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Summary
EudraCT Number:2004-001485-41
Sponsor's Protocol Code Number:AMAD001
National Competent Authority:Spain - AEMPS
Clinical Trial Type:EEA CTA
Trial Status:Ongoing
Date on which this record was first entered in the EudraCT database:2006-01-30
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 ConcernedSpain - AEMPS
A.2EudraCT number2004-001485-41
A.3Full title of the trial
A single-blinded assessment of the short-term effects of cabergoline vs. carbidopa/levodopa on SPECT dopamine transporter density in out-patient subjects with Parkinson’s Disease
A.4.1Sponsor's protocol code numberAMAD001
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 SponsorInstitute for Neurodegenerative Disorders
B.1.3.4CountryUnited States
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.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 Information not present in EudraCT
D.2.1.1.1Trade name SINEMET
D.2.1.1.2Name of the Marketing Authorisation holderBRISTOL-MYERS SQUIBB
D.2.1.2Country which granted the Marketing AuthorisationSpain
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 namecarbodopa/levadopa
D.3.4Pharmaceutical form Tablet
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 INNCARBODOPA LEVADOPA
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 Information not present in EudraCT
D.3.11.8Extractive medicinal product Information not present in EudraCT
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 Yes
D.3.11.13.1Other medicinal product typeDopamineric agent
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 Information not present in EudraCT
D.2.1.1.1Trade name SOLIGEN
D.2.1.1.2Name of the Marketing Authorisation holderPfizer Global Research & Development
D.2.1.2Country which granted the Marketing AuthorisationSpain
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 nameCabergoline
D.3.4Pharmaceutical form Tablet
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 INNCABERGOLINA
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) Information not present in EudraCT
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 Information not present in EudraCT
D.3.11.3.2Gene therapy medical product Information not present in EudraCT
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 Information not present in EudraCT
D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Information not present in EudraCT
D.3.11.7Plasma derived medicinal product Information not present in EudraCT
D.3.11.8Extractive medicinal product Information not present in EudraCT
D.3.11.9Recombinant medicinal product Information not present in EudraCT
D.3.11.10Medicinal product containing genetically modified organisms Information not present in EudraCT
D.3.11.11Herbal medicinal product Information not present in EudraCT
D.3.11.12Homeopathic medicinal product Information not present in EudraCT
D.3.11.13Another type of medicinal product Information not present in EudraCT
D.IMP: 3
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 Information not present in EudraCT
D.2.1.1.1Trade name DaTSCAN
D.2.1.1.2Name of the Marketing Authorisation holderNycomed Amersham plc
D.2.1.2Country which granted the Marketing AuthorisationSpain
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 injection
D.3.4.1Specific paediatric formulation Information not present in EudraCT
D.3.7Routes of administration for this IMPIntravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8INN - Proposed INNIoflupane [123I]
D.3.10 Strength
D.3.10.1Concentration unit MBq/ml megabecquerel(s)/millilitre
D.3.11 The IMP contains an:
D.3.11.1Active substance of chemical origin Information not present in EudraCT
D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Information not present in EudraCT
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 Information not present in EudraCT
D.3.11.3.2Gene therapy medical product Information not present in EudraCT
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 Information not present in EudraCT
D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Information not present in EudraCT
D.3.11.7Plasma derived medicinal product Information not present in EudraCT
D.3.11.8Extractive medicinal product Information not present in EudraCT
D.3.11.9Recombinant medicinal product Information not present in EudraCT
D.3.11.10Medicinal product containing genetically modified organisms Information not present in EudraCT
D.3.11.11Herbal medicinal product Information not present in EudraCT
D.3.11.12Homeopathic medicinal product Information not present in EudraCT
D.3.11.13Another type of medicinal product Information not present in EudraCT
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
Approximately 120 recently diagnosed/early Parkinson’s disease subjects, who are untreated (see exclusionary criteria).
MedDRA Classification
E.1.3Condition being studied is a rare disease Information not present in EudraCT
E.2 Objective of the trial
E.2.1Main objective of the trial
A. To determine the influence of short-term levodopa therapy on dopamine transporter density in early Parkinson’s disease.

