Cervical Dystonia
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGABP-450
ABP-450 (prabotulinumtoxinA) contains a 900kDA botulinum toxin type-A complex produced by the bacterium Clostridium botulinum.
Sponsors
AEON Biopharma, Inc.
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Qualified for and had their initial dose of study drug in the ABP-19000 study. 2. Provided written informed consent to being treated for cervical dystonia with ABP-450. 3. Were a male or female patient between 18 and 75 years of age (inclusive) when they entered the ABP-19000 study. 4. Stated willingness to comply with all study procedures, including attendance at the study center for all study visits as scheduled and have technological capabilities to have tele visits.
Exclusion criteria
1. Participated in another interventional study during participation in this study. 2. Were a pregnant or lactating female, or female of child-bearing potential not willing to use an acceptable method of contraception (ie, intrauterine device, barrier methods with spermicide, or abstinence). 3. Would not benefit from treatment with ABP-450 for their cervical dystonia, in the investigator's opinion. 4. Viral or other active infection or any medical condition that, in the opinion of the investigator, classifies the patient as unsuitable for participation in the study or patients who do not seem to be in good general health at the time of Day 0 rollover, and prior to any investigational study drug administration.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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). |
| 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. |
| 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. |
| 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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 by arm
| Arm | Count |
|---|---|
| ABP-450 - 150U ABP-450 Low Dose - Intramuscular injections into affected neck muscles. | 25 |
| ABP-450 - 250U ABP-450 Medium Dose - Intramuscular injections into affected neck muscles. | 17 |
| ABP-450 - 350U ABP-450 High Dose - Intramuscular injections into affected neck muscles. | 9 |
| Total | 51 |
Baseline characteristics
| Characteristic | ABP-450 - 150U | ABP-450 - 250U | ABP-450 - 350U | Total |
|---|---|---|---|---|
| Age, Continuous | 54.5 years STANDARD_DEVIATION 12.72 | 58.0 years STANDARD_DEVIATION 10.3 | 52.6 years STANDARD_DEVIATION 11.96 | 55.3 years STANDARD_DEVIATION 11.77 |
| BMI | 28.02 kg/m2 STANDARD_DEVIATION 4.69 | 27.22 kg/m2 STANDARD_DEVIATION 4.96 | 31.69 kg/m2 STANDARD_DEVIATION 6.18 | 28.28 kg/m2 STANDARD_DEVIATION 5.13 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 2 Participants | 0 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 21 Participants | 15 Participants | 9 Participants | 45 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) White | 22 Participants | 16 Participants | 9 Participants | 47 Participants |
| Region of Enrollment United States | 25 participants | 17 participants | 9 participants | 51 participants |
| Sex: Female, Male Female | 17 Participants | 14 Participants | 3 Participants | 34 Participants |
| Sex: Female, Male Male | 8 Participants | 3 Participants | 6 Participants | 17 Participants |
| Weight (kg) | 78.71 kg STANDARD_DEVIATION 15.18 | 73.6 kg STANDARD_DEVIATION 15.69 | 98.66 kg STANDARD_DEVIATION 24.84 | 79.86 kg STANDARD_DEVIATION 18.65 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 17 | 0 / 9 |
| other Total, other adverse events | 16 / 25 | 15 / 17 | 7 / 9 |
| serious Total, serious adverse events | 0 / 25 | 0 / 17 | 0 / 9 |
Outcome results
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.
Time frame: Up to 52 weeks
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ABP-450 - 150U | Number of Participants With Treatment-related Serious Adverse Events | 0 Participants |
| ABP-450 - 250U | Number of Participants With Treatment-related Serious Adverse Events | 0 Participants |
| ABP-450 - 350U | Number of Participants With Treatment-related Serious Adverse Events | 0 Participants |
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.
