Clinical Trials Register

Summary
EudraCT Number:	2021-001629-38
Sponsor's Protocol Code Number:	KLG0121
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:	2021-09-13
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

2021-001629-38

A.3

Full title of the trial

A phase 2, multicenter, randomized, double blind, active controlled, parallel group study assessing the analgesic effect and safety of two doses of DFL24412 in patients with chronic low back pain compared to Ketoprofen Lysine Salt (KLS).

A.3.1

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

Phase 2 trial, conducted in more than one site, in which no one knows the treatment assigned to the patient to evaluate the effect against pain and the safety of the study drug, DFL24412, respect a control drug (Ketoprofen Lysine Salt), in patient with chronic low back pain

A.4.1

Sponsor's protocol code number

KLG0121

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	Dompè Farmaceutici S.p.A.
B.1.3.4	Country	Italy
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	Dompè Farmaceutici S.p.A.
B.4.2	Country	Italy
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Dompè Farmaceutici S.p.A.
B.5.2	Functional name of contact point	Clinical Operations
B.5.3	Address:
B.5.3.1	Street Address	Via Santa Lucia 6
B.5.3.2	Town/ city	Milan
B.5.3.3	Post code	20122
B.5.3.4	Country	Italy
B.5.4	Telephone number	00390258383378
B.5.5	Fax number	00390258383324
B.5.6	E-mail	giuseppe.terpolilli@dompe.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	No
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	Co-crystal of ketoprofen, lysine and gabapentin
D.3.2	Product code	DFL24412
D.3.4	Pharmaceutical form	Capsule, hard
D.3.4.1	Specific paediatric formulation	No
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	KETOPROFEN LYSINE SALT
D.3.9.1	CAS number	57469-78-0
D.3.9.2	Current sponsor code	KLS
D.3.9.3	Other descriptive name	KETOPROFEN LYSINE
D.3.9.4	EV Substance Code	SUB02834MIG
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	80
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	GABAPENTIN
D.3.9.1	CAS number	60142-96-3
D.3.9.2	Current sponsor code	GABA
D.3.9.3	Other descriptive name	GABAPENTIN
D.3.9.4	EV Substance Code	SUB07857MIG
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	34
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	No
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	Ketoprofen Lysine Salt
D.3.2	Product code	KLS
D.3.4	Pharmaceutical form	Capsule, hard
D.3.4.1	Specific paediatric formulation	No
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	KETOPROFEN LYSINE SALT
D.3.9.1	CAS number	57469-78-0
D.3.9.2	Current sponsor code	KLS
D.3.9.3	Other descriptive name	KETOPROFEN LYSINE
D.3.9.4	EV Substance Code	SUB02834MIG
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	80
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: 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	No
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	Co-crystal of ketoprofen, lysine and gabapentin
D.3.2	Product code	DFL24412
D.3.4	Pharmaceutical form	Capsule, hard
D.3.4.1	Specific paediatric formulation	No
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	KETOPROFEN LYSINE SALT
D.3.9.1	CAS number	57469-78-0
D.3.9.2	Current sponsor code	KLS
D.3.9.3	Other descriptive name	KETOPROFEN LYSINE
D.3.9.4	EV Substance Code	SUB02834MIG
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	40
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	GABAPENTIN
D.3.9.1	CAS number	60142-96-3
D.3.9.2	Current sponsor code	GABA
D.3.9.3	Other descriptive name	GABAPENTIN
D.3.9.4	EV Substance Code	SUB07857MIG
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	17
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

Chronic Low Back Pain

Lumbalgia crónica (LC)

E.1.1.1

Medical condition in easily understood language

Chronic Low Back Pain

Lumbalgia crónica

E.1.1.2

Therapeutic area

Diseases [C] - Musculoskeletal Diseases [C05]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	21.0
E.1.2	Level	LLT
E.1.2	Classification code	10052430
E.1.2	Term	Chronic lumbago
E.1.2	System Organ Class	100000004859

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 DFL24412 80 mg-34 mg per os (p.o.) and DFL24412 40 mg-17 mg p.o. in chronic low back pain compared to KLS (80 mg) at week 2

Evaluar la eficacia de DFL24412 80 mg-34 mg por vía oral (v.o.) y DFL24412 40 mg-17 mg por vía oral en la lumbalgia crónica en comparación con KLS (80 mg) en la semana 2.

