Clinical Trials Register

Summary
EudraCT Number:	2011-000985-36
Sponsor's Protocol Code Number:	EMCAM-2011-001
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:	2012-01-25
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

2011-000985-36

A.3

Full title of the trial

Study on the Use of surface electromyography in the detection of objective differencies in patients with spasticity due to multiple sclerosis identified as "responders" and "not responders" under treatment with Sativex

Estudio de la Utilidad de la electromiografía de superficie en la detección
de diferencias objetivas en pacientes con espasticidad debida a
Esclerosis Múltiple identificados como "respondedores" y "no
respondedores"en tratamiento con Sativex

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

A.3.2

Name or abbreviated title of the trial where available

EMCAM-2011-001

A.4.1

Sponsor's protocol code number

EMCAM-2011-001

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	JOSE MANUEL GARCIA DOMINGUEZ
B.1.3.4	Country	Spain
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	NO FUNDING
B.4.2	Country	Spain
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	José Manuel García
B.5.2	Functional name of contact point	Jose Manuel García
B.5.3	Address:
B.5.3.1	Street Address	C/ Infantas 32, 4º 5
B.5.3.2	Town/ city	Madrid
B.5.3.3	Post code	28004
B.5.3.4	Country	Spain
B.5.4	Telephone number	34646109914
B.5.5	Fax number	34915868339
B.5.6	E-mail	jose_garciadom@hotmail.com

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	SATIVEX
D.2.1.1.2	Name of the Marketing Authorisation holder	GW Pharma Ltd
D.2.1.2	Country which granted the Marketing Authorisation	United Kingdom
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.3.1	Product name	sativex
D.3.2	Product code	N02BG10
D.3.4	Pharmaceutical form	Oromucosal solution
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oromucosal use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	pending
D.3.9.1	CAS number	13956-29-1
D.3.9.2	Current sponsor code	pending
D.3.9.3	Other descriptive name	CANNABIDIOL
D.3.9.4	EV Substance Code	SUB26600
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	2.7
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)	No
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	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
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	No
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

Spasticity due to multiple sclerosis identified as "responders" and "not responders" under treatment with Sativex

Espasticidad en Esclerosis Múltiple resistente a las terapias
convencionales en espasticidad

E.1.1.1

Medical condition in easily understood language

SPASTICITY IN MULTIPLE SCLEROSIS

Espasticidad en Esclerosis Múltiple resistente a las terapias
convencionales en espasticidad

E.1.1.2

Therapeutic area

Diseases [C] - Musculoskeletal Diseases [C05]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	14.1
E.1.2	Level	LLT
E.1.2	Classification code	10041416
E.1.2	Term	Spasticity
E.1.2	System Organ Class	100000004852

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To assess whether EMG (H,W waves and withdraw reflex) is useful for the characterization of spasticity

Determinar si el electromiograma (onda H, onda F y reflejo de retirada)
es útil en la caracterización de la espasticidad

E.2.2

Secondary objectives of the trial

To assess if sativex is able to modify spasticity when using objective measures.

To assess mood and behavioural changes induced by Sativex.

Determinar si sativex puede modificar la espasticidad medida de forma
objetiva (según datos electromiográficos)
Evaluar las modificaciones sobre el ánimo y el comportamiento inducidas
por Sativex

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Both sex subjects older than 18.
Diagnosis of Multiple Sclerosis according to current McDonald criteria, with moderate to severe spasticity
Patients under prescription of Sativex according to the current approved indications by EMA/AEMPS, initiating treatment in the moment of inclusion. Decision of treatment should be previous and independent of study participation.
Women in reproductive age must have a negative serum/urine pregnancy test at selection visit, and accept to take contraceptive measures from at least 14 days prior to the first dose of the drug and at least 3 months after the last dose.
Patients giving written informed consent.

