A Study to Compare Dysport® and Botox® in the Treatment of Cervical Dystonia

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

103 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2011-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

1. to examine the non-inferiority of Dysport in the clinical efficacy and safety in comparison with Botox®, assuming a bioequivalence ratio of 2.5:1 units, in the treatment of Cervical dystonia.
2. double blind, randomised, multi center, crossover study

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study Comparing Short Term Efficacy of Dysport and Dysport NG to Placebo, and to Assess Efficacy and Safety of Dysport NG of Subjects With Cervical Dystonia

NCT01261611

Cervical Dystonia

COMPLETED PHASE3

Efficacy and Safety of DYSPORT® Using 2mL Dilution in Adults With Cervical Dystonia.

NCT01753310

Cervical Dystonia

COMPLETED PHASE3

Randomized, Placebo-Controlled Study of AbobotulinumtoxinA (Dysport®) for the Treatment of Cervical Dystonia

NCT00257660

Cervical Dystonia

COMPLETED PHASE3

Open-label Extension Study of AbobotulinumtoxinA (Dysport®) for the Treatment of Cervical Dystonia

NCT00288509

Cervical Dystonia

COMPLETED PHASE3

Long Term Safety And Effectiveness Of Dysport® In Adults With Cervical Dystonia

NCT01753336

Cervical Dystonia

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

1. Prospective, randomized, head-to-head, double-blind, cross-over study.
2. Total patients: A group 51, B group 51
3. Study duration: 16 + 4 + 16 weeks. Eligible patients will be randomised at baseline to receive either Dysport® or Botox® and monitored at weeks 2, 4, 8, 12, 16 weeks. After 4 weeks of wash out period, then the patients get the other treatment (i.e, Patients who have got Dysport will be then administered with Botox)
4. Compare the TSUI change score from baseline to 4 weeks after injection.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cervical Dystonia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Dysport® to Botox®

Dysport® injection in first intervention period and Botox® in second intervention period (after washout period) cross over injection of Dysport® (abobotulinumtoxinA) and Botox® (onabotulinumtoxinA)

Group Type EXPERIMENTAL