malignancy.
    5. Clinically significant abnormalities in laboratory test results as judged by the investigator. In the case of uncertain or questionable results, laboratory tests performed during the screening visit may be repeated 1 time before participation in the study to confirm eligibility or may be judged to be clinically irrelevant.
    6. History or symptoms of any clinically significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and ophthalmologic or other major disease, as determined by the investigator (with the exception of the neurological syndrome listed in the inclusion criteria section).
    7. 12-lead ECG demonstrating QTcB >450 msec at Screening.
    8. Concomitant disease or condition that can interfere with the conduct of the study, or that in the opinion of the investigator, would pose an unacceptable risk to the subject in this study.
    9. History of trauma to the upper extremities or other orthopaedic conditions that, in the opinion of the investigator, could affect the electrophysiological measurements.
    10. Use of medications including but not limited to anticholinergics and muscle relaxants that, in the opinion of the investigator, could affect the electrophysiological measurements within 2 weeks prior to first dosing or within 6 times the elimination half-life of the medication prior to first dosing (whichever is longer).
    11. Current enrolment in any interventional clinical study in which treatment with an investigational drug or approved therapy for investigational use is administered within 30 days prior to the screening or participation in an interventional study for an investigational drug or device within 3 months prior to Screening.
    12. Pregnant, breastfeeding, or a positive pregnancy test result at Screening.
    13. A positive urine test for drugs of abuse at Screening.
    14. Unwillingness or inability to comply with study requirements.
    15. Unspecified reasons that, in the opinion of the Investigator, make the subject unsuitable for enrollment.
    E.5 End points
    E.5.1Primary end point(s)
    • ICC for nerve excitability parameters.
    E.5.1.1Timepoint(s) of evaluation of this end point
    For each occasion at pre-dose and at 1 or 2 hours post-dose and 5 or 6 hours post-dose
    E.5.2Secondary end point(s)
    • Axonal excitability parameters of motor axons in the median nerve.
    o CMAP
    o Strength Duration Time Constant (SDTC)
    o Refractoriness at 2 ms
    o Superexcitability
    o Subexcitability
    o depolarizing Threshold Electrotonus (40-60 ms)
    o depolarizing Threshold Electrotonus (90-100 ms)
    o hyperpolarizing Threshold Electrotonus (90-100 ms)
    o Rheobase
    o Hyperpolarizing I/V gradient
    • Points change in ALSFRS-R scale at 3 months compared to baseline.
    • Muscle strength and fatigue variables as measured with the POWERjar:
    o Maximum grip strength in kilograms
    o Time in seconds to reach a grip strength 10% below the maximal grip strength
    o Time in seconds to reach a torque 10% (or higher, if applicable) below the predefined resistance for torque
    o Time in seconds to fully release grip.
    E.5.2.1Timepoint(s) of evaluation of this end point
    For each occasion at pre-dose and at 1 or 2 hours post-dose and 5 or 6 hours post-dose

    ALSFRS-R will be taken at day 0 and at the 90 day follow-up phone-call.

    POWERjar will be measured in two occasions at 4 hours post dose.
    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 No
    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 Yes
    E.6.13.1Other scope of the trial description
    Biomarker development
    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 trial3
    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
    Last subject Last Contact (follow-up phone call).
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months6
    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: 18
    F.1.3Elderly (>=65 years) No
    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 state18
    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)
    None
    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 Decision2015-04-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-08-17
    P. End of Trial
    P.End of Trial StatusCompleted
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2020 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA