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

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Ipsen

Status and phase

Completed
Phase 2

Conditions

Blepharospasm

Treatments

Biological: Botulinum toxin type A

Study type

Interventional

Funder types

Industry

Identifiers

NCT00234507
Y-47-52120-706

Details and patient eligibility

About

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

Enrollment

120 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

Trial contacts and locations

14

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Data sourced from clinicaltrials.gov

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