Clinical Trials Register

Summary
EudraCT Number:	2008-000025-19
Sponsor's Protocol Code Number:	A0081183
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:	2008-03-14
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

2008-000025-19

A.3

Full title of the trial

"ESTUDIO DE PREGABALINA, ALEATORIZADO, DOBLE CIEGO, DE 6 SEMANAS DE DURACIÓN EN SUJETOS CON SÍNDROME DE PIERNAS INQUIETAS"

RANDOMIZED, DOUBLE-BLIND, 6-WEEK STUDY OF PREGABALIN IN SUBJECTS WITH RESTLESS LEG SYNDROME

A.3.2

Name or abbreviated title of the trial where available

N/A

A.4.1

Sponsor's protocol code number

A0081183

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	Pfizer, S.A.
B.1.3.4	Country	Spain
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	Lyrica
D.2.1.1.2	Name of the Marketing Authorisation holder	Pfizer Ltd.
D.2.1.2	Country which granted the Marketing Authorisation	European Union
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	Capsule*
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.3.8	INN - Proposed INN	Pregabalina
D.3.9.1	CAS number	148553-50-8
D.3.9.2	Current sponsor code	Lyrica
D.3.9.3	Other descriptive name	(s)-2-(aminomethyl)-5-methylhexanoic acid
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	25
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	Yes
D.2.1.1.1	Trade name	Lyrica
D.2.1.1.2	Name of the Marketing Authorisation holder	Pfizer Ltd.
D.2.1.2	Country which granted the Marketing Authorisation	European Union
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	Capsule*
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.3.8	INN - Proposed INN	Pregabalina
D.3.9.1	CAS number	148553-50-8
D.3.9.2	Current sponsor code	Lyrica
D.3.9.3	Other descriptive name	(s)-2-(aminomethyl)-5-methylhexanoic acid
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	50
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	Yes
D.2.1.1.1	Trade name	Lyrica
D.2.1.1.2	Name of the Marketing Authorisation holder	Pfizer Ltd.
D.2.1.2	Country which granted the Marketing Authorisation	European Union
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	Capsule*
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.3.8	INN - Proposed INN	Pregabalina
D.3.9.1	CAS number	148553-50-8
D.3.9.2	Current sponsor code	Lyrica
D.3.9.3	Other descriptive name	(s)-2-(aminomethyl)-5-methylhexanoic acid
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	75
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: 4
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	Lyrica
D.2.1.1.2	Name of the Marketing Authorisation holder	Pfizer Ltd.
D.2.1.2	Country which granted the Marketing Authorisation	European Union
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	Capsule*
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.3.8	INN - Proposed INN	Pregabalina
D.3.9.1	CAS number	148553-50-8
D.3.9.2	Current sponsor code	Lyrica
D.3.9.3	Other descriptive name	(s)-2-(aminomethyl)-5-methylhexanoic acid
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	150
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: 5
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	Lyrica
D.2.1.1.2	Name of the Marketing Authorisation holder	Pfizer Ltd.
D.2.1.2	Country which granted the Marketing Authorisation	European Union
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	Capsule*
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.3.8	INN - Proposed INN	Pregabalina
D.3.9.1	CAS number	148553-50-8
D.3.9.2	Current sponsor code	Lyrica
D.3.9.3	Other descriptive name	(s)-2-(aminomethyl)-5-methylhexanoic acid
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	225
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: 6
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	Lyrica
D.2.1.1.2	Name of the Marketing Authorisation holder	Pfizer Ltd.
D.2.1.2	Country which granted the Marketing Authorisation	European Union
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	Capsule*
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.3.8	INN - Proposed INN	Pregabalin
D.3.9.1	CAS number	148553-50-8
D.3.9.2	Current sponsor code	Lyrica
D.3.9.3	Other descriptive name	(s)-2-(aminomethyl)-5-methylhexanoic acid
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.IMP: 7
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	Lyrica
D.2.1.1.2	Name of the Marketing Authorisation holder	Pfizer Ltd.
D.2.1.2	Country which granted the Marketing Authorisation	European Union
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	Capsule*
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.3.8	INN - Proposed INN	Pregabalin
D.3.9.1	CAS number	148553-50-8
D.3.9.2	Current sponsor code	Lyrica
D.3.9.3	Other descriptive name	(s)-2-(aminomethyl)-5-methylhexanoic acid
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	100
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	Capsule*
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

"Síndrome de Piernas Inquietas (SPI)"

Restless legs syndrome (RLS)

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	9.1
E.1.2	Level	LLT
E.1.2	Classification code	10058920
E.1.2	Term	Restless legs syndrome

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Describir la relación entre dosis y respuesta de la pregabalina en el tratamiento de los síntomas del SPI en sujetos con SPI idiopático empleando la escala IRLS.

