Muscle SpasticityPhase 4BTX-ANCT01278576
Botulinum Toxin A Adult Gastrocnemius Muscle Study
A Phase 4 study testing BOTOX-A® in people with Muscle Spasticity and Stroke, run by The Catholic University of Korea at 2 sites in South Korea.
Trial summary
The study aims to compare the effectiveness of BOTOX-A® (botulinun toxin A) placed between two different injection sites, namely at the proximal portion of the gastrocnemius(GCM) versus at the midbelly of the GCM. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Muscle Spasticity, Stroke
- What is being tested?
- BOTOX-A®
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesSouth Korea
- Study dates
- Jan 2011to May 2012
- Phase
- Phase 4
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, 20 < age < 70 year old
- Hemiplegia documented after ischemic or hemorrhagic stroke, documented by CT (computed tomography) or MRI (magnetic resonance imaging) scan
- Time between the onset of stroke < 24 months
- Individuals who have been medically stable for at least 4 weeks prior to study enrollment
- Confirmed equinovarus with spastic hypertonia of the ankle
- Spasticity as defined by a MAS greater than grade 1 +
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- Botulinum toxin -naive patients
- Participants who can complete the 10 meter walking test with caregiver or walking tool assistance within 8 and 45 seconds, on 2 occasions
- Participants who will have stable treatment regimen and concomitant medication during the trial period
Who cannot join
- The patient has any of the following medical conditions that is contraindication to botulinum toxin exposure; pregnancy, lactation, neuromuscular disease, aminoglycoside, antibiotic concurrent to botulinum toxin treatment
- Fixed contracture of the ankle, previous history of surgical procedure performed on the ankle
- Cognitive deficit that disables patients to give informed consent to the procedure
- Concomitant progression of any CNS (central nervous system) or PNS (peripheral nervous system), or myopathy, or uncontrolled seizure. Underlying CNS insult should be controlled and in stable condition with no further risk of progression and further deterioration of patient's current neurological status. Those with multiple sclerosis or multiple systemic atrophy are to be excluded
- Significant cutaneous or joint inflammation
- URI or other systemic infection that would mandate the use of antibiotic concurrent to botulinum toxin injection
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- Anticoagulation treatment with INR (International Normalized Ratio) greater than 3.0
- Upper extremity spasticity greater than MAS grade 4 that may limit gait function
- Subjects with previous episodes of motor point block injection using phenol or other chemodenervating agents
- Subjects with intrathecal baclofen pump
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
Department of Rehabilitation Medicine Bucheon St Mary's Hospital, Catholic University of Korea, College of Medicine
Bucheon-si, Kyounggido
Bobath Memorial Hospital
Songnam, Kyoungido
About this study
Official title: An Efficacy Comparison of Botulinum Toxin A Injection Into Two Different Sites in Gastrocnemius Muscle for the Treatment of Spastic Patients, Randomized Controlled Trial
The study aims to compare the effectiveness of BOTOX-A® (botulinun toxin A) placed between two different injection sites, namely at the proximal portion of the gastrocnemius(GCM) versus at the midbelly of the GCM.
Read the detailed description
Previous studies have used the midbelly of a muscle as the position where the motor endplates are most densely located. The reasoning behind this method was based on the previous works that showed most bands of cholinesterase activity to be located in specific topographical patterns at the center of the muscle fiber. These results have been used as landmarks to place the injections. Current standard guidelines recommend that botulinum toxin be placed at the 4 quadrants of the midbelly portion of the gastrocnemius (GCM) muscle. However, recent cadaveric research studies on the distribution of the intramuscular endings of the GCM suggest that the highest branch density is found within the upper 20-30% length of the calf. Therefore, in accordance to the theory that effect of botulinum toxin are greatest at sites where the intramuscular endings are most dense, the location where these toxins should be placed would be at these proximal sites of the GCM rather than at the midbelly.
40 recruited patients will be allocated into either the intramuscular ending targeted (ie.upper portion of calf) or midbelly targeted group.
Each subject will undergo a total number of 4 assessments; prior to the injection and 2,4and 8 weeks post injection.
- Conditions
- Muscle Spasticity, Stroke
- Being tested
- BOTOX-A®
- Keywords
- Muscle spasticity, Stroke, Botulinum Toxins, Lower extremity, Ankle
- Medical subject headings
- Muscle Spasticity, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BOTOX-A®Drug
Also called Generic Name: Botulinum toxin type A
200 units, single treatment only
| Study group | Role | What they receive |
|---|---|---|
| Intramuscular ending Targeting | Experimental | Botox 200 units placed at the upper 2/10-3/10 length of the GCM Receives: Drug: BOTOX-A® |
| Midbelly Targeting | Active comparator | A total of 200 units will be placed at the four quadrants of the midbelly portion of the GCM. Receives: Drug: BOTOX-A® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline for EMG (electromyogram) activity
Surface EMG
Measured: week 8
Secondary outcomes (8)
Change from baseline of GCM tone a measured on the Modified Ashworth Scale (MAS)
Measured: Change from baseline at 8 weeks
Change from baseline of Ankle Range of motion
Passive range of motion of the ankle at resting state with the use of goniometer
Measured: Change from baseline at 8 weeks
Change from baseline of gait speed with 10 meters walk test
Change from baseline at 8 weeks
Measured: Change from baseline at 8 weeks
Change from baseline of ABILOCO scale
Measured: Change from baseline at 8 weeks
Change from baseline of Disability Assessment Scale
Measured: Change from baseline at 8 weeks
Change from baseline of Functional Ambulation Category Scale
Measured: Change from baseline at 8 weeks
Change of baseline of Lindmark Modified Fugyl Meyer Scale
Measured: Change from baseline at 8 weeks
Change from baseline of Tardieu angle of ankle
Measured: Change from baseline at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionDec 2011
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle SpasticityStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Catholic University of Korea
- Sponsor type
- University, hospital or other
- Collaborators
- Bobath Memorial Hospital
- Responsible party
- Principal investigator, Sun Im, The Catholic University of Korea
- Investigators
- Sun Im, MD, PhD, Principal investigator, Department of Rehabilitation Medicine, Bucheon St Mary's Hospital, Catholic University of Korea, College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01278576
- Sponsor's protocol ID
- BCMC10AH07
- Acronym
- BTX-A
- Status last verified
- Jan 2011
- First submitted
- 10 Jan 2011
- Last updated
- 15 May 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Efficacy Comparison of Botulinum Toxin A Injection Into Two Different Sites in Gastrocnemius Muscle for the Treatment of Spastic Patients, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01278576
- Acronym / sponsor ID
- BTX-A / BCMC10AH07
- Conditions
- Muscle Spasticity, Stroke
- Keywords
- Muscle spasticity, Stroke, Botulinum Toxins, Lower extremity, Ankle
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- The Catholic University of KoreaUniversity, hospital or other
- Collaborators
- Bobath Memorial Hospital
- Study start
- Jan 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 19 Jan 2011 (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 study aims to compare the effectiveness of BOTOX-A® (botulinun toxin A) placed between two different injection sites, namely at the proximal portion of the gastrocnemius(GCM) versus at the midbelly of the GCM.
