Back to resultsAn Open Label Safety and Immunogenicity Study of MYOBLOC (Neurobloc; Botulinum Toxin Type B) Injectable Solution in Patients With Cervical Dystonia
Primary Purpose
Cervical Dystonia
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Botulinum Toxin Type B
Sponsored by
About this trial
This is an interventional treatment trial for Cervical Dystonia
Eligibility Criteria
Inclusion Criteria:
- 18 years of age or older
- body weight of at least 46 kilograms
- History of Cervical Dystonia of at least one year's duration who in the opinion of the Investigator requires treatment
Exclusion Criteria:
- Inability to give informed consent
- Patient who has been previously treated with botulinum Toxin Type B
- Patient who has received a Botulinum toxin Type A injection in the last 12 weeks.
- History of phenol injections involving the neck or shoulder region in the last 12 months.
- Patients with neck contractures or cervical spine disease
Sites / Locations
Outcomes
Primary Outcome Measures
Treatment Assessment Scale (TAS), 4 Wks Post-injection Compared to Baseline (Time 0), Rating of Cervical Dystonia Symptoms
7 point rating scale (-3 = significantly worse, 0 = no change, +3 = significantly better. Comparison at Wk 4 to baseline. Rating of Cervical Dystonia Symptoms
Secondary Outcome Measures
Treatment Assessment Scale (TAS), Approx Wk 12 + 4 Wks Post-Injection Compared to Baseline. Rating of Cervical Dystonia Symptoms
7 point rating scale (-3=significantly worse, 0=no change, +3=significantly better), comparison of Wk 12 + 4, compared to baseline. Rating of Cervical Dystonia Symptoms
Treatment Assessment Scale (TAS), Approx Wk 24 + 4 Wks Post-injection Compared to Baseline. Rating of Cervical Dystonia Symptoms
7 point scale (-3=significantly worse, 0=no change, +3=significantly better). Comparison of Wk 24 + 4, compared to baseline. Rating of Cervical Dystonia Symptoms
Treatment Assessment Scale (TAS), Approx Wk 36 + 4 Wks Post-injection Compared to Baseline. Rating of Cervical Dystonia Symptoms
7 point scale (-3=significantly worse, 0=no change, +3=significantly better). Comparison of Wk 36 + 4, compared to baseline. Rating of Cervical Dystonia Symptoms
Treatment Assessment Scale (TAS), Approx Wk 48 + 4 Wks Post-injection Compared to Baseline. Rating of Cervical Dystonia Symptoms
7 point scale (-3=significantly worse, 0=no change, +3=significantly better). Comparison of Wk 48 + 4, compared to baseline. Rating of Cervical Dystonia Symptoms
Treatment Assessment Scale (TAS), Approx Wk 60 + 4 Wks Post-injection Compared to Baseline. Rating of Cervical Dystonia Symptoms
7 point scale (-3=significantly worse, 0=no change, +3=significantly better). comparison Wk 60 + 4, compared to baseline. Rating of Cervical Dystonia Symptoms
Treatment Assessment Scale (TAS), Approx Wk 72 + 4 Wks Post-injection Compared to Baseline. Rating of Cervical Dystonia Symptoms
7 point scale (-3=significantly worse, 0=no change, +3=significantly better). Comparison Wk 72 + 4, compared to baseline. Rating of Cervical Dystonia Symptoms
Treatment Assessment Scale (TAS), Approx Wk 84 + 4 Wks Post-injection Compared to Baseline. Rating of Cervical Dystonia Symptoms
7 point scale (-3=significantly worse, 0=no change, +3=significantly better). Comparison Wk 84 + 4, compared to baseline. Rating of Cervical Dystonia Symptoms
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00702754
Brief Title
An Open Label Safety and Immunogenicity Study of MYOBLOC (Neurobloc; Botulinum Toxin Type B) Injectable Solution in Patients With Cervical Dystonia
Official Title
An Open Label Safety and Immunogenicity Study of MYOBLOC (Neurobloc; Botulinum Toxin Type B) Injectable Solution in Patients With Cervical Dystonia
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
June 2001 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
September 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Solstice Neurosciences
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Five hundred patients with a confirmed clinical diagnosis of Cervical Dystonia (CD)are planned for enrollment into this open label study. These patients will be Type B toxin naive patients with CD. During this study patients will receive repeat injections of MYOBLOC when deemed appropriate by the Investigator. However, it will be recommended that injections occur not more frequently than every 12 weeks. Total duration of exposure to MYOBLOC will be targeted for at least two years, with potential exposure for up to 7 years in patients with earliest enrollment
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Dystonia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
502 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
Botulinum Toxin Type B
Other Intervention Name(s)
MYOBLOC
Intervention Description
Eligible patients could receive injections of MYOBLOC once every 12 weeks. Total Dose could range from 5,000 Units up to 25,000 Units.
