Upper Limb SpasticityPhase 3NCT07478822
A Study on Recombinant Botulinum Toxin Type A (YY001) for Injection in Multiple Treatments of Adult Upper Limb Spasticity
A Phase 3 study testing Recombinant botulinum toxin type A for injection (YY001) in people with Upper Limb Spasticity, run by Chongqing Claruvis Pharmaceutical Co., Ltd. at 16 sites in China.
Trial summary
This is an open-label, multicenter, phase III clinical study to evaluate the long-term safety and efficacy of multiple treatments with recombinant botulinum toxin type A (YY001) for injection in adult upper limb spasticity 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)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 16 sitesChina
- Study dates
- 27 Mar 2026to 1 Jun 2027
- Phase
- Phase 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 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).
Who cannot join
- History of allergy to any component of the experimental drugs.
- Previous use of any botulinum toxin within 6 months prior to 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.
Show all 9Show fewer
- History of epilepsy.
- Pregnant or breastfeeding women.
- Participation in other drug/device clinical trials within 1 month prior to enrollment.
Trial locations and contacts
16 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Xiaoyun Sun contact
16 sites in 1 country
China16 sites, 16 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing
Xinhua Wan
- Recruiting
West China Hospital，Sichuan University
Chengdu
Huifang Shang
- Recruiting
Guangdong Provincial People's Hospital
Guangdong
Jiehao Zhao
- Recruiting
Sun Yat-sen Memorial Hospital
Guangzhou
Shaoling Wu
- Recruiting
The Second People's Hospital of Hefei
Hefei
Juncang Wu
- Recruiting
Huai'an First Hospital Affiliated to Nanjing Medical University
Huai'an
Yujun Qi
- Recruiting
The First Affiliated Hospital of Henan University
Kaifeng
Qingyan Qin
- Recruiting
The Second Affiliated Hospital of Kunming Medical University
Kunming
Liqing Yao
- Recruiting
Shanghai Fudan University HuaShan Hospital
Shanghai
Fang Li
- Recruiting
Yangzhi Affiliated Rehabilitation Hospital of Tongji University
Shanghai
Lingjing Jin
- Recruiting
Shenzhen Second People's Hospital
Shenzhen
Jianjun Long
- Recruiting
The First Affiliated Hospital of Soochow University
Suzhou
Qi Fang
- Recruiting
Shanxi Bethune Hospital
Taiyuan
pingzhi Wang
- Recruiting
Tianjin Medical University General Hospital
Tianjin
Xiaodong Zhu
- Recruiting
Xuzhou Medical University Affiliated Hospital
Xuzhou
Jie Xiang
- Recruiting
Zibo Municipal Hospital
Zibo
Runming Sun
About this study
Official title: An Open-label, Multicenter Clinical Study on The Long-term Safety and Efficacy of Multiple Treatments With Recombinant Botulinum Toxin Type A (YY001) for Injection in Adult Upper Limb Spasticity (REHAB-2)
This is an open-label, multicenter, phase III clinical study to evaluate the long-term safety and efficacy of multiple treatments with recombinant botulinum toxin type A (YY001) for injection in adult upper limb spasticity
- Conditions
- Upper Limb Spasticity
- Being tested
- Recombinant botulinum toxin type A for injection (YY001)
- Keywords
- Botulinum Toxin, Recombinant Botulinum Toxin Type A, YY001, 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
Prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), intramuscular injection, the total injection dose for single treatment is 200 to 400 U.
