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Summary
EudraCT Number:2013-002896-17
Sponsor's Protocol Code Number:V1.17.05.2013
National Competent Authority:Austria - BASG
Clinical Trial Type:EEA CTA
Trial Status:Completed
Date on which this record was first entered in the EudraCT database:2013-10-01
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 ConcernedAustria - BASG
A.2EudraCT number2013-002896-17
A.3Full title of the trial
Functional evaluation of two therapy concepts: dynamic orthoses and BoNT
Funktionelle Evaluierung von zwei Theraphiekonzepten: dynamischen Orthesen und BoNT
A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
Functional evaluation of two therapy concepts: dynamic orthoses and BoNT
Funktionelle Evaluierung von zwei Theraphiekonzepten: dynamischen Orthesen und BoNT
A.4.1Sponsor's protocol code numberV1.17.05.2013
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 SponsorOrthopädisches Spital Speising
B.1.3.4CountryAustria
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 supportOrthopädisches Spital Speising
B.4.2CountryAustria
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1Name of organisationOrthopädisches Spital Speising
B.5.2Functional name of contact pointRobert Csepan
B.5.3 Address:
B.5.3.1Street AddressSpeisinger Strasse 109
B.5.3.2Town/ cityWien
B.5.3.3Post code1130
B.5.3.4CountryAustria
B.5.4Telephone number+4301801821534
B.5.6E-mailrobert.csepan@oss.at
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 Botulinumtoxin-A (BOTOX)
D.2.1.1.2Name of the Marketing Authorisation holderAllergan Ltd.
D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
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 nameBotulinumtoxin-A
D.3.2Product code 1-23699
D.3.4Pharmaceutical form Powder and solvent for solution for injection
D.3.4.1Specific paediatric formulation No
D.3.7Routes of administration for this IMPIntramuscular use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.1CAS number 93384-43-1
D.3.9.3Other descriptive nameBOTULINUM TOXIN TYPE A
D.3.9.4EV Substance CodeSUB13117MIG
D.3.10 Strength
D.3.10.1Concentration unit U unit(s)
D.3.10.2Concentration typeequal
D.3.10.3Concentration number50 Allergan
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
E. General Information on the Trial
E.1 Medical condition or disease under investigation
E.1.1Medical condition(s) being investigated
Infantile cerebral palsy
Infantile Zerebral Parese
E.1.1.1Medical condition in easily understood language
Infantile cerebral palsy
Infantile Zerebral Parese
E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
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
Ankle joint angle at initial contact
passive dorsalflexion at the ankle joint
maximum dorsiflexion during stance phase
Sprunggelenkswinkel beim initialen Bodenkontakt
Passive Dorsalflexion im oberen Sprunggelenk
Sprunggelenkswinkel in der Standphase - max. Dorsalflexion
E.2.2Secondary objectives of the trial
Several gait kinematic parameters
Walking speed
Power generation during push off
Wearing time of the orthosis
Force needed to reach a passive ankle joint
Position of 0 degree (knee joint at 0 degree and 90 degree)
Passive dorsiflexion of the ankle joint at knee
Weitere kinematische und kinetische Parameter aus der Ganganalyse
Ganggeschwindigkeit
Abdruckleistung im Sprunggelenk
Tragedauer der Orthese
Passive Dorsalextension auf 0 Grad mit Kraftsensor in Newton (N), sowohl in 0 Grad und 90 Grad Knieflexion.
E.2.3Trial contains a sub-study No
E.3Principal inclusion criteria
Diagnosis infantil cerebral palsy
Medical advice for BoNT therapy
Passive correction of the ankle joint (upper, lower) to 0 degree (0 degree knee joint)
age between 6-10 years and GMFCS Level I-II
male/female
Diagnose einer Infantile Zerebralparese (ICP)
Fachärztliche Verordnung zur Behandlung Botulinumtoxin und Unterschenkelgipsen (Gruppe B)
Passive Korrigierbarkeit im oberen Sprunggelenk (OSG) und Subtalargelenk auf Neutral-Null-Stellung bei gestrecktem Kniegelenk
Patienten der Altersgruppe von 6 bis 10 Jahren GMFCS Level I – II (muss selbstständig gehfähig sein)
männlich/weiblich
E.4Principal exclusion criteria
Surgical achilles tendon or calf muscle intervention
Structural injury within the lower leg
Additional orthosis for the leg region
Non compliance
Athetosis
Ataxia
Zustand nach Eingriffen im Bereich der Achillessehne sowie im Wadenmuskel
Strukturelle Schäden (Knorpel und Knochen) im zu therapierenden Bereich
Parallel versorgt mit anderen Unterschenkel Orthesen
Non Compliance
Athetose
Ataxie
E.5 End points
E.5.1Primary end point(s)
Flat foot or heel contact during initial contact in gait
E.5.1.1Timepoint(s) of evaluation of this end point
16 weeks, 52 weeks
E.5.2Secondary end point(s)
after 16 weeks still
initial contact with forefoot
E.5.2.1Timepoint(s) of evaluation of this end point
16 weeks
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) No
E.7.3Therapeutic confirmatory (Phase III) No
E.7.4Therapeutic use (Phase IV) Yes
E.8 Design of the trial
E.8.1Controlled No
E.8.1.1Randomised Yes
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.8.3 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 years2
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 Yes
F.1.1Number of subjects for this age range: 40
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) Yes
F.1.1.5.1Number of subjects for this age range: 40
F.1.1.6Adolescents (12-17 years) No
F.1.2Adults (18-64 years) No
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 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 state40
F.4.2 For a multinational trial
F.4.2.2In the whole clinical trial 40
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)
ongoing control with the responsible doctor
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 Decision2013-11-04
N.Ethics Committee Opinion of the trial application
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 trial2015-10-29

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