Multiple SclerosisPhase 3NCT04595045
Botulinum Toxin in Patients With Spastic Lower Limb Paresis Associated With Multiple Sclerosis
A Phase 3 study testing Botulinum toxin type A infiltrations in people with Multiple Sclerosis, run by Aránzazu Vázquez Doce at 2 sites in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Botulinum toxin type A infiltrations
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 2 sitesSpain
- Study dates
- 24 Jan 2019to 28 Jul 2022
- Phase
- Phase 3
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Hospital Universitario de la Princesa
Madrid, 28006
Hospital Universitario Puerta de Hierro
Majadahonda, Madrid, 28220
About this study
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
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.
- Conditions
- Multiple Sclerosis
- Being tested
- Botulinum toxin type A infiltrations
- Keywords
- Multiple sclerosis, Botulinum toxin type A
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum toxin type A infiltrationsDrug
Echo-guided infiltration of botulinum toxin type A (Dysport®) in the lower limbs according to normal service practice
| Study group | Role | What they receive |
|---|---|---|
| patients with spastic lower limb paresis | Experimental | patients with spastic lower limb paresis secondary to Multiple Sclerosis Receives: Drug: Botulinum toxin type A infiltrations |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
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.
Measured: 12 months
Secondary outcomes (5)
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.
Measured: 12 months
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.
Measured: 12 months
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.
Measured: 12 months
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.
Measured: 12 months
Number of adverse events.
Number of adverse events.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2020
- Study start24 Jan 2019
- Primary completion28 Jul 2022
- Study completion28 Jul 2022
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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aránzazu Vázquez Doce
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Aránzazu Vázquez Doce, Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04595045
- Sponsor's protocol ID
- LINITOX
- Status last verified
- Aug 2022
- First submitted
- 9 Sep 2020
- Last updated
- 9 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04595045
- Acronym / sponsor ID
- LINITOX
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple sclerosis, Botulinum toxin type A
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Aránzazu Vázquez DoceUniversity, hospital or other
- Study start
- 24 Jan 2019 (actual)
- Primary completion
- 28 Jul 2022 (actual)
- Study completion
- 28 Jul 2022 (actual)
- First posted
- 20 Oct 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with spastic lower limb paresis | Experimental | Drug: Botulinum toxin type A infiltrationspatients with spastic lower limb paresis secondary to Multiple Sclerosis |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
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 |
|---|---|---|
| Botulinum toxin type A infiltrationsEcho-guided infiltration of botulinum toxin type A (Dysport®) in the lower limbs according to normal service practice | Drug | patients with spastic lower limb paresis |
Primary outcome
Effectiveness of repeated Botulinum Toxin infiltrations using objective results obtained by the clinician (Six Minutes Walking Test - 6MWT).
Time frame: 12 months
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).
Time frame: 12 months
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.
5 secondary outcomes
Evaluation of spasticity using Modified Ashworth Spasticity scale (MAS scale).
Time frame: 12 months
Evaluation of disability using Expanded Disability Status Scale de Kurtzke (EDSS scale).
Time frame: 12 months
Evaluation of the quality of life after the use of botulinum toxin type A using Multiple Sclerosis Quality of Life 54 (MSQoL-54).
Time frame: 12 months
Assessment of medium and long-term objectives using Goal Attainment Scaling (GAS scale).
Time frame: 12 months
Number of adverse events.
Time frame: 12 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 9 Aug 2022.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Botulinum toxin type A infiltrations in people with Multiple Sclerosis, run by Aránzazu Vázquez Doce at 2 sites in Spain.
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 9 inclusion and 8 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 9 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Effectiveness of repeated Botulinum Toxin infiltrations using objective results obtained by the clinician (Six Minutes Walking Test - 6MWT). (time frame: 12 months). The study lists 2 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 9 Aug 2022.