Clinical Trials Register

Summary
EudraCT Number:	2010-021474-11
Sponsor's Protocol Code Number:	GE-001-013
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2010-10-14
Trial results	View 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

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A. Protocol Information

A.1

Member State Concerned

Spain - AEMPS

A.2

EudraCT number

2010-021474-11

A.3

Full title of the trial

Ensayo fase 4 multicéntrico, aleatorizado, abierto y comparativo para evaluar los cambios en el diagnóstico de demencia y en la confianza en el diagnóstico tras la realización de DaTSCAN en pacientes con un diagnóstico dudoso de demencia con cuerpos de Lewy (posible DCL)
A Multicentre, Randomised, Open-Label, Comparative Phase 4 Trial To Assess
Changes in Dementia Diagnostic Category and Diagnostic Confidence After
DaTSCAN Imaging in Subjects with an Uncertain Diagnosis of Dementia with
Lewy Bodies (Possible DLB)

A.4.1

Sponsor's protocol code number

GE-001-013

A.7

Trial is part of a Paediatric Investigation Plan

Information not present in EudraCT

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	GE Healthcare Ltd. and its Affiliates
B.1.3.4	Country	United Kingdom
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support
B.4.2	Country
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation
B.5.2	Functional name of contact point

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	DATSCAN 74 MBq/ml solución inyectable
D.2.1.1.2	Name of the Marketing Authorisation holder	GE HEALTHCARE LIMITED
D.2.1.2	Country which granted the Marketing Authorisation	Spain
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	IOFLUPANO 123I
D.3.9.1	CAS number	155798-07-5
D.3.9.3	Other descriptive name	IOFLUPANE (123I)
D.3.10	Strength
D.3.10.1	Concentration unit	MBq/ml megabecquerel(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	74
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	Information not present in EudraCT
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	Information not present in EudraCT
D.3.11.5	Radiopharmaceutical medicinal product	Yes
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	Information not present in EudraCT
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another 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.1.1

Medical condition(s) being investigated

Pacientes con posible demencia con cuerpos de Lewy (DCL) que pueden cumplir o no criterios de enfermedad de Alzheimer

MedDRA Classification

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Evaluar la influencia de las imágenes con DaTSCAN en el diagnóstico de demencia en sujetos con un diagnóstico dudoso de DCL (posible DCL).

E.2.2

Secondary objectives of the trial

Demostrar que el uso de DaTSCAN aumenta la confianza en el diagnóstico en estos sujetos.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

(1) Varones o mujeres de 55 años de edad en adelante.
(2) Puntuación en el Mini examen del estado mental entre 10 y 26.
(3) Sujetos con posible DCL según lo definido por los Criterios de Consenso Internacionales (demencia + 1 característica fundamental o 1 o más características indicativas), que pueden o no cumplir además los criterios de enfermedad de Alzheimer (EA).
(4) El sujeto y un representante legal del sujeto (por ejemplo, el cuidador) son capaces y están dispuestos a cumplir los procedimientos del estudio y se obtiene el consentimiento informado firmado y fechado de cada uno de ellos.
(5) El sujeto y un representante legal son capaces de cooperar con el protocolo y, en opinión del investigador, su participación no afectará negativamente a su tratamiento.
(6) Podrán participar en el estudio mujeres estériles quirúrgicamente (sometidas a ooforectomía o histerectomía documentadas) o posmenopáusicas (más de un año sin menstruación) sin necesidad de realizar una prueba de embarazo en la selección.

