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Therapeutic Benefit of Incobotulinum Toxin A for Spasticity of the Triceps Surae in Patients With Multiple Sclerosis (GAITOX)

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ClinicalTrials.gov Identifier: NCT04265092
Recruitment Status : Completed
First Posted : February 11, 2020
Last Update Posted : February 11, 2020
Sponsor:
Information provided by (Responsible Party):
Pôle Saint Hélier

Brief Summary:

Introduction/Objectives: In this observational study, we assessed the benefit following an injection of 200 international units (IU) of incobotulinum toxinA in patients with multiple sclerosis (MS) with spasticity of the triceps surae (TS) at 6 weeks (peak efficacy of toxin) and at 3 months (cancellation of efficacy).

Methods: This study enrolled all MS patients willing to participate with Expanded Disability Status Scale (EDSS) scores of less than 6, who required toxin for management of focal spasticity of the TS. Treatment consisted of 200 IU of incobotulinum toxinA injected into the TS. Outcome measures were assessed before injection, at 6 weeks and 3 months post-injection, using the Goal Attainment Scale (GAS), Twelve Item MS Walking (MSWS-12) Scale, Timed Up and Go (TUG) Test, 6 Minute Walk Test (6MWT). Spatiotemporal gait data was obtained by GAITRite.


Condition or disease Intervention/treatment
Multiple Sclerosis Drug: Incobotulinum toxin A

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Study Type : Observational
Actual Enrollment : 22 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Gaitox :Therapeutic Benefit of Incobotulinum Toxin A for Spasticity of the Triceps Surae in Patients With Multiple Sclerosis an Observational Study on Gait Spatiotemporal Parameters
Actual Study Start Date : January 2014
Actual Primary Completion Date : March 2014
Actual Study Completion Date : January 2019

Resource links provided by the National Library of Medicine



Intervention Details:
  • Drug: Incobotulinum toxin A
    Treatment consisted of 200 IU of incobotulinum toxinA injected into the TS. Outcome measures were assessed before injection, at 6 weeks and 3 months post-injection, using the Goal Attainment Scale (GAS), Twelve Item MS Walking (MSWS-12) Scale, Timed Up and Go (TUG) Test, 6 Minute Walk Test (6MWT). Spatiotemporal gait data was obtained by GAITRite.


Primary Outcome Measures :
  1. Spatiotemporal gait parameters [ Time Frame: at inclusion ]
    Measurement of temporospatial gait parameters by GAITRite® Portable Gait Analysis Walkway: gait velocity (m/sec)

  2. Spatiotemporal gait parameters [ Time Frame: at inclusion ]
    Measurement of temporospatial gait parameters by GAITRite® Portable Gait Analysis Walkway: cadence (nb/sec)

  3. Spatiotemporal gait parameters [ Time Frame: at inclusion ]
    Measurement of temporospatial gait parameters by GAITRite® Portable Gait Analysis Walkway: duration of stance time on the injected and non-injected side (in sec)

  4. Spatiotemporal gait parameters [ Time Frame: at inclusion ]
    Measurement of temporospatial gait parameters by GAITRite® Portable Gait Analysis Walkway: duration of swing time on the injected and non-injected side (in sec)

  5. Spatiotemporal gait parameters [ Time Frame: at inclusion ]
    Measurement of temporospatial gait parameters by GAITRite® Portable Gait Analysis Walkway: step length on the injected and non-injected side (in meters)

  6. Spatiotemporal gait parameters [ Time Frame: at inclusion ]
    Measurement of temporospatial gait parameters by GAITRite® Portable Gait Analysis Walkway: support distribution (in %).

  7. Spatiotemporal gait parameters [ Time Frame: At six weeks ]
    Measurement of temporospatial gait parameters by GAITRite® Portable Gait Analysis Walkway: gait velocity (m/sec)

  8. Spatiotemporal gait parameters [ Time Frame: At six weeks ]
    Measurement of temporospatial gait parameters by GAITRite® Portable Gait Analysis Walkway: cadence (nb/sec)

  9. Spatiotemporal gait parameters [ Time Frame: At six weeks ]
    Measurement of temporospatial gait parameters by GAITRite® Portable Gait Analysis Walkway: duration of stance time on the injected and non-injected side (in sec)

  10. Spatiotemporal gait parameters [ Time Frame: At six weeks ]
    Measurement of temporospatial gait parameters by GAITRite® Portable Gait Analysis Walkway: duration of swing time on the injected and non-injected side (in sec)

  11. Spatiotemporal gait parameters [ Time Frame: At six weeks ]
    Measurement of temporospatial gait parameters by GAITRite® Portable Gait Analysis Walkway: step length on the injected and non-injected side (in meters)

  12. Spatiotemporal gait parameters [ Time Frame: At six weeks ]
    Measurement of temporospatial gait parameters by GAITRite® Portable Gait Analysis Walkway: support distribution (in %).

