Clinical Trials Register

Summary
EudraCT Number:	2014-001157-17
Sponsor's Protocol Code Number:	PSI-HAL-2014
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:	2014-06-09
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

2014-001157-17

A.3

Full title of the trial

Efficacy and safety of intranasal administration of haloperidol in agitated schizophrenic patients: a controlled, blinded, randomized and single-center clinical trial

Eficacia y seguridad de la administración de haloperidol intranasal en pacientes esquizofrénicos agitados: ensayo clínico controlado, cegado, aleatorizado y unicéntrico

A.3.1

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

Efficacy of intranasal administration of haloperidol compared to intramuscular administration in agitated schizophrenic patients

Eficacia de la administración de haloperidol intranasal comparada con la administración intramuscular en pacientes esquizofrénicos agitados

A.4.1

Sponsor's protocol code number

PSI-HAL-2014

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	Fundació Parc Taulí
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	Fundació Parc Taulí
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	Fundació Parc Taulí
B.5.2	Functional name of contact point	Oficina de Recerca
B.5.3	Address:
B.5.3.1	Street Address	Parc Taulí nº1
B.5.3.2	Town/ city	Sabadell
B.5.3.3	Post code	08208
B.5.3.4	Country	Spain
B.5.4	Telephone number	34937458451
B.5.5	Fax number	34937175067
B.5.6	E-mail	afarre@tauli.cat

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.2.1.2	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	Nebulisation solution
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intranasal use (Noncurrent)
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Haloperidol
D.3.9.1	CAS number	52-86-8
D.3.9.3	Other descriptive name	HALOPERIDOL
D.3.9.4	EV Substance Code	SUB08005MIG
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	5
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.2.1.2	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	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intramuscular use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Haloperidol
D.3.9.1	CAS number	52-86-8
D.3.9.3	Other descriptive name	HALOPERIDOL
D.3.9.4	EV Substance Code	SUB08005MIG
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	5
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

Agitation in schizophrenic patients

Agitación en pacientes esquizofrénicos

E.1.1.1

Medical condition in easily understood language

Agitation in schizophrenic patients

Agitación en pacientes esquizofrénicos

E.1.1.2

Therapeutic area

Psychiatry and Psychology [F] - Mental Disorders [F03]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	17.0
E.1.2	Level	PT
E.1.2	Classification code	10001497
E.1.2	Term	Agitation
E.1.2	System Organ Class	10037175 - Psychiatric disorders

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Compare intranasal administration of 5 mg haloperidol in agitated patients with schizophrenia treated in the emergency room with intramuscular administration in terms of time required for patient sedation

Comparar la administración intranasal de 5mg haloperidol con la administración intramuscular en el paciente agitado con diagnóstico de esquizofrenia atendido en el Servicio de Urgencias en cuanto a tiempo requerido para conseguir la sedación del paciente

E.2.2

Secondary objectives of the trial

Compare the degree of sedation obtained with intranasal administration of 5 mg of haloperidol in agitated patients with schizophrenia compared with intramuscular administration.
Compare the time to administration of a rescue dose between the control and experimental groups.
To evaluate the safety and tolerability obtained with both administration routes.
Describe the number and severity of accidents related to the management of the patient in psychiatric emergencies during the period of turmoil

Comparar el grado de sedación obtenido con la administración intranasal de 5mg de haloperidol en pacientes con esquizofrenia agitados en comparación con la administración intramuscular.
Comparar el tiempo transcurrido hasta la administración de una dosis de rescate entre el grupo control y el experimental.
Evaluar la seguridad y tolerancia obtenida con ambas vías de administración.
Describir el número y gravedad de accidentes relacionados con la prestación sanitaria en urgencias psiquiátricas durante el período de agitación y de control posterior

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Men and women between 18 and 65.
Patients with a diagnosis of schizophrenia according to DSM V diagnostic criteria.
Patients presenting with psychomotor agitation (more than or equal to 14 score (where the max value is 35) in the overall scale score or 4 (where the max value is 7) in at least 1 of the 5 items comprising the scale).
Patients in whom the treatment with an antipsychotic by intramuscular route is indicated.
Patients who consented to participate in the study / patients whose representative granted his/her participation in the study

Hombres y mujeres entre 18 y 65 años.
Pacientes con diagnóstico previo de esquizofrenia según criterio diagnóstico DSM V.
Pacientes que presenten un cuadro de agitación psicomotora (puntuación mayor o igual a 14 (de 35) en la puntuación global de la escala o 4 (de 7) en al menos 1 de los 5 ítems que componen la escala).
Pacientes en los que esté indicado el tratamiento con un antipsicótico vía intramuscular.
Pacientes que hayan otorgado su consentimiento para la participación en el estudio / pacientes para los que su representante haya otorgado consentimiento para su participación en el estudio

E.4

Principal exclusion criteria

Pregnant or breast-feeding women.
Patients with exacerbated medical comorbidity (respiratory, hepatic, renal, gastrointestinal, cardiovascular, endocrine, neurological or haematological).
Patients with delirium.
Patients with severe risk of suicide.
Patients with hypersensitivity to haloperidol or any of the excipients or any situation in which the administration of haloperidol is contraindicated according to the summary of product characteristics: comatose state, CNS depression caused by alcohol or other depressant drugs, Parkinson's disease, basal ganglia damage).
Patients with abuse / drug dependence (alcohol and / or sympathomimetic) within the two months prior to the study.
Patients with cocaine or other sympathomimetic intoxication.
Patients who have received benzodiazepines or other short-acting hypnotics or antipsychotics by oral ir intramuscular route within the 4 hours prior to the start of clinical trial.
Patients who have been administered with a depot antipsychotic previous to the study.
Patients for which consent to participate has not been obtained
Patients who in the opinion of the responsible physician the participation in the study can be a clinical harm.

