Multiple SclerosisGAITOXNCT04265092
Therapeutic Benefit of Incobotulinum Toxin A for Spasticity of the Triceps Surae in Patients With Multiple Sclerosis
An observational study of Multiple Sclerosis, run by Pôle Saint Hélier.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Incobotulinum toxin A
- Type of treatment
- Injection or infusion
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- Jan 2014to Jan 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
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
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
- Being tested
- Incobotulinum toxin A
- Keywords
- Gait, Multiple Sclerosis, Spasticity, Toxin, Triceps surae
- Medical subject headings
- Multiple Sclerosis, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Incobotulinum toxin ADrug
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Spatiotemporal gait parameters
Measurement of temporospatial gait parameters by GAITRite® Portable Gait Analysis Walkway: gait velocity (m/sec)
Measured: at inclusion
Spatiotemporal gait parameters
Measurement of temporospatial gait parameters by GAITRite® Portable Gait Analysis Walkway: cadence (nb/sec)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: at inclusion
Spatiotemporal gait parameters
Measurement of temporospatial gait parameters by GAITRite® Portable Gait Analysis Walkway: support distribution (in %).
Measured: at inclusion
Spatiotemporal gait parameters
Measurement of temporospatial gait parameters by GAITRite® Portable Gait Analysis Walkway: gait velocity (m/sec)
Measured: At six weeks
Spatiotemporal gait parameters
Measurement of temporospatial gait parameters by GAITRite® Portable Gait Analysis Walkway: cadence (nb/sec)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: At six weeks
Spatiotemporal gait parameters
Measurement of temporospatial gait parameters by GAITRite® Portable Gait Analysis Walkway: support distribution (in %).
Measured: At six weeks
Spatiotemporal gait parameters
Measurement of temporospatial gait parameters by GAITRite® Portable Gait Analysis Walkway: gait velocity (m/sec)
Measured: At three months
Spatiotemporal gait parameters
Measurement of temporospatial gait parameters by GAITRite® Portable Gait Analysis Walkway: cadence (nb/sec)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: At three months
Spatiotemporal gait parameters
Measurement of temporospatial gait parameters by GAITRite® Portable Gait Analysis Walkway: support distribution (in %).
Measured: At three months
Secondary outcomes (4)
Six-Minute Walk Test (6MWT)
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.
Measured: at inclusion, at 6 weeks, at three months
the Multiple Sclerosis Walking Scale (MSWS-12)
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.
Measured: at inclusion, at 6 weeks, at three months
the Goal Attainment Scale (GAS) score with determination
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
Measured: at inclusion, at 6 weeks, at three months
The Timed Up and Go test (TUG)
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.
Measured: at inclusion, at 6 weeks, at three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2020
- Study startJan 2014
- Primary completionMar 2014
- Study completionJan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pôle Saint Hélier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04265092
- Sponsor's protocol ID
- Pole-sthelier
- Acronym
- GAITOX
- Status last verified
- Nov 2019
- First submitted
- 22 Oct 2019
- Last updated
- 11 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04265092
- Acronym / sponsor ID
- GAITOX / Pole-sthelier
- Conditions
- Multiple Sclerosis
- Keywords
- Gait, Multiple Sclerosis, Spasticity, Toxin, Triceps surae
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Pôle Saint HélierUniversity, hospital or other
- Study start
- Jan 2014 (actual)
- Primary completion
- Mar 2014 (actual)
- Study completion
- Jan 2019 (actual)
- First posted
- 11 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Incobotulinum toxin ATreatment 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. | Drug | – |
Primary outcome
Spatiotemporal gait parameters
Time frame: at inclusion
Measurement of temporospatial gait parameters by GAITRite® Portable Gait Analysis Walkway: gait velocity (m/sec)
Spatiotemporal gait parameters
Time frame: at inclusion
Measurement of temporospatial gait parameters by GAITRite® Portable Gait Analysis Walkway: cadence (nb/sec)
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)
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)
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)
Spatiotemporal gait parameters
Time frame: at inclusion
Measurement of temporospatial gait parameters by GAITRite® Portable Gait Analysis Walkway: support distribution (in %).
Spatiotemporal gait parameters
Time frame: At six weeks
Measurement of temporospatial gait parameters by GAITRite® Portable Gait Analysis Walkway: gait velocity (m/sec)
Spatiotemporal gait parameters
Time frame: At six weeks
Measurement of temporospatial gait parameters by GAITRite® Portable Gait Analysis Walkway: cadence (nb/sec)
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)
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)
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)
Spatiotemporal gait parameters
Time frame: At six weeks
Measurement of temporospatial gait parameters by GAITRite® Portable Gait Analysis Walkway: support distribution (in %).
Spatiotemporal gait parameters
Time frame: At three months
Measurement of temporospatial gait parameters by GAITRite® Portable Gait Analysis Walkway: gait velocity (m/sec)
Spatiotemporal gait parameters
Time frame: At three months
Measurement of temporospatial gait parameters by GAITRite® Portable Gait Analysis Walkway: cadence (nb/sec)
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)
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)
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)
Spatiotemporal gait parameters
Time frame: At three months
Measurement of temporospatial gait parameters by GAITRite® Portable Gait Analysis Walkway: support distribution (in %).
4 secondary outcomes
Six-Minute Walk Test (6MWT)
Time frame: at inclusion, at 6 weeks, at three months
the Multiple Sclerosis Walking Scale (MSWS-12)
Time frame: at inclusion, at 6 weeks, at three months
the Goal Attainment Scale (GAS) score with determination
Time frame: at inclusion, at 6 weeks, at three months
The Timed Up and Go test (TUG)
Time frame: at inclusion, at 6 weeks, at three months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2020.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Pôle Saint Hélier.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spatiotemporal gait parameters (time frame: at inclusion). The study lists 18 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2020.