Cerebrovascular AccidentPhase 3NCT02280083
A Study to Evaluate the Botulinum Toxin Type A for Injection(HengLi®) in Subjects With Post-stroke Upper Limb Spasticity
A Phase 3 study testing Botulinum Toxin Type A for Injection in people with Cerebrovascular Accident, run by Lanzhou Institute of Biological Products Co., Ltd.
Trial summary
This is a multicenter, double-blind, randomized, placebo-controlled study designed to compare Botulinum Toxin Type A for Injection (HengLi®) with placebo on the efficacy and safety of treatment in post-stroke subjects with focal wrist, finger and in some cases, thumb spasticity. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cerebrovascular Accident
- What is being tested?
- Botulinum Toxin Type A for Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- No sites listed yet
- Study dates
- Jul 2014to Sep 2016
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥40kg in weight.
- Subjects voluntarily sign the informed consent.
- Subjects with upper limb spasticity who are at least 3 months post stroke and present with spasticity of both the wrist and fingers in the study limb.
- Both wrist flexor muscle tone and finger flexor muscle tone evaluation recorded 2 or greater individually as measured by MAS (0 to 4).
- At least one functional disability item (i.e., hygiene, dressing, pain, or cosmesis) evaluated 2 or greater by DAS (0 to 3).
- If using oral anti-spasticity medications, must be stable for at least 1 month prior to study enrolment.
- If taking any physical therapy or occupational therapy, must be stable on frequency, type, and intension for at least 1 month prior to study enrolment.
- In the opinion of the investigator, subject must clearly understand the intent of the study and be willing and able to comply with study instructions and complete the entire study.
Who cannot join
- Females who are pregnant, nursing, or planning a pregnancy during the study period, or females of childbearing potential, not using a reliable means of contraception.
- Known allergy or sensitivity to study medication or its components.
- Infection or dermatological condition at the injection sites.
- Significant inflammation in the study limb limiting joint movement.
- Unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminaemia, esophageal or gastric varices or persistent jaundice), cirrhosis, known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
- History of or planned surgical intervention for spasticity of the study limb.
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- Participation in another clinical study currently, or within the one months immediately prior to enrolment.
- Within six months prior to the study had received any treatment of patients with botulinum toxin of any serotype.
- Any medical condition that may put the subject at increased risk with exposure , including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other disorder that might have interfered with neuromuscular function.
- History of or planned treatment for spasticity with phenol or alcohol block in the study limb.
- Current treatment for spasticity with an intrathecal baclofen.
- QTc criteria: (either QTcb or QTcf, machine or manual overread, males or females); include the following details as appropriate: QTc≥450 millisecond (msec) or≥480msec for subjects with Bundle Branch Block-values based on either single electrocardiogram (ECG) values or triplicate ECG averaged QTc values obtained over a brief recording period.
- Liver function tests: aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≥2xULN; alkaline phosphatase and bilirubin >1.5xULN (isolated bilirubin >1.5ULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
- Concurrent use of aminoglycoside antibiotics or other agents that might interfere with neuromuscular function.
- Presence of clinically unstable severe cardiovascular, renal or respiratory disease.
- Profound atrophy of muscles to be injected (in the investigators opinion).
- Planned or anticipated initiation of new antispasticity medications during the clinical study.
- History (within 3 months of qualification) of or planned (during study period) casting of the study limb.
- patients with severe cognitive impairment or neurological diseases affecting the implementation or evaluation of the test, and drug-dependent patients.
- Researchers believe there are other factors unfit to participate in this study of patients .
