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CompletedNCT00276315Updated Apr 28, 2020

Assessment of Effectiveness and Safety of Dysport® for the Treatment of Hemifacial Spasm

A Phase 3 interventional study of Botulinum toxin type A in Hemifacial Spasm, sponsored by Ipsen. Completed at 4 sites in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-04-28.

Sponsored by Ipsen · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
332
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

To compare the effectiveness and safety of Dysport® with the domestic Botulinum Toxin Type A (manufactured by Lanzhou Biologic Product Institute, P.R. China) for the treatment of hemifacial spasm.

02

Conditions studied

  • Hemifacial Spasm

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03

In context

Hemifacial Spasm

23 studies on the registry are indexed under Hemifacial Spasm; 3 are open to participants now.

This study's enrollment of 332 is above the median of 61 across 11 interventional studies indexed under Hemifacial Spasm.

Browse Hemifacial Spasm studies →

Lead sponsor

Ipsen is the lead sponsor of 289 studies on the registry; 17 are open to participants now.

Of its 26 completed or terminated interventional studies of FDA-regulated products, 22 (85%) have results posted.

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Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patient suffering from hemifacial spasm with at least 6 months duration (prior to visit 1)
  • Cohen scale ≥ to grade II

Exclusion criteria

Exclusion Criteria:

  • Botulinum toxin type A treatment history within last 16 weeks prior to visit 1
  • Hemifacial spasm secondary to facial palsy
  • Previous alcohol or phenol injections or surgical therapy of the facial muscles
  • Requirement for botulinum toxin injection to site(s) of the body other than in this study
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single
Enrollment
332 participants (actual)

Interventions

06

What researchers measure

Primary outcomes

  1. Percentage of responders (defined as Cohen scale improvement ≥ to 2 levels)

    Time frame: At the end of week 4

Secondary outcomes

  1. Percentage of responders (defined as Cohen scale improvement ≥ to 2 levels after medication)

    Time frame: At the end of week 1 and 12

  2. Improvement degree of spasm (Jankovic scale)

    Time frame: At the end of week 1, 4 and 12

  3. Assessment of efficacy by the subjects

    Time frame: At the end of week 1, 4 and 12

07

Study locations

4 sites
  • Neurology Department, Peking Union Medical College Hospital
    Beijing, 100730, China
  • Neurology Department, Guangdong Provincial People's Hospital
    Guangdong, 510080, China
  • Neurology Department, Sir Run Run Shaw Hospital, Zhejiang University
    Hangzhou, 310016, China
  • Neurology Department, Shanghai Ruijin Hospital
    Shanghai, 200025, China
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Dec 2005 and a completion of Jan 2007. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 12, 2006
First posted
Jan 13, 2006
Start
Dec 2005
CompletionActual
Jan 2007
Last update
Apr 28, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 28, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00276315
Lead sponsor
Ipsen
First posted
Jan 13, 2006
Start date
Dec 2005
Completion
Jan 2007
Last update
Apr 28, 2020

Study contacts

Ipsen Medical Director
study director · Ipsen
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.

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Discussion

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