Trial · NCT03821402

Efficacy and Safety of DaxibotulinumtoxinA for Injection for the Treatment of Adult Upper Limb Spasticity

NCT03821402, Phase 2, Completed, Revance Therapeutics, Inc.; results first posted 2023-09-21

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Efficacy and Safety of DaxibotulinumtoxinA for Injection for the Treatment of Adult Upper Limb Spasticity. Trials, record NCT03821402. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03821402

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Trial

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

Title: Efficacy and Safety of DaxibotulinumtoxinA for Injection for the Treatment of Adult Upper Limb Spasticity
NCT number: NCT03821402
Status: Completed
Phases: Phase 2
Enrollment: 83 participants, actual
Lead sponsor: Revance Therapeutics, Inc.
Conditions: Upper Limb Spasticity
Interventions: DAXI for injection 250 U, DAXI for injection 375 U, DAXI for injection 500 U, Placebo
First posted: 2019-01-29
Last updated: 2023-09-21
Results first posted: 2023-09-21

Source ClinicalTrials.gov

Registered outcomes6

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

List	Outcome	Time frame	Description
Primary	Change From Baseline at Week 6 on the Modified Ashworth Scale (MAS) in the Suprahypertonic Muscle Group (SMG) Score	Week 6	Mean change from baseline at Week 6 in muscle tone measured with the Modified Ashworth Scale (MAS) in the Suprahypertonic Muscle Group (SMG) in one of the following: elbow, wrist, or finger flexors. Score range: 0 (Normal tone, no in tone) to 4 (Affected part{s} rigid in flexion or extension).
Primary	Physician Global Impression of Change (PGIC) Score	Week 6	Mean score on the Physician Global Impression of Change (PGIC) score at week 6. The PGIC is a single-item, 9-point scale that measures the physician's impression of improvement following treatment. Score range: -4 (Markedly worse) to +4 (Markedly improved).
Secondary	Muscle Tone Improvement Responder Rate	Weeks 6 and 12	Percentage of subjects who improve by a full point on the Modified Ashworth Scale (MAS) in the Suprahypertonic Muscle Group (SMG). Score range: 0 (Normal tone, no increase in tone) to 4 (Affected part(s) rigid in flexion or extension)
Secondary	Physician Global Impression of Change (PGIC) Responder Rate	Weeks 6 and 12	Percentage of subjects with improvement (i.e., a score of 1 to 4) on the Physician Global Impression of Change (PGIC). The PGIC is a single-item, 9-point scale that measures the physician's impression of improvement following treatment. Score range: -4 (Markedly worse) to +4 (Markedly improved). Scores of 1 or more indicate improvement following treatment.
Secondary	Change From Baseline at Weeks 6 and 12 on the Disability Assessment Scale (DAS) Functional Impairment	Weeks 6 and 12	Change from Baseline at Weeks 6 and 12 in functional impairment as measured by the Disability Assessment Scale (DAS) for the principal treatment target (PTT). DAS score range: 0 (No disability) to 3 (Severe disability - normal activities limited).
Secondary	Duration of Effect	Up to 36 weeks	Duration of effect is defined as time from injection (in weeks) until loss of muscle tone improvement in the SMG, as indicated by a reduction from baseline in MAS score of \< 1-point and PGIC score is ≤ 0.

Source ClinicalTrials.gov

Outcomes8

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline at Week 6 on the Modified Ashworth Scale (MAS) in the Suprahypertonic Muscle Group (SMG) Score	Week 6	Intent to treat population	score on a scale	LEAST_SQUARES_MEAN
PRIMARY	Physician Global Impression of Change (PGIC) Score	Week 6	Intent to treat population	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Muscle Tone Improvement Responder Rate	Weeks 6 and 12	Intent to treat population	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Physician Global Impression of Change (PGIC) Responder Rate	Weeks 6 and 12	Intent to treat population	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Change From Baseline at Weeks 6 and 12 on the Disability Assessment Scale (DAS) Functional Impairment	Weeks 6 and 12	Intent to treat population	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Duration of Effect	Up to 36 weeks	Intent to treat population	weeks	MEDIAN
POST_HOC	Change From Baseline at Week 4 in the Suprahypertonic Muscle Group (SMG) Score	Week 4	Intent to treat population	score on a scale	LEAST_SQUARES_MEAN
POST_HOC	Change From Baseline at Week 4 in the Physician Global Impression of Change (PGIC) Score	Week 4	Intent to treat population	score on a scale	LEAST_SQUARES_MEAN

