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NCT Number: NCT06783114

A Clinical Study on Recombinant Botulinum Toxin Type A (YY001) for Injection in The Treatment of Upper Limb Spasticity in Adults

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

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Key information

Conditions

Upper Limb Spasticity

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Anhui Provincial Hospital, Hefei, Anhui, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.
  • History of epilepsy.
  • Pregnant or breastfeeding women.
  • Participation in other drug/device clinical trials within 1 month prior to randomized enrollment.

Treatment and study plan

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.

Placebo

Biological

Single treatment, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), intramuscular injection.

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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

    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.

  2. 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

  3. 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

    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.

  4. 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

    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).

  5. Incidence of Adverse Events and Serious Adverse Events

    Time frame: Within 12 weeks of treatment

  6. Incidence of Anti-drug Antibodies and Neutralizing Antibodies

    Time frame: Within 12 weeks of treatment

Study contacts

Contact information is provided by the study sponsor or research team.

Jieru Bai

CONTACT

[email protected]

+86 13883955310

Xiaoyun Sun, Ph.D

CONTACT

[email protected]

+86 13810399273

Sponsors and collaborators

Lead sponsor

Chongqing Claruvis Pharmaceutical Co., Ltd.

Industry

Registry information

Official study 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)

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jan 20, 2025
Registry last updated
Jan 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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