Detailed description
Previous studies have used the midbelly of a muscle as the position where the motor endplates are most densely located. The reasoning behind this method was based on the previous works that showed most bands of cholinesterase activity to be located in specific topographical patterns at the center of the muscle fiber. These results have been used as landmarks to place the injections. Current standard guidelines recommend that botulinum toxin be placed at the 4 quadrants of the midbelly portion of the gastrocnemius (GCM) muscle. However, recent cadaveric research studies on the distribution of the intramuscular endings of the GCM suggest that the highest branch density is found within the upper 20-30% length of the calf. Therefore, in accordance to the theory that effect of botulinum toxin are greatest at sites where the intramuscular endings are most dense, the location where these toxins should be placed would be at these proximal sites of the GCM rather than at the midbelly.
40 recruited patients will be allocated into either the intramuscular ending targeted (ie.upper portion of calf) or midbelly targeted group.
Each subject will undergo a total number of 4 assessments; prior to the injection and 2,4and 8 weeks post injection.
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 |
|---|---|---|
| Intramuscular ending Targeting | Experimental | Drug: BOTOX-A®Botox 200 units placed at the upper 2/10-3/10 length of the GCM |
| Midbelly Targeting | Active comparator | Drug: BOTOX-A®A total of 200 units will be placed at the four quadrants of the midbelly portion of the GCM. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male or female, 20 < age < 70 year old
- Hemiplegia documented after ischemic or hemorrhagic stroke, documented by CT (computed tomography) or MRI (magnetic resonance imaging) scan
- Time between the onset of stroke < 24 months
- Individuals who have been medically stable for at least 4 weeks prior to study enrollment
- Confirmed equinovarus with spastic hypertonia of the ankle
Key exclusion criteria (10 listed)
- The patient has any of the following medical conditions that is contraindication to botulinum toxin exposure; pregnancy, lactation, neuromuscular disease, aminoglycoside, antibiotic concurrent to botulinum toxin treatment
- Fixed contracture of the ankle, previous history of surgical procedure performed on the ankle
- Cognitive deficit that disables patients to give informed consent to the procedure
- Concomitant progression of any CNS (central nervous system) or PNS (peripheral nervous system), or myopathy, or uncontrolled seizure. Underlying CNS insult should be controlled and in stable condition with no further risk of progression and further deterioration of patient's current neurological status. Those with multiple sclerosis or multiple systemic atrophy are to be excluded
- Significant cutaneous or joint inflammation
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 |
|---|---|---|
| BOTOX-A®Also: Generic Name: Botulinum toxin type A200 units, single treatment only | Drug | Intramuscular ending Targeting, Midbelly Targeting |
Primary outcome
Change from baseline for EMG (electromyogram) activity
Time frame: week 8
Surface EMG
8 secondary outcomes
Change from baseline of GCM tone a measured on the Modified Ashworth Scale (MAS)
Time frame: Change from baseline at 8 weeks
Change from baseline of Ankle Range of motion
Time frame: Change from baseline at 8 weeks
Change from baseline of gait speed with 10 meters walk test
Time frame: Change from baseline at 8 weeks
Change from baseline of ABILOCO scale
Time frame: Change from baseline at 8 weeks
Change from baseline of Disability Assessment Scale
Time frame: Change from baseline at 8 weeks
Change from baseline of Functional Ambulation Category Scale
Time frame: Change from baseline at 8 weeks
Change of baseline of Lindmark Modified Fugyl Meyer Scale
Time frame: Change from baseline at 8 weeks
Change from baseline of Tardieu angle of ankle
Time frame: Change from baseline at 8 weeks
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 15 May 2012.
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Individualised Cryoneurolysis to Treat Pain in the Context of Spasticity in the Upper and Lower Extremities
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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.
Sun Im, MD, PhD principal investigator
Department of Rehabilitation Medicine, Bucheon St Mary's Hospital, Catholic University of Korea, College of Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing BOTOX-A® in people with Muscle Spasticity and Stroke, run by The Catholic University of Korea at 2 sites in South Korea.
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 10 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 15 May 2012. 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 South Korea. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Change from baseline for EMG (electromyogram) activity (time frame: week 8). 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 15 May 2012.