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    Summary
    EudraCT Number:2006-004007-19
    Sponsor's Protocol Code Number:AV-007-IM
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2006-10-19
    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 ConcernedAustria - BASG
    A.2EudraCT number2006-004007-19
    A.3Full title of the trial
    A multi-centre, double-blind, placebo-controlled, randomised, parallel group
    clinical trial to evaluate efficacy and safety of Actovegin® in diabetic type 2
    patients with symptomatic diabetic peripheral polyneuropathy
    A.3.2Name or abbreviated title of the trial where available
    Actovegin® versus placebo in patients with diabetic polyneuropathy
    A.4.1Sponsor's protocol code numberAV-007-IM
    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 SponsorNycomed Austria 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 Yes
    D.2.1.1.1Trade name ACTOVEGIN "Nycomed" 20 %-Infusionsflasche
    D.2.1.1.2Name of the Marketing Authorisation holderNycomed Austria GmbH
    D.2.1.2Country which granted the Marketing AuthorisationAustria
    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 Solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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.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 ACTOVEGIN 200 mg-Dragees
    D.2.1.1.2Name of the Marketing Authorisation holderNycomed Austria GmbH
    D.2.1.2Country which granted the Marketing AuthorisationAustria
    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 Coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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 placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCoated 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
    Diabetic Polyneuropathy
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level LLT
    E.1.2Classification code 10012685
    E.1.2Term Diabetic polyneuropathy
    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 efficacy and safety of Actovegin® (Actovegin) versus placebo given as
    intravenous (i.v.) infusions once daily for 20 days, followed by oral treatment for 140 days in patients with symptomatic diabetic peripheral polyneuropathy.
    E.2.2Secondary objectives of the trial
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Has the patient given informed consent according to local requirements before any trial related activities? A trial related activity is any procedure that would not have been performed during the routine management of the patient.
    2. Is the patient aged ≥ 18 to ≤ 65 years?
    3. Does the patient suffer from type 2 diabetes mellitus?
    4. Has the patient evidence of symptomatic diabetic peripheral polyneuropathy, i.e. TSS ≥6 and NIS-LL ≥ 2?
    5. Is the patient’s VPT measured to ≤ 30V?
    6. Has the patient adequate circulation to the foot as evidenced by a palpable pulse on posterior tibialis artery and dorsal artery of foot?
    7. Is the HbA1C level less than 10%?
    8. Is the patient able to make frequent clinic visits over the trial period?

    For patients receiving tricyclic antidepressants, anticonvulsants, mexiletine or neuroleptics as treatment of neuropathic pain:
    9. Has the regimen been stable within the last month?

    For female patients of childbearing potential (childbearing potential is considered until menopause has lasted more than 12 months):
    10. Does the patient use an acceptable contraceptive method (hormonal pills, patches, implants, injections or intrauterine device)?
    11. Is the pregnancy test negative before the 1st dose of IMP?
    (Surgically hysterectomised and surgically successfully sterilized females may be included on the same conditions as male patients).
    E.4Principal exclusion criteria
    1. Does the patient suffer from known allergy towards Actovegin or similar preparations?
    2. Has the patient asymmetrical neuropathy of the trunk or proximal lower limbs?
    3. Does the patient suffer from diabetic foot ulceration or infections?
    4. Does the patient suffer from diabetic amyotrophy?
    5. Does the patient suffer from decompensated cardiac insufficiency, pulmonary oedema, oliguria, anuria, generalised oedema?
    6. Does the patient suffer from polyneuropathy due to other underlying causes?
    7. Has the patient been hospitalised due to diabetic polyneuropathy within the last month?
    8. Has the patient participated in any other trial with an Investigational Medicinal Product (IMP) or device within 30 days before inclusion in this trial?
    9. Has the patient ever used medications that may be etiological factors for neuropathy, such as isoniazid, nitrofurantoin, vincristine and phenytoin?
    10. Has the patient used cerebrolysin or α-lipoic acid or received Transcutaneous Electric Nerve Stimulation (TENS) or acupuncture within the last month?
    11. Has the patient received opiates as treatment of his / her diabetic polyneuropathy within the last month?
    12. Does the patient suffer from any malignancy?
    13. Is the patient nursing?
    14. Does the patient suffer from any mental, psychiatric or other conditions that may
    compromise data collection and understanding of written and verbal information given in the trial?
    15. Does the patient suffer from present and / or previous chronic alcohol abuse?
    16. Is there any anamnestic evidence of hypothyroidism?
    17. Is there any anamnestic evidence of vitamin B12 deficiency?
    18. Does the patient suffer from an impaired renal function with high blood urea nitrogen (BUN) and / or increased serum creatinine (>120 μmol/L)?
    E.5 End points
    E.5.1Primary end point(s)
    Average of TSS over the treatment period calculated by Area Under the Curve (AUC),
    divided by the treatment period in number of days. According to recommendations (30), positive neuropathic sensory symptoms can serve as important endpoints for controlled clinical trials in diabetic polyneuropathy, since they are symptoms of which patients complain and for which patients come to doctors seeking relief. In tertiary neuromuscular practice, painful neuropathy is among the most common reasons for referral. The TSS range from 0 (no symptoms) to 14.64 points (all symptoms and [almost] continuously present between the groups receiving Actovegin and placebo (31).

    Average of the VPT over the treatment period using the same methods as for the TSS
    using Bio-Thesiometer, which is a quantitative sensory testing device. According to the guidelines for clinical investigations for medicinal products in the treatment of diabetes mellitus (32), efficacy should be based on clinical symptoms and signs, however, quantitative sensory tests, e.g. for vibration, can be supportive. There are published data, suggesting that test of VPT can be used as a clinical predictor for foot ulceration in diabetic patients with established neuropathy (33), and it is anticipated that vibratory sensations are conveyed by large diameter fibers, while neuropatic pain primarily conveyed by small-fiber sensations (34). There are data indicating that VPT examinations obtained with a simple, relatively inexpensive device, such as Bio- Thesiometer, are comparable to those obtained using more elaborate equipment and testing methods (35).
    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 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 concerned3
    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 Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    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 months1
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months1
    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) 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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    F.4.2.2In the whole clinical trial 550
    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 Decision2006-11-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-11-16
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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