Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00528541
Other study ID # MedAff-BTX-0616
Secondary ID
Status Completed
Phase Phase 4
First received September 10, 2007
Last updated November 14, 2011
Start date September 2007
Est. completion date September 2009

Study information

Verified date November 2011
Source Allergan
Contact n/a
Is FDA regulated No
Health authority Australia: Department of Health and Ageing Therapeutic Goods Administration
Study type Interventional

Clinical Trial Summary

The purpose of this study is to compare two types of botulinum toxin type A to treat the involuntary muscle contractions in the neck


Recruitment information / eligibility

Status Completed
Enrollment 145
Est. completion date September 2009
Est. primary completion date September 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Diagnosed with cervical dystonia/spasmodic torticollis for at least 18 months

- Successfully treated previously with botulinum toxin type A

Exclusion Criteria:

- Breast feeding, pregnant or could become pregnant

- Surgery or spinal cord stimulation for cervical dystonia

- Previous injections of phenol, alcohol for cervical dystonia

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Biological:
botulinum toxin type A
200 Units at Visit 1 (Day 1)
botulinum toxin type A
750 Units at Visit 1 (Day 1)

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Allergan

Countries where clinical trial is conducted

Australia,  Croatia,  Italy,  Poland,  Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Dysphagia Incidence Over 10 Weeks Dysphagia Incidence (difficulty swallowing) was defined as the number of patients reporting at least 1 treatment-emergent dysphagia event at any point in the study. Occurrences of dysphagia were captured as spontaneous events or were assessed during study visits using the Structured Symptom Interview (SSI) and the Dystonia Study Group Dysphagia Interview (DSGDI) for symptoms of difficulty swallowing; coughing while eating and drinking; choking while eating or drinking; or difficulty swallowing solids or liquids. 10 weeks No
Secondary Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score at Week 4 The TWSTRS assessments were conducted at each study visit. The TWSTRS is an assessment scale used to measure the impact of cervical dystonia on patients. It is comprised of 3 subscales: Severity, Disability, and Pain, each of which is scored independently. The total of these 3 comprises the TWSTRS total score which is scored from 0 (least symptoms) to 85 (worst symptoms). Higher scores indicate a greater degree of symptom severity. Baseline, Week 4 No
Secondary Physician Assessment of Cervical Dystonia Severity at Week 4 Physician assessment of cervical dystonia severity. The rating was assessed on a scale of 0 to 10, with higher scores denoting greater severity: 0 represented 'No evidence of dystonia' and 10 represented 'Worst cervical dystonia ever.' Baseline, Week 4 No
Secondary Global Assessment of Benefit by Physician at Week 4 Physician evaluation of benefit from botulinum toxin type A treatment for cervical dystonia. Ratings were on a scale of +4 to -4, with higher scores denoting improvement in cervical dystonia: +4 was 'Complete abolishment of signs and symptoms (about 100% improvement)', 0 represented 'Unchanged', and -4 represented 'Very marked worsening (about 100% worse or greater).' Week 4 No
Secondary Global Assessment of Benefit by Patient at Week 4 Patient evaluation of benefit from botulinum toxin type A treatment for cervical dystonia. Ratings were on a scale of +4 to -4, with higher scores denoting improvement in cervical dystonia: +4 was 'Complete abolishment of signs and symptoms (about 100% improvement)', 0 represented 'Unchanged', and -4 represented 'Very marked worsening (about 100% worse or greater).' Week 4 No
Secondary Patient Assessment of Need for Retreatment at Week 4 Patients were queried regarding their need for another injection of botulinum toxin type A for cervical dystonia. Patients were required to answer "How would you rate your need for another injection of botulinum toxin type A for cervical dystonia using the following scale?". The response options included 'absolutely requires injection', 'very much requires injection', 'somewhat requires injection' and 'does not require injection'. Baseline, Week 4 No
Secondary Patient Visual Analog Assessment of Pain at Week 4 Patients were required to assess their pain using a Visual Analog Scale in reference to their current perception of pain at that visit. This scale consisted of a line measuring 100 mm, and patients were instructed to put a mark on the line at the point that best described 'How much pain you are having right now'. Higher scores denoted higher pain intensity: 0 indicated 'No pain' and 100 indicated 'Worst possible pain'. Baseline, Week 4 No
Secondary Physician Comparison of Benefit to Previous Injections at Week 10 Physicians assessed the improvement in cervical dystonia after the study treatment compared to previous treatment(s) for each patient. Physicians were required to answer "How would you rate the benefit of the current treatment of cervical dystonia with botulinum toxin type A compared to the previous treatment using the following scale?". The response options were 'much worse', 'worse', 'somewhat worse', 'same as previous', 'somewhat better', 'better', and 'much better'. Week 10 No
Secondary Patient Comparison of Benefit to Previous Injections at Week 10 Patients assessed the improvement in cervical dystonia after receiving the study treatment compared to previous treatment(s). Patients were required to answer "How would you rate the benefit of the current treatment of cervical dystonia with botulinum toxin type A compared to the previous treatment using the following scale?". The response options were 'much worse', 'worse', 'somewhat worse', 'same as previous', 'somewhat better', 'better', and 'much better'. Week 10 No
See also
  Status Clinical Trial Phase
Completed NCT00210431 - Post Marketing Surveillance Study of Dysport
Completed NCT00549341 - PurTox (Botulinum Toxin Type A) for the Treatment of Adult Onset Spasmodic Torticollis/Cervical Dystonia Phase 1
Completed NCT03471923 - Non-Motor Features of Cervical Dystonia (CD)
Completed NCT01859247 - Identification of Optimal Stimulation Site for Cervical Dystonia Symptoms: An Exploratory Study N/A
Terminated NCT00432341 - Efficacy and Safety of Two Different Botulinum Toxin Type A Treatments for Moderate to Severe Cervical Dystonia Phase 4
Completed NCT00165776 - Randomized, Double-Blind, Placebo-Controlled, Parallel, Group Dose-Response, Study of E2014 in Patients WIth Spasmodic Torticollis Phase 2
Completed NCT00280384 - An Electrophysiological Study Of E2014 In Healthy Adult Male Japanese And Caucasian Subjects Phase 2