About this study
Official title: A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Botulinum Toxin Type A for Injection in Chinese Subjects With Post-stroke Upper Limb Spasticity
This is a multicenter, double-blind, randomized, placebo-controlled study designed to compare Botulinum Toxin Type A for Injection (HengLi®) with placebo on the efficacy and safety of treatment in post-stroke subjects with focal wrist, finger and in some cases, thumb spasticity. Approximately 180 subjects will be enrolled. The core period of the subjects will receive a single treatment session of intramuscular HengLi® 200U or 240U (if thumb spasticity is present) or placebo in a randomization ratio of 2:1. Research contains two parts: core phase and extension phase. In the core phase, subjects will finish 6 visits (12 weeks ) after initial injection. During the extension phase, subjects will accept two follow-up visit (6 weeks). Outcome measures include changes from baseline at every post injection visit as measured on the Modified Ashworth Scale (MAS), Disability Assessment Scale (DAS) and Global Assessment Scale(GAS). The primary efficacy endpoint is the change from baseline at week 6 for wrist flexor muscle tone as measured on the Modified Ashworth Scale. Safety parameters will also be measured including adverse events, vital signs (pulse and blood pressure) and clinical laboratory tests (haematology, serum chemistry and urinanalysis).
Read the detailed description
The primary purpose is to prove the efficacy of treatment administration with Botulinum Toxin Type A for Injection (HengLi®) beyond placebo in subjects with post-stroke upper limb spasticity of both wrist and fingers flexors as measured on the Modified Ashworth Scale (MAS).
Subjects will receive a single treatment session of intramuscular HengLi® 200U or 240U (if thumb spasticity is present) or placebo after they first enroll the core phase randomly. Totally 180 subjects will be recruited in this part. Each completed subject should finish 8 (visit 0 to 7) clinic visits. Subjects will receive a single intramuscular treatment with either HengLi® or placebo at day 0 (visit 0). The else 7 visits are at week 1, 4, 6, 8, 12, 16 and 18 (visits 1 to 7) and week 6 (visit 3) is appointed as the primary visit to determine efficacy.
The primary endpoint is the change from baseline at week 6 for wrist flexor muscle tone as measured on the Modified Ashworth Scale (MAS). The secondary endpoints involve the area under curve (AUC) for the MAS wrist score change from baseline, change from baseline for wrist/finger/thumb flexor muscle tone as measured on MAS, DAS and GAS. The safety measures involve adverse events, clinical laboratory tests and pulse, blood pressure.
- Conditions
- Cerebrovascular Accident
- Being tested
- Botulinum Toxin Type A for Injection, placebo
- Keywords
- Spasticity, Post-Stroke, Botulinum toxin type A for Injection, upper limb spasticity
- Medical subject headings
- Stroke, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum Toxin Type A for InjectionDrug
Also called HengLi®
HengLi002(Botulinum Toxin Type A for Injection,also known as "HengLi®")
placeboDrug
placebo
| Study group | Role | What they receive |
|---|---|---|
| Botulinum Toxin Type A for Injection | Experimental | HengLi002(Botulinum Toxin Type A for Injection,also known as "HengLi®") Receives: Drug: Botulinum Toxin Type A for Injection |
| placebo | Placebo comparator | excipient Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline at Week 6 of Wrist Flexor Muscle Tone is calculated by the Modified Ashworth Scale (MAS)
The investigator, physiotherapist, or occupational therapist extended the participant's wrist as quickly as possible to grade flexor muscle tone. The MAS wrist score was calculated by using the 6-point MAS (0, 1, 1+ [regarded as 1.5], 2, 3, and 4; 0=no increase in muscle tone; 4=affected part[s] rigid in flexion/extension). Change from Baseline at Week 6 was calculated as the value at Week 6 minus the value at Baseline.
Measured: Baseline (Day 0) and Week 6
Secondary outcomes (8)
Area Under the Curve (AUC) for the Change From Baseline at Weeks 6 and 12 for MAS Wrist Score
horizontal axis (HA): plotting time points; vertical axis: Mean changes from Baseline for the MAS wrist score are calculated as the value at Week 6 and Week 12 minus the value at Baseline
Measured: Baseline (Day 0), Week 6, and Week 12
Change From Baseline at Weeks 1, 4, 8, 12, 16 and 18 for Wrist Flexor Muscle Tone are calculated by the MAS
The investigator, physiotherapist, or occupational therapist extended the participant's wrist as quickly as possible to grade flexor muscle tone. The MAS wrist score was calculated by using the 6-point MAS (0, 1, 1+ [regarded as 1.5], 2, 3, and 4; 0=no increase in muscle tone; 4=affected part[s] rigid in flexion/extension). Change from Baseline at the indicated time points was calculated as the value at the indicated time points minus the value at Baseline.
