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    The EU Clinical Trials Register currently displays   44335   clinical trials with a EudraCT protocol, of which   7366   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).

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    Summary
    EudraCT Number:2011-001202-99
    Sponsor's Protocol Code Number:CNSB015CP01
    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:2011-05-16
    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 number2011-001202-99
    A.3Full title of the trial
    A Phase IIb/III, Double-Blind, Placebo-Controlled, Randomized Study Investigating the Safety, Tolerability and Efficacy of Flupirtine as Adjunct to Opioids When Administered to Cancer Subjects Who Are Experiencing Pain With Neuropathic Features
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to investigate whether the administration of flupirtine in combination with opioids is safe, tolerable and efficacious when administered to cancer patients who are suffering from pain that shows neuropathic characteristics
    A.4.1Sponsor's protocol code numberCNSB015CP01
    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 SponsorRelevare Pharmaceuticals, Ltd.
    B.1.3.4CountryAustralia
    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 supportRelevare Pharmaceuticals, Ltd.
    B.4.2CountryAustralia
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRelevare Pharmaceuticals, Ltd.
    B.5.2Functional name of contact pointVice President Clinical Operations
    B.5.3 Address:
    B.5.3.1Street Address1001 Bayhill Drive, Suite 200
    B.5.3.2Town/ citySan Bruno, California
    B.5.3.3Post code94066
    B.5.3.4CountryUnited States
    B.5.4Telephone number001650262-4226
    B.5.5Fax number001650351-0349
    B.5.6E-mailcurtis.head@relevarepharma.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 Yes
    D.2.1.1.1Trade name Katadolon 100mg, Hartkapsel
    D.2.1.1.2Name of the Marketing Authorisation holderAWD.pharma GmbH & Co. KG
    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.3.4Pharmaceutical 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 INNFLUPIRTINE MALEATE
    D.3.9.1CAS number 75507-68-5
    D.3.9.4EV Substance CodeSUB02234MIG
    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.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
    Pain with neuropathic features in cancer subjects which is inadequately controlled despite optimized opioid treatment
    E.1.1.1Medical condition in easily understood language
    Tumor pain which cannot be controlled adequately by administration of opioids
    E.1.1.2Therapeutic area Diseases [C] - Symptoms and general pathology [C23]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level LLT
    E.1.2Classification code 10045158
    E.1.2Term Tumor pain
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to explore the overall analgesic efficacy of flupirtine administered in combination with opioids for a period of 5 weeks.
    E.2.2Secondary objectives of the trial
    Secondary objectives of this study are to:
    - Investigate the safety and tolerability of flupirtine administered in combination with opioids;
    - Investigate the efficacy of flupirtine using various secondary measures of efficacy.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Presence of a solid neoplasm and between the ages of 18 and 65 years, inclusive
    2. Able to understand written and verbal communication in the primary language of the country in which the study is being undertaken
    3. Life expectancy a minimum of 3 months with Karnofsky score ≥50 at the Screening Visit (Day -7)
    4. History of daily pain attributable to cancer and requiring treatment with strong opioids for at least 3 months duration
    5. Pain with neuropathic characteristics that include one or more of the following: throbbing, shooting, stabbing, sharp, cramping, gnawing, hot-burning, aching, heavy, tender, splitting, tiring-exhausting, sickening, fearful, punishing-cruel, electric-shock, cold-freezing, piercing, caused by light touch, itching, tingling or ‘pins and needles’, or numbness.
    6. Pain inadequately relieved despite active management including strong opioids
    7. Currently taking morphine, oxycodone, hydromorphone, buprenorphine, or transdermal fentanyl for daily, non-breakthrough pain management (i.e., maintenance opioid treatment) with no changes in dose in the 2 weeks preceding the Screening Visit (Day -7)
    8. Completion of a daily diary in which the 24-hour AP score has been entered for at least 5 of the last 7 days preceding Day 1
    9. Average of non-missing 24-hour AP scores over the last 7 days before the day of randomization is 4 or greater
    10. If on gabapentin, pregabalin or selective serotonin reuptake inhibitors (SSRIs) or tricyclic antidepressants, no changes in dose in the 2 weeks preceding the Screening Visit (Day -7)
    11. Willing to maintain existing analgesic medications, including maintenance opioid treatment, at same dose(s) and schedule for a minimum of 6 weeks following the Screening Visit (Day -7)
    12. Able to take oral medication
    13. If female subject of childbearing potential, a negative serum beta human chorionic gonadotropin (hCG) pregnancy test, performed at the Screening Visit (Day -7). Must be willing to use effective methods of birth control and/or refrain from participating in a conception process during the study and for 30 days following study drug exposure.
