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Summary
EudraCT Number:2006-003934-14
Sponsor's Protocol Code Number:86,1,2006_06_01
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:2009-03-11
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
A. Protocol Information
A.1Member State ConcernedGermany - BfArM
A.2EudraCT number2006-003934-14
A.3Full title of the trial
„Eine randomisierte, placebokontrollierte Doppelblindstudie zur Evaluation der Effektivität oral verabreichten Doxycyclins bei Patienten mit Creutzfeldt-Jakob-Krankheit“
A.3.2Name or abbreviated title of the trial where available
Creutzfeld-Jakob-Krankheit
A.4.1Sponsor's protocol code number86,1,2006_06_01
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 SponsorUniversitätsmedizin Göttingen
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 support
B.4.2Country
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1Name of organisationInstitut für anwendungsorientierte Forschung und klinische Studien - IFS GmbH
B.5.2Functional name of contact pointClinical Trials Information
B.5.3 Address:
B.5.3.1Street AddressVon-Bar-Str. 2/4
B.5.3.2Town/ cityGoettingen
B.5.3.3Post codeD-37075
B.5.3.4CountryGermany
B.5.4Telephone number+49055139171236
B.5.5Fax number+49055139171344
B.5.6E-mailahmed.ifs@med.uni-goettingen.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 No
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 Information not present in EudraCT
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 INNDOXYCYCLINE
D.3.9.1CAS number 564-25-0
D.3.9.4EV Substance CodeSUB06393MIG
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) 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 No
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 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
Creutzfeldt-Jakob-Krankheit
MedDRA Classification
E.1.2 Medical condition or disease under investigation
E.1.2Version 14.0
E.1.2Level LLT
E.1.2Classification code 10055172
E.1.2Term Creutzfeld-Jakob disease
E.1.2System Organ Class 10021881 - Infections and infestations
E.1.3Condition being studied is a rare disease Yes
E.2 Objective of the trial
E.2.1Main objective of the trial
Der primäre Zielparameter soll die Überlebenszeit der Patienten von Symptombeginn an sein.
E.2.2Secondary objectives of the trial
Sekundäre Zielparameter werden die Zeit von der Randomisierung bis zum Verlust der selbständigen Nahrungsaufnahme (falls anwendbar), bis zum Verlust der Sphinkter-kontrolle (falls anwendbar) und bis zum Erreichen des Stadiums des akinetischen Mutismus (falls anwendbar) sein.
E.2.3Trial contains a sub-study No
E.3Principal inclusion criteria
•Alter zwischen 18 und 80 Jahren
•Diagnose wahrscheinliche CJK nach WHO oder hochgradiger Verdacht auf eine Frühform (1 neurologisches Symptom + 1 positiver Befund in der apparativen Diagnostik)
•Auftreten erster neurologischer Symptome vor nicht mehr als 24 Monaten
•Durchführbarer MMSE oder Barthel-Index ≥ 20%
•cMRT innerhalb von 6 Monaten, EEG innerhalb von 3 Monaten vor Einschluss
•keine bekannte Kontraindikation zum Einsatz von Tetrazyklinen
•Aufklärung und schriftliches Einverständnis seitens des Patienten oder seines gesetzlichen Vertreter oder Bevollmächtigten
•Bei Frauen im gebärfähigen Alter Anwendung einer wirksamen Kontrazeption (Zusätzliche mechanische Verhütung erforderlich, da orale Kontrazeptiva durch die gleichzeitige Einnahme von Doxycyclin in ihrer Wirksamkeit beeinträchtigt sind)

E.4Principal exclusion criteria
•Familienanamnese einer Prionerkrankung
•Leber-, Herz-, oder Nierenerkrankung im Endstadium
•Aktives Malignom
•Schwangerschaft oder Stillzeit
•Bekannte Unverträglichkeit/Überempfindlichkeit gegenüber Tetrazyklinen
•Einnahme eines experimentellen Medikaments oder Teilnahme in einer klinischen Prüfung in den letzten 3 Monaten vor der Untersuchung
•Mitarbeiter der Untersucher oder der Einrichtungen mit direkter Beteiligung an der vorgeschlagenen klinischen Prüfung
•Bestehende Patienten-/Angehörigenverfügung, welche die Verwendung von Medikamenten, die die Krankheitsprogression herauszögern, untersagt
•Unter 5.4.2 aufgeführte unzulässige Begleittherapie, die nicht abgesetzt oder durch eine zulässige Begleittherapie ersetzt werden können
• Chronischer Alkoholabusus
E.5 End points
E.5.1Primary end point(s)
Der primäre Zielparameter soll die Überlebenszeit der Patienten von Symptombeginn an sein
E.5.1.1Timepoint(s) of evaluation of this end point
until death
E.5.2Secondary end point(s)
Sekundäre Zielparameter werden die Zeit von der Randomisierung bis zum Verlust der selbständigen Nahrungsaufnahme (falls anwendbar), bis zum Verlust der Sphinkter-Kontrolle (falls anwendbar) und bis zum Erreichen des Stadiums des akinetischen Mutismus (falls anwendbar) sein.
E.5.2.1Timepoint(s) of evaluation of this end point
all visit days and phone calls after week 2 of the clinical trial
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) Yes
E.7.3Therapeutic confirmatory (Phase III) No
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 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.8.4.1Number of sites anticipated in Member State concerned1
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 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
Prüfungsbezogen

Rekrutierungszeit: 30 Monate
Geplanter Beginn (FPFV): 01.04.2009
Geplantes Ende (LPLV): 01.10.2012

Patientenbezogen

Behandlungsdauer: bis zum Versterben des Patienten (median 6,12 Monate), maximal bis zum Studienende 01.10.2012
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 months6
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 Information not present in EudraCT
F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
F.1.1.3Newborns (0-27 days) Information not present in EudraCT
F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
F.1.1.5Children (2-11years) Information not present in EudraCT
F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2009-03-11. Yes
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 Yes
F.3.3.6.1Details of subjects incapable of giving consent
Patienteneinwilligung duch den gesetzlichen Vertreter oder Bevollmächtigten
F.3.3.7Others No
F.4 Planned number of subjects to be included
F.4.1In the member state28
F.4.2 For a multinational trial
F.4.2.2In the whole clinical trial 28
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 Decision2009-04-08
N.Ethics Committee Opinion of the trial applicationFavourable
N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
N.Date of Ethics Committee Opinion
P. End of Trial
P.End of Trial StatusCompleted
P.Date of the global end of the trial2013-03-07

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