Clinical Trials Register

Summary
EudraCT Number:	2020-005653-24
Sponsor's Protocol Code Number:	IRB00003099
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:	2021-06-14
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

2020-005653-24

A.3

Full title of the trial

Effectiveness of botulinum toxin infiltration in spasticity of the 1st toe in patients with neurological pathology

Efectividad de la infiltración con toxina botulínica en la espasticidad del 1º dedo del pie en pacientes con patología neurológica

A.3.1

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

Botox injection in 1st toe to treat spasticity

Inyeccion de botox en 1º dedo del pie para la tratar espasticidad

A.4.1

Sponsor's protocol code number

IRB00003099

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 Integral del pie-Ana Sans
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	Clínica Integral del pie-Ana Sans
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	Clínica integral del pie-Ana Sans
B.5.2	Functional name of contact point	Ana Sans
B.5.3	Address:
B.5.3.1	Street Address	Avenida Sancho el fuerte 9, bajo
B.5.3.2	Town/ city	Pamplona
B.5.3.3	Post code	31007
B.5.3.4	Country	Spain
B.5.4	Telephone number	722806663
B.5.6	E-mail	anasans939@gmail.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	Botox 50
D.2.1.1.2	Name of the Marketing Authorisation holder	Allergan
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	BOTOX 50U ALLERGAN
D.3.2	Product code	SUB13117MIG
D.3.4	Pharmaceutical form	Powder for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Infiltration
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Clostridium botulinum
D.3.9.3	Other descriptive name	BOTULINUM TOXIN TYPE A
D.3.9.4	EV Substance Code	SUB13117MIG
D.3.10	Strength
D.3.10.1	Concentration unit	U/ml unit(s)/millilitre
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	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	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	Botox 50
D.2.1.1.2	Name of the Marketing Authorisation holder	Allergan
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	BOTOX 50U ALLERGAN
D.3.2	Product code	SUB13117MIG
D.3.4	Pharmaceutical form	Powder for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Infiltration
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Clostridium botulinum
D.3.9.3	Other descriptive name	BOTULINUM TOXIN TYPE A
D.3.9.4	EV Substance Code	SUB13117MIG
D.3.10	Strength
D.3.10.1	Concentration unit	U/ml unit(s)/millilitre
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	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	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

The application of Botox is described in the technical sheet for spasticity and has already been applied to the foot. This is how we speak of a phase IV clinical trial, with a low level of intervention.

La aplicación de Botox se describe en la ficha técnica de espasticidad y ya se ha aplicado en el pie. Así hablamos de un ensayo clínico fase IV, con un nivel de intervención bajo.

E.1.1.1

Medical condition in easily understood language

There are very few studies carried out on the application of botulinum toxin in foot spasticity, being a good treatment option.

Existen muy pocos estudios realizados sobre la aplicación de la toxina botulínica en la espasticidad del pie, siendo una buena opción de tratamiento.

E.1.1.2

Therapeutic area

Diseases [C] - Musculoskeletal Diseases [C05]

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 evaluate the efficacy of botulinum toxin infiltration treatment for 1st toe spasticity in neurological patients.

Evaluar la eficacia del tratamiento con infiltración de tóxina botulínica para la espasticidad del 1 dedo del pie, en pacientes neurológicos.

E.2.2

Secondary objectives of the trial

Assess the improvement in functionality, gait stability and analgesic effect.

Valorar la mejora de la funcionalidad, la estabilidad de la marcha y el efecto analgésico.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Neurological patients aged 18 to 80 years
Patients with stroke, parkinson's or multiple sclerosis, who present spasticity of the 1st toe.
Spasticity of the 1st toe, pain and gait instability.
Hyperextension of the 1st finger, causing inability to put on shoes, in neurological patients.

Pacientes neurológicos de 18 a 80 años
Pacientes con ictus, parkinson o esclerosis múltiple, que presenten espasticidad del 1º dedo del pie.
Espasticidad del 1º dedo del pie, dolor y inestabilidad de la marcha.
Hiperextensión del 1º dedo, que cause imposibilidad para calzarse, en paciente neurológicos.

E.4

Principal exclusion criteria

Skin ulcers
In pregnancy and lactation the use is contraindicated.
Minor patients and those patients who do not have the authorization of a family member or guardian.
Individuals with known hypersensitivity to botulinum toxin type A or to any of the excipients of the formulation.
In case of infection at the proposed injection site (s).
Eaton Lambert Syndrome patients.
Patients with severe dysphagia or respiratory compromise.
Patients with myasthenia gravis.

Úlceras cutáneas
En el embarazo y la lactancia el uso está contraindicado.
Pacientes menores y aquellos pacientes que no cuenten con la autorización de un familiar o tutor.
Individuos con hipersensibilidad conocida a la toxina botulínica tipo A o a alguno de los excipientes de la formulación.
En caso de infección en los lugares propuestos para la inyección.
Pacientes con síndrome de Eaton Lambert.
Pacientes con disfagia severa o compromiso respiratorio.
Pacientes con miastenia gravis.

