Upper Limb SpasticityPhase 2/3NCT06783114
A Clinical Study on Recombinant Botulinum Toxin Type A (YY001) for Injection in The Treatment of Upper Limb Spasticity in Adults
A Phase 2/3 study testing Recombinant Botulinum Toxin Type A for injection (YY001) and BOTOX® in people with Upper Limb Spasticity, run by Chongqing Claruvis Pharmaceutical Co., Ltd. at 24 sites in China.
Trial summary
This is a randomized, double-blind, multi-center phase II/III study to evaluate the efficacy and safety of Recombinant Botulinum Toxin Type A (YY001) for injection in the treatment of upper limb spasticity in adults Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Upper Limb Spasticity
- What is being tested?
- Recombinant Botulinum Toxin Type A for injection (YY001) and BOTOX®
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 254 participants
- Where
- 24 sitesChina
- Study dates
- 14 Sep 2024to 30 Sep 2026
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
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
- Age between 18 and 75 years old inclusive, at the time of signing the informed consent, regardless of gender.
- Subjects with unilateral hemiplegia due to stroke (with a time interval of ≥ 3 months from stroke onset to randomized enrollment) exhibiting upper limb spasticity.
- Subjects with Disability Assessment Scale score of at least 2 on the Principal Target of Treatment (one of four functional domains: hygiene, dressing, limb position and pain).
- If taking oral antispasticity, the dosage must be stable for at least 1 month prior to randomized enrollment.
- If the study limb receives physical therapy or occupational therapy, the frequency, type, and intensity must be stable for at least 3 weeks prior to randomized enrollment.
Who cannot join
- History of allergy to any component of the experimental drugs.
- Previous use of any botulinum toxin within 6 months prior to randomized enrollment, or plan to use other botulinum toxins not specified in the study protocol during the study.
- Fixed contractures of the studied limb.
- Any medical condition that may increase the risk to the subject when using Botulinum Toxin Type A.
- Need for treatment with drugs that interfere with neuromuscular function during the study.
- Plan or anticipate to use new antispasticity drugs during the study.
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- History of epilepsy.
- Pregnant or breastfeeding women.
- Participation in other drug/device clinical trials within 1 month prior to randomized enrollment.
Trial locations and contacts
24 sites in 1 country. Contact the study team or a site near you to ask about taking part.
24 sites in 1 country
China24 sites, 24 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality
Xinhua Wan, wxhpumch@163.com
Xinhua Wan
- Recruiting
West China Hospital，Sichuan University
Chengdu, Sichuan
Huifang Shang, hfshang2002@163.com
Huifang Shang
- Recruiting
Chongqing Traditional Chinese Medicine Hospital
Chongqing, Chongqing Municipality
Chenyu Li, 479394929@qq.com
Chenyu Li
- Recruiting
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality
Oumei Cheng, Chengoumei01@aliyun.com
Oumei Cheng
- Recruiting
Guangdong Provincial People's Hospital
Guangzhou, Guangdong
Jiehao Zhao, jiehao_zhao@163.com
Jiehao Zhao
- Recruiting
Sun Yat-sen Memorial Hospital
Guangzhou, Guangdong
Shaoling Wu, 13660183777@126.com
Shaoling Wu
- Recruiting
Anhui Provincial Hospital
Hefei, Anhui
Zhaozhao Cheng, chengzz@ustc.edu.cn
Zhaozhao Cheng
- Recruiting
The Second People's Hospital of Hefei
Hefei, Anhui
Juncang Wu, wujuncang126@126.com
Juncang Wu
- Recruiting
Huai'an First People's Hospital
Huai'an, Jiangsu
Yujun Qi, 1964708102@qq.com
Yujun Qi
- Recruiting
The First Affiliated Hospital of Henan University
Kaifeng, Henan
Qingyan Qin, qinwu216@sina.cn
Qingyan Qin
- Recruiting
The Second Affiliated Hospital of Kunming Medical University
Kunming, Yunnan
Liqing Yao, yaoliqing98731@163.com
Liqing Yao
- Recruiting
Qilu Hospital of Shandong University
Qingdao, Shandong
Cuiping Zhao, zhaocuipingzsu@126.com
Cuiping Zhao
- Recruiting
Rui Jin Hospital of Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality
Jun Liu, lj11128@rjh.com.cn
Jun Liu
- Recruiting
Shanghai Fudan University HuaShan Hospital
Shanghai, Shanghai Municipality
Fang Li, Fangl@fudan.edu.cn
Fang Li
- Recruiting
