Clinical Trials Register

Summary
EudraCT Number:	2016-002473-35
Sponsor's Protocol Code Number:	802NP302
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Prematurely Ended
Date on which this record was first entered in the EudraCT database:	2017-01-20
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

Expand All Collapse All

A. Protocol Information

A.1

Member State Concerned

Spain - AEMPS

A.2

EudraCT number

2016-002473-35

A.3

Full title of the trial

A Phase 3 Placebo-Controlled, Double-Blind Randomized Withdrawal Study to Evaluate the Efficacy and Safety of BIIB074 in Subjects With Trigeminal Neuralgia

Estudio en fase III, controlado con placebo, doble ciego y de
retirada aleatorizada para evaluar la eficacia y la seguridad
del BIIB074 en sujetos con neuralgia del trigémino

A.3.1

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

Efficacy and Safety of BIIB074 in Participants with Trigeminal Neuralgia

Eficacia y Seguridad de BIIB074 en participantes con Neuralgía de Trigemino

A.4.1

Sponsor's protocol code number

802NP302

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	Biogen Idec Research Limited
B.1.3.4	Country	United Kingdom
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	Biogen Idec Research Limited
B.4.2	Country	United Kingdom
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Biogen Idec Research Limited
B.5.2	Functional name of contact point	802NP302 Clinical Trial Team
B.5.3	Address:
B.5.3.1	Street Address	Innovation House, 70 Norden Road
B.5.3.2	Town/ city	Maidenhead, Berkshire
B.5.3.3	Post code	SL6 4AY
B.5.3.4	Country	United Kingdom
B.5.4	Telephone number	34913107608
B.5.5	Fax number	34913107110
B.5.6	E-mail	clinicaltrials@biogen.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	BIIB074
D.3.2	Product code	BIIB074
D.3.4	Pharmaceutical form	Film-coated tablet
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	N/A
D.3.9.1	CAS number	934240-31-0
D.3.9.2	Current sponsor code	BIIB074
D.3.9.3	Other descriptive name	CNV1014802
D.3.9.4	EV Substance Code	SUB32074
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	150
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	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	BIIB074
D.3.2	Product code	BIIB074
D.3.4	Pharmaceutical form	Film-coated tablet
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	N/A
D.3.9.1	CAS number	934240-31-0
D.3.9.2	Current sponsor code	BIIB074
D.3.9.3	Other descriptive name	CNV1014802
D.3.9.4	EV Substance Code	SUB32074
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	250
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
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Film-coated tablet
D.8.4	Route of administration of the placebo	Oral use
D.8 Placebo: 2
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Film-coated tablet
D.8.4	Route of administration of the placebo	Oral use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Trigeminal Neuralgia (TN)

Neuralgia del trigémino (NT)

E.1.1.1

Medical condition in easily understood language

Trigeminal Nerve Disorder

Desorden de Neuralgia del trigémino

E.1.1.2

Therapeutic area

Diseases [C] - Nervous System Diseases [C10]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	19.1
E.1.2	Level	PT
E.1.2	Classification code	10044652
E.1.2	Term	Trigeminal neuralgia
E.1.2	System Organ Class	10029205 - Nervous system 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

The primary objective of the study is to evaluate the efficacy of BIIB074 in treating pain experienced by subjects with TN.
The primary objective of the LTE phase of the study is to evaluate the long-term safety and tolerability of BIIB074 in subjects with TN.

El objetivo principal del estudio es evaluar la eficacia del BIIB074 en el tratamiento del dolor que padecen los sujetos con NT.
El objetivo principal de la Fase de Extension a Largo Plazo (ELP) del estudio es evaluar la seguridad y eficacia a largo plazo del BIIB074 en los sujetos con NT.

E.2.2

Secondary objectives of the trial

Secondary objectives include the following:
- To investigate the safety and tolerability of BIIB074 in subjects with
TN.
- To evaluate the population PK of BIIB074.

Los objetivos secundarios incluyen lo siguiente:
- Investigar la seguridad y tolerabilidad de BIIB074 en sujetos con NT.
- Evaluar la poblacion PK de BIB074.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

- A diagnosis of TN for at least 3 months based on IHS diagnostic criteria.
- Participant must have failed at least 1 prior standard of care pharmacologic treatment for TN (defined as an inadequate response or intolerance to treatment), as determined by the Investigator based on medical history.
NOTE: Other protocol defined Inclusion criteria may apply

- Diagnostico de NT al menos en los últimos basado en los criterios de diagnóstico IHS (International Headache Society)
- La respuesta al tratamiento estandar para la NT del paciente ha fallado (definido como una inadecuada respuesta o intolerancia al tratamiento), como determinado pr el investigador basado en su historia medica.
NOTA: Otro criterio de inclusion definido podria aplicar.

E.4

Principal exclusion criteria

- History or positive test result at Screening for hepatitis C virus antibody or current hepatitis B infection (defined as positive for hepatitis B surface antigen [HBsAg] and/or hepatitis B core antibody [HBcAb]).
- Positive history of human immunodeficiency virus (HIV) or a positive HIV test at Screening.
- Participants with facial pain other than TN.
- Personal or family (first-degree relative) history of seizures (except for simple febrile convulsions) or clinically significant head injury.
NOTE: Other protocol defined Exclusion criteria may apply

- Historia o test positivo para anticuerpos del virus de la hepatitis C o infeccion actual de hepatitis B (defnido como positivo para el antigeno de superficia (HBsAg) y/o anticuerpo central (HBcAB) de la hepatitis B.
- Historia de positivo para el Virus de la Inmunodeficiencia Humana (HIV) o positivo en el test de VIH durante el Screening.
- Participante con otro dolor facial diferente a NT.
- Historia familiar (primer nivel de parentesco) de convulsiones (excepto para convulsion febril simple) or daño cerebral clinicamente significativo.
NOTE: Otro criterios de exclusion de protocolo podría aplicar