E.2.2

Secondary objectives of the trial

• To further evaluate the analgesic efficacy of DFL24412 80 mg-34 mg and DFL24412 40 mg-17 mg in chronic low back pain compared to KLS 80 mg.
• To assess the efficacy of DFL24412 compared to KLS on neuropathic component in chronic low back pain.
• To assess the effect of DFL24412 compared to KLS on quality of life, Patient Global impression of Change and work and mental impact.

•Evaluar en profundidad la eficacia analgésica de DFL24412 80 mg-34 mg y DFL24412 40 mg-17 mg en la lumbalgia crónica en comparación con KLS 80 mg.
•Evaluar la eficacia de DFL24412 en comparación con KLS sobre el componente neuropático en la lumbalgia crónica.
•Evaluar el efecto de DFL24412 en comparación con KLS sobre la calidad de vida, la impresión global del cambio por parte del paciente y el impacto laboral y mental.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Provide written informed consent before the initiation of any study-specific procedures
2. Must be 18-65 years of age at the time of signing the Informed Consent Form (ICF)
3. Have a normal physical examination, vital signs, clinical laboratory test results, and electrocardiogram (ECG) results or abnormal results that are judged not clinically significant by the PI and documented as such in the eCRF
4. Diagnosis of persistent nonspecific chronic low back pain (CLBP, pain localised below the costal margin and above the inferior gluteal folds with no known specific pathology, persisting for at least 3 months), with no substantial recent change in pain severity or clinical management
5. Documented nociceptive and neuropathic components (DN4 >/= 4 for neuropatic component)
6. Report at least moderate pain (NRS>/= 4) before randomization
7. If undergoing physical and/or exercise-based therapy for back pain, therapy must be stable at least three weeks prior to study and remain the same throughout study
8. If a female with childbearing potential, have a negative serum ß-human chorionic gonadotropin (ß-hCG) pregnancy test; Women of childbearing age and potential must be willing to use highly effective contraception during the study and for 3 months after the last study treatment dose. Male patients and theirfemale partners of childbearing age and potential must be willing to use effective contraception during the study and for 3 months after the last study treatment dose.
9. Have a negative COVID-19 antigen rapid test or have received vaccination for COVID-19

1.Proporcionar el consentimiento informado por escrito antes de iniciar cualquier procedimiento específico del estudio.
2.Tener entre 18 y 65 años de edad en el momento de firmar el formulario de consentimiento informado (FCI).
3.Tener resultados normales en la exploración física, las constantes vitales, las pruebas analíticas y el electrocardiograma (ECG), o resultados anómalos que el investigador principal (IP) no considere clínicamente significativos y se documenten como tal en el cuaderno de recogida de datos electrónico (CRDe).
4.Diagnóstico de lumbalgia crónica no específica persistente (LC, dolor localizado por debajo del reborde costal y por encima de los surcos glúteos, sin enfermedad específica conocida, persistente durante al menos 3 meses) sin cambios recientes sustanciales en la intensidad del dolor o el tratamiento clínico.
5.Componentes nociceptivo y neuropático confirmados (DN4 ≥4 para el componente neuropático).
6.Referir al menos dolor moderado (escala de valoración numérica, EVN ≥4) antes de la aleatorización.
7.Si realizan fisioterapia o ejercicio físico para la lumbalgia, estos deben mantenerse estables al menos tres semanas antes del estudio y permanecer igual durante todo el estudio.
8.Si se trata de una mujer que puede quedarse embarazada, debe tener un resultado negativo en la prueba de embarazo de la gonadotropina coriónica humana β (β-hCG) en suero; las mujeres en edad fértil y con posibilidad de quedarse embarazadas deben usar métodos anticonceptivos muy eficaces durante el estudio y durante los 3 meses posteriores a la última dosis del tratamiento del estudio. Los varones y sus parejas femeninas en edad fértil y posibilidad de quedar embarazadas deben estar dispuestos a utilizar métodos anticonceptivos eficaces durante el estudio y durante los 3 meses siguientes a la última dosis del tratamiento del estudio. Los métodos anticonceptivos muy eficaces se enumeran en el anexo 4.
9.Tener una prueba rápida para antígeno de la COVID-19 negativa o estar vacunado frente a la COVID-19.

