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

Purpose

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.

Condition	Intervention	Phase
Cervical Dystonia	Biological: botulinum toxin type A Biological: botulinum toxin type A Formulation 2 Drug: Normal Saline	Phase 2

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

Resource links provided by NLM:

Genetics Home Reference related topics: dopa-responsive dystonia early-onset primary dystonia

MedlinePlus related topics: Botox Dystonia

Drug Information available for: OnabotulinumtoxinA

U.S. FDA Resources

Further study details as provided by Allergan:

Primary Outcome Measures:

Change From Baseline in Observed Total Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Score at Week 4 of Treatment Cycle 1 [ Time Frame: Baseline, Week 4 ] [ Designated as safety issue: No ]
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:

Physician's Global Assessment of Response to Treatment at Week 4 of Treatment Cycle 1 [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
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 [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
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 [ Time Frame: Baseline, Week 4 ] [ Designated as safety issue: No ]
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 [ Time Frame: Up to 6 Months ] [ Designated as safety issue: No ]
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).

Enrollment:	242
Study Start Date:	December 2007
Study Completion Date:	December 2009
Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: botulinum toxin Type A Intramuscular injections into the affected muscles. Maximum dose of 360 units. Subjects may receive up to three treatments.	Biological: botulinum toxin type A Intramuscular injections into the affected muscles. Maximum dose of 360 units. Subjects may receive up to three treatments. Other Name: BOTOX®
Active Comparator: botulinum toxin Type A Formulation 2 Intramuscular injections into the affected muscles. Maximum dose of 360 units. Subjects may receive up to three treatments.	Biological: 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 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.	Biological: botulinum toxin type A Intramuscular injections into the affected muscles. Maximum dose of 360 units. Subjects may receive up to three treatments. Other Name: BOTOX® Drug: Normal Saline Intramuscular injections of placebo (normal saline) into the affected muscles for treatment cycle 1.
Placebo (Normal Saline) / 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.	Biological: botulinum toxin type A Formulation 2 Intramuscular injections into the affected muscles. Maximum dose of 360 units. Subjects may receive up to three treatments. Drug: Normal Saline Intramuscular injections of placebo (normal saline) into the affected muscles for treatment cycle 1.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Diagnosis of cervical dystonia

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00564681

Locations

United States, North Carolina

Winston-Salem, North Carolina, United States
Canada, Nova Scotia

Halifax, Nova Scotia, Canada
Czech Republic

Prague, Czech Republic
Germany

Berlin, Germany
Hungary

Budapest, Hungary
India

Mumbai, India
Philippines

Manila, Philippines
Poland

Warsaw, Poland
Russian Federation

Moscow, Russian Federation
Serbia

Belgrade, Serbia
Singapore

Singapore, Singapore
Slovakia

Spisska Nova, Slovakia
South Africa

Cape Town, South Africa
Taiwan

Tainan, Taiwan
Thailand

Bangkok, Thailand
United Kingdom

Bristol, United Kingdom

Sponsors and Collaborators

Allergan

Investigators

Study Director:

Medical Director

Allergan

More Information

No publications provided

Responsible Party:	Allergan
ClinicalTrials.gov Identifier:	NCT00564681 History of Changes
Other Study ID Numbers:	191622-090
Study First Received:	November 26, 2007
Results First Received:	November 14, 2012
Last Updated:	November 14, 2012
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Dystonia
Dystonic Disorders
Torticollis
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Movement Disorders
Central Nervous System Diseases

Botulinum Toxins, Type A
Botulinum Toxins
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 17, 2013