| Study group | Role | What they receive |
|---|---|---|
| Recombinant botulinum toxin type A (YY001) | Experimental | Multiple injection with recombinant botulinum toxin type A for injection (YY001) in upper limb spasticity Receives: Biological: Recombinant botulinum toxin type A for injection (YY001) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events and Serious Adverse Events
Measured: Up to 48 weeks
Secondary outcomes (5)
Physician's Global Assessment (PGA) Score
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: Weeks 1, 4, 8, 12, 16, 20 and 24 after each treatment
Change From Baseline in MAS Score of Primary Target Clinical Pattern
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: Weeks 1, 4, 8, 12, 16, 20 and 24 after each treatment
Response Rates on MAS Calculated for the Primary Target Clinical Pattern
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: Weeks 1, 4, 8, 12, 16, 20 and 24 after each treatment
The Proportion with Disability Assessment Scale (DAS)- Principal Therapeutic Target Domain Score Reduction of ≥1 Point
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: Weeks 1, 4, 8, 12, 16, 20 and 24 after each treatment
Incidence of Anti-drug Antibodies and Neutralizing Antibodies
Measured: Up to 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2026
- Study start27 Mar 2026
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jun 2027 (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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chongqing Claruvis Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07478822
- Sponsor's protocol ID
- YY001-002-CN02
- Status last verified
- Mar 2026
- First submitted
- 11 Mar 2026
- Last updated
- 2 Apr 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 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multicenter Clinical Study on The Long-term Safety and Efficacy of Multiple Treatments With Recombinant Botulinum Toxin Type A (YY001) for Injection in Adult Upper Limb Spasticity (REHAB-2)
- ClinicalTrials.gov ID
- NCT07478822
- Acronym / sponsor ID
- YY001-002-CN02
- Conditions
- Upper Limb Spasticity
- Keywords
- Botulinum Toxin, Recombinant Botulinum Toxin Type A, YY001, Upper limb spasticity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Chongqing Claruvis Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 27 Mar 2026 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 18 Mar 2026 (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 an open-label, multicenter, phase III clinical study to evaluate the long-term safety and efficacy of multiple treatments with recombinant botulinum toxin type A (YY001) for injection in adult upper limb spasticity
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Recombinant botulinum toxin type A (YY001) | Experimental | Biological: Recombinant botulinum toxin type A for injection (YY001)Multiple injection with recombinant botulinum toxin type A for injection (YY001) 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 (3 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 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).
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 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)Prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), intramuscular injection, the total injection dose for single treatment is 200 to 400 U. | Biological | Recombinant botulinum toxin type A (YY001) |
Primary outcome
Incidence of Adverse Events and Serious Adverse Events
Time frame: Up to 48 weeks
5 secondary outcomes
Physician's Global Assessment (PGA) Score
Time frame: Weeks 1, 4, 8, 12, 16, 20 and 24 after each treatment
Change From Baseline in MAS Score of Primary Target Clinical Pattern
Time frame: Weeks 1, 4, 8, 12, 16, 20 and 24 after each treatment
Response Rates on MAS Calculated for the Primary Target Clinical Pattern
Time frame: Weeks 1, 4, 8, 12, 16, 20 and 24 after each treatment
The Proportion with Disability Assessment Scale (DAS)- Principal Therapeutic Target Domain Score Reduction of ≥1 Point
Time frame: Weeks 1, 4, 8, 12, 16, 20 and 24 after each treatment
Incidence of Anti-drug Antibodies and Neutralizing Antibodies
Time frame: Up to 48 weeks
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 2 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for Upper Limb Spasticity
RecruitingPhase 1
Shockwave for Elbow and Wrist Spasticity in People With Spinal Cord Injury
Spinal Cord Injury, Spasticity
Active, not recruitingPhase 3
Study to Compare the Efficacy and Safety of NT 201 (Botulinum Toxin) With Placebo for the Treatment of Lower Limb Spasticity Caused by Stroke or Traumatic Brain Injury
Lower Limb or Combined Lower Limb and Upper Limb Spasticity Due to Stroke or Traumatic Brain Injury
Active, not recruiting
FlexWave Trial: Efficacy of Extracorporeal Shock Wave Therapy in Post-Stroke Upper Limb Spasticity
Stroke, Spasticity, Muscle
Not yet recruiting
Virtual Reality-Augmented Constraint-Induced Movement Therapy Versus Conventional Constraint-Induced Therapy for Upper Limb Rehabilitation in Children With Unilateral Cerebral Palsy.
Cerebral Palsy Spastic Hemiplegic, Functionnal Neurological Disorder
RecruitingPhase 2
A Pilot Study to Evaluate the Efficacy, Safety and Tolerability of BMS-986368, a FAAH/MAGL Inhibitor, in Participants With Post-Stroke Spasticity (The STIPS Study)
Post-Stroke Spasticity
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.
Xiaoyun Sun contact
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Recombinant botulinum toxin type A for injection (YY001) in people with Upper Limb Spasticity, run by Chongqing Claruvis Pharmaceutical Co., Ltd. at 16 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 3 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 2 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 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. 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?
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?
Incidence of Adverse Events and Serious Adverse Events (time frame: Up to 48 weeks). 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 2 Apr 2026.