Yangzhi Affiliated Rehabilitation Hospital of Tongji University
Shanghai, Shanghai Municipality
Lingjing Jin, lingjingjin@163.com
Lingjing Jin
- Recruiting
Shenzhen Second People's Hospital
Shenzhen, Guangdong
Jianjun Long, longjianjun@szu.edu.cn
Jianjun Long
- Recruiting
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu
Qi Fang, fangqi_008@126.com
Qi Fang
- Recruiting
The Fourth Affiliated Hospital of Soochow University
Suzhou, Jiangsu
Qi Fang, fangqi_008@126.com
Qi Fang
- Recruiting
Shanxi Bethune Hospital
Taiyuan, Shanxi
pingzhi Wang, wpzcxl@163.com
Pingzhi Wang
- Recruiting
Shanxi provincial people's Hospital
Taiyuan, Shanxi
Qin Wu, liyujun-wuqin@163.com
Qin Wu
- Recruiting
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality
Xiaodong Zhu, zxd3516@163.com
Xiaodong Zhu
- Recruiting
RenMin Hospital Of Wuhan University
Wuhan, Hubei
Hongjuan Dong, dhjdhjdhj027@sina.com
Hongjuan Dong
- Recruiting
Xuzhou Medical University Affiliated Hospital
Xuzhou, Jiangsu
Jie Xiang, xj1111@163.com
Jie Xiang
- Recruiting
Zibo Municipal Hospital
Zibo, Shandong
Runmin Sun, runmingsun@126.com
Runmin Sun
About this study
Official title: A Clinical Study to Evaluate the Efficacy and Safety of Recombinant Botulinum Toxin Type A (YY001) for Injection in The Treatment of Upper Limb Spasticity in Adults (REHAB-1)
This is a randomized, double-blind, multi-center phase II/III study to evaluate the efficacy and safety of Recombinant Botulinum Toxin Type A (YY001) for injection in the treatment of upper limb spasticity in adults
- Conditions
- Upper Limb Spasticity
- Being tested
- Recombinant Botulinum Toxin Type A for injection (YY001), BOTOX®, Placebo
- Keywords
- YY001, Recombinant Botulinum Toxin Type A, Botulinum Toxin, Upper limb spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant Botulinum Toxin Type A for injection (YY001)Biological
Single treatment, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), intramuscular injection, the total injection dose is 200-400 U.
BOTOX®Biological
Single treatment, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), intramuscular injection, the total injection dose is 200 U.
PlaceboBiological
Single treatment, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), intramuscular injection.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Single injection with Recombinant Botulinum Toxin Type A for injection (YY001) in upper limb spasticity Receives: Biological: Recombinant Botulinum Toxin Type A for injection (YY001) |
| Active-Controlled Group | Active comparator | Single injection with BOTOX® in upper limb spasticity Receives: Biological: BOTOX® |
| Placebo-Controlled Group | Placebo comparator | Single injection with placebo in upper limb spasticity Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Modified Ashworth Scale (MAS) Score of Primary Target Clinical Pattern at Week 4
Primary target clinical pattern was defined by investigator for each subject at baseline visit and was either flexed elbow or flexed wrist or clenched fist.
The Modified Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 6-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).
Measured: Week 4 after treatment
Secondary outcomes (6)
Physician's Global Assessment (PGA) Score at Week 1, Week 4, Week 8 and Week 12
The Physician's Global Assessment is used to measure the investigator's impression of change due to treatment. The response option is a common 7-point scale that ranges from -3 = very much worse to +3 = very much improved.
Measured: Week 1, Week 4, Week 8 and Week 12 after treatment
Change From Baseline in MAS Score of Primary Target Clinical Pattern at Week 1, Week 8, Week 12
Measured: Week 1, Week 8 and Week 12 after treatment
Response Rates on MAS Calculated for the Primary Target Clinical Pattern at Week 1, Week 4, Week 8 and Week 12
Primary target clinical pattern was defined by investigator for each subject at baseline visit and was either flexed elbow or flexed wrist or clenched fist.
Subjects with a MAS reduction of one point were defined as responder.
Measured: Week 1, Week 4, Week 8 and Week 12 after treatment
Changes From Baseline in Disability Assessment Scale (DAS)- Principal Therapeutic Target Domain at Week 1, Week 4, Week 8 and Week 12
The DAS consists of the four domains hygiene, dressing, limb position and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).