Time frame: Four weeks after the dose of each cycle (4 cycles)
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABP-450 - 150U | Mean Change in Clinical Global Impression of Change (CGI-C) | Cycle 3, Week 4 | 2.1 units on a scale | Standard Deviation 0.83 |
| ABP-450 - 150U | Mean Change in Clinical Global Impression of Change (CGI-C) | Cycle 2, Week 4 | 2.5 units on a scale | Standard Deviation 1.24 |
| ABP-450 - 150U | Mean Change in Clinical Global Impression of Change (CGI-C) | Baseline | 3.4 units on a scale | Standard Deviation 1.44 |
| ABP-450 - 150U | Mean Change in Clinical Global Impression of Change (CGI-C) | Cycle 1, Week 4 | 2.1 units on a scale | Standard Deviation 0.94 |
| ABP-450 - 150U | Mean Change in Clinical Global Impression of Change (CGI-C) | Cycle 4, Week 4 | 2.0 units on a scale | Standard Deviation 0.71 |
| ABP-450 - 250U | Mean Change in Clinical Global Impression of Change (CGI-C) | Cycle 2, Week 4 | 2.0 units on a scale | Standard Deviation 1.52 |
| ABP-450 - 250U | Mean Change in Clinical Global Impression of Change (CGI-C) | Baseline | 3.7 units on a scale | Standard Deviation 1.37 |
| ABP-450 - 250U | Mean Change in Clinical Global Impression of Change (CGI-C) | Cycle 1, Week 4 | 1.9 units on a scale | Standard Deviation 0.94 |
| ABP-450 - 250U | Mean Change in Clinical Global Impression of Change (CGI-C) | Cycle 3, Week 4 | 2.2 units on a scale | Standard Deviation 1.15 |
| ABP-450 - 250U | Mean Change in Clinical Global Impression of Change (CGI-C) | Cycle 4, Week 4 | 1.8 units on a scale | Standard Deviation 0.6 |
| ABP-450 - 350U | Mean Change in Clinical Global Impression of Change (CGI-C) | Cycle 4, Week 4 | 1.8 units on a scale | Standard Deviation 0.75 |
| ABP-450 - 350U | Mean Change in Clinical Global Impression of Change (CGI-C) | Cycle 3, Week 4 | 1.9 units on a scale | Standard Deviation 0.69 |
| ABP-450 - 350U | Mean Change in Clinical Global Impression of Change (CGI-C) | Baseline | 3.8 units on a scale | Standard Deviation 1.71 |
| ABP-450 - 350U | Mean Change in Clinical Global Impression of Change (CGI-C) | Cycle 2, Week 4 | 1.7 units on a scale | Standard Deviation 0.76 |
| ABP-450 - 350U | Mean Change in Clinical Global Impression of Change (CGI-C) | Cycle 1, Week 4 | 1.7 units on a scale | Standard Deviation 0.58 |
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.
Time frame: Four weeks after the dose of each cycle (4 cycles)
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABP-450 - 150U | Mean Change in Patient Global Impression of Change (PGI-C) | Cycle 3, Week 4 | 1.8 units on a scale | Standard Deviation 0.89 |
| ABP-450 - 150U | Mean Change in Patient Global Impression of Change (PGI-C) | Cycle 2, Week 4 | 2.2 units on a scale | Standard Deviation 1.53 |
| ABP-450 - 150U | Mean Change in Patient Global Impression of Change (PGI-C) | Baseline | 3.8 units on a scale | Standard Deviation 1.68 |
| ABP-450 - 150U | Mean Change in Patient Global Impression of Change (PGI-C) | Cycle 1, Week 4 | 2.1 units on a scale | Standard Deviation 1.14 |
| ABP-450 - 150U | Mean Change in Patient Global Impression of Change (PGI-C) | Cycle 4, Week 4 | 1.8 units on a scale | Standard Deviation 0.84 |
| ABP-450 - 250U | Mean Change in Patient Global Impression of Change (PGI-C) | Cycle 2, Week 4 | 2.4 units on a scale | Standard Deviation 1.63 |
| ABP-450 - 250U | Mean Change in Patient Global Impression of Change (PGI-C) | Baseline | 4.1 units on a scale | Standard Deviation 1.35 |
| ABP-450 - 250U | Mean Change in Patient Global Impression of Change (PGI-C) | Cycle 1, Week 4 | 2.2 units on a scale | Standard Deviation 1.17 |
| ABP-450 - 250U | Mean Change in Patient Global Impression of Change (PGI-C) | Cycle 3, Week 4 | 2.4 units on a scale | Standard Deviation 1.47 |
| ABP-450 - 250U | Mean Change in Patient Global Impression of Change (PGI-C) | Cycle 4, Week 4 | 1.4 units on a scale | Standard Deviation 0.77 |
| ABP-450 - 350U | Mean Change in Patient Global Impression of Change (PGI-C) | Cycle 4, Week 4 | 2.0 units on a scale | Standard Deviation 0.63 |
| ABP-450 - 350U | Mean Change in Patient Global Impression of Change (PGI-C) | Cycle 3, Week 4 | 1.9 units on a scale | Standard Deviation 0.69 |
| ABP-450 - 350U | Mean Change in Patient Global Impression of Change (PGI-C) | Baseline | 3.8 units on a scale | Standard Deviation 2.36 |
| ABP-450 - 350U | Mean Change in Patient Global Impression of Change (PGI-C) | Cycle 2, Week 4 | 1.6 units on a scale | Standard Deviation 0.79 |
| ABP-450 - 350U | Mean Change in Patient Global Impression of Change (PGI-C) | Cycle 1, Week 4 | 1.7 units on a scale | Standard Deviation 0.58 |
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.