• Sujetos de ambos sexos con edad igual o superior a 18 años.
• Diagnóstico de EM definida según los criterios vigentes de McDonald y que presenten espasticidad moderada o severa.
• Pacientes a los que se les haya prescrito Sativex, según las condiciones de uso aprobadas en la ficha técnica del producto y que inicien su tratamiento en el momento de la inclusión. La decisión de tratamiento debe ser previa e independiente a la participación en el estudio.
• Las mujeres en edad fértil deberán obtener un resultado negativo en la prueba de embarazo en suero o en orina en la visita de selección, y aceptar el empleo de métodos anticonceptivos adecuados al menos desde los 14 días previos a la primera dosis del fármaco de estudio hasta los 3 meses siguientes a la última.
• Pacientes que otorguen su consentimiento informado por escrito.

E.4

Principal exclusion criteria

Relapse 30 days prior to inclusion
Methylprednisolone administration (orally or intranvenous) 30 days prior to inclusion.
Botullinum toxin administration for spasticity in the 4 months prior to inclusion.
Pregnancy
Contraindication for Sativex as to current indication uses.
Hypersensitivity to Cannabinoids or any excipient.
Personal history, known or suspected, or with familiar history of schizophrenia or other psycotic conditions, personal history of serious personality disorder or other important psychiatric conditions, apart from depression due to underlying disease.
Breastfeeding

• Brote clínico en los 30 días previos a la inclusión.
• Administración de metilprednisolona (intravenosa u oral) en los 30 días previos a la inclusión.
• Administración de toxina botulínica para el tratamiento de la espasticidad en los 4 meses previos a la inclusión.
• Embarazo.
• Contraindicación para la administración de Sativex según las indicaciones de ficha técnica
o Hipersensibilidad a los cannabinoides o a alguno de sus excipientes.
o Con antecedentes personales conocidos o sospechados o con antecedentes familiares de esquizofrenia u otras enfermedades psicóticas, antecedentes de trastorno grave de la personalidad u otros trastornos psiquiátricos importantes distintos de la depresión asociada a la enfermedad subyacente.
o En mujeres en período de lactancia, debido a la probabilidad de niveles considerables de cannabinoides en leche materna y a los posibles efectos adversos en el desarrollo del lactante.

E.5 End points

E.5.1

Primary end point(s)

H/M, F/M ratio and withdraw reflex slope variations

Variación en la pendiente de en el ratio H/M, F/M y en el reflejo de
retirada

E.5.1.1

Timepoint(s) of evaluation of this end point

8 weeks

8 semanas

E.5.2

Secondary end point(s)

Date of birth
Gender
Date of diagnosis
MS subtype
MS treatment
Disability as measured by EDSS
Treatment for spasticity
Ashworth scale
Numeric Rating Scale
25-feet walk test
Symbol DigitModalities Test
Modified Fatigue ImpactScale MFIS
Hamilton depression score
MultipleSclerosisQuality of Life-54 (MSQoL-54

Fecha de Nacimiento
• Sexo
• Año de Diagnóstico
• Tipo de EM
• Tratamiento para EM
• Nivel de discapacidad medida según la escala EDSS
• Tratamientopara la espasticidad
• Escala de Ashworth
• Escala Numérica Numeric Rating Scale
• Valoración de la marcha mediante la 25-feet walk test
• Función cognitiva medida por la Symbol DigitModalities Test
• Fatiga medida por la Modified Fatigue ImpactScale MFIS
• Escala de Hamilton (anexo 12)
• Cuestionario de calidad de vida MultipleSclerosisQuality of Life-54 (MSQoL-54).

E.5.2.1

Timepoint(s) of evaluation of this end point

8 weeks

8 semanas

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

Yes

E.6.4

Safety

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

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)

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

E.8.1.2

Open

E.8.1.3

Single blind

Yes

E.8.1.4

Double blind

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

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

pacientes calificados como no respondedores al fármaco en semana 4

E.8.2.4

Number of treatment arms in the trial

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

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

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

LVLP

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

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.1.2.1

Number of subjects for this age range:

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.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)

NONE

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

2013-02-22

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2012-02-15

P. End of Trial
P.	End of Trial Status	Completed

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