CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 61 enrolled
Drug / intervention
ABP-450 +1 moredrug
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/NCT04849988
NCT04849988Phase 2Completed
CompareCT.gov

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

AEON Biopharma, Inc.·interventional·Posted Apr 20, 2021·Updated Feb 14, 2024

In Brief

A Phase 2 clinical trial evaluating ABP-450 and Placebo for Cervical Dystonia. Completed, enrolled 61 participants across 21 sites.

Detailed 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. 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCervical Dystonia
CountriesUnited States
CollaboratorsPPD Development, LP

Timeline

Phase 2CompletedFinished
20222023202420252026
First PostedApr 20, 2021
Enrollment StartMar 29, 2021
Primary CompletionJul 11, 2022
TodayJul 2, 2026
Enrollment to primary: 1.3 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.

Placebodrug

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