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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00761592
First Posted: September 29, 2008
Last Update Posted: November 19, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Allergan
  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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


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 ]

    Blepharospasm Disability Index is a validated 5-point scale (0-4) with six items (e.g., reading, driving a vehicle).

    0 - no impairment, 1 - mild impairment, 2 - moderate impairment, 3 - severe impairment, 4 - not possible due to disease, N/A - Not applicable.

    The total score ranged from 0 (no impairment) to 24 (not possible due to disease). A negative change from baseline indicated improvement.



Secondary Outcome Measures:
  • Change From Baseline to Week 8 in Blepharospasm Disability Index [ Time Frame: Baseline to Week 8 ]

    Blepharospasm Disability Index is a validated 5-point (0-4) scale with six items (e.g., reading, driving a vehicle).

    0 - no impairment, 1 - mild impairment, 2 - moderate impairment, 3 - severe impairment, 4 - not possible due to disease, N/A - Not applicable.

    The total score ranged from 0 (no impairment) to 24 (not possible due to disease). A negative change from baseline indicated improvement.


  • Change From Baseline to Week 4 and Week 8 in Total Jankovic Rating Scale (JRS) (Severity and Frequency Measured on a Scale of 0-4) [ Time Frame: Baseline to Week 4 and Week 8 ]
    Jankovic Rating Scale Severity: 0 - None; 1 - Minimal; 2 - Mild; 3 - Moderate; 4 - Severe. Frequency: 0 - None; 1 - Slight increase; 2 - Fluttering duration less than 1 second; 3 - Spasm greater than 1 second and eyes open > 50% of waking time; 4 - Functionally blind. The range of the total score was from 0 (None) to 8 (Severe and Functionally Blind). A negative change from baseline indicated improvement.

  • Changes From Baseline to Week 4 and Week 8 in Patient Global Assessment (PGA) Score [ Time Frame: Baseline to Week 4 and 8 ]

    Subjective satisfaction rating: -4: marked worsening, -3: moderate worsening, -2: marked worsening in symptoms, -1: mild worsening in symptoms, 0: no effect

    +1: mild improvement in symptoms, +2: moderate improvement in symptoms, +3: mild improvement, +4: marked improvement. A positive change from baseline indicated improvement.


  • Duration of Action [ Time Frame: Interval between initial injection (Week 0) and final visit (Week 11 through Week 14) ]
    Median Duration for decision to reinject


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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00761592


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

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT00761592     History of Changes
Other Study ID Numbers: ALLBL001
First Submitted: September 25, 2008
First Posted: September 29, 2008
Results First Submitted: January 30, 2009
Results First Posted: July 9, 2009
Last Update Posted: November 19, 2013
Last Verified: October 2013

Additional relevant MeSH terms:
Blepharospasm
Eyelid Diseases
Eye Diseases
Botulinum Toxins
Botulinum Toxins, Type A
abobotulinumtoxinA
onabotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents