Study to Evaluate Safety, Efficacy of Botulinum Toxin Type A in Patients With Cervical Dystonia

Phase 2

Completed

• Conditions: Cervical Dystonia
• Interventions: Biological: botulinum toxin type A; Biological: botulinum toxin type A Formulation 2; Drug: Normal Saline

• Registration Number: NCT00564681
• Lead Sponsor: Allergan

Brief Summary

Study is to investigate the use of the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) scale in a cervical dystonia population treated with botulinum toxin type A, and placebo.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-11-26
• Study First Submitted QC: 2007-11-26
• Study First Posted: 2007-11-28
• Study Start: 2007-12
• Primary Completion: 2008-12
• Study Completion: 2009-12
• Disposition First Submitted: 2010-09-24
• Disposition First Submitted QC: 2010-09-24
• Disposition First Posted: 2010-09-29
• Results First Submitted: 2012-11-14
• Results First Submitted QC: 2012-11-14
• Results First Posted: 2012-12-11
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-04
• Last Update Posted: 2016-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 242

Inclusion Criteria

• Diagnosis of cervical dystonia

Exclusion Criteria

• Current or previous botulinum toxin treatment of any type for any condition

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo (Normal Saline) / botulinum toxin Type A Formulation 2	Normal Saline	Intramuscular injections of the assigned study medication into the affected muscles (placebo for treatment cycle 1 and botulinum toxin Type A Formulation 2 for subsequent treatments). Maximum dose of 360 units. Subjects may receive up to three treatments.
botulinum toxin Type A	botulinum toxin type A	Intramuscular injections into the affected muscles. Maximum dose of 360 units. Subjects may receive up to three treatments.
Placebo (Normal Saline) / botulinum toxin Type A	Normal Saline	Intramuscular injections of the assigned study medication into the affected muscles (placebo for treatment cycle 1 and botulinum toxin Type A for subsequent treatments). Maximum dose of 360 units. Subjects may receive up to three treatments.
botulinum toxin Type A Formulation 2	botulinum toxin type A Formulation 2	Intramuscular injections into the affected muscles. Maximum dose of 360 units. Subjects may receive up to three treatments.
Placebo (Normal Saline) / botulinum toxin Type A	botulinum toxin type A	Intramuscular injections of the assigned study medication into the affected muscles (placebo for treatment cycle 1 and botulinum toxin Type A for subsequent treatments). Maximum dose of 360 units. Subjects may receive up to three treatments.
Placebo (Normal Saline) / botulinum toxin Type A Formulation 2	botulinum toxin type A Formulation 2	Intramuscular injections of the assigned study medication into the affected muscles (placebo for treatment cycle 1 and botulinum toxin Type A Formulation 2 for subsequent treatments). Maximum dose of 360 units. Subjects may receive up to three treatments.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Observed Total Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Score at Week 4 of Treatment Cycle 1	Baseline, Week 4	Change from baseline in observed TWSTRS score at Week 4 of Treatment Cycle 1. The TWSTRS is an assessment scale used to measure the impact of cervical dystonia on patients. The score 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. A negative change from baseline represents improvement and a positive change from baseline indicates worsening.

Secondary Outcome Measures

Name	Time	Method
Physician's Global Assessment of Response to Treatment at Week 4 of Treatment Cycle 1	Week 4	Physician's global assessment of response to treatment at Week 4 of Treatment Cycle 1. Responses were measured on a 9-point scale of +4 to -4, with higher scores denoting improvement in cervical dystonia: +4 was 'Complete abolishment of signs and symptoms (100% improvement)', 0 represented 'No change', and -4 represented 'Very marked worsening (about 100% worse or greater)'.
Patient's Global Assessment of Response to Treatment at Week 4 of Treatment Cycle 1	Week 4	Patient's global assessment of response to treatment at Week 4 of Treatment Cycle 1. Responses were measured on a 9-point scale of +4 to -4, with higher scores denoting improvement in cervical dystonia: +4 was 'Complete abolishment of signs and symptoms (100% improvement)', 0 represented 'No change', and -4 represented 'Very marked worsening (about 100% worse or greater)'.
Change From Baseline in Pain as Evaluated With the TWSTRS Pain Subscale at Week 4 of Treatment Cycle 1	Baseline, Week 4	Change from baseline in pain as evaluated with the TWSTRS pain subscale at Week 4 of Treatment Cycle 1. The TWSTRS pain subscale scores range from 0 to 20 (0=no pain and 20=worst pain), based on severity of neck pain (0=no pain and 10=worst pain), the duration of pain (0=none and 5=most), and the degree of disability (0=none and 5=most). A negative number change from Baseline represents a decrease in pain (improvement).
Duration of Treatment Effect for Treatment Responders	Up to 6 Months	Duration of Treatment Effect for Treatment Responders is defined as the number of days from the date of first treatment to the first visit after Week 4 of Treatment Cycle 1, at which the Total TWSTRS score reaches at least 90% of the baseline score. A treatment responder is defined as a patient who has at least a 30% reduction in Total TWSTRS score at Week 4 after the first treatment. The TWSTRS score measures the impact of cervical dystonia on patients (0=least symptoms and 85= worst symptoms).