ICH GCP - EU Clinical trials Registry - 2022-000788-30 (PL)

Summary
EudraCT Number:	2022-000788-30
Sponsor's Protocol Code Number:	1.2022
National Competent Authority:	Poland - Office for Medicinal Products
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2022-09-29
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

A. Protocol Information

A.1

Member State Concerned

Poland - Office for Medicinal Products

A.2

EudraCT number

2022-000788-30

A.3

Full title of the trial

Evaluation of the effectiveness of Methocarbamol in the treatment of
spasticity in people with spinal cord injury.

A.3.1

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

Evaluation of the effectiveness of Methocarbamol in the treatment of
spasticity in people with spinal cord injury.

A.4.1

Sponsor's protocol code number

1.2022

A.7

Trial is part of a Paediatric Investigation Plan

No

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Uzdrowisko Kamień Pomorski S.A.
B.1.3.4	Country	Poland
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	Uzdrowisko Kamień Pomorski S.A
B.4.2	Country	Poland
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Bogumił Korczyński
B.5.2	Functional name of contact point	project manager assistant
B.5.3	Address:
B.5.3.1	Street Address	Szpitalna 14
B.5.3.2	Town/ city	Kamień Pomorski
B.5.3.3	Post code	72-400
B.5.3.4	Country	Poland
B.5.4	Telephone number	+48913821149
B.5.6	E-mail	sekretariat@u-kp.pl

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	Methocarbamol Espefa 500 mg tablets
D.2.1.1.2	Name of the Marketing Authorisation holder	Chemiczno-Farmaceutyczna Spółdzielnia Pracy ESPEFA
D.2.1.2	Country which granted the Marketing Authorisation	Poland
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	Methocarbamol Espefa
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	Methocarbamol
D.3.9.1	CAS number	532-03-6
D.3.9.4	EV Substance Code	SUB08852MIG
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	500
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

E.1.1.1

Medical condition in easily understood language

Increased muscle tension in people with spinal cord injury

E.1.1.2

Therapeutic area

Diseases [C] - Musculoskeletal Diseases [C05]

MedDRA Classification

E.1.3

Condition being studied is a rare disease

No

E.2 Objective of the trial

E.2.1

Main objective of the trial

The aim of the study is to test the effectiveness of Methocarbamol in the
treatment of spasticity after spinal cord injury.

E.2.2

Secondary objectives of the trial

To facilitate the rehabilitation process

E.2.3

Trial contains a sub-study

No

E.3

Principal inclusion criteria

• a history of spinal cord injury;
• the presence of increased muscle tension on the Ashwort scale 2 to 4;
• time since injury: 3 months;
• the patient must be circulatory and respiratory efficient, alert and aware; adapted to a vertical position;
• a patient with complete and incomplete spinal cord injury, in the cervical, thoracic and lumbar spine, in whom the flexion and extension function will be maintained in the elbow and wrist joints;
• preserved spine stabilization, stabilization of the anastomosis after surgery, completed bone union;
• no contraindications to rehabilitation, such as thrombophlebitis, pulmonary embolism, orthostatic drops in blood pressure, epilepsy, infection.

E.4

Principal exclusion criteria

• the patient's use of a myorelaxant other than methocarbamol;
• the patient's use of botulinum toxin;
• tetraplegia;
• joint contractures preventing rehabilitation with robots and other contraindications to robotic therapy, such as severe osteoporosis, circulatory and respiratory system disorders, skin lesions, thrombophlebitis, pulmonary embolism, orthostatic drops in blood pressure, epilepsy, infection;
• the presence of open, oozing bedsores;
• malnutrition, wasting of the body (muscle atrophy of the paralyzed without signs of malnutrition and wasting of the body are not the cause of exclusion);
• lack of the patient's informed consent;
• pregnancy or breast-feeding.

E.5 End points

E.5.1

Primary end point(s)

For the quantitative assessment of spasticity, the electrical activity of the muscles will be used, examined using superficial EMG for the muscles of the hip flexors and knee extensors, expressed in measurement units: uV.
The results used for statistical evaluation will represent the average of 4 replicate s EMG measurements taken during passive stretching of the muscle.

