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

NCT04265092 | Completed FDA Drug

• 1 other identifier: Pole-sthelier
• Study Type: observational
• Target: 22
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Multiple Sclerosis

Keywords

Gait; Multiple Sclerosis; Spasticity; Toxin; Triceps surae

Outcome Measures

Primary Outcomes (18)

• Spatiotemporal gait parameters

  Measurement of temporospatial gait parameters by GAITRite® Portable Gait Analysis Walkway: gait velocity (m/sec)

  at inclusion

• Spatiotemporal gait parameters

  Measurement of temporospatial gait parameters by GAITRite® Portable Gait Analysis Walkway: cadence (nb/sec)

  at inclusion

• Spatiotemporal gait parameters

  Measurement of temporospatial gait parameters by GAITRite® Portable Gait Analysis Walkway: duration of stance time on the injected and non-injected side (in sec)

  at inclusion

• Spatiotemporal gait parameters

  Measurement of temporospatial gait parameters by GAITRite® Portable Gait Analysis Walkway: duration of swing time on the injected and non-injected side (in sec)

  at inclusion

• Spatiotemporal gait parameters

  Measurement of temporospatial gait parameters by GAITRite® Portable Gait Analysis Walkway: step length on the injected and non-injected side (in meters)

  at inclusion

• Spatiotemporal gait parameters

  Measurement of temporospatial gait parameters by GAITRite® Portable Gait Analysis Walkway: support distribution (in %).

  at inclusion

• Spatiotemporal gait parameters

  Measurement of temporospatial gait parameters by GAITRite® Portable Gait Analysis Walkway: gait velocity (m/sec)

  At six weeks

• Spatiotemporal gait parameters

  Measurement of temporospatial gait parameters by GAITRite® Portable Gait Analysis Walkway: cadence (nb/sec)

  At six weeks

• Spatiotemporal gait parameters

  Measurement of temporospatial gait parameters by GAITRite® Portable Gait Analysis Walkway: duration of stance time on the injected and non-injected side (in sec)

  At six weeks

• Spatiotemporal gait parameters

  Measurement of temporospatial gait parameters by GAITRite® Portable Gait Analysis Walkway: duration of swing time on the injected and non-injected side (in sec)

  At six weeks

• Spatiotemporal gait parameters

  Measurement of temporospatial gait parameters by GAITRite® Portable Gait Analysis Walkway: step length on the injected and non-injected side (in meters)

  At six weeks

• Spatiotemporal gait parameters

  Measurement of temporospatial gait parameters by GAITRite® Portable Gait Analysis Walkway: support distribution (in %).

  At six weeks

• Spatiotemporal gait parameters

  Measurement of temporospatial gait parameters by GAITRite® Portable Gait Analysis Walkway: gait velocity (m/sec)

  At three months

• Spatiotemporal gait parameters

  Measurement of temporospatial gait parameters by GAITRite® Portable Gait Analysis Walkway: cadence (nb/sec)

  At three months

• Spatiotemporal gait parameters

  Measurement of temporospatial gait parameters by GAITRite® Portable Gait Analysis Walkway: duration of stance time on the injected and non-injected side (in sec)

  At three months

• Spatiotemporal gait parameters

  Measurement of temporospatial gait parameters by GAITRite® Portable Gait Analysis Walkway: duration of swing time on the injected and non-injected side (in sec)

  At three months

• Spatiotemporal gait parameters

  Measurement of temporospatial gait parameters by GAITRite® Portable Gait Analysis Walkway: step length on the injected and non-injected side (in meters)

  At three months

• Spatiotemporal gait parameters

  Measurement of temporospatial gait parameters by GAITRite® Portable Gait Analysis Walkway: support distribution (in %).

  At three months

Secondary Outcomes (4)

• Six-Minute Walk Test (6MWT)

  at inclusion, at 6 weeks, at three months

• the Multiple Sclerosis Walking Scale (MSWS-12)

  at inclusion, at 6 weeks, at three months

• the Goal Attainment Scale (GAS) score with determination

  at inclusion, at 6 weeks, at three months

• The Timed Up and Go test (TUG)

  at inclusion, at 6 weeks, at three months

Interventions

Incobotulinum toxin A DRUG

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pôle Saint Hélier: lead

MeSH Terms

Conditions

Multiple Sclerosis; Muscle Spasticity

Condition Hierarchy (Ancestors)

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; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2019
• First Posted: February 11, 2020
• Study Start: January 1, 2014
• Primary Completion: March 1, 2014
• Study Completion: January 1, 2019
• Last Updated: February 11, 2020

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share