E.4

Principal exclusion criteria

(1) Diagnóstico clínico establecido/seguro de probable DCL o de una forma distinta de demencia.
(2) Parkinsonismo > 1 año antes del comienzo de la demencia.
(3) Síntomas extrapiramidales graves (Escala unificada de valoración de la enfermedad de Parkinson, parte 3 [UPDRS-III] > 30) o demencia debida a la enfermedad de Parkinson.
(4) Vasculopatía significativa conocida/sospechosa con infartos múltiples o estratégicos o vasculopatía en el estriado/ganglios basales, demostrada preferiblemente en una exploración anterior por resonancia magnética (RM) o tomografía computarizada (TC). Si no es clínicamente viable una RM, se aceptará una TC cerebral realizada en los 6 meses previos a la visita basal.
(5) Síntomas indicativos de atrofia multisistémica, degeneración corticobasal, parálisis supranuclear progresiva o enfermedad de Huntington.
(6) Enfermedad mental grave persistente, como depresión, esquizofrenia y trastorno esquizoafectivo.
(7) Hidrocefalia normotensiva.
(8) Uso de cualquier medicamento del que se sabe o se sospecha que interacciona con la captación estriatal por competencia directa con la unión de DaTSCAN al DAT, siempre que no se haya suspendido durante un tiempo equivalente a 5 semividas como mínimo si el sujeto va a ser asignado al grupo de DaTSCAN (entre otros, anfetaminas, benztropina, buproprión, cocaína, mazindol, metilfenidato, fentermina y sertralina).
(9) Presencia de insuficiencia renal o hepática moderada o grave.
(10) Exposición laboral a la radiación igual o superior a 15 mSv al año.
(11) Drogadicción pasada o actual.
(12) Antecedentes de alcoholismo cuando el período de abstinencia es inferior a 3 años.
(13) Hipersensibilidad a DaTSCAN o a alguno de sus componentes.
(14) Inclusión previa en este estudio.
(15) Mujeres embarazadas o lactantes o que tengan previsto quedarse embarazadas durante el estudio o en los 3 ciclos menstruales posteriores a la finalización del estudio. Las mujeres en edad fértil deberán obtener resultados negativos en una prueba de embarazo (con tira reactiva en orina) con gonadotropina coriónica humana beta (?-HCG) en la selección y antes de recibir la especialidad farmacéutica en investigación (EFI).
(16) Participación en un estudio clínico de un medicamento no autorizado en los 30 días previos a la selección, o un radiofármaco no autorizado/autorizado en el tiempo equivalente a 5 periodos de semidesintegración radiactiva antes de la selección.
(17) Enfermedad potencialmente mortal que suponga una esperanza de vida inferior a un año o antecedentes de un traumatismo médico o de una intervención quirúrgica significativos que, en opinión de los investigadores, impida al sujeto participar en el estudio.
(18) Realización anterior de una SPECT con DaTSCAN u otra prueba de imagen funcional similar del sistema dopaminérgico presináptico o postsináptico (por ejemplo, PET con [18F] DOPA, 123I yodobenzamida).

E.5 End points

E.5.1

Primary end point(s)

Variación de la categoría diagnóstica entre el momento basal (V1) y la evaluación de la semana 8 (V2).

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

Yes

E.6.2

Prophylaxis

E.6.3

Therapy

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

Information not present in EudraCT

E.7.1.2

Bioequivalence study

Information not present in EudraCT

E.7.1.3

Other

Information not present in EudraCT

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

Yes

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

E.8.1.6

Cross over

E.8.1.7

Other

Yes

E.8.1.7.1

Other trial design description

Sin especificar

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

El grupo de control sin tratamiento seguirá los mismos procedimientos, salvo que el SPECT con DaTSCA

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

Information not present in EudraCT

E.8.7

Trial has a data monitoring committee

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

Last subject last visit

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects
F.1 Age Range
F.1.1	Trial has subjects under 18	No
F.1.1.1	In Utero	Information not present in EudraCT
F.1.1.2	Preterm newborn infants (up to gestational age < 37 weeks)	Information not present in EudraCT
F.1.1.3	Newborns (0-27 days)	Information not present in EudraCT
F.1.1.4	Infants and toddlers (28 days-23 months)	Information not present in EudraCT
F.1.1.5	Children (2-11years)	Information not present in EudraCT
F.1.1.6	Adolescents (12-17 years)	Information not present in EudraCT
F.1.2	Adults (18-64 years)	Yes
F.1.3	Elderly (>=65 years)	Yes
F.2 Gender
F.2.1	Female	Yes
F.2.2	Male	Yes
F.3 Group of trial subjects
F.3.1	Healthy volunteers	No
F.3.2	Patients	Yes
F.3.3	Specific vulnerable populations	Yes
F.3.3.1	Women of childbearing potential not using contraception	Yes
F.3.3.2	Women of child-bearing potential using contraception	No
F.3.3.3	Pregnant women	No
F.3.3.4	Nursing women	No
F.3.3.5	Emergency situation	No
F.3.3.6	Subjects incapable of giving consent personally	No
F.3.3.7	Others	No
F.4 Planned number of subjects to be included
F.4.1	In the member state	50
F.4.2	For a multinational trial
F.4.2.1	In the EEA	174

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2010-11-24

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2010-11-12

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2012-10-08

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