Measured: Baseline (Day 0) and Weeks 1, 4, 8, 12, 16 and 18
Proportion of subjects Classified as Wrist Treatment Responders at All Post-injection Visits
Definition of Wrist Treatment Responder: The MAS wrist score reduces at least 1 point. The MAS wrist score was calculated by using the 6-point MAS (0, 1, 1+ [regarded as 1.5], 2, 3, and 4; 0=no increase in muscle tone; 4=affected part[s] rigid in flexion/extension).
Measured: Weeks 1, 4, 6, 8, 12, 16 and 18
Changes From Baseline at Week 1, 4, 6, 8, 12, 16 and 18 of Finger Flexor Muscle Tone are calculated by the MAS
The investigator, physiotherapist, or occupational therapist extended the participant's finger as quickly as possible to grade the flexor muscle tone. The MAS finger score was calculated by using the 6-point MAS (0, 1, 1+ [regarded as 1.5], 2, 3, and 4; 0=no increase in muscle tone; 4=affected part[s] rigid in flexion/extension). Change from Baseline at the indicated time points was calculated as the value at Week 1, 4, 6, 8, and 12 minus the value at Baseline.
Measured: Baseline (Day 0) and Weeks 1, 4, 6, 8, 12, 16 and 18
Changes From Baseline at Week 1, 4, 6, 8, 12, 16 and 18 of Thumb Flexor Muscle Tone are calculated by the MAS
The investigator, physiotherapist, or occupational therapist extended the participant's thumb as quickly as possible to grade the flexor muscle tone. The MAS thumb score was calculated by using the 6-point MAS (0, 1, 1+ [regarded as 1.5], 2, 3, and 4; 0=no increase in muscle tone; 4=affected part[s] rigid in flexion/extension). Change from Baseline at the indicated time points was calculated as the value at Week 1, 4, 6, 8, and 12 minus the value at Baseline.
Measured: Baseline (Day 0) and Weeks 1, 4, 6, 8, 12, 16 and 18
Changes From Baseline at Week 1, 4, 6, 8, 12, 16 and 18 of individual situations are calculated by the Disability Assessment Scale (DAS)
The investigator evaluates 4 areas of disability, hygiene, pain, dressing, and limb posture, with the 4-point DAS (0=No functional disability to 3=Severe disability). Prior to the initial administration, the investigator, in consultation with the participant, selects 1 functional disability item (The item should be scored 2 or greater as measured by the DAS, indicating moderate to severe disability) from the 4 areas of disability and assessed it as a principal measure. Change from Baseline at the indicated time points was calculated at Week 1, 4, 6, 8, 12, 16 and 18 minus the value at Baseline.
Measured: Baseline (Day 0) and Weeks 1, 4, 6, 8, 12, 16 and 18
Global Assessment Scale (GAS) Score as Evaluated by the Physician at the Indicated Time Points
The investigators use the GAS to assess response after administration at each visit (visit 1 to 7). The 9-point GAS (-4, -3, -2, -1, 0, +1, +2, +3, +4; -4=very marked worsening, 0=unchanged, +4=very marked improvement) is chosen to measure at the indicated time points.
Measured: Weeks 1, 4, 6, 8, 12, 16 and 18
GAS Score as Evaluated by the Care Giver or the Participants at the Indicated Time Points
The caregivers or participants take the GAS to assess response after administration at each visit (visit 1 to 7). The 9-point GAS (-4, -3, -2, -1, 0, +1, +2, +3, +4; -4=very marked worsening, 0=unchanged, +4=very marked improvement) is chosen to measure at the indicated time points.