E.5.1.1

Timepoint(s) of evaluation of this end point

For the quantitative assessment of spasticity, the electrical activity of the muscles will be used, examined using superficial EMG for the muscles of the hip flexors and knee extensors, expressed in measurement units: uV.
The results used for statistical evaluation will represent the average of 4 replicate s EMG measurements taken during passive stretching of the muscle.

E.5.2

Secondary end point(s)

The reduction of muscle tension achieved with Methocarbamol therapy will allow the use of robotic methods in gait re-education, and as a result, better rehabilitation and functional improvement.
The Lokomat gait test will be used to assess functional improvement. During the study, the following will be compared:
- distance covered by the patient in a unit of time;
- guiding force - the support force from the robot that the patient needed for proper gait.

E.5.2.1

Timepoint(s) of evaluation of this end point

The reduction of muscle tension achieved with Methocarbamol therapy will allow the use of robotic methods in gait re-education, and as a result, better rehabilitation and functional improvement.
The Lokomat gait test will be used to assess functional improvement. During the study, the following will be compared:
- distance covered by the patient in a unit of time;
- guiding force - the support force from the robot that the patient needed for proper gait.

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

No

E.6.2

Prophylaxis

No

E.6.3

Therapy

Yes

E.6.4

Safety

No

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

No

E.6.7

Pharmacodynamic

No

E.6.8

Bioequivalence

No

E.6.9

Dose response

No

E.6.10

Pharmacogenetic

No

E.6.11

Pharmacogenomic

No

E.6.12

Pharmacoeconomic

No

E.6.13

Others

No

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

No

E.7.1.1

First administration to humans

No

E.7.1.2

Bioequivalence study

No

E.7.1.3

Other

No

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

No

E.7.3

Therapeutic confirmatory (Phase III)

No

E.7.4

Therapeutic use (Phase IV)

Yes

E.8 Design of the trial

E.8.1

Controlled

No

E.8.1.1

Randomised

No

E.8.1.2

Open

No

E.8.1.3

Single blind

No

E.8.1.4

Double blind

No

E.8.1.5

Parallel group

No

E.8.1.6

Cross over

No

E.8.1.7

Other

No

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

No

E.8.2.2

Placebo

No

E.8.2.3

Other

No

E.8.2.4

Number of treatment arms in the trial

1

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

No

E.8.4.1

Number of sites anticipated in Member State concerned

1

E.8.5

The trial involves multiple Member States

No

E.8.5.1

Number of sites anticipated in the EEA

1

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

No

E.8.6.2

Trial being conducted completely outside of the EEA

No

E.8.7

Trial has a data monitoring committee

No

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

1

E.8.9.1

In the Member State concerned months

1

E.8.9.1

In the Member State concerned days

0

E.8.9.2

In all countries concerned by the trial years

1

E.8.9.2

In all countries concerned by the trial months

1

E.8.9.2

In all countries concerned by the trial days

0

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

No

F.1.1.1

In Utero

No

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

No

F.1.1.3

Newborns (0-27 days)

No

F.1.1.4

Infants and toddlers (28 days-23 months)

No

F.1.1.5

Children (2-11years)

No

F.1.1.6

Adolescents (12-17 years)

No

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

25

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

5

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

No

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

No

F.3.3.1

Women of childbearing potential not using contraception

No

F.3.3.2

Women of child-bearing potential using contraception

No

F.3.3.3

Pregnant women

No

F.3.3.4

Nursing women

No

F.3.3.5

Emergency situation

No

F.3.3.6

Subjects incapable of giving consent personally

No

F.3.3.7

Others

No

F.4 Planned number of subjects to be included

F.4.1

In the member state

30

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)

not planned

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

N.

Competent Authority Decision

Authorised

N.

Date of Competent Authority Decision

2023-04-13

N.

Ethics Committee Opinion of the trial application

Favourable

N.

Ethics Committee Opinion: Reason(s) for unfavourable opinion

N.

Date of Ethics Committee Opinion

2022-06-23

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

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