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Cervical DystoniaPhase 2NCT04871451

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

A Phase 2 study testing ABP-450 in people with Cervical Dystonia, run by AEON Biopharma, Inc. at 20 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Cervical Dystonia
What is being tested?
ABP-450
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
51 participants
Where
20 sitesUnited States
Study dates
27 Jul 2021to 24 Jul 2023
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Qualified for and had their initial dose of study drug in the ABP-19000 study.
  • Provided written informed consent to being treated for cervical dystonia with ABP-450.
  • Were a male or female patient between 18 and 75 years of age (inclusive) when they entered the ABP-19000 study.
  • 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.

Who cannot join

  • Participated in another interventional study during participation in this study.
  • 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).
  • Would not benefit from treatment with ABP-450 for their cervical dystonia, in the investigator's opinion.
  • 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.

Trial locations and contacts

20 sites in 1 country.

20 sites in 1 country

United States20 sites

  • University of New Mexico

    Albuquerque, New Mexico, 87106

  • Emory University

    Atlanta, Georgia, 30329

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • The Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Cleveland Clinic Lou Ruvo Center for Brain Health

    Cleveland, Ohio, 89106

  • Michigan State University

    East Lansing, Michigan, 48824

  • Quest Research Institute - Hunt - PPDS

    Farmington Hills, Michigan, 48334

  • Parkinson's and Movement Disorder Institute

    Fountain Valley, California, 92708

  • Neuro Pain Medical Center

    Fresno, California, 93710

  • Infinity Clinical Research LLC

    Hollywood, Florida, 33024

  • Baylor College of Medicine

    Houston, Texas, 77030

  • Loma Linda University

    Loma Linda, California, 92354

  • Veracity Neuroscience LLC

    Memphis, Tennessee, 38157

  • Brainstorm Research

    Miami, Florida, 33176

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

  • The Orthopedic Foundation

    New Albany, Ohio, 43054

  • Arizona Neuroscience Research

    Phoenix, Arizona, 85032

  • New England Institute for Neurology and Headache

    Stamford, Connecticut, 06905

  • University of South Florida

    Tampa, Florida, 33613

  • Neurology One

    Winter Park, Florida, 32792

Other trials in United States

About this study

Official title: An Open-Label, Multicenter Study to Evaluate the Safety and Efficacy of Repeat Intramuscular ABP-450 (prabotulinumtoxinA) Injection for the Treatment of Cervical Dystonia

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.

Being tested
ABP-450
Medical subject headings
Torticollis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ABP-450Drug

    Also called prabotulinumtoxinA

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

Study groups in NCT04871451
Study groupRoleWhat they receive
ABP-450 - Between Low Dose and High DoseExperimentalABP-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.
Receives: Drug: ABP-450

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Up to 52 weeks

Secondary outcomes (6)

  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).

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: Four weeks after the dose of each cycle (4 cycles)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 May 2021
  2. Study start27 Jul 2021
  3. Primary completion24 Jul 2023
  4. Study completion24 Jul 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
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.
Masking
None (open label)
Enrolment
51 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04871451
Sponsor's protocol ID
ABP-19002
Status last verified
Aug 2024
First submitted
29 Apr 2021
Last updated
22 Aug 2024
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ABP-450 in people with Cervical Dystonia, run by AEON Biopharma, Inc. at 20 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Treatment-related Serious Adverse Events (time frame: Up to 52 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04871451.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2024.

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