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CompletedNCT04871451Updated Aug 22, 2024Results posted

Extension Study of ABP-19000 to Evaluate Safety and Efficacy of Repeat Treatments of ABP-450 in Cervical Dystonia

A Phase 2 interventional study of ABP-450 in Cervical Dystonia, sponsored by AEON Biopharma, Inc.. Completed at 20 sites in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-08-22.

Sponsored by AEON Biopharma, Inc. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
51
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Cervical Dystonia

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03

In context

Torticollis

141 studies on the registry are indexed under Torticollis; 21 are open to participants now.

This study's enrollment of 51 is above the median of 44 across 94 interventional studies indexed under Torticollis.

Browse Torticollis studies →

Lead sponsor

AEON Biopharma, Inc. is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
51 participants (actual)

Study arms

  • Experimental
    ABP-450 - Between Low Dose and High Dose

    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.

    Drug: ABP-450

Interventions

  • DrugABP-450

    ABP-450 (prabotulinumtoxinA) contains a 900kDA botulinum toxin type-A complex produced by the bacterium Clostridium botulinum.

    Also known as: prabotulinumtoxinA

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. 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)

07

Results

Posted Aug 22, 2024

Participant flow

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.

Participant flow — Overall Study
MilestoneABP-450 - 150UABP-450 - 250UABP-450 - 350U
Started25179
Completed18157
Not completed722

Outcome measures

PrimaryNumber 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
Reported as:
Count of participants · Participants
Number of Participants With Treatment-related Serious Adverse Events
ParticipantsABP-450 - 150UABP-450 - 250UABP-450 - 350U
Number of Participants With Treatment-related Serious Adverse Events000
SecondaryMean 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)
Reported as:
Mean · units on a scale
Mean Change in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score
units on a scaleABP-450 - 150UABP-450 - 250UABP-450 - 350U
Baseline41.58 ± 9.36942.87 ± 6.63145.63 ± 5.483
Cycle 1, Week 427.54 ± 15.87328.47 ± 12.74334.17 ± 6.166
Cycle 2, Week 431.17 ± 15.20524.0 ± 12.80823.71 ± 10.917
Cycle 3, Week 428.19 ± 14.17924.17 ± 12.30224.82 ± 9.558
Cycle 4, Week 431.45 ± 15.66628.6 ± 11.96727.75 ± 9.601
SecondaryMean 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)
Reported as:
Mean · units on a scale
Mean Change in the Subscale Score of Severity of the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)
units on a scaleABP-450 - 150UABP-450 - 250UABP-450 - 350U
Baseline18.8 ± 3.9219.6 ± 2.7122.3 ± 2.22
Cycle 1, Week 412.6 ± 6.3814.0 ± 4.9719.3 ± 1.53
Cycle 2, Week 415.3 ± 5.5611.0 ± 6.5514.4 ± 5.71
Cycle 3, Week 412.1 ± 5.5911.1 ± 6.4413.6 ± 5.97
Cycle 4, Week 412.6 ± 6.3914.8 ± 4.9615.8 ± 5.64
SecondaryMean 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)
Reported as:
Mean · units on a scale
Mean Change in the Subscale Score of Disability of the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Spasmodic Torticollis Rating Scale (TWSTRS)
units on a scaleABP-450 - 150UABP-450 - 250UABP-450 - 350U
Baseline11.2 ± 4.7811.9 ± 4.1712.5 ± 2.89
Cycle 1, Week 46.9 ± 6.757.8 ± 5.299.0 ± 2.65
Cycle 2, Week 48.8 ± 6.686.7 ± 5.435.0 ± 4.12
Cycle 3, Week 49.1 ± 5.626.7 ± 4.585.4 ± 2.94
Cycle 4, Week 49.6 ± 5.816.8 ± 5.716.2 ± 5.42
SecondaryMean 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)
Reported as:
Mean · units on a scale
Mean Change in the Subscale Score of Pain of the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)
units on a scaleABP-450 - 150UABP-450 - 250UABP-450 - 350U
Baseline11.576 ± 3.069711.342 ± 3.082410.875 ± 2.7195
Cycle 1, Week 48.060 ± 5.13866.639 ± 5.10715.833 ± 4.7719
Cycle 2, Week 47.167 ± 5.39406.333 ± 3.84414.286 ± 2.9595
Cycle 3, Week 46.938 ± 4.62096.348 ± 4.45735.821 ± 4.3702
Cycle 4, Week 49.250 ± 4.51046.904 ± 3.91125.750 ± 2.7884
SecondaryMean 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)
Reported as:
Mean · units on a scale
Mean Change in Patient Global Impression of Change (PGI-C)
units on a scaleABP-450 - 150UABP-450 - 250UABP-450 - 350U
Baseline3.8 ± 1.684.1 ± 1.353.8 ± 2.36
Cycle 1, Week 42.1 ± 1.142.2 ± 1.171.7 ± 0.58
Cycle 2, Week 42.2 ± 1.532.4 ± 1.631.6 ± 0.79
Cycle 3, Week 41.8 ± 0.892.4 ± 1.471.9 ± 0.69
Cycle 4, Week 41.8 ± 0.841.4 ± 0.772.0 ± 0.63
SecondaryMean 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)
Reported as:
Mean · units on a scale
Mean Change in Clinical Global Impression of Change (CGI-C)
units on a scaleABP-450 - 150UABP-450 - 250UABP-450 - 350U
Baseline3.4 ± 1.443.7 ± 1.373.8 ± 1.71
Cycle 1, Week 42.1 ± 0.941.9 ± 0.941.7 ± 0.58
Cycle 2, Week 42.5 ± 1.242.0 ± 1.521.7 ± 0.76
Cycle 3, Week 42.1 ± 0.832.2 ± 1.151.9 ± 0.69
Cycle 4, Week 42.0 ± 0.711.8 ± 0.601.8 ± 0.75

