Trial · NCT04849988

A Phase 2 Study to Evaluate the Safety and Efficacy of ABP-450 in the Treatment of Cervical Dystonia

NCT04849988, Phase 2, Completed, AEON Biopharma, Inc.; results first posted 2024-02-14

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Phase 2 Study to Evaluate the Safety and Efficacy of ABP-450 in the Treatment of Cervical Dystonia. Trials, record NCT04849988. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04849988

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Trial

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

Title: A Phase 2 Study to Evaluate the Safety and Efficacy of ABP-450 in the Treatment of Cervical Dystonia
NCT number: NCT04849988
Status: Completed
Phases: Phase 2
Enrollment: 61 participants, actual
Lead sponsor: AEON Biopharma, Inc.
Conditions: Cervical Dystonia
Interventions: ABP-450, Placebo
First posted: 2021-04-20
Last updated: 2024-02-14
Results first posted: 2024-02-14

Source ClinicalTrials.gov

Registered outcomes7

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

List	Outcome	Time frame	Description
Primary	Number of Participants With Treatment-Related Serious Adverse Events	Baseline up to 20 Weeks	The primary safety endpoint will be the number of participants with treatment-related serious adverse events since the start of treatment by Treatment Group when dosed with placebo, ABP-450 (low dose), ABP-450 (medium d dose), or ABP-450 (high dose).
Secondary	Mean Change of the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)-Total Score From Baseline to Week 4	Baseline to Week 4	The Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) scale is used to assess the severity of cervical Dystonia. The TWSTRS-total score has a minimum score of 0 and a maximum score of 85, where higher scores represent worse outcomes. It comprises 3 subscales, which are summated to get the total score: the Torticollis Severity Scale (minimum score of 0, maximum score of 35), the Disability Scale (minimum score of 0, maximum score of 30), and the Pain Scale (minimum score of 0, maximum score of 20).
Secondary	Mean Change in the Subscale Score of Disability of the Baseline Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) From Baseline to Week 4	Baseline to Week 4	The Disability subscale of the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) is used to assess the severity of disability in cervical dystonia. The disability subscale has a minimum score of 0 and maximum score of 30, where higher scores represent worse outcomes.
Secondary	Mean Change in the Subscale Score of Pain of the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) From Baseline to Week 4	Baseline to Week 4	The Pain subscale of the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) is used to assess the severity of pain in cervical dystonia. The pain subscale has a minimum score of 0 and maximum score of 20, where higher scores represent worse outcomes.
Secondary	Mean Change in the Subscale Score of Severity of the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) From Baseline to Week 4	Baseline to Week 4	The Severity subscale of the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) is used to assess the severity of torticollis in cervical dystonia. The severity subscale has a minimum score of 0 and maximum score of 35, where higher scores represent worse outcomes.
Secondary	Mean Change in Patient Global Impression of Change (PGI-C) From Baseline to Week 4	Baseline to Week 4	The PGI-C enables the patient to rate changes in their perception of their general health status over the duration of the assessment via a 7-point scale ranging from "much improved" to "much worse". The 7-point scale range is much improved (+3) to much worse (-3) with no change at "0". The mean change in the subject's assessment of the change in clinical status since the start of treatment measured by the Patients' Global Impression of Change (PGI-C) Scale was assessed by Treatment Group at Week 4.
Secondary	Mean Change in Clinical Global Impression of Change (CGI-C) From Baseline to Week 4	Baseline to Week 4	The CGI-C enables the patient to rate changes in their perception of their general health status over the duration of the assessment via a 7-point scale ranging from "much improved" to "much worse". The 7-point scale range is much improved (+3) to much worse (-3) with no change at "0". The mean change from Baseline in the Clinical Global Impression of Change (CGI-C) Score was assessed by Treatment Group at Week 4.

Source ClinicalTrials.gov

Outcomes7

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Participants With Treatment-Related Serious Adverse Events	Baseline up to 20 Weeks	All treated patients are accounted for in the Treatment-related Serious Adverse Events data table including the two patients with changes in background medications.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Mean Change of the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)-Total Score From Baseline to Week 4	Baseline to Week 4	Two patients were excluded from the analysis due to a change in their background medication.	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Mean Change in the Subscale Score of Disability of the Baseline Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) From Baseline to Week 4	Baseline to Week 4	Two patients were excluded from the analysis due to a change in their background medication.	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Mean Change in the Subscale Score of Pain of the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) From Baseline to Week 4	Baseline to Week 4	Two patients were excluded from the analysis due to a change in their background medication.	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Mean Change in the Subscale Score of Severity of the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) From Baseline to Week 4	Baseline to Week 4	Two patients were excluded from the analysis due to a change in their background medication.	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Mean Change in Patient Global Impression of Change (PGI-C) From Baseline to Week 4	Baseline to Week 4	Two patients were excluded from the analysis due to a change in their background medication.	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Mean Change in Clinical Global Impression of Change (CGI-C) From Baseline to Week 4	Baseline to Week 4	Two patients were excluded from the analysis due to a change in their background medication.	units on a scale	LEAST_SQUARES_MEAN

Source ClinicalTrials.gov

Results by group28

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

Outcome	Group	Value	Spread	Units
Number of Participants With Treatment-Related Serious Adverse Events	Placebo	0		Participants
Number of Participants With Treatment-Related Serious Adverse Events	ABP-450 - 150U	0		Participants
Number of Participants With Treatment-Related Serious Adverse Events	ABP-450 - 250U	0		Participants
Number of Participants With Treatment-Related Serious Adverse Events	ABP-450 - 350U	0		Participants
Mean Change of the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)-Total Score From Baseline to Week 4	Placebo	3.57	Standard Error 2.67	score on a scale
Mean Change of the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)-Total Score From Baseline to Week 4	ABP-450 - 150U	14.01	Standard Error 2.63	score on a scale
Mean Change of the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)-Total Score From Baseline to Week 4	ABP-450 - 250U	11.28	Standard Error 2.70	score on a scale
Mean Change of the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)-Total Score From Baseline to Week 4	ABP-450 - 350U	9.92	Standard Error 2.54	score on a scale
Mean Change in the Subscale Score of Disability of the Baseline Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) From Baseline to Week 4	Placebo	1.02	Standard Error 1.11	score on a scale
Mean Change in the Subscale Score of Disability of the Baseline Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) From Baseline to Week 4	ABP-450 - 150U	4.53	Standard Error 1.09	score on a scale

1 to 10 of 28Source ClinicalTrials.gov

See all 28 results by group

Participant flow32

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	15
Overall Study	STARTED	ABP-450 - 150U	15
Overall Study	STARTED	ABP-450 - 250U	16
Overall Study	STARTED	ABP-450 - 350U	15
Overall Study	Randomized But Not Dosed	Placebo	1
Overall Study	Randomized But Not Dosed	ABP-450 - 150U	1
Overall Study	Randomized But Not Dosed	ABP-450 - 250U	0
Overall Study	Randomized But Not Dosed	ABP-450 - 350U	0
Overall Study	Treated	Placebo	14
Overall Study	Treated	ABP-450 - 150U	14

1 to 10 of 32Source ClinicalTrials.gov

See all 32 participant flow

Adverse events88

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
other	Dysphagia	Gastrointestinal disorders	Placebo	0	14
other	Dysphagia	Gastrointestinal disorders	ABP-450 - 150U	0	14
other	Dysphagia	Gastrointestinal disorders	ABP-450 - 250U	2	16
other	Dysphagia	Gastrointestinal disorders	ABP-450 - 350U	3	15
other	Muscular Weakness	Gastrointestinal disorders	Placebo	0	14
other	Muscular Weakness	Gastrointestinal disorders	ABP-450 - 150U	2	14
other	Muscular Weakness	Gastrointestinal disorders	ABP-450 - 250U	1	16
other	Muscular Weakness	Gastrointestinal disorders	ABP-450 - 350U	1	15
other	Headache	Nervous system disorders	Placebo	1	14
other	Headache	Nervous system disorders	ABP-450 - 150U	2	14

1 to 10 of 88Source ClinicalTrials.gov

See all 88 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo	0	14
Total, all-cause mortality	ABP-450 - 150U	0	14
Total, all-cause mortality	ABP-450 - 250U	0	16
Total, all-cause mortality	ABP-450 - 350U	0	15
Total, other adverse events	Placebo	9	14
Total, other adverse events	ABP-450 - 150U	8	14
Total, other adverse events	ABP-450 - 250U	12	16
Total, other adverse events	ABP-450 - 350U	11	15
Total, serious adverse events	Placebo	0	14
Total, serious adverse events	ABP-450 - 150U	0	14

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.

GET https://conductscience.org/api/trials/v1/NCT04849988

GET https://conductscience.org/api/trials/v1/NCT04849988/results?page=2

API reference For AI assistants