E.2.2

Secondary objectives of the trial

• Evaluar la tolerabilidad y la seguridad de la pregabalina en sujetos con SPI teniendo en cuenta el nivel de dosis.
• Evaluar la respuesta de los criterios siguientes a la dosis de pregabalina:
- Sujetos con respuesta en la CGI-I;
- Percepción subjetiva del sueño;
- Calidad de vida en el SPI;
- Retiradas prematuras del estudio debidas a acontecimientos adversos.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Diagnóstico de SPI realizado por un médico con experiencia y/o formación en el SPI. Síndrome de piernas inquietas (SPI) idiopático con la presencia de sus cuatro manifestaciones clínicas:
• Fuerte necesidad de mover las piernas, habitualmente con disestesias: fuerte necesidad de mover las piernas, habitualmente acompañada o causada por sensaciones incómodas y desagradables en las piernas. (En ocasiones, la necesidad de mover las piernas no se acompaña de sensaciones incómodas y a veces resultan afectados los brazos u otras partes del organismo, además de las piernas);
• Inicio o exacerbación con el reposo: la necesidad de moverse o las sensaciones desagradables empiezan o empeoran en períodos de reposo o inactividad, por ejemplo, estando tumbado o sentado;
• Alivio con el movimiento: la necesidad de moverse o las sensaciones desagradables se alivian de forma total o parcial con movimientos como caminar o estirarse, al menos mientras dura la actividad;
• Patrón circadiano: la necesidad de moverse o las sensaciones desagradables son peores a última hora de la tarde o por la noche que por el día o sólo ocurren por la tarde o por la noche (cuando los síntomas son muy intensos, puede que no se advierta el empeoramiento nocturno, pero debe haber estado presente);
2. Los síntomas del SPI aparecen sobre todo a última hora de la tarde;
3. Antecedentes o presencia de síntomas de SPI que afectan al inicio o al mantenimiento del sueño 15 ó más noches por mes durante 6 meses como mínimo;
4. Los sujetos deberán presentan una puntuación en la escala internacional del síndrome de piernas inquietas (IRSL) ≥15 en la selección y en el momento basal, así como ≥15 noches con síntomas del SPI en el mes previo a la selección. Los sujetos que estén recibiendo tratamiento para el SPI en el momento de la selección deberán haber pasado ≥ 15 noches con síntomas del SPI al mes antes de empezar a recibir este tratamiento;
5. Pacientes de ambos sexos. Edad de 18 a 65 años;
6. Prueba de un documento de consentimiento informado firmado y fechado personalmente en el que se indique que el sujeto (o su representante legal) ha sido informado de todos los aspectos pertinentes del ensayo;
7. Disposición y capacidad de cumplir las visitas programadas, el plan de tratamiento, los análisis de laboratorio y otros procedimientos del estudio.

