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This Open-label Extension trial will evaluate the safety and efficacy of ABP-450 for the treatment of cervical dystonia in adults. The study will enroll 60 patients across approximately 42 sites in the United States from Phase 2 (ABP-19000) trial. Study subjects who had their initial dose of study drug in the Phase 2 trial, irrespective of treatment allocation, will be eligible to enroll in this OLE study.
This Open-label Extension trial will evaluate the safety and efficacy of ABP-450 for the treatment of cervical dystonia in adults. The study will enroll 60 patients across approximately 42 sites in the United States from Phase 2 (ABP-19000) trial. Study subjects who had their initial dose of study drug in the Phase 2 trial, irrespective of treatment allocation, will be eligible to enroll in this OLE study. Study subjects will receive a predetermined dose of ABP-450 between the Low Dose and High Dose, based on the investigator's discretion and clinical judgment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ABP-450 - Between Low Dose and High Dose | Experimental | ABP-450 Between Low Dose and High Dose - Intramuscular injections into affected neck muscles with investigator's determined dose within the range of low dose and high dose - 4 injection cycles at 3-month intervals. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABP-450 | Drug | ABP-450 (prabotulinumtoxinA) contains a 900kDA botulinum toxin type-A complex produced by the bacterium Clostridium botulinum. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-related Serious Adverse Events | 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. | Up to 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score | 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cynthia Comella | Rush University Medical Center | Principal Investigator |
| Joseph Jankovic | Baylor St. Luke's Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Neuroscience Research | Phoenix | Arizona | 85032 | United States | ||
| Parkinson's and Movement Disorder Institute |
Individual Participant Data collected during the trial, after deidentification may be shared following review of the clinical study report by the FDA review division and if a decision is made to publish the results in a publication outside posting the results in clinicaltrials.gov
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Of the 57 who completed ABP-19000 study, 51 participants were dosed and 51were included in the modified full analysis set (mFAS) for the efficacy analysis.
Participants who completed ABP-19000 study had the option to roll over to this ABP-19002 study at the same site they were previously enrolled.
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| ID | Title | Description |
|---|---|---|
| FG000 | ABP-450 - 150U | ABP-450 Low Dose - Intramuscular injections into affected neck muscles. |
| FG001 | ABP-450 - 250U | ABP-450 Medium Dose - Intramuscular injections into affected neck muscles. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 13, 2021 | Jul 22, 2024 |
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Approximately 60 subjects from ABP-19000 study, irrespective of treatment allocation, will have the option to continue treatment with ABP-450 via intramuscular injection into affected neck muscles.
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|
| Four weeks after the dose of each cycle (4 cycles) |
| Mean Change in the Subscale Score of Severity of the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) | 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. | Four weeks after the dose of each cycle (4 cycles) |
| Mean Change in the Subscale Score of Disability of the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Spasmodic Torticollis Rating Scale (TWSTRS) | 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. | Four weeks after the dose of each cycle (4 cycles) |
| Mean Change in the Subscale Score of Pain of the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) | 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. | Four weeks after the dose of each cycle (4 cycles) |
| Mean Change in Patient Global Impression of Change (PGI-C) | 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. | Four weeks after the dose of each cycle (4 cycles) |
| Mean Change in Clinical Global Impression of Change (CGI-C) | 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. | Four weeks after the dose of each cycle (4 cycles) |
| Fountain Valley |
| California |
| 92708 |
| United States |
| Neuro Pain Medical Center | Fresno | California | 93710 | United States |
| Loma Linda University | Loma Linda | California | 92354 | United States |
| New England Institute for Neurology and Headache | Stamford | Connecticut | 06905 | United States |
| Infinity Clinical Research LLC | Hollywood | Florida | 33024 | United States |
| Brainstorm Research | Miami | Florida | 33176 | United States |
| University of South Florida | Tampa | Florida | 33613 | United States |
| Neurology One | Winter Park | Florida | 32792 | United States |
| Emory University | Atlanta | Georgia | 30329 | United States |
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
| Michigan State University | East Lansing | Michigan | 48824 | United States |
| Quest Research Institute - Hunt - PPDS | Farmington Hills | Michigan | 48334 | United States |
| University of New Mexico | Albuquerque | New Mexico | 87106 | United States |
| The Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| Cleveland Clinic Lou Ruvo Center for Brain Health | Cleveland | Ohio | 89106 | United States |
