Clinical Trials Register

Summary
EudraCT Number:	2011-002825-22
Sponsor's Protocol Code Number:	PROPUDO
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:	2011-11-22
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

2011-002825-22

A.3

Full title of the trial

Pilot, placebo-controlled, double-blind, randomized, parallel propofol effective in preventing refractory chronic migraine

Estudio piloto, controlado con placebo, doble ciego, aleatorizado y paralelo de la eficacia de propofol en la prevención de la migraña crónica refractaria

A.3.1

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

Study to determine whether propofol helps prevent headache when the patient has exhausted standard treatments for such pain.

Estudio para conocer si el propofol ayuda a prevenir el dolor de cabeza cuando el paciente ya ha agotado los tratamientos habituales para dicho dolor.

A.4.1

Sponsor's protocol code number

PROPUDO

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	Hospital General Universitario de Alicante
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	Hospital General Universitario de Alicante
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	Hospital General Universitario de Alicante (HGUA)
B.5.2	Functional name of contact point	Fundación Investigación (HGUA)
B.5.3	Address:
B.5.3.1	Street Address	C/ Pintor Baeza, 12
B.5.3.2	Town/ city	Alicante
B.5.3.3	Post code	03010
B.5.3.4	Country	Spain
B.5.4	Telephone number	+34965913868
B.5.5	Fax number	+34965913896
B.5.6	E-mail	garcia_silpal@gva.es

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	Diprivan 1%
D.2.1.1.2	Name of the Marketing Authorisation holder	Astra Zeneca Spain
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	Emulsion for injection/infusion
D.3.4.1	Specific paediatric formulation	No
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	PROPOFOL
D.3.9.1	CAS number	2078-54-8
D.3.9.2	Current sponsor code	58785
D.3.9.3	Other descriptive name	Diprivan
D.3.9.4	EV Substance Code	SUB10116MIG
D.3.10	Strength
D.3.10.1	Concentration unit	% percent
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	1
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.IMP: 2
D.1.2 and D.1.3	IMP Role	Comparator
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	Intralipid 100 mg/ml
D.2.1.1.2	Name of the Marketing Authorisation holder	FRESENIUS KABI ESPAÑA S.A.
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	Emulsion for infusion
D.3.4.1	Specific paediatric formulation	No
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	Soy Oil
D.3.9.1	CAS number	8001-22-7
D.3.9.2	Current sponsor code	43166
D.3.9.3	Other descriptive name	SOYA OIL
D.3.9.4	EV Substance Code	SUB15344MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
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)	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

Refractory chronic migraine

Migraña crónica refractaria.

E.1.1.1

Medical condition in easily understood language

Headache not responding to standard therapy.

Dolor de cabeza que no responde al tratamiento habitual.

E.1.1.2

Therapeutic area

Diseases [C] - Nervous System Diseases [C10]

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

To assess the analgesic efficacy of Diprivan ® infusion in the prevention of migraine refractory to medical therapy.

Valorar la eficacia analgésica de la infusión de Diprivan® en la prevención de la migraña refractaria a tratamiento farmacológico.

E.2.2

Secondary objectives of the trial

To assess the tolerability and safety of the infusion of Diprivan® in the prevention of migraine refractory to treatment.
-Reduction in the mean frequency of migraine attacks at 6 months after initiation of study treatment compared to baseline. responders.
-Number of days with migraine per month of treatment.-half intensity of headache attacks during each month of follow-up (VAS) .
- Speed effect in reducing the frequency of attacks by comparing the frequency of attacks per month of Treatment.
-Consumption of medication for acute treatment accounted mensual.
-Evaluation of the patient's subjective improvement through quality of life test of migraine.
-Assessment of disability caused by migraine using the MIDAS questionnaire.

-Valorar la tolerabilidad y seguridad de la infusión de Diprivan® en la prevención de la migraña refractaria a tratamiento.
-Reducción en la media de la frecuencia de ataques de migraña a los 6 meses del inicio del tratamiento del estudio respecto a la situación basal.
-Tasa de respondedores.
-Número de días con migraña por cada mes de tratamiento.
-Intensidad de la cefalea media durante los ataques por cada mes de seguimiento (EAV).
-Rapidez del efecto en la reducción de la frecuencia de los ataques, mediante la comparación de las frecuencias de ataques por cada mes de tratamiento.-Consumo de medicación para el tratamiento agudo contabilizado mensual.
-Evaluación de la mejoría subjetiva del paciente mediante Test de Calidad de Vida relacionado con la migraña.
-Evaluación de la discapacidad producida por la migraña mediante el cuestionario MIDAS.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1.18-65 years old (inclusive), at the time of study inclusion, and can be of any race or sex.2. Age of onset of migraine under 50.3.Free acceptance of trial participation, with written informed consent.4.Ability to properly complete the registration data to assess.5.Diagnostic criteria for chronic migraine according to IHS: * Migraine without aura that occurs 15 days / month for> 3 months in the absence of medication overuse and not attributable to other disorders. * Besides the headache is a disorder that manifests as recurrent attacks that last 4-72 5 hours and has 2 of the following features:- unilateral location; pulsatile-quality, moderate or severe-intensity;-aggravated or improved by avoiding routine physical activities, and during the headache, 1 of the following:-nausea and / or vomiting, photophobia and prophylactic fonofobia.6.Prophilactic medicación unchanged in the last 3 months prior to inclusión.7.If you have left of prophylactic medication must have spent> 1 month to ensure a sufficient washout period for drugs with long elimination half-life.