    14. Willing and able to comply with protocol requirements for the duration of study participation
    15. Contractual capability and signed informed consent
    E.4Principal exclusion criteria
    1. Medical condition or illness other than solid neoplasm that would, in the opinion of the Investigator, preclude study participation or interfere with the assessment of pain
    2. Abnormal liver or kidney function as defined by alanine aminotransferase (ALT), aspartate aminotransferase (AST) or alkaline phosphatase in excess of 3 times the upper limit of normal, or chronic kidney disease worse than stage II (glomerular filtration rate <60 mL/min as calculated by Cockroft-Gault formula [(140-age) x (weight in kilograms) x (0.85 if female) / (72 x serum creatinine in mg/dl)])
    3. Significant pain with neuropathic features which cannot be attributed to underlying malignancy
    4. Proven hypersensitivity to flupirtine or one of the other ingredients
    5. Cholestasis, pre-existing liver disease, or at risk of hepatic encephalopathy
    6. Use of paracetamol-containing medications or carbamazepine
    7. History of radiotherapy or a nerve block or other anesthetic procedure to the presumed site of nerve damage within 4 weeks preceding the Screening Visit (Day -7). Such procedures after the Screening Visit will necessitate withdrawal from the study.
    8. If receiving a bisphosphonate medication, change in dose or frequency within 3 months preceding the Screening Visit (Day -7)
    9. If receiving a hormonal contraceptive, change in dose or frequency within 3 months preceding the Screening Visit (Day -7)
    10. Systemic radioisotope therapy within 1 month preceding the Screening Visit (Day-7)
    11. Significant history of illicit drug or alcohol abuse
    12. Current or previous (within 30 days of first study dosing) treatment with another investigational drug or participation in another clinical study
    13. Change in chemotherapy regimen anticipated within 6 weeks following the Screening Visit
    14. Pregnant or lactating females. Serum pregnancy test must be performed within 7 days prior to study treatment start, or within 14 days with a confirmatory urine pregnancy test within 7 days prior to study treatment start;
    15. Known hepatitis B or C or HIV infection
    16. Not suitable for study participation in the Investigator’s judgment
    17. Previous participation in this study
    18. Patient is a relative of, or staff directly reporting to the Investigator
    19. Patient is an employee of the sponsor
    20. Subject is committed under official or judicial order
    21. Patient with a known diagnosis of myasthenia gravis
    22. Patient with a known diagnosis of tinitus
    23. Patients with metastatic liver disease (accompanied by change in LFTs to >2x ULN)
    E.5 End points
    E.5.1Primary end point(s)
    Change in the 11-point Likert scale for average daily pain from the baseline mean pain score (the mean of non-missing daily diary entries for average pain during the 7 days before randomization) to the final mean pain score (the mean of last 7 daily diary entries for average pain during the Treatment Period)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 36 visit
    E.5.2Secondary end point(s)
    - Percentage of subjects achieving at least 30% improvement from baseline based on the primary efficacy endpoint;
    - Physician and Subject Global Assessment of study drug;
    - Change in the 11-point Likert scale from the baseline mean pain score to the mean pain score during each week of the Treatment Period;
    - Percentage of subjects achieving pre-specified pain reduction thresholds (e.g., 20% to 100%); and
    - Opioid consumption, BPI (short-form), average pain the past 24 hours, least pain in past 24 hours, and worst pain in past 24 hours.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 36 visit
    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 No
    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) 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 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 No
    E.8.2.4Number of treatment arms in the trial3
    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 concerned25
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA50
    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's follow-up telephone call
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    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.1.1Number of subjects for this age range: 0
    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: 280
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 state150
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 300
    F.4.2.2In the whole clinical trial 300
    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)
    Subjects believed to be benefiting from participation in the CNSB015CP01 trial may also be eligible to enroll in an open-label extension study upon completion of study procedures.
    Patients who are not continuing with participation in the open-label extension study will be treated according to the medical standard.
    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 Decision2011-10-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-08-02
    P. End of Trial
    P.End of Trial StatusCompleted
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