Clinical Trials Register

Summary
EudraCT Number:	2016-002177-35
Sponsor's Protocol Code Number:	GNB-2015
National Competent Authority:	Czechia - SUKL
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2017-01-18
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

Czechia - SUKL

A.2

EudraCT number

2016-002177-35

A.3

Full title of the trial

The effect of gabapentin used as a preemptive to the emergence and development chronic neuropathic pain in patients after spinal cord trauma

Vliv preemptivního podávání gabapentinu na vznik a rozvoj chronické neuropatické bolesti u pacientů po míšním traumatu

A.3.1

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

Study of the effect of gabapentin used as a preemptive to the emergence and development chronic neuropathic pain in patients after spinal cord trauma

Vliv preemptivního podávání gabapentinu na vznik a rozvoj chronické neuropatické bolesti u pacientů po míšním traumatu

A.3.2

Name or abbreviated title of the trial where available

GabaNeuBol

A.4.1

Sponsor's protocol code number

GNB-2015

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	Masarykova univerzita
B.1.3.4	Country	Czech Republic
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	Masarykova univerzita
B.4.2	Country	Czech Republic
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Masarykova univerzita - Lékařská fakulta
B.5.2	Functional name of contact point	Centrum pro klinická hodnocení
B.5.3	Address:
B.5.3.1	Street Address	Kamenice 5
B.5.3.2	Town/ city	Brno
B.5.3.3	Post code	62500
B.5.3.4	Country	Czech Republic
B.5.4	Telephone number	00420549496526

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	Czech Republic
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	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	Gabapentinum
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.3.11 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	Czech Republic
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	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	Metamizole Sodium
D.3.9.1	CAS number	68-89-3
D.3.9.3	Other descriptive name	METAMIZOLE SODIUM
D.3.9.4	EV Substance Code	SUB08810MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
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	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	Czech Republic
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	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	TRAMADOL
D.3.9.3	Other descriptive name	TRAMADOL HYDROCHLORIDE
D.3.9.4	EV Substance Code	SUB04927MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
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 neuropathic pain in patients after spinal cord trauma

Chronická neuropatická bolest u pacientů po míšním traumatu

E.1.1.1

Medical condition in easily understood language

Chronic neuropathic pain in patients after spinal cord trauma

Chronická neuropatická bolest u pacientů po míšním traumatu

E.1.1.2

Therapeutic area

Diseases [C] - Nervous System Diseases [C10]

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

Assessment the analgesic effect of gabapentin (up to a maximum dose of 1800 mg) in chronic neuropathic pain in the 3rd month after the start of treatment compared to the group of patients without anticonvulsant medication

Zhodnocení analgetického účinku gabapentinu (do maximální dávky 1 800 mg) na chronickou neuropatickou bolest ve 3. měsíci od zahájení podávání ve srovnání se skupinou pacientů bez antikonvulzivní medikace

E.2.2

Secondary objectives of the trial

To evaluate analgesic effects of gabapentin (up to a maximum dose of 1800 mg) in chronic neuropathic pain in 6, 9 and 12 months compared to patients with no anticonvulsant medication

The incidence of chronic neuropathic pain in patients after spinal cord trauma taking gabapentin versus patients without anticonvulsant medication

The estimate quality of life, evaluation of neurological pain and mental condition (PainDETECT, SQUALA and SCL-R) in patients after spinal cord trauma taking gabapentin and patients without anticonvulsant medication

To evaluate safety and tolerability of gabapentin treatment

Zhodnocení analgetického účinku gabapentinu (do maximální dávky 1 800 mg) na chronickou neuropatickou bolest v 6., 9. a 12. měsíci ve srovnání se skupinou pacientů bez antikonvulzivní medikace

Srovnání výskytu chronické neuropatické bolesti u pacientů po míšním traumatu užívajících gabapentin a u pacientů bez antikonvulzivní medikace

Srovnání kvality života, zhodnocení neurologické bolesti a psychického stavu (PainDETECT, SQUALA a SCL-R) u pacientů po míšním traumatu užívajících gabapentin a u pacientů bez antikonvulzivní medikace

Zhodnocení bezpečnosti a tolerance léčby gabapentinem.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Men and women, age 18 – 65 years
2. Signed written informed consent
3. Patients after complete/non-complete spinal lesion, after surgery
4. Patients with spinal cord trauma caused mechanically demanding (due a injury of a bone fragment, a disk, a translation spinal canal)
5. Patient willing and able to comply with the study protocol
6. Male and females with a highly effective method of birth control plus an additional barrier method

1. Muži nebo ženy ve věku od 18 – 65 let, včetně.
2. Podepsaný informovaný souhlas.
3. Pacienti po kompletní i nekompletní míšní lézi po operaci.
4. Pacienti s míšním traumatem způsobeným mechanicky působící silou (poraněním kostním fragmentem, ploténkou, translací páteřního kanálu).
5. Schopnost subjektu hodnocení spolupracovat dle požadavků protokolu.
6. Muži a ženy užívající vhodné metody antikoncepce a to vždy jednu vysoce spolehlivou metodu (např. nitroděložní tělísko, nebo hormonální antikoncepci) plus jednu doplňkovou bariérovou metodu