Adverse events

Collected over 52 Weeks. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
ABP-450 - 150U0/25 (0%)0/25 (0%)16/25 (64%)
ABP-450 - 250U0/17 (0%)0/17 (0%)15/17 (88.2%)
ABP-450 - 350U0/9 (0%)0/9 (0%)7/9 (77.8%)
Most frequent other events
Showing 10 of 21
Most frequent other events
EventABP-450 - 150UABP-450 - 250UABP-450 - 350U
COVID-19Infections and infestations6/254/171/9
DysphagiaGastrointestinal disorders3/253/172/9
VertigoEar and labyrinth disorders1/250/172/9
Neck PainMusculoskeletal and connective tissue disorders2/253/170/9
Injection site painGeneral disorders3/250/170/9
NasopharyngitisInfections and infestations0/252/171/9
SinusitisInfections and infestations1/252/170/9
TorticollisMusculoskeletal and connective tissue disorders0/252/170/9
ParesthesiaNervous system disorders1/252/170/9
MigraineNervous system disorders0/252/170/9

Baseline characteristics

Age, Continuous
Age, Continuous(years)ABP-450 - 150UABP-450 - 250UABP-450 - 350UTotal
Mean54.5 ± 12.7258.0 ± 10.352.6 ± 11.9655.3 ± 11.77
Sex: Female, Male
Sex: Female, Male(Participants)ABP-450 - 150UABP-450 - 250UABP-450 - 350UTotal
Female1714334
Male83617
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)ABP-450 - 150UABP-450 - 250UABP-450 - 350UTotal
Hispanic or Latino4206
Not Hispanic or Latino2115945
Unknown or Not Reported0000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)ABP-450 - 150UABP-450 - 250UABP-450 - 350UTotal
American Indian or Alaska Native0000
Asian0000
Native Hawaiian or Other Pacific Islander0000
Black or African American2002
White2216947
More than one race0000
Unknown or Not Reported1102
Region of Enrollment
Region of Enrollment(participants)ABP-450 - 150UABP-450 - 250UABP-450 - 350UTotal
United States2517951
Weight (kg)
Weight (kg)(kg)ABP-450 - 150UABP-450 - 250UABP-450 - 350UTotal
Mean78.71 ± 15.1873.6 ± 15.6998.66 ± 24.8479.86 ± 18.65
BMI
BMI(kg/m2)ABP-450 - 150UABP-450 - 250UABP-450 - 350UTotal
Mean28.02 ± 4.6927.22 ± 4.9631.69 ± 6.1828.28 ± 5.13
08

Study locations

20 sites
  • Arizona Neuroscience Research
    Phoenix, Arizona 85032, United States
  • Parkinson's and Movement Disorder Institute
    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
09

References and documents

Study documents

  • Study protocol · May 13, 2021
  • Statistical analysis plan · Aug 24, 2023

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No — 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

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jul 2021 to primary completion in Jul 2023, 23 months.

Results were first posted in Aug 2024, 1 year after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 29, 2021
First posted
May 4, 2021
StartActual
Jul 27, 2021
Primary completionActual
Jul 24, 2023
CompletionActual
Jul 24, 2023
Results first posted
Aug 22, 2024
Last update
Aug 22, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 22, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04871451
Lead sponsor
AEON Biopharma, Inc.
Responsible party
Sponsor
First posted
May 4, 2021
Start date
Jul 27, 2021
Primary completion
Jul 24, 2023
Completion
Jul 24, 2023
Results posted
Aug 22, 2024
Last update
Aug 22, 2024

Study contacts

Cynthia Comella
principal investigator · Rush University Medical Center
Joseph Jankovic
principal investigator · Baylor St. Luke's Medical Center

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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