Hemifacial SpasmPhase 2NCT01564979
Effect on Tear Functions of Pretarsal and Preseptal Techniques of Botulinum Toxin Type A Injection in Hemifacial Spasm
A Phase 2 study testing preseptal injection of botulinum toxin type A and pretarsal injection of Botulinum toxin type A in people with Hemifacial Spasm, run by Khon Kaen University at 1 site in Thailand.
Trial summary
The purpose of this study is to determine whether pretarsal and preseptal techniques of Botulinum toxin type A injection have any effect on tear functions. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Hemifacial Spasm
- What is being tested?
- preseptal injection of botulinum toxin type A and pretarsal injection of Botulinum toxin type A
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteThailand
- Study dates
- Apr 2012to Dec 2012
- Phase
- Phase 2
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patient diagnosed with hemifacial spasm
Who cannot join
- previous history of botulinum toxin treatment for hemifacial spasm
- ocular surface disorders
- tear disorders
- evidence of infection at or around eyelids
- pregnant woman
- other neurologic disease, i.e. OMG
- coagulopathy or treatment with thrombolytic agent
- treatment with aminoglycosides, chloroquine, hydroxychloroquine
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Khon Kaen University
Muang, Changwat Khon Kaen, 40002
kitthisak kitthaweesin, MD
Pawat Phusetwong, MD
About this study
The purpose of this study is to determine whether pretarsal and preseptal techniques of Botulinum toxin type A injection have any effect on tear functions.
Read the detailed description
Botulinum toxin type A has been used for hemifacial spasm since 1986. of Botulinum toxin type A can be subcutaneously injected at pretarsal or preseptal portion of orbicularis muscle. Blepharoptosis has been reported less frequently with pretarsal technique, however dry eye was noticed in one patient treated with pretarsal botulinum toxin type A for cosmetic purpose.
- Conditions
- Hemifacial Spasm
- Being tested
- preseptal injection of botulinum toxin type A, pretarsal injection of Botulinum toxin type A
- Keywords
- botulinum toxin, facial nerve, hemifacial spasm, tears
- Medical subject headings
- Hemifacial Spasm, Lacerations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
preseptal injection of botulinum toxin type ADrug
Also called Botox
botulinum toxin type A (Botox)2.5 units, 5 points
pretarsal injection of Botulinum toxin type ADrug
Also called Botox
Botulinum toxin type A 2,5 units, 5 points
| Study group | Role | What they receive |
|---|---|---|
| preseptal | Experimental | Not described Receives: Drug: preseptal injection of botulinum toxin type A |
| pretarsal | Experimental | Not described Receives: Drug: pretarsal injection of Botulinum toxin type A |
What is being measured
The primary outcome is the main question the study is designed to answer.
tear break up time
unit of measure; minutes
Measured: change from baseline in tear break up time at 12 weeks
Secondary outcomes (1)
schirmer's test
units of measurement; millimeters
Measured: change from baseline of schirmer's test at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2012 (estimated)
- Study startApr 2012
- Primary completionSep 2012 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hemifacial SpasmStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Khon Kaen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, kitthisak kitthaweesin, Khon Kaen University
- Investigators
- kitthisak kithaweesin, MD, Principal investigator, Khon Kaen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01564979
- Sponsor's protocol ID
- KTS-001-BTX
- Status last verified
- Mar 2012
- First submitted
- 18 Mar 2012
- Last updated
- 28 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Price J, O'Day J. A comparative study of tear secretion in blepharospasm and hemifacial spasm patients treated with botulinum toxin. J Clin Neuroophthalmol. 1993 Mar;13(1):67-71.
PubMed 8501266
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect on Tear Functions of Pretarsal and Preseptal Techniques of Botulinum Toxin Type A Injection in Hemifacial Spasm
- ClinicalTrials.gov ID
- NCT01564979
- Acronym / sponsor ID
- KTS-001-BTX
- Conditions
- Hemifacial Spasm
- Keywords
- botulinum toxin, facial nerve, hemifacial spasm, tears
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Khon Kaen UniversityUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Sep 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 28 Mar 2012 (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.
The purpose of this study is to determine whether pretarsal and preseptal techniques of Botulinum toxin type A injection have any effect on tear functions.
Detailed description
Botulinum toxin type A has been used for hemifacial spasm since 1986. of Botulinum toxin type A can be subcutaneously injected at pretarsal or preseptal portion of orbicularis muscle. Blepharoptosis has been reported less frequently with pretarsal technique, however dry eye was noticed in one patient treated with pretarsal botulinum toxin type A for cosmetic purpose.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| preseptal | Experimental | Drug: preseptal injection of botulinum toxin type A |
| pretarsal | Experimental | Drug: pretarsal injection of Botulinum toxin type A |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patient diagnosed with hemifacial spasm
Key exclusion criteria (8 listed)
- previous history of botulinum toxin treatment for hemifacial spasm
- ocular surface disorders
- tear disorders
- evidence of infection at or around eyelids
- pregnant woman
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 |
|---|---|---|
| preseptal injection of botulinum toxin type AAlso: Botoxbotulinum toxin type A (Botox)2.5 units, 5 points | Drug | preseptal |
| pretarsal injection of Botulinum toxin type AAlso: BotoxBotulinum toxin type A 2,5 units, 5 points | Drug | pretarsal |
Primary outcome
tear break up time
Time frame: change from baseline in tear break up time at 12 weeks
unit of measure; minutes
1 secondary outcome
schirmer's test
Time frame: change from baseline of schirmer's test at 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2012.
- Results publication: PubMed 8501266Price J, O'Day J. A comparative study of tear secretion in blepharospasm and hemifacial spasm patients treated with botulinum toxin. J Clin Neuroophthalmol. 1993 Mar;13(1):67-71.
Related trials for Hemifacial Spasm
RecruitingPhase 4
Effects of DaxibotulinumtoxinA for Blepharospasm and Hemifacial Spasm
Benign Essential Blepharospasm, Hemifacial Spasm
Not yet recruitingObservational study
Prospective Register Study to Assess Eligibility for and Efficacy of Surgical Treatment in Patients With nEuRovascular Conflict
Trigeminal Neuralgia, Tic Douloureux
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.
kitthisak kithaweesin, MD principal investigator
Khon Kaen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing preseptal injection of botulinum toxin type A and pretarsal injection of Botulinum toxin type A in people with Hemifacial Spasm, run by Khon Kaen University at 1 site in Thailand.
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 1 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 28 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact kitthisak kitthaweesin, ND (6643348383, kitthisak@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
tear break up time (time frame: change from baseline in tear break up time at 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01564979, which also lists 1 linked publication.
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 Mar 2012.