| The Orthopedic Foundation | New Albany | Ohio | 43054 | United States |
| Veracity Neuroscience LLC | Memphis | Tennessee | 38157 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| Baylor College of Medicine | Houston | Texas | 77030 | United States |
| FG002 | ABP-450 - 350U | ABP-450 High Dose - Intramuscular injections into affected neck muscles. |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | ABP-450 - 150U | ABP-450 Low Dose - Intramuscular injections into affected neck muscles. |
| BG001 | ABP-450 - 250U | ABP-450 Medium Dose - Intramuscular injections into affected neck muscles. |
| BG002 | ABP-450 - 350U | ABP-450 High Dose - Intramuscular injections into affected neck muscles. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Weight (kg) | Mean | Standard Deviation | kg |
| |||||||||||||||
| BMI | Mean | Standard Deviation | kg/m2 |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Treatment-related Serious Adverse Events | 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. | 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. | Posted | Count of Participants | Participants | Up to 52 weeks |
|
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| Secondary | Mean Change in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score | 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). | 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. | Posted | Mean | Standard Deviation | units on a scale | Four weeks after the dose of each cycle (4 cycles) |
| |||||||||||||||||||||||||||||||||
| Secondary | Mean Change in the Subscale Score of Severity of the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | Four weeks after the dose of each cycle (4 cycles) |
| |||||||||||||||||||||||||||||||||
| Secondary | Mean Change in the Subscale Score of Disability of the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Spasmodic Torticollis Rating Scale (TWSTRS) | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | Four weeks after the dose of each cycle (4 cycles) |
| |||||||||||||||||||||||||||||||||
| Secondary | Mean Change in the Subscale Score of Pain of the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | Four weeks after the dose of each cycle (4 cycles) |
| |||||||||||||||||||||||||||||||||
| Secondary | Mean Change in Patient Global Impression of Change (PGI-C) | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | Four weeks after the dose of each cycle (4 cycles) |
| |||||||||||||||||||||||||||||||||
| Secondary | Mean Change in Clinical Global Impression of Change (CGI-C) | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | Four weeks after the dose of each cycle (4 cycles) |
|
52 Weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ABP-450 - 150U | ABP-450 Low Dose - Intramuscular injections into affected neck muscles. | 0 | 25 | 0 | 25 | 16 | 25 |
| EG001 | ABP-450 - 250U | ABP-450 Medium Dose - Intramuscular injections into affected neck muscles. | 0 | 17 | 0 | 17 | 15 | 17 |
| EG002 | ABP-450 - 350U | ABP-450 High Dose - Intramuscular injections into affected neck muscles. | 0 | 9 | 0 | 9 | 7 | 9 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COVID-19 | Infections and infestations | Non-systematic Assessment |
| ||
| Nasopharyngitis | Infections and infestations | Non-systematic Assessment |
| ||
| Sinusitis | Infections and infestations | Non-systematic Assessment |
| ||
| Upper Respiratory tract infection | Infections and infestations | Non-systematic Assessment |
| ||
| Tooth Infection | Infections and infestations | Non-systematic Assessment |
| ||
| Herpes Zoster | Infections and infestations | Non-systematic Assessment |
| ||
| Neck Pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Myalgia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Rotator Cuff Syndrome | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Torticollis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Paresthesia | Nervous system disorders | Non-systematic Assessment |
| ||
| Headache | Nervous system disorders | Non-systematic Assessment |
| ||
| Migraine | Nervous system disorders | Non-systematic Assessment |
| ||
| Tremor | Nervous system disorders | Non-systematic Assessment |
| ||
| Dysphagia | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Fall | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Tooth Fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Blood Cholesterol Increased | Investigations | Non-systematic Assessment |
| ||
| Injection site pain | General disorders | Non-systematic Assessment |
| ||
| Vertigo | Ear and labyrinth disorders | Non-systematic Assessment |
| ||
| Anxiety | Psychiatric disorders | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dana Testa, PharmD | AEON Biopharma, Inc. | 949-354-6499 | dt@aeonbiopharma.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 24, 2023 | Jul 22, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D014103 | Torticollis |
| ID | Term |
|---|---|
| D004421 | Dystonia |
| D020820 | Dyskinesias |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000630868 | prabotulinumtoxin A |
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| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| OG002 |
| ABP-450 - 350U |
ABP-450 High Dose - Intramuscular injections into affected neck muscles. |
|
|
ABP-450 High Dose - Intramuscular injections into affected neck muscles.
|
|
ABP-450 High Dose - Intramuscular injections into affected neck muscles.
|
|
|
|
| OG002 | ABP-450 - 350U | ABP-450 High Dose - Intramuscular injections into affected neck muscles. |
|
|
| OG002 | ABP-450 - 350U | ABP-450 High Dose - Intramuscular injections into affected neck muscles. |
|
|