An Open Label Safety and Immunogenicity Study of MYOBLOC (Neurobloc; Botulinum Toxin Type B) Injectable Solution in Patients With Cervical Dystonia

NCT00702754 | Completed Phase 4 Results

• 1 other identifier: 401CDNA
• Study Type: interventional
• Target: 502
• Locations: 0 countries
• Sites: N/A

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

Conditions

Cervical Dystonia

Outcome Measures

Primary Outcomes (1)

• 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

  Session 1 - Time 0, 4 weeks post-injection compared to baseline

Secondary Outcomes (7)

• Treatment Assessment Scale (TAS), Approx Wk 12 + 4 Wks Post-Injection Compared to Baseline. Rating of Cervical Dystonia Symptoms

  Session 2 (12 wks) - 4 weeks post-injection compared to baseline

• Treatment Assessment Scale (TAS), Approx Wk 24 + 4 Wks Post-injection Compared to Baseline. Rating of Cervical Dystonia Symptoms

  Session 3 (24 Wks) - 4 weeks post-injection compared to baseline

• Treatment Assessment Scale (TAS), Approx Wk 36 + 4 Wks Post-injection Compared to Baseline. Rating of Cervical Dystonia Symptoms

  Session 4 (36 Wks) - 4 weeks post-injection compared to baseline

• Treatment Assessment Scale (TAS), Approx Wk 48 + 4 Wks Post-injection Compared to Baseline. Rating of Cervical Dystonia Symptoms

  Session 5 (48 Wks) - 4 weeks post-injection compared to baseline

• Treatment Assessment Scale (TAS), Approx Wk 60 + 4 Wks Post-injection Compared to Baseline. Rating of Cervical Dystonia Symptoms

  Session 6 (60 Wks) - 4 weeks post-injection compared to baseline

Interventions

Botulinum Toxin Type B BIOLOGICAL

Eligible patients could receive injections of MYOBLOC once every 12 weeks. Total Dose could range from 5,000 Units up to 25,000 Units.

Also known as: MYOBLOC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Solstice Neurosciences: lead

MeSH Terms

Conditions

Torticollis

Interventions

rimabotulinumtoxinB

Condition Hierarchy (Ancestors)

Dystonia; Dyskinesias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Regulatory Affairs Specialist
• Organization: Solstice Neurosciences, Inc

regulatoryaffairs@usworldmeds.com

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2008
• First Posted: June 20, 2008
• Study Start: June 1, 2001
• Primary Completion: May 1, 2008
• Study Completion: September 1, 2008
• Last Updated: May 10, 2019
• Results First Posted: September 23, 2009

Record last verified: 2019-04