COMPARISON BETWEEN GROUP TREATED WITH BOTULINUM TOXIN AND PLACEBOPhase 3FOLOTOXNCT01821573
Study of the Effect of Botulinum Toxin Injection in Rectus Femoris and Triceps on the Length and the Strength During Locomotion in Chronic Hemiparetic Patients
A Phase 3 study testing botulinum toxin type A and injection of NaCl 0.9% in people with COMPARISON BETWEEN GROUP TREATED WITH BOTULINUM TOXIN AND PLACEBO, run by Assistance Publique - Hôpitaux de Paris at 3 sites in France.
Trial summary
The aim of this randomized controlled study is to quantify the modification during locomotion of chronic hemiparetic patients of the strength and the length of Rectus Femoris and Triceps Surae induced by botulinum toxin injection type A. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COMPARISON BETWEEN GROUP TREATED WITH BOTULINUM TOXIN AND PLACEBO
- What is being tested?
- botulinum toxin type A and injection of NaCl 0.9%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 3 sitesFrance
- Study dates
- Jul 2013to 23 May 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- men or women aged > 18 ans
- unilateral stroke more than 6 months
- ability to walk 10 meters without assistive device
- decrease of peak knee flexion in swing phase of the gait cycle due to a spasticity of Rectus femoris muscle
- plantarflexion in swing phase of the gait cycle due to a spasticity of the triceps surae
- informed consent approved
- oral contraception
Who cannot join
- Aphasia
- anteriority of lower limb surgery less than 6 months
- underlying disease
- pre-existing neuro-muscular disorders
- pregnancy
- absence of oral contraception
Show all 9Show fewer
- last botulinum toxin injection < 3months
- hypersensitivity reactions
- co-administration of aminoglycosides
Trial locations and contacts
3 sites in 1 country.
France3 sites
Centre de rééducation de l'ADAPT Montargis
Amilly, Loiret, 45420
Service de médecine physique et réadaptation CHU de Brest
Brest, Brittany Region, 29290
Nicolas Roche
Garches, Hauts-de-Seine, 92380
About this study
Official title: Double Blind Randomized Controlled Study of the Effect of Botulinum Toxin Injection in Rectus Femoris and Triceps on the Length and the Strength of These Muscles During Locomotion in Chronic Hemiparetic Patients
The aim of this randomized controlled study is to quantify the modification during locomotion of chronic hemiparetic patients of the strength and the length of Rectus Femoris and Triceps Surae induced by botulinum toxin injection type A.
The main hypotheses of this study based on previous studies are that botulinum toxin injection increases on one hand the length of the muscle injected during gait and on the other hand decreased the strength of the muscles injected.
The investigators also hypothesized that botulinum toxin injection improved the strength of the antagonist muscles and normalized the pattern of strength of the muscles injected during gait.
Read the detailed description
The aim of this study is to compare versus placebo the effects of BTX-A injection on :
- the maximal length of the muscles injected during gait
- the maximal lengthening velocity of the muscles injected during gait
- the maximal strength of muscles injected during gait
- the inter-limb coordination assessed by continuous relative phase
- the kinematic parameters such as peak knee flexion during swing phase of the gait cycle and peak ankle dorsiflexion during stance phase.
To that end each patient included in the study will be assessed before injection, one month after the BTX-A injection and 3 months after BTX-A injections.
All patients will underwent a clinical examination, a 3D gait analysis and a isokinetic dynamometer analysis.
The comparison of the results in the group treated by BTX-A will permit to show that one month after BTX-A injection peak length during gait of muscles injected, maximal lengthening velocity peak knee flexion during swing phase and peak ankle dorsiflexion increase significantly.
It will also permit to show that the maximal strength of muscles injected decreases whereas the strength of antagonist increases It will also permit to demonstrate that multisite BTX-A injection improve coordination of paretic and non paretic lower limb the inter-group comparison will permit to demonstrate that these modification are mainly due to multisite BTX-A injections.
