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Completed

NCT Number: NCT00234507

Study of a Single Administration of 3 Doses of Dysport® for the Treatment of Benign Essential Blepharospasm

The purpose of this study is to compare the effectiveness of 3 doses of Dysport® with placebo by assessing functional disability in blepharospasm.

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Key information

Conditions

Blepharospasm Eye Diseases Eyelid Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Banner Health Research Institute, Phoenix, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients with a confirmed diagnosis of bilateral benign essential blepharospasm, and having symptoms of such for at least 6 months prior to the baseline visit
  • naïve patients to botulinum toxin type A treatment, or patients who had received a single treatment of botulinum toxin type A, or those who had demonstrated a satisfactory response, in the investigator's opinion, to the last 2 injections of botulinum toxin type A with a minimum of 12 weeks since the last injection and where a further injection at full dosage was now indicated
  • patients with a minimum score of 8 on the BDS

Exclusion criteria

  • patients with either neuroleptic-induced blepharospasm, isolated levator dysfunction or apraxia
  • previous surgical, chemical and thermal myectomy or neurectomy
  • any condition where intramuscular injection is contraindicated
  • ophthalmolgical infection
  • myasthenia gravis or other disorders of the neuromuscular junction
  • prescription of antispastic, muscle relaxants or medications affecting neuromuscular junction transmission, or medication where the dose or choice of medication has not been constant for the last 30 days

Treatment and study plan

Botulinum toxin type A

Biological

Other names: AbobotulinumtoxinA (Dysport®)

Primary outcomes

  1. The functional disability as measured by the percentage of normal activity (PNA) derived from the Blepharospasm Disability Scale (BDS) at 4 weeks post-treatment.

Secondary outcomes

  1. Frequency of involuntary movements (FIM) and severity of oculo-facial spasm (measured by the Severity Rating Scale [SRS]) at 4 weeks post-treatment.

  2. PNA, FIM and SRS at 8, 12 and 16 weeks post-treatment.

  3. Severity of global impairment due to blepharospasm as measured by the Visual Analogue Scale (VAS) at 4, 8, 12 and 16 weeks post-treatment.

  4. Change from baseline in BDS, FIM, severity of oculo-facial spasm and in severity of global impairment due to blepharospasm (measured by VAS) at 4, 8, 12 and 16 weeks post treatment.

  5. Percentage of patients withdrawn from the study due to lack of efficacy at each assessment point.

  6. Patient assessment of benefit and need for re-treatment, evaluated at the end of the study.

  7. Investigator assessment of benefit and need for re-treatment, evaluated at the end of the study.

  8. To compare the safety of each of the 3 doses of Dysport with placebo in terms of adverse event incidence, vital signs and physical examinations.

Sponsors and collaborators

Lead sponsor

Ipsen

Industry

Registry information

Official study title

Phase II, Multi-centre, Randomised, Double-blind, Parallel Group, Placebo-controlled Study to Assess the Efficacy and Safety of a Single Administration, by Subcutaneous Injection, of Three Doses of Dysport (40 Units/Eye, 80 Units/Eye, and 120 Units/Eye) for the Treatment of Benign Essential Blepharospasm

Important dates

Study start
2003
Primary completion
2004
Study completion
2004
First posted
Oct 7, 2005
Registry last updated
Jul 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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