Clinical Trials Register

Summary
EudraCT Number:	2004-004519-43
Sponsor's Protocol Code Number:	NN18344
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:	2007-02-06
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

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A. Protocol Information

A.1

Member State Concerned

Spain - AEMPS

A.2

EudraCT number

2004-004519-43

A.3

Full title of the trial

Estudio de Fase 2, Multicéntrico, Aleatorizado, Doble Ciego, Controlado con Placebo, de Grupos Paralelos y de Escalada de Dosis para determinar el Efecto del RO0506997 sobre las lesiones en Imagen de Resonancia Magnética y su seguridad en Esclerosis Múltiple Recidivante

A.4.1

Sponsor's protocol code number

NN18344

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	F. Hoffmann-La Roche Ltd
B.1.3.4	Country	Switzerland
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	No
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.3.2	Product code	RO0506997
D.3.4	Pharmaceutical form	Film-coated tablet
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.2	Current sponsor code	RO0506997
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	10
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	No
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.IMP: 2
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	No
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.3.2	Product code	RO0506997
D.3.4	Pharmaceutical form	Film-coated tablet
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.2	Current sponsor code	RO0506997
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	40
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	No
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.IMP: 3
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	No
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.3.2	Product code	RO0506997
D.3.4	Pharmaceutical form	Film-coated tablet
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.2	Current sponsor code	RO0506997
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	300
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	No
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
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Film-coated tablet
D.8.4	Route of administration of the placebo	Oral use
D.8 Placebo: 2
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Film-coated tablet
D.8.4	Route of administration of the placebo	Oral use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Esclerosis Múltiple Recidivante

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

Determinar el efecto de RO0506997 sobre la EM mediante la evaluación del número de nuevas lesiones hipercaptantes de gadolinio que se desarrollan durante el tratamiento (específicamente, la suma de nuevas lesiones registradas en las MRIs de las semanas 4, 8 y 12).

E.2.2

Secondary objectives of the trial

Efecto sobre otras lesiones en Imagen de Resonancia Magnética, estado clínico y seguridad en la Esclerosis Múltiple

E.2.3

Trial contains a sub-study

Yes

E.2.3.1

Full title, date and version of each sub-study and their related objectives

Roche Sample Repository Research Project in association with protocol NN18344

E.3

Principal inclusion criteria

4.1.1Criterios de Inclusión relacionados con la EM
1) Diagnóstico de EM recidivante tipos 1-4, basado en los “criterios de McDonald”, según la revisión de 2005 (Anexo 1), sin tener en consideración los resultados MRI de la Selección.
2) Puntuación EDSS ≤ 6,5 (Anexo 2)
3) Entre 12 meses y 1 mes antes: 1 o más ataques de EM (documentado en registros médicos anteriores) o una MRI cerebral con una lesión hipercaptante de gadolinio consistente con una lesión de EM (basada en un informe radiológico o la revisión de la MRI por parte del investigador).

4.1.3 Otros Criterios de Inclusión
1) Consentimiento informado firmado
2) Hombres o mujeres de 18 a 59 años de edad
3) En el caso de la mujer: postmenopáusica durante el año anterior (confirmado por un nivel de FSH mayor que 25 mUI/ml, a menos que la paciente esté recibiendo HRT), o quirúrgicamente esterilizada (es decir, ligadura de trompas, histerectomía), o potencialmente fértil con un método anticonceptivo fiable:
i)Dispositivo intrauterino
ii)Anticoncepción hormonal sistémica por parte de la mujer
iii)Espermicida con o sin un método de barrera masculino o femenino
iv)Abstinencia
4.2.1.Criterios de Inclusión en la Visita Basal.
1) La MRI de la Visita de Selección satisface los “criterios de Paty” de: ≥ 4 lesiones en T2 o ≥ 3 lesiones en T2, si al menos 1 es periventricular15. Esta determinación se encuentra bajo la responsabilidad de un investigador del centro.