- Being tested
- botulinum toxin type A, injection of NaCl 0.9%
- Keywords
- botulinum toxin injection,3D motion analysis, muscular lengthening,muscle strength
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Also called Botox® allergan Inc
Experimental arm group:
- 150 Units in rectus femoris ( 3 ml and 3 points)
- 70 units in medial gastrocnemius (1.4 ml and 1 point)
- 70 units in lateral gastrocnemius ( 1.4 ml and 1 point)
- 60 units in soleus ( 1.2 ml and 3 points)
injection of NaCl 0.9%Drug
Placebo comparator group: injection of NaCl 0.9%:
- 3 ml of NaCl 0.9% in rectus femoris in 3 points
- 1.4 ml of NaCl 0.9% in medial gastrocnemius in 1 point
- 1.4 ml of Nacl 0.9% in lateral gastrocnemius in 1 point
- 1.2 ml of NaCl 0.9% in soleus in 3 points
| Study group | Role | What they receive |
|---|---|---|
| Botox Injection | Experimental | Patients treated by botulinum toxin. Receives: Drug: botulinum toxin type A |
| Saline Solution | Placebo comparator | Patients treated with saline solution. Receives: Drug: injection of NaCl 0.9% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure of the maximal length of the muscles treated by Botulinum
The maximal length of the muscles treated by Botulinum Toxin during locomotion quantified using 3D motion analysis and musculo-skeletal model.
This measure will be performed one month after Botulinum toxin injection.
Measured: 1.5 hours
Secondary outcomes (3)
The maximal strength measure
The maximal strength developed by injected muscles during gait.
Measured: 1.5 hours
Inter-segmental coordination measure
The modification of inter-segmental coordination during locomotion induced by botulinum toxin and quantified by continuous relative phase injection
Measured: 1.5 hours
Measure of joint torque at knee and ankle level.
The modification of joint torque at knee and ankle level induced by botulinum toxin injection.
Measured: 1.5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2013 (estimated)
- Study startJul 2013
- Primary completion5 Sep 2017
- Study completion23 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COMPARISON BETWEEN GROUP TREATED WITH BOTULINUM TOXIN AND PLACEBOStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Allergan
- Responsible party
- Sponsor
- Investigators
- Nicolas Roche, MD, Principal investigator, Physical medicine and rehabilation Department, Hôpital RAYMOND POINCARE, 92380 Garches, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01821573
- Sponsor's protocol ID
- P110136 / AOM11223
- Other IDs
- 2012-001203-21
- Acronym
- FOLOTOX
- Status last verified
- Feb 2019
- First submitted
- 27 Mar 2013
- Last updated
- 30 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Supiot A, Geiger M, Bensmail D, Aegerter P, Pradon D, Roche N. Effect of botulinum toxin injection on length and force of the rectus femoris and triceps surae muscles during locomotion in patients with chronic hemiparesis (FOLOTOX). BMC Neurol. 2018 Aug 2;18(1):104. doi: 10.1186/s12883-018-1110-8.
PubMed 30068305
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double Blind Randomized Controlled Study of the Effect of Botulinum Toxin Injection in Rectus Femoris and Triceps on the Length and the Strength of These Muscles During Locomotion in Chronic Hemiparetic Patients
- ClinicalTrials.gov ID
- NCT01821573
- Acronym / sponsor ID
- FOLOTOX / P110136 / AOM11223
- Keywords
- botulinum toxin injection,3D motion analysis, muscular lengthening,muscle strength
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Allergan
- Study start
- Jul 2013 (actual)
- Primary completion
- 5 Sep 2017 (actual)
- Study completion
- 23 May 2019 (actual)
- First posted
- 1 Apr 2013 (estimated)
- 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.
The aim of this randomized controlled study is to quantify the modification during locomotion of chronic hemiparetic patients of the strength and the length of Rectus Femoris and Triceps Surae induced by botulinum toxin injection type A.
The main hypotheses of this study based on previous studies are that botulinum toxin injection increases on one hand the length of the muscle injected during gait and on the other hand decreased the strength of the muscles injected.
The investigators also hypothesized that botulinum toxin injection improved the strength of the antagonist muscles and normalized the pattern of strength of the muscles injected during gait.