E.4

Principal exclusion criteria

1. History of major thoraco-abdominal or low back surgery in the last 3 months
2. CLBP due to malignancy, fibromyalgia,ochronosis, recent trauma, infection, juvenile scoliosis or congenital malformation
3. Previous diagnosis of psychosis, bipolar disorder, schizoaffective disorder, major depressive disorder or neurological disorder
4. CLPB management requiring opiod or surgery
5. Any concomitant use of antidepressants and/or anticonvulsants, opioids, nonsteroidal anti-inflammatory drugs, muscle relaxants, and/or any other prohibited medication during the trial or being anticipated by the investigator to be required
6. Any concurrent medical condition that, in the judgment of the PI, might interfere with the conduct of the study, confound the interpretation of the study results, or endanger the patient’s well-being
7. History of drug and/or alcohol abuse or dependence, excluding nicotine and caffeine
8. Have alanine aminotransferase or aspartate aminotransferase higher than 100 International Units per Liter (IU/L) or total bilirubin higher than 1.6 milligram per deciliter (mg/dL)
9. Have serum creatinine level higher than 1.6mg/dL or creatinine clearance <60, or had renal transplantation or receiving renal dialysis
10. Severe or unstable cardiovascular, hepatic, renal, metabolic, respiratory, or hematologic diseases, symptomatic peripheral vascular disease, hemorrhagic diathesis, haemolytic anemia, systemic immune-mediated and rheumatologic disorders, or other medical condition or psychiatric conditions that, in the opinion of investigator, would compromise participation or be likely to lead to hospitalization during the course of the study
11. History of bronchial asthma, peptic ulcer, gastrointestinal bleeding, ulceration or perforation
12. Crohn’s disease or ulcerative colitis
13. Positive test for hepatitis B surface antigen (HBsAg), anti-hepatitis C antibody (antiHCV) or human immunodeficiency virus I and II antibodies (anti-HIV I/II)
14. History of intolerance or hypersensitivity to: ketoprofen lysine salt or other drugs of the same class, gabapentin, rescue medications, component of the formulation; any history of severe drug allergy or hypersensitivity
15. Female patients who meet the following criteria: Pregnant, breast-feeding, and/or planning to become pregnant and/or breast-feed during the study
16. Treatment with any investigational product (IP) during the study and within the 3 months (or at least 5 half-lives, whichever is longer) prior to Visit1
17. Be an employee or a relative of an employee of the investigational study center
18. Inability to speak and understand the local language sufficiently to understand the nature of the study, to provide written informed consent, and to allow the completion of all study assessments
19. Unable or unlikely to comply with the study protocol, to fulfill eDiary and questionnaires appropriately or unsuitable for any other reason, as judged by the PI

