NCT00528541

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

Trial Health

93
On Track

Trial Health Score

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

Enrollment
145

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Sep 2007

Geographic Reach
5 countries

5 active sites

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

September 1, 2007

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

September 10, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 12, 2007

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
2.3 years until next milestone

Results Posted

Study results publicly available

December 16, 2011

Completed
Last Updated

December 16, 2011

Status Verified

November 1, 2011

Enrollment Period

2 years

First QC Date

September 10, 2007

Results QC Date

November 14, 2011

Last Update Submit

November 14, 2011

Conditions

Spasmodic Torticollis

Outcome Measures

Primary Outcomes (1)

  • Dysphagia Incidence Over 10 Weeks

    Dysphagia Incidence (difficulty swallowing) was defined as the number of patients reporting at least 1 treatment-emergent dysphagia event at any point in the study. Occurrences of dysphagia were captured as spontaneous events or were assessed during study visits using the Structured Symptom Interview (SSI) and the Dystonia Study Group Dysphagia Interview (DSGDI) for symptoms of difficulty swallowing; coughing while eating and drinking; choking while eating or drinking; or difficulty swallowing solids or liquids.

    10 weeks

Secondary Outcomes (8)

  • Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score at Week 4

    Baseline, Week 4

  • Physician Assessment of Cervical Dystonia Severity at Week 4

    Baseline, Week 4

  • Global Assessment of Benefit by Physician at Week 4

    Week 4

  • Global Assessment of Benefit by Patient at Week 4

    Week 4

  • Patient Assessment of Need for Retreatment at Week 4

    Baseline, Week 4

  • +3 more secondary outcomes

Study Arms (2)

BOTOX®

ACTIVE COMPARATOR

botulinum toxin type A (BOTOX®)

Biological: botulinum toxin type A

Dysport®

ACTIVE COMPARATOR

botulinum toxin type A (Dysport®)

Biological: botulinum toxin type A

Interventions

botulinum toxin type ABIOLOGICAL

200 Units at Visit 1 (Day 1)

Also known as: BOTOX®
BOTOX®

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Unknown Facility

Adelaide, South Australia, Australia

Location

Unknown Facility

Zagreb, Croatia

Location

Unknown Facility

Rome, Italy

Location

Unknown Facility

Krakow, Poland

Location

Unknown Facility

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Torticollis

Interventions

Botulinum Toxins, Type AabobotulinumtoxinA

Condition Hierarchy (Ancestors)

DystoniaDyskinesiasNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Botulinum ToxinsMetalloendopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesMetalloproteasesBacterial ProteinsProteinsAmino Acids, Peptides, and ProteinsBacterial ToxinsToxins, BiologicalBiological Factors

Results Point of Contact

Title
Vice President Medical Affairs
Organization
Allergan, Inc.
clinicaltrials@allergan.com
714-246-4500

Study Officials

  • Medical Director

    Allergan

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 10, 2007

First Posted

September 12, 2007

Study Start

September 1, 2007

Primary Completion

September 1, 2009

Study Completion

September 1, 2009

Last Updated

December 16, 2011

Results First Posted

December 16, 2011

Record last verified: 2011-11

Locations

IT(1)CR(1)PL(1)TU(1)AU(1)