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

Seoul National University Hospital103 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

103

Conditions

Cervical Dystonia

Interventions

Dysport® (abobotulinumtoxinA)DRUG

Cross over injection of Dysport® (\<500IU), Botox® (200IU)assuming a bioequivalence ratio of 2.5:1 units

Botox® (onabotulinumtoxinA)DRUG

Cross over injection of Dysport® (\<500IU), Botox® (200IU)assuming a bioequivalence ratio of 2.5:1 units

Eligibility

Sex: ALLMin age: 20 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients ≥ 18 years of age of both genders, * Cervical dystonia * symptoms with a minimum duration of 18 months, * Negative pregnancy test in sexually active women, * Able to participate in the study (understand goals of botulinum toxin A treatment and sign Informed Consent Form). Exclusion Criteria: * Patient with cervical contractures * Known significant underlying dysphasia * Patients who have received botulinum toxin treatment within the past 4 months. * Contraindication to botulinum toxin treatment * Any disease that might affect neuromuscular function (Myasthenia Gravis, Eaton-Lambert syndrome, ALS …) * Patients who have received oral anti-spasticity medication, phenol therapy, myotomy or denervation surgery, deep brain stimulation for cervical dystonia, * Patients who required more than 500 units of Dysport or 200 units of Botox. * Any concomitant treatment that could interfere with the action of botulinum toxin, * Subjects having participated within the last 3 months or currently participating in an investigational drug study, * Pregnancy, * Lactation.

Locations (7)

Bundang Seoul Natiuonal University Hospital

Seongnam-si, Gyeonggi-do, South Korea

Dong-A University Hospital

Busan, South Korea

Hanyang University Hospital

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

Outcomes

Primary Outcomes

Reduction of Total Tsui Score at 4 Weeks From Baseline

Tsui scale is an impairment scale which evaluates the amplitude and duration of sustained posture and intermittent movements of the head, as well as the presence of shoulder elevation and tremor. Tsui scale (range: 0-25, higher values represent worse cervical dystonia.) Negative numbers to represent decreases of Tsui scale.

Time frame: 4 weeks after injection from baseline

Secondary Outcomes

Reduction of Total TWSTRS Score at 4 Weeks From Baseline

TWSTRS (Toronto western spasmodic torticollis rating scale) The TWSTRS is a composite scale which covers different features of cervical dystonia(CD). The first part is based on the physical findings (severity subscale), the second part rates disability, and the third part pain. (range: 0-80, higher values represent worse cervical dystonia.) Details of the TWSTRS are displayed on the Web site http://www.wemove.org. Negative numbers to represent decreases of TWSTRS.

Time frame: 4 weeks after injection from baseline

CGI-I (Clinical Global Impression of Illness)

The proportion of patients with 'normal/ not at all ill' or 'borderline mildly ill' on the CGI (Clinical global impression of illness, CGI-I) 1 = normal / not at all ill'; 2 = 'borderline mildly ill'; 3 = 'mildly ill'; 4 = 'moderlately ill'; 5 = 'markedly ill'; 6 = 'severely ill'; 7 = 'the most extremely ill'.

Time frame: 4, 8, 12 and 16 weeks after injection

PGI-I (Patient's Global Impression of Improvement)

The proportion of patients with 'very much improved' or 'much improved' on the PGI (Patient's global impression of impairment, PGI-I) 1 = very much improved, 2= much improved, 3 = slightly improved, 4 = no change, 5 = slightly aggravated, 6 = much aggravated, and 7 = very much aggravated

Time frame: 4, 8, 12 and 16 weeks after injection

Data from ClinicalTrials.gov

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