E.4

Principal exclusion criteria

4.1.2Criterios de Exclusión relacionados con la EM
1) Ataque de EM o corticosteroides sistémicos dentro del mes anterior
2) Tratamientos de EM que se administran principalmente para tratar los síntomas:
a)dentro de los 3 meses previos: si forma parte de un ensayo aprobado por IRB(EC
b)de lo contrario, puede permanecer bajo el régimen si no ha variado en el mes anterior y es improbable que lo haga antes de la semana 16. Esto incluye agentes relacionados con el cannabis, así como categorías de especialidades farmacéuticas publicitarias, suplementos de hierbas y nutricionales.
Los siguientes apartados se refieren a cualquier otro producto administrado para tratar la EM (aprobado o no):
3) Dentro de los 3 meses anteriores: interferón beta, acetato de glatirámero, o plasmaféresis
4) Dentro de los 12 meses anteriores: natalizumab, inmunoglobulina intravenosa, citaféresis, azatiaprina, clabride, ciclofosfamida, metotrexato, mitoxantrona, micofenolato, pixantrona, sirolimus, tacrolimus u otros agentes utilizados típicamente para prevenir el rechazo de trasplantes o como quimioterapia contra el cáncer, excluidos los tratamientos hormonales
5) Haber recibido en cualquier momento: trasplante de células madre o médula ósea, irradiación linfoide total, vacuna terapéutica para EM o anticuerpos monoclonales cuyos efectos puedan durar más de 1 año, tales como alemtuzumab, daclizumab o rituxan (rituximab)
6) Dentro de los 3 meses previos: cualquier otro agente administrado para el tratamiento no sintomático de la EM que no se haya incluido en los anteriores puntos 3-5, tales como inhibidores de la HMGCoA-reductasa, antidiabéticos de tipo “glitazona”, 4-aminopiridina o productos relacionados con 4-aminopiridina, antibióticos, tratamiento hormonal, así como categorías tales como especialidades farmacéuticas publicitarias, suplementos de hierbas y nutricionales. No obstante, si el producto se está tomando principalmente para tratar otro trastorno médico, su uso está permitido siempre que la dosis haya permanecido invariable dentro de los 3 meses anteriores y es improbable que se modifique antes de la semana 16
4.1.4Otros Criterios de Exclusión
1) Mujeres gestantes o que pueden estar en periodo de lactancia antes de la semana 16
2) Dentro del mes anterior: una infección que requiera un tratamiento antiinfeccioso sistémico, o una vacunación. Excepciones: tratamiento de una infección no complicada del tracto urinario o infección del tracto respiratorio superior.
3) Dentro de los 3 meses anteriores: participación en cualquier ensayo de medicamento de investigación controlado por IRB/EC o tratamiento con anti-TNF u otros agentes potencialmente inmunomoduladores que no se hayan mencionado anteriormente.
4) Dentro de los 6 meses anteriores: abuso de alcohol o drogas, según la evaluación del investigador
5) Antecedentes de infección por VIH o leucoencefalopatía multifocal progresiva (PML)
6) Antecedentes de inmunodeficiencia hereditaria o adquirida, excepto la causada por una intervención farmacéutica; o inmunodeficiencia hereditaria o adquirida presente en la actualidad, incluida la causada por una intervención farmacéutica
7) Trastorno médico o neurológico que a) pueda interferir de manera significativa con la absorción de un medicamento oral, b) que requiera probablemente una nueva medicación u hospitalización dentro de los 6 meses siguientes, ó c) que pueda interferir con la evaluación de la EM.
8) Presencia de marcapasos u objetos metálicos extraños en ojos, piel ó cuerpo que contraindica la realización de un escáner MRI.
4.2.2Criterios de Exclusión
1) Desde la selección, excepto el uso de corticosteroides sistémicos para un ataque de EM (véase la Sección 5), empleo de cualquier nuevo tratamiento aprobado ó cuyo efecto se esté evaluando sobre la EM
2) Desde la selección, desarrollo o agravamiento de un trastorno médico o neurológico que a) pueda interferir de manera significativa con la absorción de un medicamento oral, b) requiera probablemente una nueva medicación u hospitalización dentro de los 6 meses siguientes, o c) que pueda interferir con la evaluación de la EM
3) Intervalo QTcF en el ECG > 450 mseg
4) Prueba de embarazo positiva
5) Prueba de screening de VIH positiva
Los 5 puntos siguientes se refieren solamente a la última evaluación antes de la Visita basal. Así, por ejemplo, si el resultado de la selección hubiera excluido seguir hasta la Visita basal, se puede repetir la prueba y el paciente puede ser incluido, con la condición de que el último valor antes de la basal sea aceptable.
6) Hemoglobina < 5,6 mmol/l ó < 9,5 g/dl
7) Recuento leucocitario < 3.000 /mm3
8) Recuento linfocitario <1.000 /mm3
9) Recuento plaquetario <75.000 /mm3
10) Nitrógeno procedente de urea, bilirrubina total, ALT ó AST > 2,5 veces el límite superior de normalidad.

E.5 End points

E.5.1

Primary end point(s)

La variable principal de eficacia es el número acumulado de lesiones MRI hipercaptantes de gadolinio registrado durante el período de tratamiento doble ciego

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

Yes

E.6.7

Pharmacodynamic

Yes

E.6.8

Bioequivalence

E.6.9

Dose response

Yes

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

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

Yes

E.8.2.3

Other

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

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

Information not present in EudraCT

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

E.8.7

Trial 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

The end of the trial is defined as the last visit of the last subject taking part in the trial.

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

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.3

Elderly (>=65 years)

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

160

F.4.2.2

In the whole clinical trial

200

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)

After completion of the study participation, the patients will be treated according to their physicians decision on the normal treatment for their condition.

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

2007-04-23

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2007-03-06

P. End of Trial
P.	End of Trial Status	Ongoing

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Orphan Designation Number:
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