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

NCT04849988 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2024-02-14

Study results available
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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.

Conditions

  • Cervical Dystonia

Interventions

DRUG

ABP-450

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

DRUG

Placebo

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

Sponsors & Collaborators

  • PPD Development, LP

    collaborator INDUSTRY

  • AEON Biopharma, Inc.

    lead INDUSTRY

Principal Investigators

  • Cynthia Comella, MD · Rush University Medical Center

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2021-03-29
Primary Completion
2022-07-11
Completion
2022-07-11
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs

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 NCT04849988 on ClinicalTrials.gov