Measured: Weeks 1, 4, 6, 8, 12, 16 and 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2014 (estimated)
- Study startJul 2014
- Primary completionFeb 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebrovascular AccidentStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lanzhou Institute of Biological Products Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xinhua Wan, archiater, Study director, Peking Union Medical College HospitalShengyuan Yu, archiater, Principal investigator, The General Hospital of People's Liberation Army(301 hospital)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02280083
- Sponsor's protocol ID
- HengLi002
- Status last verified
- Sep 2016
- First submitted
- 29 Oct 2014
- Last updated
- 26 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Botulinum Toxin Type A for Injection in Chinese Subjects With Post-stroke Upper Limb Spasticity
- ClinicalTrials.gov ID
- NCT02280083
- Acronym / sponsor ID
- HengLi002
- Conditions
- Cerebrovascular Accident
- Keywords
- Spasticity, Post-Stroke, Botulinum toxin type A for Injection, upper limb spasticity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Lanzhou Institute of Biological Products Co., LtdIndustry (pharma, biotech, devices)
- Study start
- Jul 2014
- Primary completion
- Feb 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 31 Oct 2014 (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.
This is a multicenter, double-blind, randomized, placebo-controlled study designed to compare Botulinum Toxin Type A for Injection (HengLi®) with placebo on the efficacy and safety of treatment in post-stroke subjects with focal wrist, finger and in some cases, thumb spasticity. Approximately 180 subjects will be enrolled. The core period of the subjects will receive a single treatment session of intramuscular HengLi® 200U or 240U (if thumb spasticity is present) or placebo in a randomization ratio of 2:1. Research contains two parts: core phase and extension phase. In the core phase, subjects will finish 6 visits (12 weeks ) after initial injection. During the extension phase, subjects will accept two follow-up visit (6 weeks). Outcome measures include changes from baseline at every post injection visit as measured on the Modified Ashworth Scale (MAS), Disability Assessment Scale (DAS) and Global Assessment Scale(GAS). The primary efficacy endpoint is the change from baseline at week 6 for wrist flexor muscle tone as measured on the Modified Ashworth Scale. Safety parameters will also be measured including adverse events, vital signs (pulse and blood pressure) and clinical laboratory tests (haematology, serum chemistry and urinanalysis).
Detailed description
The primary purpose is to prove the efficacy of treatment administration with Botulinum Toxin Type A for Injection (HengLi®) beyond placebo in subjects with post-stroke upper limb spasticity of both wrist and fingers flexors as measured on the Modified Ashworth Scale (MAS).
Subjects will receive a single treatment session of intramuscular HengLi® 200U or 240U (if thumb spasticity is present) or placebo after they first enroll the core phase randomly. Totally 180 subjects will be recruited in this part. Each completed subject should finish 8 (visit 0 to 7) clinic visits. Subjects will receive a single intramuscular treatment with either HengLi® or placebo at day 0 (visit 0). The else 7 visits are at week 1, 4, 6, 8, 12, 16 and 18 (visits 1 to 7) and week 6 (visit 3) is appointed as the primary visit to determine efficacy.
The primary endpoint is the change from baseline at week 6 for wrist flexor muscle tone as measured on the Modified Ashworth Scale (MAS). The secondary endpoints involve the area under curve (AUC) for the MAS wrist score change from baseline, change from baseline for wrist/finger/thumb flexor muscle tone as measured on MAS, DAS and GAS. The safety measures involve adverse events, clinical laboratory tests and pulse, blood pressure.
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 |
|---|---|---|
| Botulinum Toxin Type A for Injection | Experimental | Drug: Botulinum Toxin Type A for InjectionHengLi002(Botulinum Toxin Type A for Injection,also known as "HengLi®") |
| placebo | Placebo comparator | Drug: placeboexcipient |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- ≥40kg in weight.
- Subjects voluntarily sign the informed consent.
- Subjects with upper limb spasticity who are at least 3 months post stroke and present with spasticity of both the wrist and fingers in the study limb.
