Lower Limb Spasticity After StrokePhase 2/3A2NTXNCT01910363
Study of a New Generation Botulinum Toxin A2NTX to Treat Spasticity After Stroke
A Phase 2/3 study testing A2NTX and BOTOX in people with Lower Limb Spasticity After Stroke, run by University of Tokushima at 1 site in Japan.
Trial summary
To test the safety and efficacy of a new generation botulinum toxin preparation A2NTX for treating stroke patients with lower limb spasticity. we study the degree of spasticity in the ankle and knee joints, and walking speed in 30 patients with stroke before and after injecting 300 units of BOTOX or A2NTX in a blinded… Read more about this study
- Who is it for?
- Ages 40 to 79 years
- Conditions the study is for
- Lower Limb Spasticity After Stroke
- What is being tested?
- A2NTX and BOTOX
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteJapan
- Study dates
- Jul 2013to Jan 2014
- Phase
- Phase 2/3
- 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 40 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with lower limb spasticity after stroke
- duration more than 6 months
- Modified Ashworth Scale of ankle joint more than 2
Who cannot join
- patients with previous botulinum toxin injections to lower limbs
- patients with serious hepatic, renal or cardiac dysfunction
- patients with respiratory failure
- patients who cannot understand the instructions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Clinical Efficacy of Botulinum Neurotoxin Type A1 and A2 for Post-Stroke Lower Limb Spasticity: Phase 2/3
To test the safety and efficacy of a new generation botulinum toxin preparation A2NTX for treating stroke patients with lower limb spasticity.
- we study the degree of spasticity in the ankle and knee joints, and walking speed in 30 patients with stroke before and after injecting 300 units of BOTOX or A2NTX in a blinded manner as for the patient, the physician, and the examiner.
- we also assess the safety of A2NTX and compare it to that of BOTOX.
- Conditions
- Lower Limb Spasticity After Stroke
- Being tested
- A2NTX, BOTOX
- Keywords
- poststroke spasticity, lower limb, botulinum toxin, A2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A2NTXDrug
Also called A2NTX:low molecular weight (150kDalton) purified botulinum toxin type A2 preparation
Intramuscular injection of the botulinum toxin preparation in 300 units (mouse LD50) into tibialis posterior and medial gastrocnemius muscles on the affected side.
BOTOXDrug
Also called BOTOX®:onabotulinumtoxinA (Allergan Co Ltd), commercially available botulinum toxin type A1
Intramuscular injection of the botulinum toxin preparation in 300 units (mouse LD50) into tibialis posterior and medial gastrocnemius muscles on the affected side.
| Study group | Role | What they receive |
|---|---|---|
| A2NTX | Experimental | single intramuscular injection of 300 units of A2NTX, a purified low molecular weight (150 kDalton) botulinum toxin preparation of type A2 Receives: Drug: A2NTX |
| BOTOX | Active comparator | single intramuscular injection of 300 units of BOTOX®, a commercially available botulinum toxin preparation of type A1 Receives: Drug: BOTOX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Modified Ashworth Scale of the ankle joint
Modified Ashworth Scale is measured at baseline, 30(27-33) days and 60 (56-63) days after injection. Area under curve of Modified Ashworth Scale changes at day 30 and day 60 after injection
Measured: 30-60 days after injection
Secondary outcomes (1)
Change in Functional Independence Measure (FIM)
Measured: 30 days after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2013 (estimated)
- Study startJul 2013
- Primary completionJan 2014 (estimated)
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 Lower Limb Spasticity After StrokeStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Tokushima
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Labour and Welfare, Japan
- Responsible party
- Principal investigator, Ryuji Kaji, University of Tokushima
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01910363
- Sponsor's protocol ID
- A1A2BONT
- Other IDs
- TU001
- Acronym
- A2NTX
- Status last verified
- Jan 2014
- First submitted
- 18 Jul 2013
- Last updated
- 10 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Kaji R. Clinical differences between A1 and A2 botulinum toxin subtypes. Toxicon. 2015 Dec 1;107(Pt A):85-8. doi: 10.1016/j.toxicon.2015.09.025. Epub 2015 Sep 21.
PubMed 26394198
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Clinical Efficacy of Botulinum Neurotoxin Type A1 and A2 for Post-Stroke Lower Limb Spasticity: Phase 2/3
- ClinicalTrials.gov ID
- NCT01910363
- Acronym / sponsor ID
- A2NTX / A1A2BONT
- Conditions
- Lower Limb Spasticity After Stroke
- Keywords
- poststroke spasticity, lower limb, botulinum toxin, A2
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of TokushimaUniversity, hospital or other
- Collaborators
- Ministry of Health, Labour and Welfare, Japan
- Study start
- Jul 2013
- Primary completion
- Jan 2014 (estimated)
- First posted
- 29 Jul 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.
To test the safety and efficacy of a new generation botulinum toxin preparation A2NTX for treating stroke patients with lower limb spasticity.
- we study the degree of spasticity in the ankle and knee joints, and walking speed in 30 patients with stroke before and after injecting 300 units of BOTOX or A2NTX in a blinded manner as for the patient, the physician, and the examiner.
- we also assess the safety of A2NTX and compare it to that of BOTOX.
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 |
|---|---|---|
| A2NTX | Experimental | Drug: A2NTXsingle intramuscular injection of 300 units of A2NTX, a purified low molecular weight (150 kDalton) botulinum toxin preparation of type A2 |
| BOTOX | Active comparator | Drug: BOTOXsingle intramuscular injection of 300 units of BOTOX®, a commercially available botulinum toxin preparation of type A1 |
Who may qualify
- Ages
- 40 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients with lower limb spasticity after stroke
- duration more than 6 months
- Modified Ashworth Scale of ankle joint more than 2
Key exclusion criteria (4 listed)
- patients with previous botulinum toxin injections to lower limbs
- patients with serious hepatic, renal or cardiac dysfunction
- patients with respiratory failure
- patients who cannot understand the instructions
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 |
|---|---|---|
| A2NTXAlso: A2NTX:low molecular weight (150kDalton) purified botulinum toxin type A2 preparationIntramuscular injection of the botulinum toxin preparation in 300 units (mouse LD50) into tibialis posterior and medial gastrocnemius muscles on the affected side. | Drug | A2NTX |
| BOTOXAlso: BOTOX®:onabotulinumtoxinA (Allergan Co Ltd), commercially available botulinum toxin type A1Intramuscular injection of the botulinum toxin preparation in 300 units (mouse LD50) into tibialis posterior and medial gastrocnemius muscles on the affected side. | Drug | BOTOX |
Primary outcome
Change in Modified Ashworth Scale of the ankle joint
Time frame: 30-60 days after injection
Modified Ashworth Scale is measured at baseline, 30(27-33) days and 60 (56-63) days after injection. Area under curve of Modified Ashworth Scale changes at day 30 and day 60 after injection
1 secondary outcome
Change in Functional Independence Measure (FIM)
Time frame: 30 days after injection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2014.
- Derived from this study: PubMed 26394198Kaji R. Clinical differences between A1 and A2 botulinum toxin subtypes. Toxicon. 2015 Dec 1;107(Pt A):85-8. doi: 10.1016/j.toxicon.2015.09.025. Epub 2015 Sep 21.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing A2NTX and BOTOX in people with Lower Limb Spasticity After Stroke, run by University of Tokushima at 1 site in Japan.
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 3 inclusion and 4 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 10 Jan 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 Japan. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
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 in Modified Ashworth Scale of the ankle joint (time frame: 30-60 days after injection). 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 NCT01910363, 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 10 Jan 2014.