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Trial · NCT07478822

A Study on Recombinant Botulinum Toxin Type A (YY001) for Injection in Multiple Treatments of Adult Upper Limb Spasticity

NCT07478822, Phase 3, Recruiting, Chongqing Claruvis Pharmaceutical Co., Ltd.

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. A Study on Recombinant Botulinum Toxin Type A (YY001) for Injection in Multiple Treatments of Adult Upper Limb Spasticity. Trials, record NCT07478822. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07478822

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
A Study on Recombinant Botulinum Toxin Type A (YY001) for Injection in Multiple Treatments of Adult Upper Limb Spasticity
NCT number
NCT07478822
Status
Recruiting
Phases
Phase 3
Enrollment
300 participants, estimated
Lead sponsor
Chongqing Claruvis Pharmaceutical Co., Ltd.
Conditions
Upper Limb Spasticity
Interventions
Recombinant botulinum toxin type A for injection (YY001)
First posted
2026-03-18
Last updated
2026-04-02

Source ClinicalTrials.gov

Registered outcomes6

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryIncidence of Adverse Events and Serious Adverse EventsUp to 48 weeks
SecondaryPhysician's Global Assessment (PGA) ScoreWeeks 1, 4, 8, 12, 16, 20 and 24 after each 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.
SecondaryChange From Baseline in MAS Score of Primary Target Clinical PatternWeeks 1, 4, 8, 12, 16, 20 and 24 after each 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).
SecondaryResponse Rates on MAS Calculated for the Primary Target Clinical PatternWeeks 1, 4, 8, 12, 16, 20 and 24 after each 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.
SecondaryThe Proportion with Disability Assessment Scale (DAS)- Principal Therapeutic Target Domain Score Reduction of ≥1 PointWeeks 1, 4, 8, 12, 16, 20 and 24 after each 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).
SecondaryIncidence of Anti-drug Antibodies and Neutralizing AntibodiesUp to 48 weeks

Outcomes0

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

None in this release.

Results by group0

Each measurement the trial posted, group by group, in the words and numbers it posted.

None in this release.

Participant flow0

How many started, completed or left each group, period by period.

None in this release.

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals0

The totals the trial posted for each group.

None in this release.

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT07478822

GET https://conductscience.org/api/trials/v1/NCT07478822/registered