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

NCT04871451 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2024-08-22

Study results available
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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.

Conditions

  • Cervical Dystonia

Interventions

DRUG

ABP-450

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

Sponsors & Collaborators

  • AEON Biopharma, Inc.

    lead INDUSTRY

Principal Investigators

  • Cynthia Comella · Rush University Medical Center

  • Joseph Jankovic · Baylor St. Luke's Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-27
Primary Completion
2023-07-24
Completion
2023-07-24
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04871451 on ClinicalTrials.gov