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Botulinum Toxin in Patients With Spastic Lower Limb Paresis Associated With Multiple Sclerosis

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Phase 3
Locations
Spain
Study Type
Interventional
Intervention
Botulinum toxin type A infiltrations
Sponsored by
Aránzazu Vázquez Doce
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring Multiple sclerosis, Botulinum toxin type A

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

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 Botulinum Toxin for the treatment of MS previously detected.
  • Sensitivity to Botulinum Toxin 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 Botulinum Toxin.
  • 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.

Sites / Locations

  • Hospital Universitario Puerta de Hierro
  • Hospital Universitario de la Princesa

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

patients with spastic lower limb paresis

Arm Description

patients with spastic lower limb paresis secondary to Multiple Sclerosis

Outcomes

Primary Outcome Measures

Effectiveness of repeated Botulinum Toxin infiltrations using objective results obtained by the clinician (Six Minutes Walking Test - 6MWT).
To assess the effectiveness of repeated Botulinum Toxin 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 (Six Minutes Walking Test - 6MWT). Higher scores mean a better outcome.
Effectiveness of repeated Botulinum Toxin infiltrations using results reported by the patient (Twelve item Multiple Sclerosis Walking Scale - MSWS-12).
To assess the effectiveness of repeated Botulinum Toxin 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 results reported by the patient (Twelve item Multiple Sclerosis Walking Scale - MSWS-12). Higher scores mean a worse outcome.

Secondary Outcome Measures

Evaluation of spasticity using Modified Ashworth Spasticity scale (MAS scale).
Evaluation of spasticity using Modified Ashworth Spasticity scale (MAS scale). Higher scores mean a worse outcome.
Evaluation of disability using Expanded Disability Status Scale de Kurtzke (EDSS scale).
Evaluation of disability using Expanded Disability Status Scale de Kurtzke (EDSS scale). Higher scores mean a worse outcome.
Evaluation of the quality of life after the use of botulinum toxin type A using Multiple Sclerosis Quality of Life 54 (MSQoL-54).
Evaluation of the quality of life after the use of botulinum toxin type A using Multiple Sclerosis Quality of Life 54 (MSQoL-54). Higher scores mean a better outcome.
Assessment of medium and long-term objectives using Goal Attainment Scaling (GAS scale).
Assessment of medium and long-term objectives using Goal Attainment Scaling (GAS scale). Higher scores mean a better outcome.
Number of adverse events.
Number of adverse events.

Full Information

First Posted
September 9, 2020
Last Updated
August 8, 2022
Sponsor
Aránzazu Vázquez Doce
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1. Study Identification

Unique Protocol Identification Number
NCT04595045
Brief Title
Botulinum Toxin in Patients With Spastic Lower Limb Paresis Associated With Multiple Sclerosis
Official Title
Effectiveness of Botulinum Toxin Type A Infiltrations in the Gait and Quality of Life in Adults With Spastic Lower Limb Paresis Secondary to Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
January 24, 2019 (Actual)
Primary Completion Date
July 28, 2022 (Actual)
Study Completion Date
July 28, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Aránzazu Vázquez Doce

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Spastic paraparesis is one of the most disabling functional deficits in the population with multiple sclerosis between 18 and 80 years of age and at any functional level. Infiltration with Botulinum Toxin is a clinical practice that has been carried out for years with clinical evidence of improvement in the patient's walking patterns and quality of life. We assume that the infiltration of this product can generate a direct benefit in the walking ability of these patients and secondarily improve their quality of life.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Multiple sclerosis, Botulinum toxin type A

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
84 (Actual)

8. Arms, Groups, and Interventions

Arm Title
patients with spastic lower limb paresis
Arm Type
Experimental
Arm Description
patients with spastic lower limb paresis secondary to Multiple Sclerosis
Intervention Type
Drug
Intervention Name(s)
Botulinum toxin type A infiltrations
Intervention Description
Echo-guided infiltration of botulinum toxin type A (Dysport®) in the lower limbs according to normal service practice
Primary Outcome Measure Information:
Title
Effectiveness of repeated Botulinum Toxin infiltrations using objective results obtained by the clinician (Six Minutes Walking Test - 6MWT).
Description
To assess the effectiveness of repeated Botulinum Toxin 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 (Six Minutes Walking Test - 6MWT). Higher scores mean a better outcome.
Time Frame
12 months
Title
Effectiveness of repeated Botulinum Toxin infiltrations using results reported by the patient (Twelve item Multiple Sclerosis Walking Scale - MSWS-12).
Description
To assess the effectiveness of repeated Botulinum Toxin 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 results reported by the patient (Twelve item Multiple Sclerosis Walking Scale - MSWS-12). Higher scores mean a worse outcome.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Evaluation of spasticity using Modified Ashworth Spasticity scale (MAS scale).
Description
Evaluation of spasticity using Modified Ashworth Spasticity scale (MAS scale). Higher scores mean a worse outcome.
Time Frame
12 months
Title
Evaluation of disability using Expanded Disability Status Scale de Kurtzke (EDSS scale).
Description
Evaluation of disability using Expanded Disability Status Scale de Kurtzke (EDSS scale). Higher scores mean a worse outcome.
Time Frame
12 months
Title
Evaluation of the quality of life after the use of botulinum toxin type A using Multiple Sclerosis Quality of Life 54 (MSQoL-54).
Description
Evaluation of the quality of life after the use of botulinum toxin type A using Multiple Sclerosis Quality of Life 54 (MSQoL-54). Higher scores mean a better outcome.
Time Frame
12 months
Title
Assessment of medium and long-term objectives using Goal Attainment Scaling (GAS scale).
Description
Assessment of medium and long-term objectives using Goal Attainment Scaling (GAS scale). Higher scores mean a better outcome.
Time Frame
12 months
Title
Number of adverse events.
Description
Number of adverse events.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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. 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 Botulinum Toxin for the treatment of MS previously detected. Sensitivity to Botulinum Toxin 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 Botulinum Toxin. 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.
Facility Information:
Facility Name
Hospital Universitario Puerta de Hierro
City
Majadahonda
State/Province
Madrid
ZIP/Postal Code
28220
Country
Spain
Facility Name
Hospital Universitario de la Princesa
City
Madrid
ZIP/Postal Code
28006
Country
Spain

12. IPD Sharing Statement

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Botulinum Toxin in Patients With Spastic Lower Limb Paresis Associated With Multiple Sclerosis

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