NCT01384214

Brief Summary

The purpose of this study is to evaluate swallowing efficiency in patients with cervical dystonia following treatment with botulinum toxin Type A.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Oct 2008

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

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

October 1, 2008

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

June 27, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 29, 2011

Completed
Last Updated

June 29, 2011

Status Verified

June 1, 2011

Enrollment Period

8 months

First QC Date

June 27, 2011

Last Update Submit

June 28, 2011

Conditions

Torticollis

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline in Oropharyngeal Swallow Efficiency (OPSE)

    Baseline, Week 2

Secondary Outcomes (5)

  • Toronto Western Spasmodic Torticollis Scale (TWSTRS) Total Score

    Week 4

  • Physician Assessment of Cervical Dystonia Severity

    Week 4

  • Global Assessment of Benefit by Physician

    Week 4

  • Global Assessment of Benefit by Patient

    Week 4

  • Patient Visual Analog Assessment of Pain

    Week 4

Study Arms (1)

1

EXPERIMENTAL

botulinum toxin Type A

Biological: botulinum toxin Type A

Interventions

botulinum toxin Type ABIOLOGICAL

750 U at Visit 1

Also known as: Dysport®
1

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed with cervical dystonia
  • Successfully completed Allergan study MedAff BTX-0616 with 16 weeks since last botulinum toxin Type A injection
  • In need of additional botulinum toxin Type A injections

You may not qualify if:

  • Surgery or spinal cord stimulation for cervical dystonia
  • Previous injections of phenol or alcohol for cervical dystonia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Zagreb, Croatia

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

Study Officials

  • Medical Director

    Allergan

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 27, 2011

First Posted

June 29, 2011

Study Start

October 1, 2008

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

June 29, 2011

Record last verified: 2011-06

Locations

CR(1)