Clinical Trials Register

Summary
EudraCT Number:	2014-000868-17
Sponsor's Protocol Code Number:	DEXPROPAR
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:	2014-03-17
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

2014-000868-17

A.3

Full title of the trial

Effect of dexmedetomidine vs propofol on basal ganglia activity (local field potentials) recorded through implanted stimulators

Efecto de dexmedetomidina vs propofol en el registro de la actividad cerebral profunda (potenciales de campo) medida a través de estimulador implantado

A.3.1

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

Effect of dexmedetomidine vs propofol on basal ganglia activity (local field potentials) recorded through implanted stimulators

Efecto de dexmedetomidina vs propofol en el registro de la actividad cerebral profunda (potenciales de campo) medida a través de estimulador implantado

A.4.1

Sponsor's protocol code number

DEXPROPAR

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	Clínica Universidad de Navarra/Universidad de Navarra
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	Orion Corporation
B.4.2	Country	Finland
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Clinica Universidad de Navarra
B.5.2	Functional name of contact point	UCICEC
B.5.3	Address:
B.5.3.1	Street Address	Avda. Pío XII, 36
B.5.3.2	Town/ city	Pamplona
B.5.3.3	Post code	31008
B.5.3.4	Country	Spain
B.5.4	Telephone number	34948255 4001144
B.5.5	Fax number	34948296 667
B.5.6	E-mail	ucicec@unav.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	Dexdor
D.2.1.1.2	Name of the Marketing Authorisation holder	Orion Corporation
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.3.1	Product name	Dexdor
D.3.4	Pharmaceutical form	Concentrate for solution 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	DEXMEDETOMIDINE
D.3.9.1	CAS number	113775-47-6
D.3.9.3	Other descriptive name	DEXMEDETOMIDINA
D.3.9.4	EV Substance Code	SUB07037MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg/kg/h milligram(s)/kilogram/hour
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	0.0002 to 0.0014
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	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	Propofol-Lipuro
D.2.1.1.2	Name of the Marketing Authorisation holder	B. Braun Melsungen AG
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.3.1	Product name	Propofol-Lipuro
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	PROPOFOL
D.3.9.3	Other descriptive name	PROPOFOL
D.3.9.4	EV Substance Code	SUB10116MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg/kg/h milligram(s)/kilogram/hour
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	0.5 to 4
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

Parkinson's disease

Enfermedad de Parkinson

E.1.1.1

Medical condition in easily understood language

Parkinson's disease

Enfermedad de Parkinson

E.1.1.2

Therapeutic area

Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	16.1
E.1.2	Level	LLT
E.1.2	Classification code	10013113
E.1.2	Term	Disease Parkinson's
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

Study whether there are changes (and their characteristics) in local field potentials recordings in deep subcortical structures, obtained through the stimulators implanted to treat Parkinson's disease, with the administration of dexmedetomidine and propofol.

Establecer si se producen cambios (y caracterizarlos en caso de que ocurran) en el registro de los potenciales de campo en estructuras profundas subcorticales, obtenido a través de estimulador implantado para tratar la enfermedad de Parkinson, con la administración de dexmedetomidina y propofol.

E.2.2

Secondary objectives of the trial

Make a comparative analysis of possible changes in the patient´ score of the UPDRS-III scale at ?off? situation, with dexmedetomidine and different estimated plasma levels of propofol.

Realizar un análisis comparativo de los posibles cambios en la puntuación de la escala UPDRS-III del paciente en situación ?off?, con dexmedetomidina y con diferentes concentraciones plasmáticas estimadas de propofol.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

All patients must meet all the following inclusion criteria:
1. Ability to provide informed consent and express their desire to satisfy all requirements of the protocol during the study period.
2. The patient should, in the investigator's opinion, be able to meet all the requirements of the clinical trial.
3. The patient must be an adult (more than 18 years old).
4. The patient will undergo placement of a deep brain stimulator for Parkinson's disease in subthalamic nucleus or globus pallidus under sedation, by indication of the responsible physician.

Todos los pacientes deben cumplir todos los siguientes criterios de inclusión:
1. Capacidad para otorgar consentimiento informado y expresar su deseo de cumplir todos los requisitos del protocolo durante el periodo de estudio.
2. El/la paciente debe, en opinión del investigador, ser capaz de cumplir con todos los requerimientos del ensayo clínico.
3. El paciente deberá ser mayor de edad.
4. El paciente va a someterse a la colocación de un estimulador cerebral profundo por enfermedad de Parkinson en núcleo subtalámico o globo pálido bajo sedación, por indicación de su médico responsable.

E.4

Principal exclusion criteria

Patients with any of the following exclusion criteria will not be included in the clinical trial:
1. Hypersensitivity to dexmedetomidine or propofol.
2. Heart block type 2nd or 3rd degree without pacemaker.
3. Symptomatic hypotension.
4. Patient with severe stroke.
5. Pregnant or lactating patient.

Los pacientes que presenten alguno de los siguientes criterios de exclusión no podrán ser incluidos en el ensayo clínico:
1. Antecedentes de hipersensibilidad a dexmedetomidina o propofol.
2. Bloqueo cardíaco en 2º o 3º grado sin marcapasos.
3. Hipotensión sintomática.
4. Paciente con enfermedad cerebrovascular grave.
5. Paciente embarazada o en período de lactancia.

E.5 End points

E.5.1

Primary end point(s)

Registration signal potency of deep brain activity at different frequencies through the stimulator (microvolts?m-2).

Potencia de la señal del registro de la actividad cerebral profunda en distintas frecuencias a través del estimulador (microvoltios?m-2).

E.5.1.1

Timepoint(s) of evaluation of this end point

In "baseline" situation without anesthetic medication (day 4), with dexmedetomidine (day 1) and after different concentrations of propofol (day 6).

En situación ?basal? sin medicación anestésica (día 4), con dexmedetomidina (día 1) y tras diferentes concentraciones de propofol (día 6).

E.5.2

Secondary end point(s)

? Demographic data (gender, age, weight).
? Parkinson disease type, duration and regular medication.
? Score of the UPDRS-III scale at "off" and "on" situation.
? Stimulation target nucleus. Subthalamic nucleus or globus pallidus.
? Changes in the score UPDRS-III scale with the administration of dexmedetomidine and propofol.
? Adverse events observed during the study.

? Variables demográficas (sexo, edad, peso).
? Tipo de enfermedad de Parkinson, tiempo de evolución y medicación habitual.
? Puntuación en la escala UPDRS-III en situación ?off? y ?on?.
? Núcleo diana de la estimulación. Núcleo subtalámico o globo pálido.
? Tipo de intervención realizada. Unilateral o bilateral.
? Cambios en la puntuación de la escala UPDRS-III con la administración de dexmedetomidina y propofol.
? Acontecimientos adversos observados a lo largo del estudio.

E.5.2.1

Timepoint(s) of evaluation of this end point

At different moments during the study

A lo largo del estudio

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

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

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)

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

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

En el mismo paciente

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

LVLS

UVUS

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

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)

Yes

F.1.3.1

Number of subjects for this age range:

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.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)

Will continue with the usual treatment for the pathology

Se continuará con el tratamiento habitual para la patología

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

2014-06-26

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2014-05-02

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

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