EFFECTIVENESS OF REPEATED INJECTIONS OF BOTULINUM TOXIN IN THE GAIT AND QUALITY OF LIFE OF ADULT PATIENTS WITH WEAKNESS AND MUSCLE RIGIDITY DUE TO MULTIPLE ESCLEROSIS

• Register: EUCTR
• Last refreshed on: 7 January 2019
• Main ID: EUCTR2018-003231-30-ES
• Date of registration: 17/09/2018
• Prospective Registration: Yes
• Primary sponsor: Aránzazu Vázquez Doce
• Public title: EFFECTIVENESS OF REPEATED INJECTIONS OF BOTULINUM TOXIN IN THE GAIT AND QUALITY OF LIFE OF ADULT PATIENTS WITH WEAKNESS AND MUSCLE RIGIDITY DUE TO MULTIPLE ESCLEROSIS
• Scientific title: EFFECTIVENESS OF THE REPEATED INFILTRATIONS OF BOTULINUM TOXIN A IN THE GAIT AND QUALITY OF LIFE IN ADULTS WITH SPASTIC PARAPARESIA SECONDARY TO MULTIPLE SCLEROSIS - BOTULINUM TOXIN IN PATIENTS WITH SPASTIC PARAPARESIA ASSOCIATED WITH ESCLEROSIS MULTIPLE
• Date of first enrolment: 19/10/2018
• Target sample size: 84
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2018-003231-30
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no; Randomised: no; Open: yes; Single blind: no; Double blind: no; Parallel group: no; Cross over: no; Other: yes; Other trial design description: Prospective, single-arm, low-level intervention trial.; If controlled, specify comparator, Other Medicinial Product: no; Placebo: no; Other: no
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Spain

Contacts

• Name: Aránzazu Vázquez Doce
• Affiliation: Aránzazu Vázquez Doce

• Name: Aránzazu Vázquez Doce
• Affiliation: Aránzazu Vázquez Doce

Key inclusion & exclusion criteria

Inclusion criteria:
- Acceptance and signature of informed consent.
- Age between 18 and 80 years old, both included.
- Patients with relapsing remitting multiple sclerosis (RRMS), progressive secondary (SP) and primary progressive (PP), with spasticity resistant to usual treatment, either because of the severity of the spasticity or because of intolerance to side effects.
- Outpatients with spastic paraparesis that causes gait deficiency.
- Patients with an EDSS score between 2 and 6, both included.
- Patients with segmental involvement in MAS >1 in two or more muscle groups in the lower extremities.
- Absence of cognitive disability. Score less than 5 on the SPMSQ scale of Pfeiffer.
- Possibility of carrying out the treatment (method of administration, scheduled visits) and scales correctly.
- Women of childbearing potential should use an effective contraceptive method (hormonal contraceptives, intrauterine device, condom) or refrain from having sex in order not to get pregnant. A woman is considered to be fertile after menarche and to become postmenopausal, unless she has undergone a permanent sterilization procedure (hysterectomy, salpingectomy, bilateral oophorectomy). A postmenopausal state is defined as absence of menstruation for 12 months without an alternative medical cause.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 74
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion criteria:
- Psychiatric illness that hinders participation in the trial.
- Comorbidity that threatens the patient's life in the short term (severe liver disease, cardiovascular disease, etc.).
- Osteoarticular disorder that prevents physical activity.
- Pregnancy or lactation.
- Lack of primary or secondary response to any type of TXB for the treatment of MS previously detected.
- Sensitivity to TXB or to any excipient.
- Any medical condition that, in the opinion of the investigator, may compromise compliance with the objectives and / or procedures of this protocol or preclude the administration of TXB.
- Changes in the treatment regimen of any drug that directly or indirectly interferes with neuromuscular function within 4 weeks before the start of the study treatment.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Multiple sclerosis
MedDRA version: 20.1 Level: PT Classification code 10028245 Term: Multiple sclerosis System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0 Level: PT Classification code 10063400 Term: Secondary progressive multiple sclerosis System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1 Level: PT Classification code 10063401 Term: Primary progressive multiple sclerosis System Organ Class: 10029205 - Nervous system disorders

Intervention(s)

Trade Name: Dysport
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: BOTULINUM TOXIN TYPE A
CAS Number: 93384-43-1
Current Sponsor code: Dysport
Other descriptive name: BOTULINUM TOXIN TYPE A
Concentration unit: U unit(s)
Concentration type: range
Concentration number: 250-1000

Primary Outcome(s)

Secondary Objective: - Evaluation of spasticity (Modified Ashworth Spasticity scale - MAS scale).
- Evaluation of disability (EDSS scale).
- Evaluation of the quality of life after the use of botulinum toxin type A (MSQoL-54).
- Assessment of medium and long-term objectives (GAS scale).
- Evaluation of tolerance and side effects.

Primary end point(s): - Change from baseline observed in the maximum distance that a patient can walk in 6 minutes (6MWT) at 4 weeks after each infiltration.
- Changes from baseline in the score obtained in the MSWS-12 scale, at 4 weeks after each infiltration.

Main Objective: To assess the effectiveness of repeated TXB infiltrations on gait in patients with Multiple Sclerosis who presented limb spasticity less than 4 weeks after infiltration and its maintenance over time at 12 months, using objective results obtained by the clinician (6MWT ) and reported by the patient (MSWS-12).

Timepoint(s) of evaluation of this end point: The values in these scales will be measured before the patient receives the treatment and 4 weeks after each injection. Each patient will undergo 3-4 treatment cycles of 12-16 weeks each.

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: The values in these scales will be measured before the patient receives the treatment and 4 weeks after each injection. Each patient will undergo 3-4 treatment cycles of 12-16 weeks each.

Secondary end point(s): - Change observed in the total score of the EDSS scale before and after the application of the treatment.
- Observed change in the quality of life of patients before and after treatment, evaluated through the MSQoL-54 questionnaire.
- Evaluation of the achievement of the treatment goal through the GAS scale.
- Incidence of serious and not serious adverse reactions.
- Incidence of serious and non-serious adverse events.
- Tolerance to treatment.
- Discontinuation due to adverse reactions.

Secondary ID(s)

Linitox

Source(s) of Monetary Support

IPSEN