E.4

Principal exclusion criteria

1. Cualquier forma de SPI secundario;
2. Necesidad de tratamiento de los síntomas de SPI diurnos (de 7:00 a 17:00);
3. Sujetos con respuesta al placebo, definida por una mejora de la puntuación de la IRLS >40 % entre las visitas de selección y basal;
4. Toda neuropatía sintomática o cualquier diagnóstico actual (clínicamente relevante) de trastornos concomitantes que puedan confundir la evaluación a criterio del investigador, por ejemplo, síndrome de dolor en las piernas y de movimiento de los dedos de los pies;
5. Radiculopatía lumbar o estenosis raquídea central clínicamente significativas, según los antecedentes o la exploración;
6. Presencia de otras enfermedades degenerativas del sistema nervioso central graves, como enfermedad de Parkinson, demencia, parestesia supranuclear progresiva, atrofia multisistémica, corea de Huntington, esclerosis lateral amiotrófica o enfermedad de Alzheimer;
7. Falta de respuesta a la gabapentina o al pramipexol en la historia clínica;
8. Hipersensibilidad a cualquiera de los componentes de la medicación del ensayo o de fármacos similares;
9. Ferritina sérica < 10 µg/l;
10. Antecedentes o presencia (en las visitas de selección o basal) de un trastorno del sueño importante que pueda confundir las evaluaciones (es decir, si se ha realizado un estudio del sueño con anterioridad: Índice de apnea/hipopnea >20);
11. Uso de medicamentos que puedan influir en la arquitectura del sueño o en las manifestaciones motrices durante el sueño antes de la visita basal (VB), sin un período de lavado adecuado. Nota: Véase la tabla de medicamentos previos, medicamentos que requieren lavado o prohibidos. Se trata de neurolépticos, hipnóticos, sedantes, antidepresivos, ansiolíticos, antiepilépticos, psicoestimulantes, barbitúricos y opiáceos;
12. Trabajadores por turnos (por ejemplo, en trabajos que alteren el ciclo circadiano normal de sueño-vigilia, como los trabajos nocturnos o por turnos rotatorios);
13. Necesidad de prescripción médica para trastornos concurrentes que puedan interferir en las evaluaciones de la eficacia;
14. Hepatopatía clínicamente significativa o elevación de la bilirrubina, la aspartato aminotransferasa (AST) o la alanina aminotransferasa (ALT) > 3 veces x límite superior de la normalidad (LSN);
15. Nefropatía clínicamente significativa o aclaramiento de creatinina <60 ml/min (calculado a partir de la creatinina sérica);
16. Cualquier otro trastorno clínicamente significativo (p. ej., disfunción cardíaca, neoplasia activa) o anomalía de las pruebas de laboratorio, que pueda afectar a la capacidad del sujeto para participar en el estudio;
17. Mujeres embarazadas o en período de lactancia, o mujeres en edad fértil que no hayan sido esterilizadas por métodos quirúrgicos, o que lleven menos de dos años de menopausia, o que no utilicen dos métodos anticonceptivos combinados y aceptables desde el punto de vista médico;
18. Participación en otros estudios farmacológicos experimentales o tratamiento con otros fármacos experimentales en los 30 días previos a la visita de selección;
19. Otros trastornos clínicamente significativos, médicos o psiquiátricos, agudos o crónicos, o anomalías de laboratorio que puedan aumentar el riesgo asociado a la participación en el estudio o a la administración del fármaco del estudio o que, en opinión del investigador, puedan interferir en la interpretación de los resultados del estudio;
20. Antecedentes de abuso crónico de alcohol o drogas en los últimos doce meses.

E.5 End points

E.5.1

Primary end point(s)

Variación desde el momento basal hasta el final del estudio de la intensidad de los síntomas del SPI, valorada mediante la puntuación total en la Escala de valoración de la intensidad sintomática del Grupo de estudio internacional del síndrome de piernas inquietas (IRLS), en la semana 6 teniendo en cuenta el nivel de dosis.

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

Yes

E.6.7

Pharmacodynamic

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

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)

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

Information not present in EudraCT

E.8.4

The trial involves multiple sites in the Member State concerned

Information not present in EudraCT

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

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)	No
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	No
F.3.3.1	Women of childbearing potential not using contraception	Information not present in EudraCT
F.3.3.2	Women of child-bearing potential using contraception	Information not present in EudraCT
F.3.3.3	Pregnant women	Information not present in EudraCT
F.3.3.4	Nursing women	Information not present in EudraCT
F.3.3.5	Emergency situation	Information not present in EudraCT
F.3.3.6	Subjects incapable of giving consent personally	Information not present in EudraCT
F.3.3.7	Others	Information not present in EudraCT
F.4 Planned number of subjects to be included
F.4.1	In the member state	9
F.4.2	For a multinational trial
F.4.2.1	In the EEA	50
F.4.2.2	In the whole clinical trial	100

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

2008-05-12

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2008-04-23

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2009-01-17

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