B. To determine the influence of short-term treatment with cabergoline on dopamine transporter density in early Parkinson’s disease.
E.2.2Secondary objectives of the trial
C. This study will also serve to further develop the AMADEUS consortium, a collaboration of clinical-imaging SPECT DAT sites able to obtain data using comparable techniques and transmit imaging to a central analysis site.
E.2.3Trial contains a sub-study Information not present in EudraCT
E.3Principal inclusion criteria
(a)The subject is aged 40 years or older.
(b)Written informed consent is obtained.
(c)Subjects have a diagnosis of idiopathic Parkinson’s disease.
(d)Hoehn and Yahr stages for subjects are I-II.
E.4Principal exclusion criteria
(a)The subject has atypical or drug-induced Parkinson’s disease.
(b)The subject has dementia.
(c)The subject has clinically significant abnormal laboratory values, and/or clinically significant or unstable medical or psychiatric illness.
(d)The subject is pregnant.
(e)The subject has a history of alcohol, narcotic, or any other drug abuse as defined by the Diagnostic and Statistical Manual of the American Psychiatric Association, 4th Edition (DSM IV) {American Psychiatric Association, 1994 #2}within the past 2 years.
(f)The subject has received an investigational drug within 30 days before the screening visit.
(g)The subject has been treated with any anti-Parkinson drug including levodopa, dopamine agonists (including pramipexole, ropinirole, cabergoline, pergolide), amantadine, selegeline, rasagiline for greater than a total of 14 days or at any time within 60 days of the baseline visit.
(h)The subject has used any prescription or clinically significant over-the-counter (OTC) drugs disallowed by the protocol (anticholinergic drugs, dopamine antagonists, or antihistamines as identified in section 6) within 14 (60 days for antiparkinson’s agents) days before the baseline visit.
E.5 End points
E.5.1Primary end point(s)
The primary outcome measure will be striatal dopamine transporter density. This is a region of interest (ROI) based analysis (calculated as [total striatal uptake/nondisplaceable uptake]-1) of the striatum.

Also putamen and caudate uptake and UPDRS scores
E.6 and E.7 Scope of the trial
E.6Scope of the trial
E.6.1Diagnosis Information not present in EudraCT
E.6.2Prophylaxis Information not present in EudraCT
E.6.3Therapy Yes
E.6.4Safety Information not present in EudraCT
E.6.5Efficacy Information not present in EudraCT
E.6.6Pharmacokinetic Information not present in EudraCT
E.6.7Pharmacodynamic Information not present in EudraCT
E.6.8Bioequivalence Information not present in EudraCT
E.6.9Dose response Information not present in EudraCT
E.6.10Pharmacogenetic Information not present in EudraCT
E.6.11Pharmacogenomic Information not present in EudraCT
E.6.12Pharmacoeconomic Information not present in EudraCT
E.6.13Others Information not present in EudraCT
E.7Trial type and phase
E.7.1Human pharmacology (Phase I) Information not present in EudraCT
E.7.1.1First administration to humans Information not present in EudraCT
E.7.1.2Bioequivalence study Information not present in EudraCT
E.7.1.3Other Information not present in EudraCT
E.7.1.3.1Other trial type description
E.7.2Therapeutic exploratory (Phase II) Information not present in EudraCT
E.7.3Therapeutic confirmatory (Phase III) Information not present in EudraCT
E.7.4Therapeutic use (Phase IV) Yes
E.8 Design of the trial
E.8.1Controlled Yes
E.8.1.1Randomised Yes
E.8.1.2Open Yes
E.8.1.3Single blind Information not present in EudraCT
E.8.1.4Double blind Information not present in EudraCT
E.8.1.5Parallel group Information not present in EudraCT
E.8.1.6Cross over Information not present in EudraCT
E.8.1.7Other Information not present in EudraCT
E.8.2 Comparator of controlled trial
E.8.2.1Other medicinal product(s) Information not present in EudraCT
E.8.2.2Placebo Information not present in EudraCT
E.8.2.3Other Information not present in EudraCT
E.8.3 The trial involves single site in the Member State concerned Information not present in EudraCT
E.8.4 The trial involves multiple sites in the Member State concerned Yes
E.8.5The trial involves multiple Member States Yes
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 Information not present in EudraCT
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
The definition of the end of trial is included in the protocol.
Closure of the study can only occur once all data has been received and evaluated at the coordinating center the study.
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 months10
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 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) Information not present in EudraCT
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 Information not present in EudraCT
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 2006-01-30. Yes
F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
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 Information not present in EudraCT
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 120
F.4.2.2In the whole clinical trial 120
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 Decision2005-04-28
N.Ethics Committee Opinion of the trial applicationFavourable
N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
N.Date of Ethics Committee Opinion2005-04-14
P. End of Trial
P.End of Trial StatusOngoing

Sponsor e collaboratori

Condizioni mediche

Interventi farmacologici

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