SynkinesisPhase 4NCT05167760
Efficacy of Topical Apraclonidine for the Treatment of Ocular Synkinesis
A Phase 4 study testing Apraclonidine in people with Synkinesis and Facial Nerve Palsy, run by University of Alabama at Birmingham.
Trial summary
The purpose of this study is to determine efficacy of apraclonidine for patients with ocular synkinesis, who are seen in the UAB Facial Nerve Clinic. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Synkinesis, Facial Nerve Palsy
- What is being tested?
- Apraclonidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Dec 2025to Nov 2028
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- Ability to speak and comprehend English
- Ability to consent for themselves
- Diagnosis of synkinesis affecting eye movement
Who cannot join
- Age less than 18 years
- Unable to speak and comprehend English
- Unable to consent for themselves
- Diagnosis of congenital ptosis, Horner syndrome, myasthenia travis, mechanical ptosis
- Visual field loss from causes unrelated to facial nerve injury
- Currently receiving monoamine oxidase inhibitors
- Known hypersensitivity to apraclonidine or other components of the drug under study
About this study
The purpose of this study is to determine efficacy of apraclonidine for patients with ocular synkinesis, who are seen in the UAB Facial Nerve Clinic.
Read the detailed description
UAB has a large Facial Nerve Clinic that treats patients with acquired facial nerve palsies and the associated difficulties of swallowing/speaking, and visual field defects from ptosis (a drooping or falling of the upper eyelid) and synkinesis (unwanted contractions of the muscles of the face during attempted movement.). Commonly, patients will experience involuntary eyelid contraction with oral movements like smiling. For eyelid synkinesis causing significant aesthetic or functional difficulty, surgery or botox is often the first line treatment. However, not all patients desire this, and some are poor surgical candidates due to other comorbidities. Botox has been shown to work well for these patients, but can be only partially effective. In addition, patients experience a wearing off period between treatments.
Several eye drops are available for the medical treatment of ptosis, including apraclonidine and 0.1% oxymetazoline. Both are alpha 2 adrenergic agonists, which stimulates Mullers muscle, causing muscle contraction and upper eyelid lifting. In addition, apraclonidine has been shown to be beneficial in patients with blepharospasm in a pilot study by Vijayakumar et. al.
We hypothesize that patients with synkinesis, similar to patients with ptosis and blepharospasm, could have symptomatic improvement with apraclonidine use.
Our study will initially be a pilot study, designed similarly to the Vijayakumar study. If this shows improvement for these patients, our hope is to pursue a randomized control trial.
- Conditions
- Synkinesis, Facial Nerve Palsy
- Being tested
- Apraclonidine
- Medical subject headings
- Synkinesis, Bell Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApraclonidineDrug
Also called Iopidine
1-2 drops per eye every 8 hours for 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Participants will receive the study drug, apraclonidine, per its FDA-approved package labelling Receives: Drug: Apraclonidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in synkinesis symptoms
A 30 second video clip will be taken prior to administration of the study drug to record the unwanted movements of the facial muscles around the eyes. Approximately 20 minutes after study drug administration, a second 30-second video clip will be taken. Video clips from all of the participants will be pooled together at the end of the study and given to two independent raters. The raters will use the Sunnybrook Facial Grading System to assess each video and rate improvement of synkinesis after administration of the study drug. The Sunnybrook Facial Grading System rates resting symmetry (a scale of 0-2), symmetry of voluntary movement (a scale of 1-5), and synkinesis (a scale of 0-3), and computes a composite score. The higher the composite score, the better - full range of movement is scored as 100 percent.
Measured: Baseline - 20 minutes after study drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2021
- Study startDec 2025 (estimated)
- Primary completionNov 2027 (estimated)
- Study completionNov 2028 (estimated)
Why it stopped: The project never opened.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SynkinesisStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Benjamin Greene, University of Alabama at Birmingham
- Investigators
- Benjamin Greene, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05167760
- Sponsor's protocol ID
- IRB-300008023
- Status last verified
- Jul 2024
- First submitted
- 22 Nov 2021
- Last updated
- 19 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Topical Apraclonidine for the Treatment of Ocular Synkinesis
- ClinicalTrials.gov ID
- NCT05167760
- Acronym / sponsor ID
- IRB-300008023
- Conditions
- Synkinesis, Facial Nerve Palsy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The project never opened.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- Dec 2025 (estimated)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Nov 2028 (estimated)
- First posted
- 22 Dec 2021 (actual)
- 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 efficacy of apraclonidine for patients with ocular synkinesis, who are seen in the UAB Facial Nerve Clinic.