1.Tener entre 18-65 años (ambos inclusive), en el momento de la inclusión del estudio, pudiendo pertenecer a cualquier raza o sexo.2.Edad de inicio de la migraña inferior a los 50 años.3.Aceptación libre de participar en el ensayo, con consentimiento informado por escrito.4.Capacidad para cumplimentar adecuadamente el registro de los datos a valorar.5.Criterios diagnósticos de migraña crónica según la IHS: Migraña sin aura* que ocurre 15 días/mes durante > 3 meses, en ausencia de abuso de medicación y no atribuible a otros trastornos. *Además la cefalea es un trastorno recurrente que se manifiesta como 5 ataques que duran 4-72 horas y tiene 2 de las siguientes características:-localización unilateral;-calidad pulsátil;-intensidad moderada o severa;-se agrava o mejora al evitar las actividades físicas rutinarias;-Y durante la cefalea, 1 de los siguientes:-naúsea y/o vómitos;-fotofobia y fonofobia.6.Medicación profiláctica sin cambios en los últimos 3 meses previos a la inclusión.7.Si ha abandonado parte de la medicación profiláctica debe haber pasado > 1 mes para garantizar un periodo de lavado suficiente en fármacos con semivida de eliminación prolongada.

E.4

Principal exclusion criteria

1. Women in the period of pregnancy or nursing women and suspected in the probability of pregnancy by history data. 2.Patients without prophylactic medication for migraine or it has started less than three months. 3.Allergy to either drug, including its excipients (soy, peanut, egg) and allergy to fat emulsions. 4.Patients with hypertriglyceridemia (> 150 mg / dl) .5. Patients who do not meet the IHS criteria (ICHD-IIR1) .6. Patients with serious hepatic impairment who received propofol.7.Patients in the 6 months prior to entry into the study.8.Patients with severe renal insufficiency (creatinine> 3 mg / dl) .9. Patients with cronic pancreatitis. with poor venous access crónica.10.Pacientes periférico.11.Patients with poor peripheral venous access. 12.Patients with diminished capacity to give informed consent.13.Familiares of staff involved in the research.

1.Mujeres en el periodo de embarazo o lactancia y mujeres en las que se sospeche la probabilidad de embarazo por los datos de la anamnesis. 2.Pacientes sin medicación profiláctica para migraña o que ésta se haya iniciado hace menos de tres meses. 3.Alergia a cualquiera de los dos fármacos, incluidos sus excipientes (soja, cacahuete, huevo) y alergia a emulsiones grasas. 4.Pacientes con hipertrigliceridemia (> 150 mg/dl).5.Pacientes que no cumplan criterios de la IHS (ICHD-IIR1).6.Pacientes con insuficiencia hepática grave.7.Pacientes que hayan recibido propofol en los 6 meses anteriores al ingreso en el estudio.8.Pacientes con insuficiencia renal severa (creatinina > 3 mg/dl).9.Pacientes con pancreatitis crónica.10.Pacientes con mal acceso venoso periférico.11.Pacientes que presentan alguna condición médica que interfiera a juicio del investigador en el desarrollo del estudio.12.Pacientes con capacidad disminuida para dar su consentimiento informado.13.Familiares del personal implicado en la investigación.

E.5 End points

E.5.1

Primary end point(s)

Reduction in the average frequency of migraine attacks per month and 3 months after initiation of study treatment compared to baseline.

Reducción en la media de la frecuencia de ataques de migraña al mes y a los 3 meses del inicio del tratamiento del estudio respecto a la situación basal.

E.5.1.1

Timepoint(s) of evaluation of this end point

Month and three months.

Al mes y a los tres meses.

E.5.2

Secondary end point(s)

-Reduction in the average frequency of migraine attacks at 6 months after initiation of study treatment on the situation respondedores. basal.-Number of days with migraine per month of Treatment.-Intensity of headache average during attacks per month of follow-up [Scale categorical and VAS] .- Speed effect in reducing the frequency of attacks, by comparing the frequency of attacks per month of treatment.-Medication consumption acute treatment accounted monthly.-Evaluation of the patient's subjective improvement through Quality of Life Test related migraine.-Assessment of disability caused by migraine using the MIDAS questionnaire.

-Reducción en la media de la frecuencia de ataques de migraña a los 6 meses del inicio del tratamiento del estudio respecto a la situación basal.-Tasa de respondedores.-Número de días con migraña por cada mes de tratamiento.-Intensidad de la cefalea media durante los ataques por cada mes de seguimiento [Escala categórica y EAV].-Rapidez del efecto en la reducción de la frecuencia de los ataques, mediante la comparación de las frecuencias de ataques por cada mes de tratamiento.-Consumo de medicación para el tratamiento agudo contabilizado mensual.-Evaluación de la mejoría subjetiva del paciente mediante Test de Calidad de Vida relacionado con la migraña.-Evaluación de la discapacidad producida por la migraña mediante el cuestionario MIDAS.

E.5.2.1

Timepoint(s) of evaluation of this end point

Month, 3 months and at 6 months.

Al mes, a los 3 meses y a los 6 meses.

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

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)

Yes

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)

Yes

E.8.2.2

Placebo

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

Yes

E.8.4

The trial involves multiple sites in the 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

Cuando el último sujeto incluido en el ensayo haya completado la última visita del estudio.

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

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

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

F.4.2.2

In the whole clinical trial

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)

It will be the standard treatment for refractory chronic migraine.

Va a ser el tratamiento habitual para la migraña crónica refractaria.

G. Investigator Networks to be involved in the Trial
G.4 Investigator Network to be involved in the Trial: 1
G.4.1	Name of Organisation	Unidad de Ensayos Clínicos de Alicante
G.4.3.4	Network Country	Spain

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

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2011-12-29

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2011-09-29

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

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