Time frame: Four weeks after the dose of each cycle (4 cycles)
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABP-450 - 150U | Mean Change in the Subscale Score of Disability of the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Spasmodic Torticollis Rating Scale (TWSTRS) | Cycle 3, Week 4 | 9.1 units on a scale | Standard Deviation 5.62 |
| ABP-450 - 150U | Mean Change in the Subscale Score of Disability of the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Spasmodic Torticollis Rating Scale (TWSTRS) | Cycle 2, Week 4 | 8.8 units on a scale | Standard Deviation 6.68 |
| ABP-450 - 150U | Mean Change in the Subscale Score of Disability of the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Spasmodic Torticollis Rating Scale (TWSTRS) | Baseline | 11.2 units on a scale | Standard Deviation 4.78 |
| ABP-450 - 150U | Mean Change in the Subscale Score of Disability of the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Spasmodic Torticollis Rating Scale (TWSTRS) | Cycle 1, Week 4 | 6.9 units on a scale | Standard Deviation 6.75 |
| ABP-450 - 150U | Mean Change in the Subscale Score of Disability of the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Spasmodic Torticollis Rating Scale (TWSTRS) | Cycle 4, Week 4 | 9.6 units on a scale | Standard Deviation 5.81 |
| ABP-450 - 250U | Mean Change in the Subscale Score of Disability of the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Spasmodic Torticollis Rating Scale (TWSTRS) | Cycle 2, Week 4 | 6.7 units on a scale | Standard Deviation 5.43 |
| ABP-450 - 250U | Mean Change in the Subscale Score of Disability of the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Spasmodic Torticollis Rating Scale (TWSTRS) | Baseline | 11.9 units on a scale | Standard Deviation 4.17 |
| ABP-450 - 250U | Mean Change in the Subscale Score of Disability of the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Spasmodic Torticollis Rating Scale (TWSTRS) | Cycle 1, Week 4 | 7.8 units on a scale | Standard Deviation 5.29 |
| ABP-450 - 250U | Mean Change in the Subscale Score of Disability of the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Spasmodic Torticollis Rating Scale (TWSTRS) | Cycle 3, Week 4 | 6.7 units on a scale | Standard Deviation 4.58 |
| ABP-450 - 250U | Mean Change in the Subscale Score of Disability of the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Spasmodic Torticollis Rating Scale (TWSTRS) | Cycle 4, Week 4 | 6.8 units on a scale | Standard Deviation 5.71 |
| ABP-450 - 350U | Mean Change in the Subscale Score of Disability of the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Spasmodic Torticollis Rating Scale (TWSTRS) | Cycle 4, Week 4 | 6.2 units on a scale | Standard Deviation 5.42 |
| ABP-450 - 350U | Mean Change in the Subscale Score of Disability of the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Spasmodic Torticollis Rating Scale (TWSTRS) | Cycle 3, Week 4 | 5.4 units on a scale | Standard Deviation 2.94 |
| ABP-450 - 350U | Mean Change in the Subscale Score of Disability of the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Spasmodic Torticollis Rating Scale (TWSTRS) | Baseline | 12.5 units on a scale | Standard Deviation 2.89 |
| ABP-450 - 350U | Mean Change in the Subscale Score of Disability of the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Spasmodic Torticollis Rating Scale (TWSTRS) | Cycle 2, Week 4 | 5.0 units on a scale | Standard Deviation 4.12 |
| ABP-450 - 350U | Mean Change in the Subscale Score of Disability of the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Spasmodic Torticollis Rating Scale (TWSTRS) | Cycle 1, Week 4 | 9.0 units on a scale | Standard Deviation 2.65 |
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.