Source ClinicalTrials.gov

Results by group44

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

Outcome	Group	Category	Value	Spread	Units
Change From Baseline at Week 6 on the Modified Ashworth Scale (MAS) in the Suprahypertonic Muscle Group (SMG) Score	DAXI 250 U		-0.9	Standard Error 0.25	score on a scale
Change From Baseline at Week 6 on the Modified Ashworth Scale (MAS) in the Suprahypertonic Muscle Group (SMG) Score	DAXI 375 U		-1.0	Standard Error 0.26	score on a scale
Change From Baseline at Week 6 on the Modified Ashworth Scale (MAS) in the Suprahypertonic Muscle Group (SMG) Score	DAXI 500 U		-1.5	Standard Error 0.27	score on a scale
Change From Baseline at Week 6 on the Modified Ashworth Scale (MAS) in the Suprahypertonic Muscle Group (SMG) Score	Placebo		-0.8	Standard Error 0.26	score on a scale
Physician Global Impression of Change (PGIC) Score	DAXI 250 U		1.5	Standard Error 0.29	score on a scale
Physician Global Impression of Change (PGIC) Score	DAXI 375 U		1.7	Standard Error 0.30	score on a scale
Physician Global Impression of Change (PGIC) Score	DAXI 500 U		1.7	Standard Error 0.32	score on a scale
Physician Global Impression of Change (PGIC) Score	Placebo		1.2	Standard Error 0.28	score on a scale
Muscle Tone Improvement Responder Rate	DAXI 250 U	Week 6	13		Participants
Muscle Tone Improvement Responder Rate	DAXI 375 U	Week 6	11		Participants

1 to 10 of 44Source ClinicalTrials.gov

See all 44 results by group

Participant flow12

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

Period	Milestone	Group	Participants
Overall Study	STARTED	DAXI 250 U	22
Overall Study	STARTED	DAXI 375 U	19
Overall Study	STARTED	DAXI 500 U	18
Overall Study	STARTED	Placebo	24
Overall Study	COMPLETED	DAXI 250 U	15
Overall Study	COMPLETED	DAXI 375 U	12
Overall Study	COMPLETED	DAXI 500 U	15
Overall Study	COMPLETED	Placebo	18
Overall Study	NOT COMPLETED	DAXI 250 U	7
Overall Study	NOT COMPLETED	DAXI 375 U	7

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events144

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

Type	Event	Organ system	Group	Affected	At risk	Events
other	Muscular weakness	Musculoskeletal and connective tissue disorders	DAXI 250 U	2	22	2
other	Muscular weakness	Musculoskeletal and connective tissue disorders	DAXI 375 U	0	19	0
other	Muscular weakness	Musculoskeletal and connective tissue disorders	DAXI 500 U	1	18	1
other	Muscular weakness	Musculoskeletal and connective tissue disorders	Placebo	0	24	0
other	Anemia	Blood and lymphatic system disorders	DAXI 250 U	0	22	0
other	Anemia	Blood and lymphatic system disorders	DAXI 375 U	1	19	1
other	Anemia	Blood and lymphatic system disorders	DAXI 500 U	0	18	0
other	Anemia	Blood and lymphatic system disorders	Placebo	0	24	0
other	Vertigo	Ear and labyrinth disorders	DAXI 250 U	0	22	0
other	Vertigo	Ear and labyrinth disorders	DAXI 375 U	0	19	0

1 to 10 of 144Source ClinicalTrials.gov

See all 144 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	DAXI 250 U	0	22
Total, all-cause mortality	DAXI 375 U	0	19
Total, all-cause mortality	DAXI 500 U	0	18
Total, all-cause mortality	Placebo	0	24
Total, other adverse events	DAXI 250 U	4	22
Total, other adverse events	DAXI 375 U	12	19
Total, other adverse events	DAXI 500 U	6	18
Total, other adverse events	Placebo	4	24
Total, serious adverse events	DAXI 250 U	2	22
Total, serious adverse events	DAXI 375 U	0	19

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

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.

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GET https://conductscience.org/api/trials/v1/NCT03821402/results?page=2

API reference For AI assistants