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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05167760
Other study ID # IRB-300008023
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received
Last updated
Start date December 2025
Est. completion date November 2028

Study information

Verified date May 2024
Source University of Alabama at Birmingham
Contact Benjamin Greene, MD
Phone (205) 801-7855
Email bgreene@uabmc.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 10
Est. completion date November 2028
Est. primary completion date November 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Age 18 years or older - Ability to speak and comprehend English - Ability to consent for themselves - Diagnosis of synkinesis affecting eye movement Exclusion Criteria: - 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

Study Design


Intervention

Drug:
Apraclonidine
1-2 drops per eye every 8 hours for 2 weeks

Locations

Country Name City State
United States University of Alabama at Birmingham Birmingham Alabama

Sponsors (1)

Lead Sponsor Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Baseline - 20 minutes after study drug administration
See also
  Status Clinical Trial Phase
Completed NCT04148872 - Mixed Methods Investigation of Chronic Facial Paralysis in Individuals With Synkinesis Phase 4
Completed NCT03048383 - Comparison of Three Botulinum Neuromodulators for Management of Facial Synkinesis Phase 4
Enrolling by invitation NCT05945615 - Oxymetazoline Drops for Acquired Blepharoptosis From Synkinesis Phase 3
Recruiting NCT05191719 - Neurotomy to Treat Synkinesis Following Peripheral Facial Palsy N/A
Recruiting NCT03059420 - Genetic Studies of Strabismus, Congenital Cranial Dysinnervation Disorders (CCDDs), and Their Associated Anomalies