Time frame: Four weeks after the dose of each cycle (4 cycles)
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABP-450 - 150U | Mean Change in the Subscale Score of Pain of the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) | Cycle 3, Week 4 | 6.938 units on a scale | Standard Deviation 4.6209 |
| ABP-450 - 150U | Mean Change in the Subscale Score of Pain of the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) | Cycle 2, Week 4 | 7.167 units on a scale | Standard Deviation 5.394 |
| ABP-450 - 150U | Mean Change in the Subscale Score of Pain of the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) | Baseline | 11.576 units on a scale | Standard Deviation 3.0697 |
| ABP-450 - 150U | Mean Change in the Subscale Score of Pain of the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) | Cycle 4, Week 4 | 9.250 units on a scale | Standard Deviation 4.5104 |
| ABP-450 - 150U | Mean Change in the Subscale Score of Pain of the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) | Cycle 1, Week 4 | 8.060 units on a scale | Standard Deviation 5.1386 |
| ABP-450 - 250U | Mean Change in the Subscale Score of Pain of the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) | Cycle 1, Week 4 | 6.639 units on a scale | Standard Deviation 5.1071 |
| ABP-450 - 250U | Mean Change in the Subscale Score of Pain of the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) | Baseline | 11.342 units on a scale | Standard Deviation 3.0824 |
| ABP-450 - 250U | Mean Change in the Subscale Score of Pain of the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) | Cycle 2, Week 4 | 6.333 units on a scale | Standard Deviation 3.8441 |
| ABP-450 - 250U | Mean Change in the Subscale Score of Pain of the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) | Cycle 3, Week 4 | 6.348 units on a scale | Standard Deviation 4.4573 |
| ABP-450 - 250U | Mean Change in the Subscale Score of Pain of the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) | Cycle 4, Week 4 | 6.904 units on a scale | Standard Deviation 3.9112 |
| ABP-450 - 350U | Mean Change in the Subscale Score of Pain of the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) | Cycle 4, Week 4 | 5.750 units on a scale | Standard Deviation 2.7884 |
| ABP-450 - 350U | Mean Change in the Subscale Score of Pain of the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) | Cycle 3, Week 4 | 5.821 units on a scale | Standard Deviation 4.3702 |
| ABP-450 - 350U | Mean Change in the Subscale Score of Pain of the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) | Baseline | 10.875 units on a scale | Standard Deviation 2.7195 |
| ABP-450 - 350U | Mean Change in the Subscale Score of Pain of the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) | Cycle 2, Week 4 | 4.286 units on a scale | Standard Deviation 2.9595 |
| ABP-450 - 350U | Mean Change in the Subscale Score of Pain of the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) | Cycle 1, Week 4 | 5.833 units on a scale | Standard Deviation 4.7719 |
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.
