New shot could loosen stiff arms after stroke
NCT ID NCT06783114
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new injection called YY001 (a type of botulinum toxin) to reduce muscle stiffness in the arm or hand of adults who had a stroke. About 254 people will receive either the study drug or a placebo to see if it improves movement and daily tasks like dressing or hygiene. The goal is symptom relief, not a cure.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2/3
Runs two stages together: whether the treatment works, then large-scale confirmation.
- Participants
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About 254 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2024
- Expected to finish
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Sep 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age between 18 and 75 years old inclusive, at the time of signing the informed consent, regardless of gender. 2. Subjects with unilateral hemiplegia due to stroke (with a time interval of ≥ 3 months from stroke onset to randomized enrollment) exhibiting upper limb spasticity. 3. 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). 4. If taking oral antispasticity, the dosage must be stable for at least 1 month prior to randomized enrollment. 5. 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. Exclusion Criteria: 1. History of allergy to any component of the experimental drugs. 2. 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. 3. Fixed contractures of the studied limb. 4. Any medical condition that may increase the risk to the subject when using Botulinum Toxin Type A. 5. Need for treatment with drugs that interfere with neuromuscular function during the study. 6. Plan or anticipate to use new antispasticity drugs during the study. 7. History of epilepsy. 8. Pregnant or breastfeeding women. 9. Participation in other drug/device clinical trials within 1 month prior to randomized enrollment.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
24 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Anhui Provincial Hospital
RECRUITINGHefei, Anhui, China
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Chongqing Traditional Chinese Medicine Hospital
RECRUITINGChongqing, Chongqing Municipality, China
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Guangdong Provincial People's Hospital
RECRUITINGGuangzhou, Guangdong, China
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Huai'an First People's Hospital
RECRUITINGHuai'an, Jiangsu, China
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Peking Union Medical College Hospital
RECRUITINGBeijing, Beijing Municipality, China
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Qilu Hospital of Shandong University
RECRUITINGQingdao, Shandong, China
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RenMin Hospital Of Wuhan University
RECRUITINGWuhan, Hubei, China
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Rui Jin Hospital of Shanghai Jiao Tong University School of Medicine
RECRUITINGShanghai, Shanghai Municipality, China
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Shanghai Fudan University HuaShan Hospital
RECRUITINGShanghai, Shanghai Municipality, China
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Shanxi Bethune Hospital
RECRUITINGTaiyuan, Shanxi, China
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Shanxi provincial people's Hospital
RECRUITINGTaiyuan, Shanxi, China
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Shenzhen Second People's Hospital
RECRUITINGShenzhen, Guangdong, China
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Sun Yat-sen Memorial Hospital
RECRUITINGGuangzhou, Guangdong, China
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The First Affiliated Hospital of Chongqing Medical University
RECRUITINGChongqing, Chongqing Municipality, China
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The First Affiliated Hospital of Henan University
RECRUITINGKaifeng, Henan, China
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The First Affiliated Hospital of Soochow University
RECRUITINGSuzhou, Jiangsu, China
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The Fourth Affiliated Hospital of Soochow University
RECRUITINGSuzhou, Jiangsu, China
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The Second Affiliated Hospital of Kunming Medical University
RECRUITINGKunming, Yunnan, China
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The Second People's Hospital of Hefei
RECRUITINGHefei, Anhui, China
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Tianjin Medical University General Hospital
RECRUITINGTianjin, Tianjin Municipality, China
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West China Hospital,Sichuan University
RECRUITINGChengdu, Sichuan, China
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Xuzhou Medical University Affiliated Hospital
RECRUITINGXuzhou, Jiangsu, China
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Yangzhi Affiliated Rehabilitation Hospital of Tongji University
RECRUITINGShanghai, Shanghai Municipality, China
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Zibo Municipal Hospital
RECRUITINGZibo, Shandong, China
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