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The European Union Clinical Trials Register   allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   43715   clinical trials with a EudraCT protocol, of which   7255   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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    EudraCT Number:2016-001164-11
    Sponsor's Protocol Code Number:KF7013-03
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-03-28
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2016-001164-11
    A.3Full title of the trial
    Open-label safety trial of intravenous neridronic acid in subjects with complex regional pain syndrome (CRPS)
    Otwarte badanie oceniające bezpieczeństwo kwasu neridronowego, podawanego dożylnie pacjentom z algodystrofią (CRPS)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Safety of intravenous neridronic acid in complex regional pain syndrome (CRPS)
    Bezpieczeństwo dożylnego kwasu neridronowego w CRPS
    A.4.1Sponsor's protocol code numberKF7013-03
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02972359
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1180-8099
    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 SponsorGrünenthal GmbH
    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 supportGrünenthal GmbH
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGrünenthal GmbH
    B.5.2Functional name of contact pointGrünenthal Trial Information Desk
    B.5.3 Address:
    B.5.3.1Street AddressZieglerstr. 6
    B.5.3.2Town/ cityAachen
    B.5.3.3Post code52078
    B.5.4Telephone number492415693223
    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. name Nerixia 100 mg/8 mL concentrate for solution for infusion
    D. of the Marketing Authorisation holderAbiogen Pharma S.p.A.
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameNeridronic acid 100 mg/8 mL concentrate for solution for infusion
    D.3.2Product code GRT7013
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 80729-79-9
    D.3.9.2Current sponsor codeGRT7013
    D.3.9.3Other descriptive nameSodium neridronate hemihydrate
    D.3.9.4EV Substance CodeSUB27150
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Complex regional pain syndrome (CRPS)
    E.1.1.1Medical condition in easily understood language
    Complex regional pain syndrome
    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 20.0
    E.1.2Level LLT
    E.1.2Classification code 10064334
    E.1.2Term Complex regional pain syndrome Type I
    E.1.2System Organ Class 100000014344
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10064335
    E.1.2Term Complex regional pain syndrome Type II
    E.1.2System Organ Class 100000014344
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the safety and tolerability of neridronic acid in subjects with complex regional pain syndrome.
    E.2.2Secondary objectives of the trial
    To assess the safety and tolerability of neridronic acid in subjects with complex regional pain syndrome.
    To assess the efficacy of neridronic acid in treatment of complex regional pain syndrome.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Informed consent signed.
    2. Male or female subjects at least 18 years of age at Visit 1.
    3. A diagnosis of CRPS according to the clinical diagnostic criteria recommended by the International Association for the Study of Pain (IASP; “Budapest clinical criteria”).
    4. Ongoing moderate to severe chronic pain, including a baseline current pain intensity score of 4 or greater using an 11-point NRS, referring to the CRPS-affected limb.
    5. In stable treatment and follow-up therapy for CRPS for at least 1 month prior to allocation to treatment.
    6. Women of child-bearing potential must have a negative urine (β-HCG) pregnancy test and must be using 2 forms of medically
    acceptable contraception.
    7. Subjects must be able to communicate meaningfully, be able to differentiate with regard to location and intensity of the pain, and be able to answer the questions in the questionnaires used in this trial.
    E.4Principal exclusion criteria
    1. Evidence of renal impairment (estimated glomerular filtration rate [eGFR] less than 60 mL/min/1.73 m2 or a urinary albumin creatinine ratio greater than 30 mg/g). Note: If 2 consecutive laboratory tests indicate eGFR levels greater or equal to 60 mL/min/1.73 m2 or a single repeat laboratory test of the urinary albumin creatinine ratio is less than 30 mg/g during the enrollment period, the subject is eligible.
    2. Serum calcium or magnesium outside of the central laboratory’s reference range.
    3. Vitamin D deficiency, defined as a 25(OH)D level less than 30 ng/mL.
    4. Corrected QT interval (QTcF) greater than 470 ms; serum potassium outside the central laboratory’s reference range; clinically unstable cardiac disease; evidence of complete left bundle branch block; complete atrioventricular block; history of Long QT Syndrome or a relative with this condition; or any other known risk factor for torsade de pointes.
    5. Subjects receiving medications with a known risk of torsades de pointes within 7 days prior to allocation. Subjects receiving selective serotonin re-uptake inhibitor antidepressants (e.g., citalopram, escotalopram) or tricyclic antidepressants are eligible if the QT-interval
    values do not meet the exclusion criteria, the medication was started at least 1 month prior to allocation, the dose is stable, and the dose is anticipated to remain stable until at least 4 days after the last infusion of IMP.
    6. Anticipated requirement for treatment with oral or intravenous bisphosphonate for another condition, or administration of denosumab, or other drugs affecting bone turnover or bone metabolism within 6 months prior to Visit 1.
    7. History of any allergic or hypersensitivity reaction to neridronic acid or other bisphosphonate, acetaminophen, or to vitamin D or calcium supplements.
    8. Recent tooth extraction or other invasive dental procedure, unhealed or infected extraction site, or significant dental/periodontal disease that may predispose to need for tooth extraction or other invasive dental procedures during the trial.
    9. Evidence of denture-related gum trauma or improperly fitting dentures causing injury.
    10. Prior radiation therapy of the head or neck.
    11. History of malignancy within 2 years prior to Visit 1, with the exception of basal cell carcinoma.
    12. Use of nerve blocks, ketamine infusions, intravenous immunoglobulin, acupuncture, electromagnetic field treatment, or initiation/implementation of radiofrequency ablation or other sympathectomy procedures, or peripheral nerve stimulation within 6 weeks prior to Visit 1.
    13. Evidence of current alcohol or drug abuse, or history of alcohol or drug abuse within 2 years of Visit 1.
    14. Any other severe medical condition, including severe depression, or any other severe mood disorder, that in the opinion of the investigator may affect efficacy or safety assessments or may compromise the subject’s safety during trial participation.
    15. Women who are pregnant or breastfeeding.
    16. Elevated aspartate aminotransferase or alanine aminotransferase greater than 2-fold upper limit of normal or current evidence of chronic liver disease.
    17. Participation in another investigational drug trial within 3 months prior to Visit 1.
    18. Subject is engaged in litigation related to their disability from CRPS in which monetary gain or loss (or other compensation) may affect their objective participation in the trial.
    E.5 End points
    E.5.1Primary end point(s)
    Occurrence of any treatment emergent adverse event (TEAE).
    E.5.1.1Timepoint(s) of evaluation of this end point
    TEAE occurrence from baseline to Week 52.
    E.5.2Secondary end point(s)
    1) Occurrence of permanent discontinuation from treatment due to an adverse event.
    2) Change in the current pain intensity score, using a numerical rating scale (NRS).
    3) Response to treatment, defined as at least 30% and at least 50% decrease from baseline in the current pain intensity score.
    4) Patient Global Impression of Change (PGIC).
    5) Change in the Pain Interference score of the Brief Pain Inventory (BPI).
    E.5.2.1Timepoint(s) of evaluation of this end point
    1) Day 1 to Day 10
    2) Baseline to Week 12 and Week 26
    3) at Week 12 and Week 26
    4) at Week 12 and Week 26
    5) Baseline to Week 12 and Week 26
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    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. 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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA14
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    United States
    E.8.7Trial has a data monitoring committee Yes
    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 months2
    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 months10
    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: 200
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 25
    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 state45
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 85
    F.4.2.2In the whole clinical trial 225
    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)
    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 Decision2017-09-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-03-27
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-01-09
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