Hemiplegic Patients Post-AVCPhase 3NCT01829763
Central Effects of Botulinum Toxin: Neurophysiological Study in Stroke Patients With Spastic Lower Limb
A Phase 3 study testing injection botox in people with Hemiplegic Patients Post-AVC, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
Spasticity is a motor disorder characterized by a velocity-dependent increase in tonic stretch reflex with exaggerated tendon jerk (Lance 1980). Patients with brain lesion often display spasticity due to the interruption of the descending pathways that control the spinal reflex networks, which results in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemiplegic Patients Post-AVC
- What is being tested?
- injection botox
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2013to Nov 2015
- 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
- More than 18-years-old Patient
- Patient presenting a hemiplegia séquellaire of an AVC above - tentoriel dating more than 12 months
- Patient presenting a spasticité of the muscles of the leg
- Patient for him(it) ( a ) which an indication of treatment(processing) by botulinal toxin is carried(worn)
- Patient not having received from treatment(processing) by botulinal toxin at the level of the lower limb for six months
- Patient not having benefited from alcoholization or surgical gesture(movement) at the level of the lower limb for twelve months
- Spasticité focused the muscles of leg: soleus, gastrocnémiens, with score of Ashworth > or = 2 on the concerned muscles and/or the presence of a clonus on the soleus or gastrocnémiens,
Who cannot join
- Patient for him(it) ( a ) which the upright posture and/or the walking(step) are impossible
- Patient presenting a contraindication to the use of the botulinal toxin
- Patient presenting a contraindication to the use of the intramuscular way
- Patient susceptible not to participate in the totality of the study
- Woman pregnant or susceptible to be pregnant during the year
- Patient who can not give himself(itself) his consent (held(detained), major under guardianship)
- Patient incapable to understand(include) the nature and the purposes of the study, or presenting difficulties of understanding which can compromise the good progress of the study
Trial locations and contacts
1 site in 1 country.
laurent BENSOUSSAN contact
France1 site, 1 recruiting
- Recruiting
Assistance Publique Hopitaux de Marseille
Marseille, 13354
laurent bensoussan, laurent.bensoussan@ap-hm.fr
About this study
Spasticity is a motor disorder characterized by a velocity-dependent increase in tonic stretch reflex with exaggerated tendon jerk (Lance 1980). Patients with brain lesion often display spasticity due to the interruption of the descending pathways that control the spinal reflex networks, which results in hyperexcitability of the monosynaptic reflex triggered by stretch of the muscle spindles. Spasticity in lower limb muscle impairs the gait, especially in strokes that are the main cause of neurological disability. While 80% of the stroke survivors recover the ability to walk, the poor quality of their gait constitutes a serious handicap in daily life (Bensoussan et al. 2004; Bensoussan et al. 2006).
Local injection of Botulinum toxin (BTx) has become a mainstay of the treatment of focal spasticity, particularly in post-stroke patients. BTx weakens the excessive muscle contraction by blocking the release of acethylcholine from motoneuron terminals at the neuromuscular junction and transiently paralyzing the muscle for several months. Besides this peripheral action, BTx is assumed to have also a central effect (Curra et al. 2004; Gracies 2004; Krishnan 2005; Palomar and Mir 2012). In particular, by affecting also the fusimotor synapses on intrafusal muscles fibers (Rosales and Dressler 2010; Trompetto et al. 2008; Trompetto et al. 2006), BTx may reduce the discharge from muscle spindles, which may be indirectly responsible for functional changes in central motor mechanisms at both spinal and supraspinal levels. Animal experiments also suggested that BTx is carried by retrograde axonal transport to motoneuron soma and possibly transynaptically, and can affect the spinal cholinergic synaptic transmission in the spinal cord. Until now, electrophysiological findings are limited and controversial, probably due to the various motor disorders investigated, the physiological mechanisms tested and the different toxin injection protocols used in the few studies available (Frascarelli et al. 2011; Girlanda et al. 1997; Modugno et al. 1998; Naumann and Reiners 1997; Pauri et al. 2000; Priori et al. 1995; Wohlfarth et al. 2001). Hence, the central action of the toxin in spasticity remains uncertain.