1.Antecedentes de cirugía toracoabdominal o de la zona lumbar en los últimos 3 meses.
2.LC debida a neoplasia maligna, fibromialgia, ocronosis, traumatismo reciente, infección, escoliosis juvenil o malformación congénita.
3.Diagnóstico previo de psicosis, trastorno bipolar, trastorno esquizoafectivo, trastorno depresivo mayor o trastorno neurológico.
4.Tratamiento para la LC que requiere opioides o cirugía.
5.Uso concomitante de antidepresivos, anticonvulsivos, opioides, antiinflamatorios no esteroideos, relajantes musculares o cualquier otro tipo de medicamento prohibido según se indica en el anexo 6, durante el ensayo, o según considere el investigador.
6.Cualquier afección médica concomitante que, a criterio del IP, pueda interferir en la realización del estudio, confundir la interpretación de los resultados del estudio o poner en peligro el bienestar del paciente.
7.Antecedentes de abuso o dependencia de drogas o alcohol, excepto nicotina y cafeína.
8.Niveles de alanina-aminotransferasa o aspartato-aminotransferasa superiores a 100 Unidades Internacionales por litro (UI/l) o bilirrubina total superior a 1,6 miligramos por decilitro (mg/dl).
9.Niveles de creatinina sérica superiores a 1,6 mg/dl o un aclaramiento de creatinina <60, o trasplante renal o diálisis renal.
10. Enfermedades cardiovasculares, hepáticas, renales, metabólicas, respiratorias o hematológicas graves o inestables, angiopatía periférica sintomática, diátesis hemorrágica, anemia hemolítica, trastornos inmunitarios o reumatológicos sistémicos, u otras afecciones médicas o psiquiátricas que, en opinión del investigador, pudieran comprometer la participación o provocar la hospitalización durante el transcurso del estudio.
11.Antecedentes de asma bronquial, úlcera péptica, hemorragia gastrointestinal, úlcera o perforación.
12.Enfermedad de Crohn o colitis ulcerosa.
13.Resultado positivo en la prueba de detección del antígeno de superficie de la hepatitis B (HBsAg), anticuerpos contra el virus de la hepatitis C (anti-VHC) o anticuerpos frente al virus de la inmunodeficiencia humana I y II (anti-VIH I/II).
14.Antecedentes de intolerancia o hipersensibilidad a: ketoprofeno sal de lisina u otros fármacos de la misma clase, gabapentina, medicamentos de rescate, componente de la formulación; antecedentes de alergia medicamentosa grave o hipersensibilidad.
15.Mujeres que cumplen los siguientes criterios: embarazo, lactancia y/o que planean quedarse embarazadas y/o amamantar durante el estudio.
16.Tratamiento con cualquier producto en investigación (PI) durante el estudio y en los 3 meses (o al menos 5 semividas, el período que sea más largo) previos a la visita 1.
17.Ser empleado o familiar de un empleado del centro de investigación.
18.Incapacidad de hablar y comprender el idioma local de forma suficiente para comprender la naturaleza del estudio, proporcionar el consentimiento informado por escrito y permitir la finalización de todas las evaluaciones del estudio.
19.Incapacidad o poca probabilidad de cumplir con el protocolo del estudio, cumplimentar el diario electrónico y los cuestionarios de forma adecuada o no apto/a por cualquier otro motivo, según el criterio del IP.

E.5 End points

E.5.1

Primary end point(s)

Change From Baseline in Average Daily Low Back Pain (LBP) intensity as Measured by an 11-point Numeric Rating Scale (NRS) at Week 2

Cambio con respecto al inicio en la intensidad diaria media de la lumbalgia, determinada mediante una escala de valoración numérica (EVN) de 11 puntos en la semana 2

E.5.1.1

Timepoint(s) of evaluation of this end point

Time Frame: Baseline, Week 2

período de tiempo: inicio, semana 2

E.5.2

Secondary end point(s)

