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Cervical DystoniaPhase 2NCT04849988

A Phase 2 Study to Evaluate the Safety and Efficacy of ABP-450 in the Treatment of Cervical Dystonia

A Phase 2 study testing ABP-450 in people with Cervical Dystonia, run by AEON Biopharma, Inc. at 21 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 Phase 2 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 30 sites in the United States. 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?
Yes, some participants may receive a placebo
How many people
61 participants
Where
21 sitesUnited States
Study dates
29 Mar 2021to 11 Jul 2022
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

  • Male or female patients between 18 and 75 years of age (inclusive)
  • A clinical diagnosis of cervical dystonia (ie, spasmodic torticollis) defined by:
  • TWSTRS total score ≥20
  • TWSTRS severity score ≥10
  • TWSTRS disability score ≥3
  • TWSTRS pain score ≥1
Show all 11Show fewer
  • On a stable dose of medications (if any) used for focal dystonia treatment (eg, anticholinergics and benzodiazepines) for at least 3 months prior to and expected throughout the study duration
  • For pre-treated patients only: Source documentation (eg, patient history) of the last 2 consecutive injection sessions with a botulinum toxin type A
  • For pre-treated patients only: At least 16 weeks must have passed between the last injection with botulinum toxin for cervical dystonia and baseline treatment (patients can be screened at Week 15 but cannot be enrolled until 16 weeks [for Day 0 injection])
  • Provided written informed consent to being treated for cervical dystonia with ABP-450
  • 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 televisits

Who cannot join

  • Traumatic torticollis or tardive torticollis
  • Predominant retrocollis or anterocollis
  • Myotomy or denervation surgery in the affected muscles (eg, peripheral denervation and/or spinal cord stimulation)
  • Hypersensitivity to human serum albumin, sucrose, or botulinum toxin type A
  • Previous treatment for cervical dystonia with rimabotulinumtoxin B
  • Diagnosis of myasthenia gravis, Lambert-Eaton syndrome, amyotrophic lateral sclerosis, or any other significant neuromuscular disease that might interfere with the trial
Show all 16Show fewer
  • Current swallowing disorder of any origin (dysphagia scale ≥3, ie, severe, with swallowing difficulties and requiring a change in diet)
  • Marked limitation on passive range of motion that suggests contractures or other structural abnormality, eg, cervical contractures or cervical spine syndrome
  • Treatment with botulinum toxins of any type for any indication other than cervical dystonia within 16 weeks prior to baseline and during the study
  • Medical or psychiatric conditions that may increase the risk associated with study participation or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study
  • Participation in another interventional study during participation in this study
  • Pregnant or lactating females, or females of child-bearing potential not willing to use an acceptable method of contraception (ie, intrauterine device, barrier methods with spermicide, or abstinence)
  • For pre-treated patients only: The patient's most recent injection with botulinum toxin exceeding the number of units specified as follows:
  • OnabotulinumtoxinA (BOTOX®): >300 units
  • IncobotulinumtoxinA (Xeomin®): >300 units
  • AbobotulinumtoxinA (Dysport®): >750 units

Trial locations and contacts

21 sites in 1 country.

21 sites in 1 country

United States21 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

  • The Neurology Research Group

    Miami, Florida, 33176

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

  • The Orthopedic Foundation

    New Albany, Ohio, 43054

  • Arizona Neuroscience Research

    Phoenix, Arizona, 85032

  • Movement Disorder Center of Arizona

    Scottsdale, Arizona, 85258

  • 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: A Phase 2, Randomized, Double-Blind, Multicenter, Placebo Controlled Study to Evaluate the Safety and Efficacy of Intramuscular ABP-450 (prabotulinumtoxinA) Injection for the Treatment of Cervical Dystonia

This Phase 2 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 30 sites in the United States. Study subjects will be divided evenly across a low dose group, a medium dose group, a high dose group, and a placebo group for one treatment cycle.

Read the detailed description

This Phase 2 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 30 sites in the United States. Study subjects will be divided evenly across a low dose, a medium dose group, a high dose and placebo group for one treatment cycle.

Being tested
ABP-450, Placebo
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.

  • PlaceboDrug

    Also called 0.9% sodium chloride, saline

    0.9% sodium chloride, sterile, unpreserved, USP/Ph.Eur.

Study groups in NCT04849988
Study groupRoleWhat they receive
ABP-450 - Low DoseExperimentalABP-450 Low Dose - Intramuscular injections into affected neck muscles.
Receives: Drug: ABP-450
ABP-450 - Medium DoseExperimentalABP-450 Mid Dose - Intramuscular injections into affected neck muscles.
Receives: Drug: ABP-450
ABP-450 - High DoseExperimentalABP-450 High Dose - Intramuscular injections into affected neck muscles.
Receives: Drug: ABP-450
PlaceboPlacebo comparatorPlacebo (0.9% saline, sterile, unpreserved, USP/Ph.Eur.) - Intramuscular injections into affected neck muscles.
Receives: Drug: Placebo

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 number of participants with treatment-related serious adverse events since the start of treatment by Treatment Group when dosed with placebo, ABP-450 (low dose), ABP-450 (medium d dose), or ABP-450 (high dose).

    Measured: Baseline up to 20 Weeks

Secondary outcomes (6)

  1. Mean Change of the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)-Total Score From Baseline to Week 4

    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: Baseline to Week 4

  2. Mean Change in the Subscale Score of Disability of the Baseline Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) From Baseline to Week 4

    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: Baseline to Week 4

  3. Mean Change in the Subscale Score of Pain of the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) From Baseline to Week 4

    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: Baseline to Week 4

  4. Mean Change in the Subscale Score of Severity of the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) From Baseline to Week 4

    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: Baseline to Week 4

  5. Mean Change in Patient Global Impression of Change (PGI-C) From Baseline to Week 4

    The 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".

    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: Baseline to Week 4

  6. Mean Change in Clinical Global Impression of Change (CGI-C) From Baseline to Week 4

    The 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".

    The mean change from Baseline in the Clinical Global Impression of Change (CGI-C) Score was assessed by Treatment Group at Week 4.

    Measured: Baseline to Week 4

Timeline

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

  1. First posted20 Apr 2021
  2. Study start29 Mar 2021
  3. Primary completion11 Jul 2022
  4. Study completion11 Jul 2022

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
Randomised
Intervention model
Parallel groups
Model description
Approximately 60 patients will be randomized in a 1:1:1:1 ratio and receive one of the four treatments: ABP-450 low dose, ABP-450 mid dose, ABP-450 high dose, or placebo via intramuscular injection into affected neck muscles.
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
61 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04849988
Sponsor's protocol ID
ABP-19000
Status last verified
Jan 2024
First submitted
14 Apr 2021
Last updated
14 Feb 2024
Data monitoring committee
No
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 21 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 11 inclusion and 16 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 14 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 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. Some participants in this study may receive a placebo. 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 14 Feb 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: Baseline up to 20 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 NCT04849988.

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 14 Feb 2024.

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