Time frame: Four weeks after the dose of each cycle (4 cycles)
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABP-450 - 150U | Mean Change in the Subscale Score of Severity of the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) | Cycle 3, Week 4 | 12.1 units on a scale | Standard Deviation 5.59 |
| ABP-450 - 150U | Mean Change in the Subscale Score of Severity of the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) | Cycle 2, Week 4 | 15.3 units on a scale | Standard Deviation 5.56 |
| ABP-450 - 150U | Mean Change in the Subscale Score of Severity of the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) | Baseline | 18.8 units on a scale | Standard Deviation 3.92 |
| ABP-450 - 150U | Mean Change in the Subscale Score of Severity of the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) | Cycle 1, Week 4 | 12.6 units on a scale | Standard Deviation 6.38 |
| ABP-450 - 150U | Mean Change in the Subscale Score of Severity of the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) | Cycle 4, Week 4 | 12.6 units on a scale | Standard Deviation 6.39 |
| ABP-450 - 250U | Mean Change in the Subscale Score of Severity of the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) | Cycle 2, Week 4 | 11.0 units on a scale | Standard Deviation 6.55 |
| ABP-450 - 250U | Mean Change in the Subscale Score of Severity of the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) | Baseline | 19.6 units on a scale | Standard Deviation 2.71 |
| ABP-450 - 250U | Mean Change in the Subscale Score of Severity of the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) | Cycle 1, Week 4 | 14.0 units on a scale | Standard Deviation 4.97 |
| ABP-450 - 250U | Mean Change in the Subscale Score of Severity of the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) | Cycle 3, Week 4 | 11.1 units on a scale | Standard Deviation 6.44 |
| ABP-450 - 250U | Mean Change in the Subscale Score of Severity of the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) | Cycle 4, Week 4 | 14.8 units on a scale | Standard Deviation 4.96 |
| ABP-450 - 350U | Mean Change in the Subscale Score of Severity of the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) | Cycle 4, Week 4 | 15.8 units on a scale | Standard Deviation 5.64 |
| ABP-450 - 350U | Mean Change in the Subscale Score of Severity of the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) | Cycle 3, Week 4 | 13.6 units on a scale | Standard Deviation 5.97 |
| ABP-450 - 350U | Mean Change in the Subscale Score of Severity of the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) | Baseline | 22.3 units on a scale | Standard Deviation 2.22 |
| ABP-450 - 350U | Mean Change in the Subscale Score of Severity of the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) | Cycle 2, Week 4 | 14.4 units on a scale | Standard Deviation 5.71 |
| ABP-450 - 350U | Mean Change in the Subscale Score of Severity of the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) | Cycle 1, Week 4 | 19.3 units on a scale | Standard Deviation 1.53 |
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).
Time frame: Four weeks after the dose of each cycle (4 cycles)
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABP-450 - 150U | Mean Change in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score | Baseline | 41.58 units on a scale | Standard Deviation 9.369 |
| ABP-450 - 150U | Mean Change in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score | Cycle 3, Week 4 | 28.19 units on a scale | Standard Deviation 14.179 |
| ABP-450 - 150U | Mean Change in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score | Cycle 2, Week 4 | 31.17 units on a scale | Standard Deviation 15.205 |
| ABP-450 - 150U | Mean Change in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score | Cycle 4, Week 4 | 31.45 units on a scale | Standard Deviation 15.666 |
| ABP-450 - 150U | Mean Change in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score | Cycle 1, Week 4 | 27.54 units on a scale | Standard Deviation 15.873 |
| ABP-450 - 250U | Mean Change in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score | Cycle 3, Week 4 | 24.17 units on a scale | Standard Deviation 12.302 |
| ABP-450 - 250U | Mean Change in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score | Baseline | 42.87 units on a scale | Standard Deviation 6.631 |
| ABP-450 - 250U | Mean Change in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score | Cycle 1, Week 4 | 28.47 units on a scale | Standard Deviation 12.743 |
| ABP-450 - 250U | Mean Change in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score | Cycle 2, Week 4 | 24.0 units on a scale | Standard Deviation 12.808 |
| ABP-450 - 250U | Mean Change in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score | Cycle 4, Week 4 | 28.6 units on a scale | Standard Deviation 11.967 |
| ABP-450 - 350U | Mean Change in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score | Cycle 1, Week 4 | 34.17 units on a scale | Standard Deviation 6.166 |
| ABP-450 - 350U | Mean Change in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score | Cycle 3, Week 4 | 24.82 units on a scale | Standard Deviation 9.558 |
| ABP-450 - 350U | Mean Change in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score | Baseline | 45.63 units on a scale | Standard Deviation 5.483 |
| ABP-450 - 350U | Mean Change in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score | Cycle 4, Week 4 | 27.75 units on a scale | Standard Deviation 9.601 |
| ABP-450 - 350U | Mean Change in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score | Cycle 2, Week 4 | 23.71 units on a scale | Standard Deviation 10.917 |