Hemifacial SpasmPhase 3NCT00276315
Assessment of Effectiveness and Safety of Dysport® for the Treatment of Hemifacial Spasm
A Phase 3 study testing Botulinum toxin type A in people with Hemifacial Spasm, run by Ipsen at 4 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hemifacial Spasm
- What is being tested?
- Botulinum toxin type A
- How many people
- 332 participants
- Where
- 4 sitesChina
- Study dates
- Dec 2005to Jan 2007
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient suffering from hemifacial spasm with at least 6 months duration (prior to visit 1)
- Cohen scale ≥ to grade II
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
China4 sites
Neurology Department, Peking Union Medical College Hospital
Beijing, 100730
Neurology Department, Guangdong Provincial People's Hospital
Guangdong, 510080
Neurology Department, Sir Run Run Shaw Hospital, Zhejiang University
Hangzhou, 310016
Neurology Department, Shanghai Ruijin Hospital
Shanghai, 200025
About this study
Official title: A Phase III, Multicentre, Randomised, Assessor-blind, Parallel Groups, Reference Drug Controlled Study to Assess the Efficacy and Safety of a Single Administration, by Subcutaneous Injection of Dysport® for the Treatment of Hemifacial Spasm
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.
- Conditions
- Hemifacial Spasm
- Being tested
- Botulinum toxin type A
- Medical subject headings
- Hemifacial Spasm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum toxin type ABiological
Also called AbobotulinumtoxinA (Dysport®)
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of responders (defined as Cohen scale improvement ≥ to 2 levels)
Measured: At the end of week 4
Secondary outcomes (3)
Percentage of responders (defined as Cohen scale improvement ≥ to 2 levels after medication)
Measured: At the end of week 1 and 12
Improvement degree of spasm (Jankovic scale)
Measured: At the end of week 1, 4 and 12
Assessment of efficacy by the subjects
Measured: At the end of week 1, 4 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2006 (estimated)
- Study startDec 2005
- Study completionJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemifacial SpasmStudies of the same condition, open and under way.
- More trials run by IpsenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 332 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ipsen
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Ipsen Medical Director, Study director, Ipsen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00276315
- Sponsor's protocol ID
- A-38-52120-074
- Status last verified
- Apr 2020
- First submitted
- 12 Jan 2006
- Last updated
- 28 Apr 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Multicentre, Randomised, Assessor-blind, Parallel Groups, Reference Drug Controlled Study to Assess the Efficacy and Safety of a Single Administration, by Subcutaneous Injection of Dysport® for the Treatment of Hemifacial Spasm
- ClinicalTrials.gov ID
- NCT00276315
- Acronym / sponsor ID
- A-38-52120-074
- Conditions
- Hemifacial Spasm
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 332 participants (actual)
- Lead sponsor
- IpsenIndustry (pharma, biotech, devices)
- Study start
- Dec 2005
- Study completion
- Jan 2007 (actual)
- First posted
- 13 Jan 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient suffering from hemifacial spasm with at least 6 months duration (prior to visit 1)
- Cohen scale ≥ to grade II
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Botulinum toxin type AAlso: AbobotulinumtoxinA (Dysport®) | Biological | – |
Primary outcome
Percentage of responders (defined as Cohen scale improvement ≥ to 2 levels)
Time frame: At the end of week 4
3 secondary outcomes
Percentage of responders (defined as Cohen scale improvement ≥ to 2 levels after medication)
Time frame: At the end of week 1 and 12
Improvement degree of spasm (Jankovic scale)
Time frame: At the end of week 1, 4 and 12
Assessment of efficacy by the subjects
Time frame: At the end of week 1, 4 and 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ipsen Medical Director study director
Ipsen
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Botulinum toxin type A in people with Hemifacial Spasm, run by Ipsen at 4 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of responders (defined as Cohen scale improvement ≥ to 2 levels) (time frame: At the end of week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2020.