NCT00702754

Brief Summary

Open label study to evaluate the safety and immunogenicity of MYOBLOC (Botulinum Toxin Type B) in adult patients with a clinical diagnosis of Cervical Dystonia (CD).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
502

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jun 2001

Longer than P75 for phase_4

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2001

Completed
6.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 12, 2008

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 20, 2008

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

September 23, 2009

Completed
Last Updated

May 11, 2026

Status Verified

April 1, 2026

Enrollment Period

6.9 years

First QC Date

June 12, 2008

Results QC Date

May 12, 2009

Last Update Submit

April 20, 2026

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

  • +2 more secondary outcomes

Study Arms (1)

Open-Label Treatment

EXPERIMENTAL

5,000 units up to 25,000 units of MYOBLOC (Botulinum Toxin Type B) injections every 12 weeks

Biological: Botulinum Toxin Type B

Interventions

Botulinum Toxin Type BBIOLOGICAL

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
Open-Label Treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Torticollis

Interventions

rimabotulinumtoxinB

Condition Hierarchy (Ancestors)

DystoniaDyskinesiasNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Head of Clinical Development
Organization
Supernus Pharmaceuticals, Inc.
clinicaltrials@supernus.com

Study Officials

  • Jonathan T Rubin, MD

    Supernus Pharmaceuticals, Inc.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
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 11, 2026

Results First Posted

September 23, 2009

Record last verified: 2026-04