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

NCT00432341 | Terminated Phase 4 Results

• 1 other identifier: MedAff-BTX-0615
• Study Type: interventional
• Target: 54
• Locations: 3 countries
• Sites: 3

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

Conditions

Spasmodic Torticollis

Outcome Measures

Primary Outcomes (1)

• Duration of Treatment Benefit

  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) \[loss of 80% of benefit\].

  20 Weeks

Secondary Outcomes (9)

• 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

Study Arms (2)

BOTOX®

EXPERIMENTAL

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 A BIOLOGICAL

200 Units at Visit 1 (Day 1)

Also known as: BOTOX®

BOTOX®

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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

Sponsors & Collaborators

• Allergan: lead

Study Sites (3)

Unknown Facility

Buenos Aires, Argentina

Location

Unknown Facility

Parkville, Victoria, Australia

Location

Unknown Facility

New Delhi, New Delhi, India

Location

MeSH Terms

Conditions

Torticollis

Interventions

Botulinum Toxins, Type A; abobotulinumtoxinA

Condition Hierarchy (Ancestors)

Dystonia; Dyskinesias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Limitations and Caveats

The study was terminated early due to difficulties with patient recruitment.

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: February 5, 2007
• First Posted: February 7, 2007
• Study Start: June 1, 2007
• Primary Completion: March 1, 2009
• Study Completion: June 1, 2009
• Last Updated: December 16, 2011
• Results First Posted: December 16, 2011

Record last verified: 2011-11

Locations

AR (1); IN (1); AU (1)