E.5 End points

E.5.1

Primary end point(s)

1. Time from randomization to loss of therapeutic response (LOTR).
2. Change from baseline to Week 12 of the double-blind period in weekly
mean ADP.
3. Proportion of subjects with a response in number of paroxysms at
Week 12 of the double-blind period.
4. Proportion of subjects with a PGIC response at Week 12 of the doubleblind
period.
5. Change from baseline to Week 12 of the double-blind period in the
Penn Facial Pain Scale-Revised (PENN-FPS-R) score.
The primary endpoint of LTE phase is assessment of the following safety
parameters:
- Incidence of AEs and SAEs
- Laboratory safety tests
- Vital signs
- 12-lead ECG parameters C-SSRS

1. Tiempo desde la aleatorización hasta la pérdida de respuesta terapéutica (PRT).
2. Cambio desde el inicio hasta la semana 12 del periodo doble ciego en la media semanal del DMD.
3. Proporción de sujetos con respuesta en número de paroxismos en la semana 12 del periodo doble ciego.
4. Proporción de sujetos con una respuesta ajustada a la
impresión global del cambio por parte del paciente (Patient Global Impression of Change, PGIC) en la semana 12 del periodo doble ciego.
5. Cambio desde el inicio hasta la semana 12 del periodo doble ciego en la puntuación de la escala revisada de neuralgia del trigémino de Penn (Penn Facial Pain Scale-Revised, PENN-FPS-R).
* El criterio de Valoracion primario para la fase ELP es valorar los siguientes parametros de seguridad:
- Indicencia de AA y AAG
- Análisis clínicos de la seguridad
- Constantes vitales
- Parámetros de los ECG de 12 derivaciones
- Escala de Columbia de valoración de la intensidad de las ideas suicidas (Columbia Suicide Severity Rating Scale, C-SSRS)

E.5.1.1

Timepoint(s) of evaluation of this end point

1. Tiempo desde aleatorización hasta la PRT.
2. Cambio desde el inicio hasta la semana 12 del periodo doble ciego en la media semanal del DMD.
3. Proporción de sujetos con respuesta en número de paroxismos en la semana 12 del periodo doble ciego.
4. Proporción de sujetos con una respuesta ajustada a la impresión global del cambio por parte del paciente (PGIC) en la semana 12 del periodo doble ciego.
5. Cambio desde el inicio hasta la semana 12 del periodo doble ciego en la puntuación de la escala de NT de Penn (PENN-FPS-R).
El criterio de Valoracion primario para la fase ELP son los siguientes:
- AA y AAG
- Análisis clínicos de seguridad
- Constantes vitales
- Parámetros ECG de 12 derivaciones
- Escala Columbia de valoración de la intensidad de las ideas suicidas (C-SSRS)

E.5.2

Secondary end point(s)

The endpoints that relate to this objective are as follows:
- AEs and SAEs
- Vital signs
- ECG parameters
- Laboratory safety tests
- C-SSRS
The secondary endpoints of LTE phase include the following:
- Proportion of subjects with a response in ADP based on ≥30%
reduction in weekly mean ADP at each week of the LTE compared with
baseline (run-in)
- Change from baseline in weekly mean ADP
- Proportion of subjects with PGIC response of "much improved" or
"very much improved"
- Change from baseline in the PENN-FPS-R score

El criterio de valoración principal relacionado con este objetivo es:
- AA y AAG
- Constantes vitales
- Parámetros de los ECG
- Análisis clínicos de la seguridad
- C-SSRS
Los criterios de valoracion secundarios para la fase ELP son los siguientes:
-Proporción de sujetos con una respuesta en el DMD basada en una reducción ≥30 % en la media semanal del DMD en cada semana de la ELP en comparación con el inicio (preinclusión).
• Cambio desde el inicio en la media semanal del DMD.
• Proporción de sujetos con respuesta ajustada a la PGIC de “mucha mejoría” o “muchísima mejoría”.
• Cambio desde el inicio en la puntuación de PENN-FPS-R.

E.5.2.1

Timepoint(s) of evaluation of this end point

El tiempo de valoración principal relacionado con este objetivo son el siguientes:
- AA y AAG
- Constantes vitales
- Parámetros de los ECG
- Análisis clínicos de la seguridad
- C-SSRS
Los criterios de valoracion secundarios para la fase ELP son los siguientes:
-Proporción de sujetos con una respuesta en el DMD basada en una reducción ≥30 % en la media semanal del DMD en cada semana de la ELP en comparación con el inicio (preinclusión).
• Cambio desde el inicio en la media semanal del DMD.
• Proporción de sujetos con respuesta ajustada a la PGIC de “mucha mejoría” o “muchísima mejoría”.
• Cambio desde el inicio en la puntuación de PENN-FPS-R.

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

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

Yes

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

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

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

Australia

Czech Republic

France

Germany

Hungary

Israel

Italy

Japan

Mexico

Poland

Russian Federation

Spain

Switzerland

Taiwan

United States

E.8.7

Trial has a data monitoring committee

Yes

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

UVUP

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

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:

250

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

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

250

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

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

2017-04-19

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2017-02-22

P. End of Trial
P.	End of Trial Status	Prematurely Ended
P.	Date of the global end of the trial	2023-02-15

Select Country:	Select Age Range:
Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
Clear advanced search filters

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials