Trial · NCT04871451
Extension Study of ABP-19000 to Evaluate Safety and Efficacy of Repeat Treatments of ABP-450 in Cervical Dystonia
NCT04871451, Phase 2, Completed, AEON Biopharma, Inc.; results first posted 2024-08-22
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Extension Study of ABP-19000 to Evaluate Safety and Efficacy of Repeat Treatments of ABP-450 in Cervical Dystonia. Trials, record NCT04871451. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04871451
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Extension Study of ABP-19000 to Evaluate Safety and Efficacy of Repeat Treatments of ABP-450 in Cervical Dystonia
- NCT number
- NCT04871451
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 51 participants, actual
- Lead sponsor
- AEON Biopharma, Inc.
- Conditions
- Cervical Dystonia
- Interventions
- ABP-450
- First posted
- 2021-05-04
- Last updated
- 2024-08-22
- Results first posted
- 2024-08-22
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 | Up to 52 weeks | The primary safety endpoint will be the incidence of treatment-related serious adverse events since the start of treatment by Treatment Group when dosed with ABP-450 between Low Dose and High Dose. |
| Secondary | Mean Change in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score | Four weeks after the dose of each cycle (4 cycles) | 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 Severity of the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) | Four weeks after the dose of each cycle (4 cycles) | 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 the Subscale Score of Disability of the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Spasmodic Torticollis Rating Scale (TWSTRS) | Four weeks after the dose of each cycle (4 cycles) | 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) | Four weeks after the dose of each cycle (4 cycles) | 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 Patient Global Impression of Change (PGI-C) | Four weeks after the dose of each cycle (4 cycles) | The Patient Global Impression of Change (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". For the analysis, the data was transformed to a linear 7 point scale where 1 = much better and 7 = much worse. 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) | Four weeks after the dose of each cycle (4 cycles) | The Clinical Global Impression of Change (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". For the analysis, the data was transformed to a linear 7 point scale where 1 = much better and 7 = much worse. 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 | Up to 52 weeks | The safety analysis set consisted of all patients who received at least 1 dose of ABP-450. The safety analysis set was used to analyze all safety data. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Mean Change in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score | Four weeks after the dose of each cycle (4 cycles) | Included all patients in the safety analysis set, but excluded patients who had significant changes to their stable background medication, received a dose outside the dose range or received alternative or prohibited medications, or did not receive at least 1 treatment of ABP-450 during the OLE study. The number of participants in each treatment cycle could change due to dose multiplication, however for the outcome measure data table the numbers reflect cycle 1. | units on a scale | MEAN |
| SECONDARY | Mean Change in the Subscale Score of Severity of the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) | Four weeks after the dose of each cycle (4 cycles) | Included all patients in the safety analysis set, but excluded patients who had significant changes to their stable background medication, received a dose outside the dose range or received alternative or prohibited medications, or did not receive at least 1 treatment of ABP-450 during the OLE study. The number of participants in each treatment cycle could change due to dose multiplication, however for the outcome measure data table the numbers reflect cycle 1. | units on a scale | MEAN |
| SECONDARY | Mean Change in the Subscale Score of Disability of the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Spasmodic Torticollis Rating Scale (TWSTRS) | Four weeks after the dose of each cycle (4 cycles) | Included all patients in the safety analysis set, but excluded patients who had significant changes to their stable background medication, received a dose outside the dose range or received alternative or prohibited medications, or did not receive at least 1 treatment of ABP-450 during the OLE study. The number of participants in each treatment cycle could change due to dose multiplication, however for the outcome measure data table the numbers reflect cycle 1. | units on a scale | MEAN |
| SECONDARY | Mean Change in the Subscale Score of Pain of the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) | Four weeks after the dose of each cycle (4 cycles) | Included all patients in the safety analysis set, but excluded patients who had significant changes to their stable background medication, received a dose outside the dose range or received alternative or prohibited medications, or did not receive at least 1 treatment of ABP-450 during the OLE study. The number of participants in each treatment cycle could change due to dose multiplication, however for the outcome measure data table the numbers reflect cycle 1. | units on a scale | MEAN |
| SECONDARY | Mean Change in Patient Global Impression of Change (PGI-C) | Four weeks after the dose of each cycle (4 cycles) | Included all patients in the safety analysis set, but excluded patients who had significant changes to their stable background medication, received a dose outside the dose range or received alternative or prohibited medications, or did not receive at least 1 treatment of ABP-450 during the OLE study. The number of participants in each treatment cycle could change due to dose multiplication, however for the outcome measure data table the numbers reflect cycle 1. | units on a scale | MEAN |
| SECONDARY | Mean Change in Clinical Global Impression of Change (CGI-C) | Four weeks after the dose of each cycle (4 cycles) | Included all patients in the safety analysis set, but excluded patients who had significant changes to their stable background medication, received a dose outside the dose range or received alternative or prohibited medications, or did not receive at least 1 treatment of ABP-450 during the OLE study. The number of participants in each treatment cycle could change due to dose multiplication, however for the outcome measure data table the numbers reflect cycle 1. | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group93
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 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 in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score | ABP-450 - 150U | Baseline | 41.58 | Standard Deviation 9.369 | units on a scale |
| Mean Change in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score | ABP-450 - 250U | Baseline | 42.87 | Standard Deviation 6.631 | units on a scale |
| Mean Change in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score | ABP-450 - 350U | Baseline | 45.63 | Standard Deviation 5.483 | units on a scale |
| Mean Change in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score | ABP-450 - 150U | Cycle 1, Week 4 | 27.54 | Standard Deviation 15.873 | units on a scale |
| Mean Change in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score | ABP-450 - 250U | Cycle 1, Week 4 | 28.47 | Standard Deviation 12.743 | units on a scale |
| Mean Change in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score | ABP-450 - 350U | Cycle 1, Week 4 | 34.17 | Standard Deviation 6.166 | units on a scale |
| Mean Change in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score | ABP-450 - 150U | Cycle 2, Week 4 | 31.17 | Standard Deviation 15.205 | units on a scale |
1 to 10 of 93Source ClinicalTrials.gov
See all 93 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | ABP-450 - 150U | 25 | |
| Overall Study | STARTED | ABP-450 - 250U | 17 | |
| Overall Study | STARTED | ABP-450 - 350U | 9 | |
| Overall Study | COMPLETED | ABP-450 - 150U | 18 | |
| Overall Study | COMPLETED | ABP-450 - 250U | 15 | |
| Overall Study | COMPLETED | ABP-450 - 350U | 7 | |
| Overall Study | NOT COMPLETED | ABP-450 - 150U | 7 | |
| Overall Study | NOT COMPLETED | ABP-450 - 250U | 2 | |
| Overall Study | NOT COMPLETED | ABP-450 - 350U | 2 |
Source ClinicalTrials.gov
Adverse events63
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 | COVID-19 | Infections and infestations | ABP-450 - 150U | 6 | 25 | |
| other | COVID-19 | Infections and infestations | ABP-450 - 250U | 4 | 17 | |
| other | COVID-19 | Infections and infestations | ABP-450 - 350U | 1 | 9 | |
| other | Nasopharyngitis | Infections and infestations | ABP-450 - 150U | 0 | 25 | |
| other | Nasopharyngitis | Infections and infestations | ABP-450 - 250U | 2 | 17 | |
| other | Nasopharyngitis | Infections and infestations | ABP-450 - 350U | 1 | 9 | |
| other | Sinusitis | Infections and infestations | ABP-450 - 150U | 1 | 25 | |
| other | Sinusitis | Infections and infestations | ABP-450 - 250U | 2 | 17 | |
| other | Sinusitis | Infections and infestations | ABP-450 - 350U | 0 | 9 | |
| other | Upper Respiratory tract infection | Infections and infestations | ABP-450 - 150U | 2 | 25 |
1 to 10 of 63Source ClinicalTrials.gov
See all 63 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | ABP-450 - 150U | 0 | 25 |
| Total, all-cause mortality | ABP-450 - 250U | 0 | 17 |
| Total, all-cause mortality | ABP-450 - 350U | 0 | 9 |
| Total, other adverse events | ABP-450 - 150U | 16 | 25 |
| Total, other adverse events | ABP-450 - 250U | 15 | 17 |
| Total, other adverse events | ABP-450 - 350U | 7 | 9 |
| Total, serious adverse events | ABP-450 - 150U | 0 | 25 |
| Total, serious adverse events | ABP-450 - 250U | 0 | 17 |
| Total, serious adverse events | ABP-450 - 350U | 0 | 9 |
Source ClinicalTrials.gov
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.
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/NCT04871451
GET https://conductscience.org/api/trials/v1/NCT04871451/results?page=2