- Both wrist flexor muscle tone and finger flexor muscle tone evaluation recorded 2 or greater individually as measured by MAS (0 to 4).
- At least one functional disability item (i.e., hygiene, dressing, pain, or cosmesis) evaluated 2 or greater by DAS (0 to 3).
Key exclusion criteria (20 listed)
- Females who are pregnant, nursing, or planning a pregnancy during the study period, or females of childbearing potential, not using a reliable means of contraception.
- Known allergy or sensitivity to study medication or its components.
- Infection or dermatological condition at the injection sites.
- Significant inflammation in the study limb limiting joint movement.
- Unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminaemia, esophageal or gastric varices or persistent jaundice), cirrhosis, known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
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 for InjectionAlso: HengLi®HengLi002(Botulinum Toxin Type A for Injection,also known as "HengLi®") | Drug | Botulinum Toxin Type A for Injection |
| placeboplacebo | Drug | placebo |
Primary outcome
Change From Baseline at Week 6 of Wrist Flexor Muscle Tone is calculated by the Modified Ashworth Scale (MAS)
Time frame: Baseline (Day 0) and Week 6
The investigator, physiotherapist, or occupational therapist extended the participant's wrist as quickly as possible to grade flexor muscle tone. The MAS wrist score was calculated by using the 6-point MAS (0, 1, 1+ [regarded as 1.5], 2, 3, and 4; 0=no increase in muscle tone; 4=affected part[s] rigid in flexion/extension). Change from Baseline at Week 6 was calculated as the value at Week 6 minus the value at Baseline.
8 secondary outcomes
Area Under the Curve (AUC) for the Change From Baseline at Weeks 6 and 12 for MAS Wrist Score
Time frame: Baseline (Day 0), Week 6, and Week 12
Change From Baseline at Weeks 1, 4, 8, 12, 16 and 18 for Wrist Flexor Muscle Tone are calculated by the MAS
Time frame: Baseline (Day 0) and Weeks 1, 4, 8, 12, 16 and 18
Proportion of subjects Classified as Wrist Treatment Responders at All Post-injection Visits
Time frame: Weeks 1, 4, 6, 8, 12, 16 and 18
Changes From Baseline at Week 1, 4, 6, 8, 12, 16 and 18 of Finger Flexor Muscle Tone are calculated by the MAS
Time frame: Baseline (Day 0) and Weeks 1, 4, 6, 8, 12, 16 and 18
Changes From Baseline at Week 1, 4, 6, 8, 12, 16 and 18 of Thumb Flexor Muscle Tone are calculated by the MAS
Time frame: Baseline (Day 0) and Weeks 1, 4, 6, 8, 12, 16 and 18
Changes From Baseline at Week 1, 4, 6, 8, 12, 16 and 18 of individual situations are calculated by the Disability Assessment Scale (DAS)
Time frame: Baseline (Day 0) and Weeks 1, 4, 6, 8, 12, 16 and 18
Global Assessment Scale (GAS) Score as Evaluated by the Physician at the Indicated Time Points
Time frame: Weeks 1, 4, 6, 8, 12, 16 and 18
GAS Score as Evaluated by the Care Giver or the Participants at the Indicated Time Points
Time frame: Weeks 1, 4, 6, 8, 12, 16 and 18
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 26 Sep 2016.
- Individual participant dataSharing planned: No
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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.
Xinhua Wan, archiater study director
Peking Union Medical College Hospital
Shengyuan Yu, archiater principal investigator
The General Hospital of People's Liberation Army(301 hospital)
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Botulinum Toxin Type A for Injection in people with Cerebrovascular Accident, run by Lanzhou Institute of Biological Products Co., Ltd.
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 8 inclusion and 20 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 26 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Change From Baseline at Week 6 of Wrist Flexor Muscle Tone is calculated by the Modified Ashworth Scale (MAS) (time frame: Baseline (Day 0) and Week 6). 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 26 Sep 2016; AzTrials last refreshed its copy on 27 Oct 2026.