- Conditions
- Hemiplegic Patients Post-AVC
- Being tested
- injection botox
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
injection botoxDrug
| Study group | Role | What they receive |
|---|---|---|
| botox | Experimental | Not described Receives: Drug: injection botox |
What is being measured
The primary outcome is the main question the study is designed to answer.
injection Botulinum toxin type-A (BTx-A)
Measured: 24 MONTHS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2013 (estimated)
- Study startApr 2013
- Primary completionApr 2015 (estimated)
- Study completionNov 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemiplegic Patients Post-AVCStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- LOIC MONDOLONI, Study director, Assistance Publique Hopitaux De Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01829763
- Sponsor's protocol ID
- 2013-000600-42
- Other IDs
- 2013-02
- Status last verified
- Jul 2014
- First submitted
- 8 Apr 2013
- Last updated
- 24 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Central Effects of Botulinum Toxin: Neurophysiological Study in Stroke Patients With Spastic Lower Limb
- ClinicalTrials.gov ID
- NCT01829763
- Acronym / sponsor ID
- 2013-000600-42
- Conditions
- Hemiplegic Patients Post-AVC
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Apr 2015 (estimated)
- Study completion
- Nov 2015 (estimated)
- First posted
- 11 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.
Spasticity is a motor disorder characterized by a velocity-dependent increase in tonic stretch reflex with exaggerated tendon jerk (Lance 1980). Patients with brain lesion often display spasticity due to the interruption of the descending pathways that control the spinal reflex networks, which results in hyperexcitability of the monosynaptic reflex triggered by stretch of the muscle spindles. Spasticity in lower limb muscle impairs the gait, especially in strokes that are the main cause of neurological disability. While 80% of the stroke survivors recover the ability to walk, the poor quality of their gait constitutes a serious handicap in daily life (Bensoussan et al. 2004; Bensoussan et al. 2006).
Local injection of Botulinum toxin (BTx) has become a mainstay of the treatment of focal spasticity, particularly in post-stroke patients. BTx weakens the excessive muscle contraction by blocking the release of acethylcholine from motoneuron terminals at the neuromuscular junction and transiently paralyzing the muscle for several months. Besides this peripheral action, BTx is assumed to have also a central effect (Curra et al. 2004; Gracies 2004; Krishnan 2005; Palomar and Mir 2012). In particular, by affecting also the fusimotor synapses on intrafusal muscles fibers (Rosales and Dressler 2010; Trompetto et al. 2008; Trompetto et al. 2006), BTx may reduce the discharge from muscle spindles, which may be indirectly responsible for functional changes in central motor mechanisms at both spinal and supraspinal levels. Animal experiments also suggested that BTx is carried by retrograde axonal transport to motoneuron soma and possibly transynaptically, and can affect the spinal cholinergic synaptic transmission in the spinal cord. Until now, electrophysiological findings are limited and controversial, probably due to the various motor disorders investigated, the physiological mechanisms tested and the different toxin injection protocols used in the few studies available (Frascarelli et al. 2011; Girlanda et al. 1997; Modugno et al. 1998; Naumann and Reiners 1997; Pauri et al. 2000; Priori et al. 1995; Wohlfarth et al. 2001). Hence, the central action of the toxin in spasticity remains uncertain.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| botox | Experimental | Drug: injection botox |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- More than 18-years-old Patient
- Patient presenting a hemiplegia séquellaire of an AVC above - tentoriel dating more than 12 months
- Patient presenting a spasticité of the muscles of the leg
- Patient for him(it) ( a ) which an indication of treatment(processing) by botulinal toxin is carried(worn)
- Patient not having received from treatment(processing) by botulinal toxin at the level of the lower limb for six months
Key exclusion criteria (7 listed)
- Patient for him(it) ( a ) which the upright posture and/or the walking(step) are impossible
- Patient presenting a contraindication to the use of the botulinal toxin
- Patient presenting a contraindication to the use of the intramuscular way
- Patient susceptible not to participate in the totality of the study
- Woman pregnant or susceptible to be pregnant during the year
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 |
|---|---|---|
| injection botox | Drug | botox |
Primary outcome
injection Botulinum toxin type-A (BTx-A)
Time frame: 24 MONTHS
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2014.
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.
laurent BENSOUSSAN contact
LOIC MONDOLONI study director
Assistance Publique Hopitaux De Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing injection botox in people with Hemiplegic Patients Post-AVC, run by Assistance Publique Hopitaux De Marseille at 1 site 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 7 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: status not confirmed, as of the sponsor's last update on 24 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact laurent BENSOUSSAN (laurent.bensoussan@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
injection Botulinum toxin type-A (BTx-A) (time frame: 24 MONTHS). 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 24 Jul 2014.