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Comparison of Efficacy and Safety of Two Different Types of Botulinum Toxin Type A in Moderate to Severe Cervical Dystonia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT00528541
First received: September 10, 2007
Last updated: November 14, 2011
Last verified: November 2011
  Purpose

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


Condition Intervention Phase
Spasmodic Torticollis
Biological: botulinum toxin type A
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Allergan:

Primary Outcome Measures:
  • Dysphagia Incidence Over 10 Weeks [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score at Week 4 [ Time Frame: Baseline, Week 4 ] [ Designated as safety issue: No ]
    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.

  • Physician Assessment of Cervical Dystonia Severity at Week 4 [ Time Frame: Baseline, Week 4 ] [ Designated as safety issue: No ]
    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.'

  • Global Assessment of Benefit by Physician at Week 4 [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
    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).'

  • Global Assessment of Benefit by Patient at Week 4 [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
    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).'

  • Patient Assessment of Need for Retreatment at Week 4 [ Time Frame: Baseline, Week 4 ] [ Designated as safety issue: No ]
    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'.

  • Patient Visual Analog Assessment of Pain at Week 4 [ Time Frame: Baseline, Week 4 ] [ Designated as safety issue: No ]
    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'.

  • Physician Comparison of Benefit to Previous Injections at Week 10 [ Time Frame: Week 10 ] [ Designated as safety issue: No ]
    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'.

  • Patient Comparison of Benefit to Previous Injections at Week 10 [ Time Frame: Week 10 ] [ Designated as safety issue: No ]
    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'.


Enrollment: 145
Study Start Date: September 2007
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: BOTOX®
botulinum toxin type A (BOTOX®)
Biological: botulinum toxin type A
200 Units at Visit 1 (Day 1)
Other Name: BOTOX®
Active Comparator: Dysport®
botulinum toxin type A (Dysport®)
Biological: botulinum toxin type A
750 Units at Visit 1 (Day 1)
Other Name: Dysport®

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00528541

Locations
Australia, South Australia
Adelaide, South Australia, Australia
Croatia
Zagreb, Croatia
Italy
Rome, Italy
Poland
Krakow, Poland
Turkey
Istanbul, Turkey
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

No publications provided

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT00528541     History of Changes
Other Study ID Numbers: MedAff-BTX-0616
Study First Received: September 10, 2007
Results First Received: November 14, 2011
Last Updated: November 14, 2011
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Additional relevant MeSH terms:
Torticollis
Central Nervous System Diseases
Dyskinesias
Dystonia
Dystonic Disorders
Movement Disorders
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Botulinum Toxins
Botulinum Toxins, Type A
Anti-Dyskinesia Agents
Central Nervous System Agents
Neuromuscular Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014