E.5 End points

E.5.1

Primary end point(s)

The main variable is that the study subjects will be randomized so that this provides statistical power. Two possible treatment concentrations 25U or 50U will be applied, assigned to each of the groups, in a single application. Never exceed with this dose, what is allowed according to the drug's technical data sheet.

La variable principal es que los sujetos de estudio serán asignados al azar para que esto brinde poder estadístico. Se aplicarán dos posibles concentraciones de tratamiento 25U o 50U, asignados a cada uno de los grupos, en una única aplicación. Nunca se sobrepasa con esta dosis, lo permitido según ficha técnica del medicamento.

E.5.1.1

Timepoint(s) of evaluation of this end point

A control visit will be made a month, and thus assess the therapeutic effects achieved.
Returning to perform the tests and ranges of movement, to assess quantitatively.

Se realizará una visita de control al mes y así valorar los efectos terapéuticos logrados.
Volviendo a realizar los test y rangos de movimiento, para evaluar cuantitativamente.

E.5.2

Secondary end point(s)

PATIENT ASSESSMENT TEST, SPECIFIC OBJECTIVES OF THE INFILTRATION:
1-Improve activities of daily living mainly hygiene tasks yes / no
2-Improve functionality yes / no
3-Reduce pain yes / no
4-Adaptation of orthotic aids yes / no
5-Allow a better adaptation in the sitting position yes / no
6-Reduce the number of spasms yes / no
7-Improve joint range yes / no
8-Improve gait pattern yes / no
9-Prevent the appearance of contractures and muscle shortening yes / no
10-Prevent deformities or orthopedic alterations: scoliosis, subluxation or dislocation of the hip and clubfoot ankle dysplasia yes / no

TEST DE VALORACIÓN AL PACIENTE ,OBJETIVOS ESPECÍFICOS DE LA INFILTRACIÓN:
1-Mejorar las actividades de la vida diaria (AVD) principalmente tareas de higiene sí/no
2-Mejorar funcionalidad sí/no
3-Disminuir dolor sí/no
4-Adaptación de ayudas ortésicas sí/no
5-Permitir una mejor adaptación en la sedestación sí/no
6-Disminuir el número de espasmos sí/no
7-Mejorar el rango articular sí/no
8-Mejorar el patrón de marcha sí/no
9-Prevenir la aparición de contracturas y acortamientos musculares sí/no
10-Prevenir deformidades o alteraciones ortopédicas: escoliosis, subluxación o luxación de cadera y pie equino-varo displasia de tobillo sí/no

E.5.2.1

Timepoint(s) of evaluation of this end point

Will be made
Neurological test
Romberg test
Biomechanical study of gait

Balance
Claudication or limb paresis
Tandem gait
Toe or heel gait
Astasia-Abasia
Taboo march

Observations
Clinical report and consultation sheet, if applicable.

Se realizarán
test Neurológicas
Prueba de Romberg

Estudio biomecánico de la marcha
Equilibrio
Claudicación o paresia miembro
Marcha tándem
Marcha puntillas o talones
Astasia-Abasia
Marcha tabética

Observaciones
Informe clínico y hoja de interconsulta con neurólogo que nos instruye, si procede.

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

Yes

E.8.1.2

Open

Yes

E.8.1.3

Single blind

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

Compare 2 posibles dosis de fármaco eficaces; indicado para espasticidad y aplicado en el pie.

Compare 2 possible effective drug doses; indicated for spasticity and applied to the foot.

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

It is considered that as a conservative treatment, it is a safe, non-painful treatment that achieves a significant reduction in spasticity of the muscles in which it is injected. Improving the pain produced by said spasticity and increasing the quality of life of the patient. The minimum dose for this effect is sought, therefore we will infiltrate 25 U and 50U; considering that 50 U will have a greater therapeutic effect.

Se considera que como tratamiento conservador, es un tratamiento seguro, no doloroso que consigue una reducción importante de la espasticidad de los músculos en los que se inyecta. Mejorando el dolor producido por dicha espasticidad y aumentando la calidad de vida del paciente. Se busca aquella dosis mínima para dicho efecto, por ello infiltraremos 25 U y 50U; considerando que 50 U tendrá mayor efecto terapéutico.

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

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

Yes

F.3.3.7.1

Details of other specific vulnerable populations

Treated patient is unable to understand the consent of their legal guardian

Paciente tratado tenga incampacidad de comprensión consentimiento de su tutor legal

F.4 Planned number of subjects to be included

F.4.1

In the member state

120

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
G.4 Investigator Network to be involved in the Trial: 1
G.4.1	Name of Organisation	Clínica integraldel pie-Ana Sans
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

2021-06-28

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2021-06-14

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

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