  13. Spatiotemporal gait parameters [ Time Frame: At three months ]
    Measurement of temporospatial gait parameters by GAITRite® Portable Gait Analysis Walkway: gait velocity (m/sec)

  14. Spatiotemporal gait parameters [ Time Frame: At three months ]
    Measurement of temporospatial gait parameters by GAITRite® Portable Gait Analysis Walkway: cadence (nb/sec)

  15. Spatiotemporal gait parameters [ Time Frame: At three months ]
    Measurement of temporospatial gait parameters by GAITRite® Portable Gait Analysis Walkway: duration of stance time on the injected and non-injected side (in sec)

  16. Spatiotemporal gait parameters [ Time Frame: At three months ]
    Measurement of temporospatial gait parameters by GAITRite® Portable Gait Analysis Walkway: duration of swing time on the injected and non-injected side (in sec)

  17. Spatiotemporal gait parameters [ Time Frame: At three months ]
    Measurement of temporospatial gait parameters by GAITRite® Portable Gait Analysis Walkway: step length on the injected and non-injected side (in meters)

  18. Spatiotemporal gait parameters [ Time Frame: At three months ]
    Measurement of temporospatial gait parameters by GAITRite® Portable Gait Analysis Walkway: support distribution (in %).


Secondary Outcome Measures :
  1. Six-Minute Walk Test (6MWT) [ Time Frame: at inclusion, at 6 weeks, at three months ]
    The 6 MWT is a simple test which requires a 30-meter course, calm, indoors, flat, in a rectilinear rectangular corridor. The route is marked every 3 meters with colored marks. The U-turn should be viewed with a cone. The purpose of this test is to walk as much as possible for 6 minutes. The score is between 0 meters for a non-ambulatory person and about 900 meters for a healthy subject.

  2. the Multiple Sclerosis Walking Scale (MSWS-12) [ Time Frame: at inclusion, at 6 weeks, at three months ]
    From the numbers circled against these questions, the healthcare professional can calculate the MSWS-12 score. This is done by adding the numbers you have circled, giving a total out of 60, and then transforming this to a scale with a range from 0 to 100. Higher scores indicate a greater impact on walking than lower scores.

  3. the Goal Attainment Scale (GAS) score with determination [ Time Frame: at inclusion, at 6 weeks, at three months ]
    In collaboration with the patient, the doctor define a primary and a secondary objectives, with a specific mark for each: -2: worse than before, -1: no change, 0: objective achieved, 1: result better than expected, 2: unexpected result

  4. The Timed Up and Go test (TUG) [ Time Frame: at inclusion, at 6 weeks, at three months ]
    TUG performance is rated on a scale of 1 to 5, where 1 indicates "normal functioning" and 5 indicates "severe abnormal behavior", according to the individual's perception of the risk of falling (Podsiadlo & Richardson, 1991) . The score consists of the time taken to complete the test, in seconds.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Twenty-two MS patients with a mean age of 48.2 +/- 12 years were enrolled in this study, 15 women and 7 men. In 13 patients, the disease had been in a relapsing-remitting mode for 15.2 +/- 12 years, 4 patients had secondary-progressive disease and 5 had primary progressive disease, with a mean EDSS of 4.2 +/- 1.5. Triceps surae spasticity on the Modified Ashworth Scale was 2.4 +/- 0.7.
Criteria

Inclusion Criteria:

  • MS patients aged over 18 years
  • with gait problems related to spasticity of the triceps surae,
  • walking 10 m in less than a minute,
  • with or without technical assistance,
  • with an EDSS of 6.5 or less
  • triceps surae spasticity of between 1 and 3 on the Modified Ashworth Scale.

Exclusion Criteria:

  • Comprehension problems preventing the patient from expressing his/her free and informed consent to the study.
  • Intolerance to botulinum toxin;
  • botulinum toxin injection in the previous three months.
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Responsible Party: Pôle Saint Hélier
ClinicalTrials.gov Identifier: NCT04265092    
Other Study ID Numbers: Pole-sthelier
First Posted: February 11, 2020    Key Record Dates
Last Update Posted: February 11, 2020
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: This prospective study is an observational pilot study, which seeks to evaluate the impact of a common treatment, as administered on a daily basis, without any change in the patients usual treatment pathway.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Pôle Saint Hélier:
Gait
Multiple Sclerosis
Spasticity
Toxin
Triceps surae
Additional relevant MeSH terms:
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Muscle Spasticity
Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations