Phase 2
N=51
Extension Study of ABP-19000 to Evaluate Safety and Efficacy of Repeat Treatments of ABP-450 in Cervical Dystonia
Cervical Dystonia
Bottom Line
View on ClinicalTrials.gov: NCT04871451 ↗Enrolled (actual)
51
Serious AEs
0.0%
Results posted
Aug 2024
Primary outcome: Primary: Number of Participants With Treatment-related Serious Adverse Events — 0; 0; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- ABP-450 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AEON Biopharma, Inc.
- Primary completion
- Jul 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment-related Serious Adverse Events |
0; 0; 0 | — |
| SECONDARY Mean Change in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score |
41.58; 42.87; 45.63; 27.54; 28.47; 34.17 | — |
| SECONDARY Mean Change in the Subscale Score of Severity of the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) |
18.8; 19.6; 22.3; 12.6; 14.0; 19.3 | — |
| SECONDARY Mean Change in the Subscale Score of Disability of the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Spasmodic Torticollis Rating Scale (TWSTRS) |
11.2; 11.9; 12.5; 6.9; 7.8; 9.0 | — |
| SECONDARY Mean Change in the Subscale Score of Pain of the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) |
11.576; 11.342; 10.875; 8.060; 6.639; 5.833 | — |
| SECONDARY Mean Change in Patient Global Impression of Change (PGI-C) |
3.8; 4.1; 3.8; 2.1; 2.2; 1.7 | — |
| SECONDARY Mean Change in Clinical Global Impression of Change (CGI-C) |
3.4; 3.7; 3.8; 2.1; 1.9; 1.7 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT04871451). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.