Detailed description
UAB has a large Facial Nerve Clinic that treats patients with acquired facial nerve palsies and the associated difficulties of swallowing/speaking, and visual field defects from ptosis (a drooping or falling of the upper eyelid) and synkinesis (unwanted contractions of the muscles of the face during attempted movement.). Commonly, patients will experience involuntary eyelid contraction with oral movements like smiling. For eyelid synkinesis causing significant aesthetic or functional difficulty, surgery or botox is often the first line treatment. However, not all patients desire this, and some are poor surgical candidates due to other comorbidities. Botox has been shown to work well for these patients, but can be only partially effective. In addition, patients experience a wearing off period between treatments.
Several eye drops are available for the medical treatment of ptosis, including apraclonidine and 0.1% oxymetazoline. Both are alpha 2 adrenergic agonists, which stimulates Mullers muscle, causing muscle contraction and upper eyelid lifting. In addition, apraclonidine has been shown to be beneficial in patients with blepharospasm in a pilot study by Vijayakumar et. al.
We hypothesize that patients with synkinesis, similar to patients with ptosis and blepharospasm, could have symptomatic improvement with apraclonidine use.
Our study will initially be a pilot study, designed similarly to the Vijayakumar study. If this shows improvement for these patients, our hope is to pursue a randomized control trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Drug: ApraclonidineParticipants will receive the study drug, apraclonidine, per its FDA-approved package labelling |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 years or older
- Ability to speak and comprehend English
- Ability to consent for themselves
- Diagnosis of synkinesis affecting eye movement
Key exclusion criteria (7 listed)
- Age less than 18 years
- Unable to speak and comprehend English
- Unable to consent for themselves
- Diagnosis of congenital ptosis, Horner syndrome, myasthenia travis, mechanical ptosis
- Visual field loss from causes unrelated to facial nerve injury
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 |
|---|---|---|
| ApraclonidineAlso: Iopidine1-2 drops per eye every 8 hours for 2 weeks | Drug | Treatment Group |
Primary outcome
Improvement in synkinesis symptoms
Time frame: Baseline - 20 minutes after study drug administration
A 30 second video clip will be taken prior to administration of the study drug to record the unwanted movements of the facial muscles around the eyes. Approximately 20 minutes after study drug administration, a second 30-second video clip will be taken. Video clips from all of the participants will be pooled together at the end of the study and given to two independent raters. The raters will use the Sunnybrook Facial Grading System to assess each video and rate improvement of synkinesis after administration of the study drug. The Sunnybrook Facial Grading System rates resting symmetry (a scale of 0-2), symmetry of voluntary movement (a scale of 1-5), and synkinesis (a scale of 0-3), and computes a composite score. The higher the composite score, the better - full range of movement is scored as 100 percent.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2024.
- Individual participant dataSharing planned: No
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Evaluation of the Effectiveness of Virtual Reality Self-rehabilitation in the Treatment of Facial Paralysis and Synkinesis
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Congenital Fibrosis of Extraocular Muscles, Duane Retraction Syndrome
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Motor Imagery and Mirror Therapy on Synkinesis, Facial Asymmetry, Facial Function and QoF in Bell's Palsy Patients.
Bell Palsy
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.
Benjamin Greene, MD principal investigator
University of Alabama at Birmingham
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Apraclonidine in people with Synkinesis and Facial Nerve Palsy, run by University of Alabama at Birmingham.
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 4 inclusion and 7 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: withdrawn, as of the sponsor's last update on 19 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 was withdrawn before enrolling participants, so there are no results.
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?
Improvement in synkinesis symptoms (time frame: Baseline - 20 minutes after study drug administration). 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 19 Jul 2024.