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 versi
Conditions
Interventions
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: BOTU
Sponsors
Aránzazu Vázquez Doce
Eligibility
Sex/Gender
All
Inclusion 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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).;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.;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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Spain
Contacts
Public ContactAránzazu Vázquez Doce
Aránzazu Vázquez Doce
Outcome results
None listed