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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 (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT00761592
First received: September 25, 2008
Last updated: October 25, 2013
Last verified: October 2013
  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:


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 ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

    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) ] [ Designated as safety issue: No ]
    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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: Allergan
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: October 25, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Blepharospasm
Eye Diseases
Eyelid Diseases
Botulinum Toxins
Botulinum Toxins, Type A
Anti-Dyskinesia Agents
Central Nervous System Agents
Neuromuscular Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014