Mujeres embarazadas o en periodo de lactancia.
Pacientes con comorbilidad médica agudizada (respiratoria, hepática, renal, gastrointestinal, cardiovascular, endocrina, neurológica o hematológica)
Pacientes con delirium.
Pacientes con riesgo severo de suicidio.
Pacientes con hipersensibilidad al haloperidol o a alguno de los excipientes o cualquier situación en la que la administración de haloperidol esté contraindicada según la ficha técnica: Estado comatoso, depresión del SNC producida por el alcohol u otros medicamentos depresores, enfermedad de Parkinson, lesión de los ganglios basales).
Pacientes con abuso/dependencia a drogas (alcohol y/o simpaticomiméticos) durante los dos meses anteriores al estudio
Pacientes que presenten intoxicación por cocaína u otros simpaticomiméticos.
Pacientes que hayan recibido benzodiacepinas u otros hipnóticos o antipsicóticos orales o intramusculares de acción corta en las 4 horas antes al inicio del ensayo clínico.
Pacientes a los que se haya administrado un antipsicótico depot en el intervalo previo al estudio.
Pacientes para los que no se haya obtenido el consentimiento para participar.
Pacientes en los que se considere que la participación en el estudio puede suponer un perjuicio clínico, en opinión del médico responsable del cuidado del paciente

E.5 End points

E.5.1

Primary end point(s)

Proportion of patients with controlled agitation (defined as an average score of 9 in the PANSS scale-EC (5 items)) at 20 minutes after administration of treatment)

Proporción de pacientes en los que se ha controlado la agitación (obtención de una puntuación media de 9 en la escala de PANSS-EC (5 ítems)) a los 20 minutos de la administración del tratamiento

E.5.1.1

Timepoint(s) of evaluation of this end point

20 minutes after administration

20 minutos después de la administración

E.5.2

Secondary end point(s)

Proportion of responders, defined by a score of 1 or 2 of the CGI-S scale after 45 minutes of administration of the medication.
Changes from baseline in the PANSS-EC scale from 20 minutes in the different evaluations performed up to 6 hours.
Elapsed time to administration of the second dose.
Number and type of reported adverse effects: Adverse effects will be controlled through the continuous monitoring of patients, physical and laboratory examination. If necessary a specific medical - psychiatric intervention will be done by the responsible investigator. If the patient has extrapyramidal symptoms including acute dystonia, anticholinergic biperiden 4mg will be administered intramuscularly.
Excessive sedation, as assessed via BARS scale after two hours of dosing.
Number and severity of related incidents related to the agitation and the administration of treatment to control it.
Rating of the difficulty in administration of treatment measured by means of a VAS scale

Proporción de pacientes respondedores, definidos por una puntuación de 1 o 2 de la escala CGI-S al cabo de 45 minutos de la administración de la medicación.
Cambios respecto al estado basal en la escala PANSS-EC a partir de los 20 minutos en las distintas evaluaciones que se realicen hasta las 6 horas.
Tiempo transcurrido hasta la administración de la segunda dosis.
Número y tipo de efectos adversos reportados: los efectos adversos serán controlados a través de la monitorización continuada de los pacientes, examen físico y de laboratorio. Si fuese necesario se realizaría un intervención médica-psiquiátrica específica por parte de los responsables investigadores. Si el paciente presentara síntomas extrapiramidales como distonía aguda, se administraría anticolinérgico biperideno 4mg por vía intramuscular.
Exceso de sedación, evaluada a través de la escala BARS después de dos horas de administración del fármaco.
Número y gravedad de incidentes relacionados con el estado de agitación y con la administración del tratamiento para el control de la agitación.
Valoración de la dificultad de aplicación de administración, mediante una escala VAS.

E.5.2.1

Timepoint(s) of evaluation of this end point

different timeponits during 6 hours after administration

diferentes tiempos durante las 6 horas después de la administración

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

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

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

Evaluación ciega por terceros

Observer Blind

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

Haloperidol Intramuscular

Intramuscular Haloperidol

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

Last patient last visit

Último paciente última visita

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)

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

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

Yes

F.3.3.6.1

Details of subjects incapable of giving consent

Due to the mental state of some of the patients in the study, it is possible that informed consent has to be authorized by the representative

Debido al estado psíquico de algunos de los pacientes del estudio, es posible que el consentimiento informado tenga que ser autorizado por su representante

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)

None

Ninguno

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

2014-07-29

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2014-04-29

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

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