1. Change From Baseline in Average Daily LBP Intesity as Measured by an 11-point Numeric Rating Scale (NRS) at Week 1
2. Change From Baseline in Average Daily Low Back Pain (LBP) Intensity as Measured by an 11-point Numeric Rating Scale (NRS) at the follow-up visit
3. Change from baseline in Neuropathic Pain Symptom Inventory (NPSI) score at week 2
4. Change from baseline in Douleur Neuropathique en 4 Questions (DN4) score at week 2
5. Change from baseline in Douleur Neuropathique en 4 Questions (DN4) score at the follow-up visit
6. Number of Participants Withdrawn Due to Lack of Efficacy
7. Change From Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 2
8. Change from Baseline in Hospital Anxiety and Depression Scale (HADS) total score at Week 2
9. Patient Global Impression of Change (PGI-C) Score
10. Change From Baseline in European Quality of Life Questionnaire-5 Dimension-5 Level (EQ-5D-5L) to Week 2
11. Change From Baseline in Work Productivity and Activity Impairment (WPAI) Instrument to Week 2
12. Number of rescue interventions

1. Cambio con respecto al inicio en la intensidad diaria media de la lumbalgia, determinada mediante una EVN de 11 puntos en la semana 1
2. Cambio con respecto al inicio en la intensidad diaria media de la lumbalgia, determinada mediante una EVN de 11 puntos en la visita de seguimiento
3. Cambio con respecto al inicio en la puntuación del inventario de síntomas del dolor neuropático (Neuropathic Pain Symptom Inventory, NPSI) en la semana 2
4. Cambio con respecto al inicio en la puntuación del dolor neuropático en 4 preguntas (DN4) en la semana 2
5. Cambio respecto con respecto al inicio en la puntuación del dolor neuropático en 4 preguntas (DN4) en la visita de seguimiento
6. Número de participantes retirados por falta de eficacia
7. Cambio con respecto al inicio en la puntuación total del Cuestionario de discapacidad de Roland-Morris (Roland-Morris Disability Questionnaire, RMDQ) en la semana 2
8. Cambio con respecto al inicio en la puntuación total de la escala de ansiedad y depresión hospitalaria (Hospital Anxiety and Depression Scale, HADS) en la semana 2
9. Puntuación de la impresión global del cambio por parte del paciente (Patient Global Impression of Change, PGI-C)
10. Cambio con respecto al inicio en el Cuestionario europeo de calidad de vida con 5 dimensiones y 5 niveles (European Quality of Life Questionnaire-5 Dimension-5 Level, EQ-5D-5L) hasta la semana 2
11. Cambio con respecto al inicio en el instrumento de deterioro de la actividad y productividad laboral (Work Productivity and Activity Impairment, WPAI) hasta la semana 2
12. Número de intervenciones de rescate

E.5.2.1

Timepoint(s) of evaluation of this end point

1. Time Frame: Baseline, Week 1
2. Time Frame: Baseline, Day 28
3. Time Frame: Baseline, Week 2
4. Time Frame: Baseline, Week 2
5. Time Frame: Baseline, Day 28
6. Time Frame: Baseline, Week 2
7. Time Frame: Baseline, Week 2
8. Time Frame: Baseline, Week 2
9. Time Frame: Week 2
10. Time Frame: Baseline, Week 2
11. Time Frame: Baseline, Week 2
12. Time Frame: week 2

1.período de tiempo: inicio, semana 1
2.período de tiempo: inicio, día 28
3.periodo de tiempo: inicio, semana 2
4.periodo de tiempo: inicio, semana 2
5.periodo de tiempo: inicio, día 28
6.periodo de tiempo: inicio, semana 2
7.periodo de tiempo: inicio, semana 2
8.periodo de tiempo: inicio, semana 2
9.periodo de tiempo: semana 2
10.periodo de tiempo: inicio, semana 2
11.periodo de tiempo: inicio, semana 2
12.periodo de tiempo: semana 2

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)

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)

Yes

E.8.2.2

Placebo

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

Same drug different dosage

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

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

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

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:

140

F.1.3

Elderly (>=65 years)

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

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

150

F.4.2.2

In the whole clinical trial

150

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)

N/A

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

2022-02-21

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2022-02-16

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

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