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Comparison of Two Botulinum Type A Products in the Treatment of Blepharospasm

This study has been completed.
Sponsor:
Information provided by:
Allergan
ClinicalTrials.gov Identifier:
NCT00761592
First received: September 25, 2008
Last updated: May 18, 2009
Last verified: May 2009
History of Changes
  Purpose

This pilot study estimates the treatment effects of two different types of botulinum toxin type A in the treatment of Blepharospasm. Blepharospasm is characterised by excessive contraction of the muscles around the eye and can lead to repetitive blinking or sustained closure of the eyelids.


Condition Intervention Phase
Blepharospasm
 Biological: Botulinum Toxin Type A 900kDa
Biological: Botulinum Toxin Type A 150kDa
 Phase 4

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

Resource links provided by NLM:

MedlinePlus related topics: Botox
U.S. FDA Resources

Further study details as provided by Allergan:

Primary Outcome Measures:
  • Change From Baseline to Week 4 in Blepharospasm Disability Index [ Time Frame: Baseline to Week 4 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change From Baseline to Week 8 in Blepharospasm Disability Index [ Time Frame: Baseline to Week 8 ] [ Designated as safety issue: No ]
  • Change From Baseline to Week 4 and Week 8 in Total Jankovic Rating Scale (Severity and Frequency Measured on a Scale of 0-4) [ Time Frame: Baseline to Week 4 and Week 8 ] [ Designated as safety issue: No ]
  • Changes From Baseline to Week 4 and Week 8 in Patient Global Assessment Score [ Time Frame: Baseline to Week 4 and 8 ] [ Designated as safety issue: No ]
  • Duration of Action [ Time Frame: Interval between initial injection (Week 0) and final visit (Week 11 through Week 14) ] [ Designated as safety issue: No ]
  • Adverse Events [ Time Frame: Injection to Week 14 ] [ Designated as safety issue: No ]

Enrollment: 65
Study Start Date: July 2006
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Biological: Botulinum Toxin Type A 900kDa
6 to 16 injections, with maximum of 21, at a dose of ≥20U/eye (≥40U total dose)
Other Name: BOTOX®
Active Comparator: 2 Biological: Botulinum Toxin Type A 150kDa
6 to 16 injections, with a maximum of 21, at a dose of ≥20U/eye (≥40U total dose)
Other Name: Xeomin®

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosed with benign essential blepharospasm
  • Received ≥20U/eye of BOTOX® for at least one visit prior to study entry and required, in the investigators opinion, the same dose at the study injection visit.
  • Combined Jankovic Rating Score of >2

Exclusion Criteria:

  • Female subjects who were pregnant, breastfeeding, or who were of childbirth potential and not practicing birth control.
  • Profound atrophy of the muscles in the target area(s) of injection.
  • Myasthenia Gravis, Lambert-Eaton Syndrome, Amyotrophic Lateral Sclerosis or any other disease that might interfere with neuromuscular function.
  • Known significantly impaired renal and/or hepatic function
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00761592

Locations
Germany
Bonn, Germany
Wiesbaden, Germany
Zwickau, Germany
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

No publications provided

Responsible Party: Therapeutic Area Head, Allergan, Inc.
ClinicalTrials.gov Identifier: NCT00761592     History of Changes
Other Study ID Numbers: ALLBL001
Study First Received: September 25, 2008
Results First Received: January 30, 2009
Last Updated: May 18, 2009
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Blepharospasm
Eyelid Diseases
Eye 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 May 21, 2013