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    Summary
    EudraCT Number:2012-005312-26
    Sponsor's Protocol Code Number:FACEG
    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:2013-01-11
    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 number2012-005312-26
    A.3Full title of the trial
    Sustained release 4-aminopyridine (Fampyra®) in cerebellar gait disorder
    Retardiertes 4-Aminopyridin (Fampyra®) bei cerebellärer Gangstörung
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Analysis of the effectiveness of the drug Fampyra® in patients with gait disorder
    A.4.1Sponsor's protocol code numberFACEG
    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 SponsorHospital of the University of Munich, Grosshadern
    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 supportBiogen Idec GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHospital of the University of Munich
    B.5.2Functional name of contact pointStudienzentrale DSGZ
    B.5.3 Address:
    B.5.3.1Street AddressMarchioninistr. 15
    B.5.3.2Town/ cityMunich
    B.5.3.3Post code81377
    B.5.3.4CountryGermany
    B.5.4Telephone number004989440076986
    B.5.5Fax number004989440078795
    B.5.6E-mailingrid.berger@med.uni-muenchen.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 Yes
    D.2.1.1.1Trade name Fampyra
    D.2.1.1.2Name of the Marketing Authorisation holderBiogen Idec Ltd.
    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 Prolonged-release 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 INNFAMPRIDINE
    D.3.9.1CAS number 504-24-5
    D.3.9.4EV Substance CodeSUB07505MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 placeboFilm-coated tablet
    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
    cerebellar gait disorder, cerebellar ataxia, sensorimotor adaption and ocular motor disorders, postural sway, dysarthria
    E.1.1.1Medical condition in easily understood language
    Imbalance, dizziness, vertigo, fall incidence, fatigue, speech disorder
    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 19.0
    E.1.2Level PT
    E.1.2Classification code 10008025
    E.1.2Term Cerebellar ataxia
    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
    Primary objective:
    1) To demonstrate the effectiveness of sustained released 4-aminopyridine regarding the reduction of the gait variability (improvement of gait) at maximum walking speed compared to placebo.
    2) To demonstrate the effectiveness of sustained released 4-aminopyridine regarding the increase of individual preferred walking speed compared to placebo.
    E.2.2Secondary objectives of the trial
    Secondary objective:
    1) Comparison of the gait variability at maximum walking speed at the end of the 12-week treatment phase under sustained released 4-aminopyridine or placebo (long term effect).
    2) Analysis of the difference in the (relative) change of the individual preferred walking speed at the end of the 12-week treatment phase versus pre-treatment (baseline) under sustained released 4-aminopyridine or placebo (long term effect).
    3) Quantitative description or comparison of the changes in various ataxia-, mobility- and QoL-scores within the two treatment groups compared to baseline value (after 14 days, 12 weeks, or follow-up visit).
    4) Comparison of the number of falls under sustained released 4-aminopyridine or placebo.
    5) Study the frequency of (S)AEs under sustained released 4-aminopyridine compared to placebo.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects will only be included in the study if they meet all of the following criteria:
    1. Patients male or female, aged between 18 and 80 years
    2. Clinical evaluated diagnosis of cerebellar ataxia with at least 2 points in the scale for the assessment and rating of ataxia (SARA)
    3. Written informed consent of the subject
    4. Subjects, with the ability to follow study instructions and likely to attend and complete all required visits (Compliance).
    E.4Principal exclusion criteria
    Subjects will not be included in the study if any of the following criteria applies:
    1. Weight of 40 kg or less
    2. Pregnancy or breast-feeding
    3. Concurrend treatment with inhibitors of organic cation transporter 2 (OCT2), e.g. cimetidine
    4. Cardiovascular diseases e.g. recent heart attack (within the last 3 months), cardiac arrhythmia (QTc interval > 500 ms, atrial fibrillation, AV block grade ≥ II), unstable angina pectoris (chest tightness due to impaired blood flow to the heart), severe heart failure (NYHA class IV)
    5. Recently occurred stroke (within the last 3 months)
    6. Epileptic seizure currently or in the past
    7. Severe arterial hypertension (grade III according to the guidelines of the German society of cardiology, 2008)
    8. Liver insufficiency (e.g. cirrhosis of the liver)
    9. Asthma (severity ≥ grade III)
    10. Milde or severe renal failure (Creatinine Clearance ≤ 80ml/min)
    11. Unadjusted thyroid dysfunction
    12. Acute gastric and intestinal ulcer
    13. Other acute, serious illness of the subject
    14. Subject is unable to understand the nature, scope, significance and consequences of this clinical trial.
    15. Subject is unable to comply with the study design
    16. Previous participation in this clinical trial or simultaneous participation in another clinical trial or participation in any clinical trial involving an investigational medicinal product within 30 days prior to written informed consent for this clinical trial

    Note to Exclusion Criterion 10. Mild or severe renal failure (Creatinine Clearance ≤ 80ml/min):
    If Creatinine Clearance at Screening Visit is > 80ml/min a 24 hour urin sample will be taken (collection start at day of Screening Visit) for re-assessment of Creatinine Clearance.
    E.5 End points
    E.5.1Primary end point(s)
    Primary end point:
    1) Logarithmized gait variability at maximum walking speed (CVmax [%])
    2) Logarithmized individual preferred walking speed (G_pref)
    E.5.1.1Timepoint(s) of evaluation of this end point
    14 days after beginnig of a 12-week treatment phase (Visit 2 and Visit 5)
    E.5.2Secondary end point(s)
    Secondary end point:
    1) Logarithmized gait variability at maximum walking speed
    2) Change of the logarithmized individual preferred walking speed [m/sec]
    3) Number of falls analysed via a standarized fall diary
    4) Changes in ataxia-score (SCAFI) and in mobility- and QoL-scores (FES, ABC, BDI-II, EQ-5D-5L, FSS)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Regarding end points 1 & 2:
    At the end of each 12-week treatment phase (Visit 3 and Visit 6) and after an additional 1-month follow-up period.
    Regarding end points 3:
    Messured during each 12-week treatment phase and after an additional 1-month follow-up period.
    Regarding end points 4:
    14 days after beginning of each treatment phase (Visit 2 and Visit 5) or rather at the end of each 12-week treatment phase (Visit 3 and Visit 6) and after an additional 1-month follow-up period.

    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) 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 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
    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.1.3Elderly (>=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 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 state75
    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)
    4 weeks after last administration of IMPs, there will be a follow-up visit.
    After the clinical trial, patients will have the opportunity to make regular appointments and to get medical advice in the german center of vertigo and balance disorders.
    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 Decision2013-03-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-02-06
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-11-02
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