CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 51 enrolled
Drug / intervention
ABP-450drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04871451
NCT04871451Phase 2Completed
CompareCT.gov

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

AEON Biopharma, Inc.·interventional·Posted May 4, 2021·Updated Aug 22, 2024

In Brief

A Phase 2 clinical trial evaluating ABP-450 for Cervical Dystonia. Completed, enrolled 51 participants across 20 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCervical Dystonia
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20222023202420252026
First PostedMay 4, 2021
Enrollment StartJul 27, 2021
Primary CompletionJul 24, 2023
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 5.2 years ago

Interventions

ABP-450drug

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