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    The EU Clinical Trials Register currently displays   44338   clinical trials with a EudraCT protocol, of which   7368   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:2007-001206-24
    Sponsor's Protocol Code Number:16901
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2007-08-09
    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 number2007-001206-24
    A.3Full title of the trial
    Effect of selective COX-2 inhibition on neuroinflammation in Parkinson's disease
    A.3.2Name or abbreviated title of the trial where available
    COXPKPD
    A.4.1Sponsor's protocol code number16901
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberCCT-NAPN-16254
    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 SponsorUMCG
    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 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.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
    Parkinson's disease
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To measure in vivo effect on neuroinflammation of treatment with celecoxib, a selective COX-2 inhibitor, in PD using PK111-95 and PET.
    Celecoxib showed broad utility in animal models of neurodegeneration. Neurochemical effect of the treatment on microglia activation in humans will be measured in vivo comparing the PET scans of 10 early stage PD patients before and after one month of treatment. Differences between the first and second scan will be compared to a first and second scan in a group of 10 PD patients without treatment with celecoxib, to compare test-retest variability.

    This study is meant to be a pilot study which tries to deliver a proof of principle, namely whether neuroinflammation of the brain can be blocked by available medication and whether this can be monitored by the applied radiotracer scans. If a positive result is achieved then a larger study is warranted to investigate longitudinally whether long-term treatment has a positive clinical effect.
    E.2.2Secondary objectives of the trial
    no
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Age over 40
    -Informed consent.
    -Regarded by the treating physician to have competence of judgement.
    -Compliance with the criteria for possible or probable PD as proposed by Gelb, Oliver and Gilman [1999]
    -early stage PD; Hoehn and Yahr stages 1-2.
    E.4Principal exclusion criteria
    - Prior cardiovascular brain disease, other brain disease (including former traumatic contusion)
    - Evidence of any significant general medical disease in medical history or at clinical exam; e.g. significant kidney or liver disease, evidence of autoimmune disease.
    - Evidence of psychiatric disease in medical history; e.g. depressive disorder, schizophrenia.
    - Use of anti-inflammatory medication: NSAID’s and steroids.
    - Use of benzodiazepines. Benzodiazepines have affinity for the PBR receptor that binds the PET tracer PK11195 and can interfere with the study.
    - Contra-indications for celecoxib use: active gastric ulcers or gastric bleeding. Asthma attack, urticaria, angio-edema after use of prostaglandine synthetase inhibitors. Inflammatory bowel disease. Moderate or severe liver or kidney disease. Severe heart failure. Allergy to sulphonamide.
    - Abnormalities at clinical neurological examination (other than PD)
    - Pregnancy in women of childbearing potential.
    - Exposure to a significant amount of radiation in the past year.
    - Radiological workers.
    E.5 End points
    E.5.1Primary end point(s)
    [11C]-PK111-95 Binding Potential (BP) images will be generated based on a simplified reference tissue model4;13. Cluster analysis will be used to extract and identify a normal brain reference input function for individual PD cases. The reference tissue model will be compared to parametric analysis, using plasma input data and Logan analysis to generate distribution volume images. Pixel-by-pixel analysis will be done using Statistical Parametric Mapping program (SPM2)14. A coupled t-test will be applied to evaluate differences between the two scans. P-value of 0.001, uncorrected for multiple comparisons / 0.05 after correction will be taken for statistical significance.
    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 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) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Information not present in EudraCT
    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 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 No
    E.8.2.3Other No
    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 Information not present in EudraCT
    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
    End is after completion of the protocol in 20 patients. End of 2007
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months9
    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.1.1.1In 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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 0
    F.4.2.2In the whole clinical trial 20
    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)
    No difference
    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 Decision2007-03-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-07-31
    P. End of Trial
    P.End of Trial StatusOngoing
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