Measured: Week 1, Week 4, Week 8 and Week 12 after treatment
Incidence of Adverse Events and Serious Adverse Events
Measured: Within 12 weeks of treatment
Incidence of Anti-drug Antibodies and Neutralizing Antibodies
Measured: Within 12 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2025
- Study start14 Sep 2024
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Limb 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Placebo- and active-controlled
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 254 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chongqing Claruvis Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xinhua Wan, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06783114
- Sponsor's protocol ID
- YY001-002-CN01
- Status last verified
- Jan 2026
- First submitted
- 14 Jan 2025
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study to Evaluate the Efficacy and Safety of Recombinant Botulinum Toxin Type A (YY001) for Injection in The Treatment of Upper Limb Spasticity in Adults (REHAB-1)
- ClinicalTrials.gov ID
- NCT06783114
- Acronym / sponsor ID
- YY001-002-CN01
- Conditions
- Upper Limb Spasticity
- Keywords
- YY001, Recombinant Botulinum Toxin Type A, Botulinum Toxin, Upper limb spasticity
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 254 participants (estimated)
- Lead sponsor
- Chongqing Claruvis Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 14 Sep 2024 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 20 Jan 2025 (actual)
- 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 randomized, double-blind, multi-center phase II/III study to evaluate the efficacy and safety of Recombinant Botulinum Toxin Type A (YY001) for injection in the treatment of upper limb spasticity in adults
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Placebo- and active-controlled
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Biological: Recombinant Botulinum Toxin Type A for injection (YY001)Single injection with Recombinant Botulinum Toxin Type A for injection (YY001) in upper limb spasticity |
| Active-Controlled Group | Active comparator | Biological: BOTOX®Single injection with BOTOX® in upper limb spasticity |
| Placebo-Controlled Group | Placebo comparator | Biological: PlaceboSingle injection with placebo in upper limb spasticity |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age between 18 and 75 years old inclusive, at the time of signing the informed consent, regardless of gender.
- Subjects with unilateral hemiplegia due to stroke (with a time interval of ≥ 3 months from stroke onset to randomized enrollment) exhibiting upper limb spasticity.
- Subjects with Disability Assessment Scale score of at least 2 on the Principal Target of Treatment (one of four functional domains: hygiene, dressing, limb position and pain).
- If taking oral antispasticity, the dosage must be stable for at least 1 month prior to randomized enrollment.
- If the study limb receives physical therapy or occupational therapy, the frequency, type, and intensity must be stable for at least 3 weeks prior to randomized enrollment.
Key exclusion criteria (9 listed)
- History of allergy to any component of the experimental drugs.
- Previous use of any botulinum toxin within 6 months prior to randomized enrollment, or plan to use other botulinum toxins not specified in the study protocol during the study.
- Fixed contractures of the studied limb.
- Any medical condition that may increase the risk to the subject when using Botulinum Toxin Type A.
- Need for treatment with drugs that interfere with neuromuscular function during the study.
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 |
|---|---|---|
| Recombinant Botulinum Toxin Type A for injection (YY001)Single treatment, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), intramuscular injection, the total injection dose is 200-400 U. | Biological | Treatment Group |
| BOTOX®Single treatment, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), intramuscular injection, the total injection dose is 200 U. | Biological | Active-Controlled Group |
| PlaceboSingle treatment, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), intramuscular injection. | Biological | Placebo-Controlled Group |
Primary outcome
Change From Baseline in Modified Ashworth Scale (MAS) Score of Primary Target Clinical Pattern at Week 4
Time frame: Week 4 after treatment
Primary target clinical pattern was defined by investigator for each subject at baseline visit and was either flexed elbow or flexed wrist or clenched fist. The Modified Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 6-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).
6 secondary outcomes
Physician's Global Assessment (PGA) Score at Week 1, Week 4, Week 8 and Week 12
Time frame: Week 1, Week 4, Week 8 and Week 12 after treatment
Change From Baseline in MAS Score of Primary Target Clinical Pattern at Week 1, Week 8, Week 12
Time frame: Week 1, Week 8 and Week 12 after treatment
Response Rates on MAS Calculated for the Primary Target Clinical Pattern at Week 1, Week 4, Week 8 and Week 12
Time frame: Week 1, Week 4, Week 8 and Week 12 after treatment
Changes From Baseline in Disability Assessment Scale (DAS)- Principal Therapeutic Target Domain at Week 1, Week 4, Week 8 and Week 12
Time frame: Week 1, Week 4, Week 8 and Week 12 after treatment
Incidence of Adverse Events and Serious Adverse Events
Time frame: Within 12 weeks of treatment
Incidence of Anti-drug Antibodies and Neutralizing Antibodies
Time frame: Within 12 weeks of treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
- 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.
Xinhua Wan principal investigator
Peking Union Medical College Hospital
24 sites 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 Recombinant Botulinum Toxin Type A for injection (YY001) and BOTOX® in people with Upper Limb Spasticity, run by Chongqing Claruvis Pharmaceutical Co., Ltd. at 24 sites in China.
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 5 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: looking for participants now, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in China. 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jieru Bai (+86 13883955310, bai.jieru@claruvis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Modified Ashworth Scale (MAS) Score of Primary Target Clinical Pattern at Week 4 (time frame: Week 4 after treatment). 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 22 Jan 2026.