Detailed description
The aim of this study is to compare versus placebo the effects of BTX-A injection on :
- the maximal length of the muscles injected during gait
- the maximal lengthening velocity of the muscles injected during gait
- the maximal strength of muscles injected during gait
- the inter-limb coordination assessed by continuous relative phase
- the kinematic parameters such as peak knee flexion during swing phase of the gait cycle and peak ankle dorsiflexion during stance phase.
To that end each patient included in the study will be assessed before injection, one month after the BTX-A injection and 3 months after BTX-A injections.
All patients will underwent a clinical examination, a 3D gait analysis and a isokinetic dynamometer analysis.
The comparison of the results in the group treated by BTX-A will permit to show that one month after BTX-A injection peak length during gait of muscles injected, maximal lengthening velocity peak knee flexion during swing phase and peak ankle dorsiflexion increase significantly.
It will also permit to show that the maximal strength of muscles injected decreases whereas the strength of antagonist increases It will also permit to demonstrate that multisite BTX-A injection improve coordination of paretic and non paretic lower limb the inter-group comparison will permit to demonstrate that these modification are mainly due to multisite BTX-A injections.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Botox Injection | Experimental | Drug: botulinum toxin type APatients treated by botulinum toxin. |
| Saline Solution | Placebo comparator | Drug: injection of NaCl 0.9%Patients treated with saline solution. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- men or women aged > 18 ans
- unilateral stroke more than 6 months
- ability to walk 10 meters without assistive device
- decrease of peak knee flexion in swing phase of the gait cycle due to a spasticity of Rectus femoris muscle
- plantarflexion in swing phase of the gait cycle due to a spasticity of the triceps surae
Key exclusion criteria (9 listed)
- Aphasia
- anteriority of lower limb surgery less than 6 months
- underlying disease
- pre-existing neuro-muscular disorders
- pregnancy
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 AAlso: Botox® allergan IncExperimental arm group: * 150 Units in rectus femoris ( 3 ml and 3 points) * 70 units in medial gastrocnemius (1.4 ml and 1 point) * 70 units in lateral gastrocnemius ( 1.4 ml and 1 point) * 60 units in soleus ( 1.2 ml and 3 points) | Drug | Botox Injection |
| injection of NaCl 0.9%Placebo comparator group: injection of NaCl 0.9%: * 3 ml of NaCl 0.9% in rectus femoris in 3 points * 1.4 ml of NaCl 0.9% in medial gastrocnemius in 1 point * 1.4 ml of Nacl 0.9% in lateral gastrocnemius in 1 point * 1.2 ml of NaCl 0.9% in soleus in 3 points | Drug | Saline Solution |
Primary outcome
Measure of the maximal length of the muscles treated by Botulinum
Time frame: 1.5 hours
The maximal length of the muscles treated by Botulinum Toxin during locomotion quantified using 3D motion analysis and musculo-skeletal model. This measure will be performed one month after Botulinum toxin injection.
3 secondary outcomes
The maximal strength measure
Time frame: 1.5 hours
Inter-segmental coordination measure
Time frame: 1.5 hours
Measure of joint torque at knee and ankle level.
Time frame: 1.5 hours
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 30 May 2019.
- Derived from this study: PubMed 30068305Supiot A, Geiger M, Bensmail D, Aegerter P, Pradon D, Roche N. Effect of botulinum toxin injection on length and force of the rectus femoris and triceps surae muscles during locomotion in patients with chronic hemiparesis (FOLOTOX). BMC Neurol. 2018 Aug 2;18(1):104. doi: 10.1186/s12883-018-1110-8.
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.
Nicolas Roche, MD principal investigator
Physical medicine and rehabilation Department, Hôpital RAYMOND POINCARE, 92380 Garches, France
3 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 and injection of NaCl 0.9% in people with COMPARISON BETWEEN GROUP TREATED WITH BOTULINUM TOXIN AND PLACEBO, run by Assistance Publique - Hôpitaux de Paris at 3 sites in France.
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 7 inclusion and 9 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 30 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. 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. Some participants in this study may receive a placebo. 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?
Measure of the maximal length of the muscles treated by Botulinum (time frame: 1.5 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01821573, which also lists 1 linked publication.
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 30 May 2019.