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

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Brief Title

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

Official 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

Brief Summary

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


Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

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 Outcome

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

Condition

Blepharospasm

Intervention

Botulinum toxin type A


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Biological

Estimated Enrollment

120

Start Date

January 2003

Completion Date

May 25, 2004

Primary Completion Date

May 25, 2004

Eligibility Criteria

        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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Ipsen Study Director, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00234507

Organization ID

Y-47-52120-706



Study Sponsor

Ipsen


Study Sponsor

Ipsen Study Director, Study Director, Ipsen


Verification Date

July 2019