Clinical Trials Register

Summary
EudraCT Number:	2018-003110-40
Sponsor's Protocol Code Number:	LACOSAMIDE-2018
National Competent Authority:	Denmark - DHMA
Clinical Trial Type:	EEA CTA
Trial Status:	Prematurely Ended
Date on which this record was first entered in the EudraCT database:	2018-08-17
Trial results	View 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

Denmark - DHMA

A.2

EudraCT number

2018-003110-40

A.3

Full title of the trial

The effect of lacosamide in peripheral neuropathic pain:
a randomized, double-blind, placebo-controlled, phenotype-stratified study

A.3.1

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

The effect of lacosamide in peripheral neuropathic pain:
a randomized, double-blind, placebo-controlled, stratified beased on clinical characteristics

A.3.2

Name or abbreviated title of the trial where available

The effect of lacosamide in peripheral neuropathic pain

A.4.1

Sponsor's protocol code number

LACOSAMIDE-2018

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	Aarhus University
B.1.3.4	Country	Denmark
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	Novo Nordisk Foundation
B.4.2	Country	Denmark
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Aarhus University
B.5.2	Functional name of contact point	Danish Pain Research Center
B.5.3	Address:
B.5.3.1	Street Address	Norrebrogade 44
B.5.3.2	Town/ city	Aarhus
B.5.3.3	Post code	8000
B.5.3.4	Country	Denmark
B.5.4	Telephone number	4578464230
B.5.6	E-mail	finnerup@clin.au.dk

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	Vimpat
D.2.1.1.2	Name of the Marketing Authorisation holder	UCB Pharma S.A.
D.2.1.2	Country which granted the Marketing Authorisation	Denmark
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	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	LACOSAMIDE
D.3.9.1	CAS number	175481-36-4
D.3.9.4	EV Substance Code	SUB25407
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	50
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	Capsule
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

Peripheral Neuropathic pain

E.1.1.1

Medical condition in easily understood language

Pain generated in the nervous system

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	20.0
E.1.2	Level	LLT
E.1.2	Classification code	10077974
E.1.2	Term	Peripheral neuropathic pain
E.1.2	System Organ Class	100000004852

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 compare the change in pain intensity during treatment with a sodium-channel blocker (lacosamide) in patients with peripheral neuropathic pain with and without the irritable nociceptor phenotype

E.2.2

Secondary objectives of the trial

To compare the change in Pain intensity during lacosamide vs placebo the the two phenotypes

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Age ≥ 18 years.
2. Probable or definite peripheral neuropathic pain for at least 3 months.
3. Average pain intensity of at least 4 and not above 9 on a 0-10 NRS during the 7-day baseline week.
3. Written informed consent.

E.4

Principal exclusion criteria

1. Other causes of pain in the same area or other concomitant pain that cannot be distinguished from the neuropathic pain.
2. Patients who cannot cooperate or are unable to complete the project and patients who do not speak Danish.
3. Known and current cardiac conduction disturbance (2nd or 3rd atrioventricular block, prolonged QTc interval >450 ms, heart rate <50 or >110 bpm, a QRS interval > 120 ms (12-lead ECG required)), significant cardiac disease (e.g. history of myocardial infarction, heart failure, or cardiovascular syncope), significant renal disease or liver disease or other severe illness (sodium, potassium, creatinine, eGRF, ALAT, basic phosphatase, LDH and for patients with diabetes: HA1c will be taken unless they are available within the past 3 months; the cut-off values for inclusion will be at the discretion of the investigator). Sitting diastolic blood pressure below 50 mm Hg or above 105 mm Hg. In patients treated with pregabalin also PQ interval >0.2s and cardiac disease.
4. Major depressive episode within 6 months, recurrent depressive disorder or other significant psychiatric disease, alcohol, illicit drug or drug abuse.
5. Pregnancy or lactation.
6. Women of child-bearing potential unless they use an acceptable effective contraception measure during the study and at least 2 weeks after or their male partner is vasectomized and their sole partner. Acceptable effective contraception is defined in the Clinical Trials Facilitation Group (CTFG) http://www.hma.eu/fileadmin/dateien/Human_Medicines/01-About_HMA/Working_Groups/CTFG/2014_09_HMA_CTFG_Contraception.pdf) and include intrauterine device or hormone-releasing system or hormonal contraception or total abstinence when this reflects their usual lifestyle or female sterilization (bilateral oophorectomy or total hysterectomy at least 6 weeks before). They should also have a negative pregnancy test.
7. Known allergy to lacosamide or excipients.
8. Concomitant pain treatment with tricyclic antidepressants (can be associated with PR prolongation), topical analgesics (lidocaine, capsaicin), cannabinoids, or strong opioids that cannot be discontinued. Other concomitant treatments for neuropathic pain are allowed in a stable dose (from 14 days before randomization to completion of the trial), if they cannot be tapered off completely.
9. Concomitant treatment with products known to be associated with PQ (PR) prolongation other than pregabalin.
9. Patients inappropriate for placebo.
10. Planned surgery.
11. Use of sodium channel blockers within at least five half-lives and investigational drugs within 30 days.
12. Patients on a controlled sodium diet, unless the amount of sodium in the capsules is acceptable for their diet.
13. The score “yes” on item 4 or item 5 of the Suicidal Ideation section of the Columbia Suicide Severity Rating Scale (C-SSRS), if this ideation occurred in the past 6 months, or “yes” on any item of the Suicidal Behavior section, except for the “Non-Suicidal Self-Injurious Behavior” (item also included in the Suicidal Behavior section), if this behavior occurred in the past 2 years.

E.5 End points

E.5.1

Primary end point(s)

The difference in the mean value of the patient's daily ratings of average pain intensity in the baseline week and the last week during treatment as experienced during the past 24 hours rated on a 0-10 point numeric rating scale (NRS; 0 = no pain, 10 = worst possible pain).

E.5.1.1

Timepoint(s) of evaluation of this end point

Last week of treatment

E.5.2

Secondary end point(s)

•Pain relief: complete, good, moderate, mild, none, worse
•Use of escape medication (paracetamol)

E.5.2.1

Timepoint(s) of evaluation of this end point

For Pain relief: End of treatment
For Escape medication: During treatment

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)

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)

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

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 (last telephone call)

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

F.4 Planned number of subjects to be included

F.4.1

In the member state

108

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

2018-08-29

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2018-09-11

P. End of Trial
P.	End of Trial Status	Prematurely Ended
P.	Date of the global end of the trial	2022-06-03

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