Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/NCT00432341
NCT00432341TerminatedPhase 4

Efficacy and Safety of Two Different Botulinum Toxin Type A Treatments for Moderate to Severe Cervical Dystonia

Allergan3 sites in 3 countries54 target enrollmentStarted: June 1, 2007Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditions

Trial Snapshot

Phase
Phase 4
Status
Terminated
Sponsor
Allergan
Enrollment
54
Locations
3
Primary Endpoint
Duration of Treatment Benefit
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

The purpose of this study is to compare two types of botulinum toxin type A to treat the involuntary muscle contractions in the neck

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Diagnosed with cervical dystonia/spasmodic torticollis for at least 18 months
  • •Successfully treated previously with botulinum toxin type A

Exclusion Criteria

  • •Breast feeding, pregnant, or could become pregnant
  • •Surgery or spinal cord stimulation for cervical dystonia
  • •Previous injections of phenol, alcohol for cervical dystonia

Outcomes

Primary Outcomes

Duration of Treatment Benefit

Time Frame: 20 Weeks

Duration of treatment benefit was measured as the time (days) from Baseline until patients had a loss of therapeutic benefit, as defined by the achievement of their Toronto Western Spasmodic Torticollis Rating Scale Duration Target Score (TDTS) \[loss of 80% of benefit\].

Secondary Outcomes

  • Toronto Western Spasmodic Torticollis Rating Scale Duration Target Score (TDTS) at Week 4(Week 4)
  • Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score at Week 4(Baseline, Week 4)
  • Global Assessment of Benefit by Patient at Week 4(Week 4)
  • Global Assessment of Benefit by Physician at Week 4(Week 4)
  • Physician Assessment of Cervical Dystonia Severity at Week 4(Baseline, Week 4)
  • Physician Comparison of Benefit to Previous Injections at Week 20(Week 20)
  • Patient Comparison of Benefit to Previous Injections at Week 20(Week 20)
  • Patient Visual Analog Assessment of Pain at Week 4(Baseline, Week 4)
  • Patient Assessment of Need for Retreatment at Week 4(Baseline, Week 4)

Investigators

Sponsor
Allergan
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (3)

Loading locations...

Similar Trials

Completed
Phase 4
Comparison of Efficacy and Safety of Two Different Types of Botulinum Toxin Type A in Moderate to Severe Cervical DystoniaSpasmodic Torticollis
NCT00528541Allergan145
Completed
Phase 4
Safety and Efficacy of Two Types of Botulinum Toxin Type A For the Treatment of Glabellar LinesGlabellar Lines
NCT01271452Allergan224
Completed
Phase 4
Comparison of Two Botulinum Type A Products in the Treatment of BlepharospasmBlepharospasm
NCT00761592Allergan65
Completed
Phase 4
Botulinum Toxin A Adult Gastrocnemius Muscle StudyMuscle SpasticityStroke
NCT01278576The Catholic University of Korea40
Completed
Phase 3
Safety and Efficacy Study of Botulinum Toxin Type A for the Treatment of Crow's Feet Lines and Frown LinesFacial RhytidesCrow's Feet LinesGlabellar Lines
NCT01224015Allergan684
Efficacy and Safety of Two Different... | Clinical Trial