Primary Outcome Measure Information:
Title
Treatment Assessment Scale (TAS), 4 Wks Post-injection Compared to Baseline (Time 0), Rating of Cervical Dystonia Symptoms
Description
7 point rating scale (-3 = significantly worse, 0 = no change, +3 = significantly better. Comparison at Wk 4 to baseline. Rating of Cervical Dystonia Symptoms
Time Frame
Session 1 - Time 0, 4 weeks post-injection compared to baseline
Secondary Outcome Measure Information:
Title
Treatment Assessment Scale (TAS), Approx Wk 12 + 4 Wks Post-Injection Compared to Baseline. Rating of Cervical Dystonia Symptoms
Description
7 point rating scale (-3=significantly worse, 0=no change, +3=significantly better), comparison of Wk 12 + 4, compared to baseline. Rating of Cervical Dystonia Symptoms
Time Frame
Session 2 (12 wks) - 4 weeks post-injection compared to baseline
Title
Treatment Assessment Scale (TAS), Approx Wk 24 + 4 Wks Post-injection Compared to Baseline. Rating of Cervical Dystonia Symptoms
Description
7 point scale (-3=significantly worse, 0=no change, +3=significantly better). Comparison of Wk 24 + 4, compared to baseline. Rating of Cervical Dystonia Symptoms
Time Frame
Session 3 (24 Wks) - 4 weeks post-injection compared to baseline
Title
Treatment Assessment Scale (TAS), Approx Wk 36 + 4 Wks Post-injection Compared to Baseline. Rating of Cervical Dystonia Symptoms
Description
7 point scale (-3=significantly worse, 0=no change, +3=significantly better). Comparison of Wk 36 + 4, compared to baseline. Rating of Cervical Dystonia Symptoms
Time Frame
Session 4 (36 Wks) - 4 weeks post-injection compared to baseline
Title
Treatment Assessment Scale (TAS), Approx Wk 48 + 4 Wks Post-injection Compared to Baseline. Rating of Cervical Dystonia Symptoms
Description
7 point scale (-3=significantly worse, 0=no change, +3=significantly better). Comparison of Wk 48 + 4, compared to baseline. Rating of Cervical Dystonia Symptoms
Time Frame
Session 5 (48 Wks) - 4 weeks post-injection compared to baseline
Title
Treatment Assessment Scale (TAS), Approx Wk 60 + 4 Wks Post-injection Compared to Baseline. Rating of Cervical Dystonia Symptoms
Description
7 point scale (-3=significantly worse, 0=no change, +3=significantly better). comparison Wk 60 + 4, compared to baseline. Rating of Cervical Dystonia Symptoms
Time Frame
Session 6 (60 Wks) - 4 weeks post-injection compared to baseline
Title
Treatment Assessment Scale (TAS), Approx Wk 72 + 4 Wks Post-injection Compared to Baseline. Rating of Cervical Dystonia Symptoms
Description
7 point scale (-3=significantly worse, 0=no change, +3=significantly better). Comparison Wk 72 + 4, compared to baseline. Rating of Cervical Dystonia Symptoms
Time Frame
Session 7 (72 Wks) - 4 weeks post-injection compared to baseline
Title
Treatment Assessment Scale (TAS), Approx Wk 84 + 4 Wks Post-injection Compared to Baseline. Rating of Cervical Dystonia Symptoms
Description
7 point scale (-3=significantly worse, 0=no change, +3=significantly better). Comparison Wk 84 + 4, compared to baseline. Rating of Cervical Dystonia Symptoms
Time Frame
Session 8 (84 Wks) - 4 weeks post-injection compared to baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18 years of age or older
body weight of at least 46 kilograms
History of Cervical Dystonia of at least one year's duration who in the opinion of the Investigator requires treatment
Exclusion Criteria:
Inability to give informed consent
Patient who has been previously treated with botulinum Toxin Type B
Patient who has received a Botulinum toxin Type A injection in the last 12 weeks.
History of phenol injections involving the neck or shoulder region in the last 12 months.
Patients with neck contractures or cervical spine disease
12. IPD Sharing Statement
Learn more about this trial
An Open Label Safety and Immunogenicity Study of MYOBLOC (Neurobloc; Botulinum Toxin Type B) Injectable Solution in Patients With Cervical Dystonia
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