E.4

Principal exclusion criteria

1. Patients with spinal cord lesion ischemic etiology
2. Pregnant women, nursing or childbearing age with a positive pregnancy test input
3. Patients unable or unwilling to comply with the study protocol
4. Acute pancreatitis in 1 year to the start of the study
5. Chronic pancreatitis in the case history
6. Active or uncontrolled infectious diseases
7. Hypersensitivity to any component of the investigational product
8. Active autoimmune disease
9. Serious neurological disease with the incidence chronic neuropathic pain
10. Age > 65
11. Diabetes mellitus,
12. Liver disease ALT/ AST 5 times upper limit of normal (ULN)
13. Kidney disease clearance ≥80 ml/min
14. Gastrointestinal disease threatening the absorption in the case history
15. The presence of a mental disease, which could be an obstacle to progress in accordance with the study protocol
16. Chronic alcohol abuse
17. Chronic drug abuse

1. Pacienti s míšní lézi s ischemickou etiologií.
2. Ženy těhotné, kojící či ve fertilním věku s pozitivním těhotenským testem vstupně.
3. Pacienti neschopní či neochotní se podrobit protokolu studie.
4. Akutní pankreatitida do 1 roku do startu studie
5. Anamnéza chronické pankreatitidy.
6. Aktivní či nekontrolované infekční onemocnění.
7. Hypersenzitivita na jakoukoli součást hodnoceného přípravku.
8. Aktivní autoimunitní onemocnění.
9. Závažné neurologické onemocnění s výskytem chronické neuropatické bolesti.
10. Věk > 65 let.
11. Diabetes mellitus.
12. Onemocnění jater - ALT/ AST - pětinásobek ULN (horní hranice normy).
13. Onemocnění ledvin - clearance ≥80 ml/min.
14. Onemocnění GIT ovlivňující absorpci v anamnéze.
15. Duševní onemocnění působící překážku postupu dle protokolu v anamnéze.
16. Chronický abusus alkoholu.
17. Chronický abusus drog.

E.5 End points

E.5.1

Primary end point(s)

The decrease of the incidence of chronic neuropathic pain in 3 months after initiation of the gabapentin treatment

Snížení výskytu chronické neuropatické bolesti ve 3. měsíci od zahájení léčby gabapentinem

E.5.1.1

Timepoint(s) of evaluation of this end point

in 3 months after initiation of the gabapentin treatment

Ve 3. měsíci od zahájení léčby gabapentinem

E.5.2

Secondary end point(s)

1. The decrease of the incidence of chronic neuropathic pain in 6., 9. and 12. months after initiation of the gabapentin treatment
2. The number of painful episodes requiring treatment of rescue medication (in 3., 6., 9. and 12. months after initiation of the gabapentin treatment)
3. The decrease of the consumption of rescue medication in 3., 6., 9. and 12. months after initiation of the gabapentin treatment
4. Absolute and percentage change in average pain after initiation of therapy with gabapentin (baseline) in 3., 6., 9. and 12. months
5. Quality of life, assessment of neurological pain and psychological state measured by questionnaires PainDETECT, SQUALA and SCL-R (in week 1, 3., 6., 9. and 12. months after initiation of the gabapentin treatment)

1. Snížení výskytu chronické neuropatické bolesti v 6., 9. a 12. měsíci od zahájení léčby gabapentinem.
2. Počet bolestivých epizod vyžadujících nasazení záchranné medikace (do 3., 6., 9. a 12. měsíce od zahájení léčby gabapentinem ).
3. Snížení spotřeby záchranné medikace do 3., 6., 9. a 12. měsíce od zahájení léčby gabapentinem.
4. Kvalita života, zhodnocení neurologické bolesti a psychického stavu pacienta dotazníky PainDETECT, SQUALA a SCL-R (v 1. týdnu, 3., 6., 9. a 12. měsíci od zahájení léčby gabapentinem).
5. Absolutní a procentuální změna průměrné bolesti od zahájení léčby gabapentinem (baseline) do 3., 6., 9. a 12. měsíce.

E.5.2.1

Timepoint(s) of evaluation of this end point

In week 1 and 3., 6., 9. and 12. months after initiation of the gabapentin treatment

v 1. týdnu a 3., 6., 9. a 12. měsíci od zahájení léčby gabapentinem

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

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)

Yes

E.8.2.2

Placebo

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

Tramadol, metamizole sodium

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

LPLV september 2019

LPLV září 2019 poslední návštěva posledního pacienta

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:

108

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

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

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

2018-05-07

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2017-05-03

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2019-02-22

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