DaxibotulinumtoxinA for Blepharospasm

This study is looking at how well and for how long DaxibotulinumtoxinA (DAXI) works to treat blepharospasm. Blepharospasm is a condition that causes uncontrolled blinking or muscle spasms around the eyes, which can make it hard to see and do daily activities. Researchers want to understand the real-world benefits and safety of DAXI for adults with this condition. You may be able to join if you are an adult (18 or older) with a diagnosis of blepharospasm that requires ongoing botulinum toxin injections and is disruptive. The study will measure how long it takes before you need another DAXI injection. The study is currently unclear about its recruitment status and plans to enroll 20 participants.

Study design: This is a single-center, open-label, single-arm study, meaning all 20 participants will receive DAXI, and both you and the researchers will know what treatment is being given.
What's involved: You may receive two to three DAXI injections over about 12 months, with treatments spaced at least 90 days apart but no more than 180 days.
Compensation: Not stated in the trial record.
Follow-up: The study will assess the time to retreatment during your second and third injection visits, which will occur between days 180-280 and 270-280 respectively.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

DaxibotulinumtoxinA for Blepharospasm

Not Yet Recruiting

PHASE2Ages 18+InterventionalTreatment

University of Pennsylvania

~20 participants

Updated 2026-08-24 on ClinicalTrials.gov

What's tested:Botulinum Neurotoxin Type A

At a glance

Recruiting sites

0 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

First time to retreatment

Measured over Outcome will be assessed during Visit 5 (2nd study injection visit) and reported at study conclusion. Visit 5 will take place for each individual subject between days 180 and 280.

+1 more outcome measured

Conditions

Blepharospasm of Both Eyelids

Blepharospasm of Left Eyelid

Blepharospasm of Right Eyelid

Blepharospasm, Benign Essential

Blepharospasm

Where it's being run

1 sites across 1 states

Pennsylvania1

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Adults (18 years of age, or older)

Clinical diagnosis of Blepharospasm that is disruptive enough to warrant ongoing clinical botulinum toxin injections and scoring ≥2 on the BSRS during screening. Blepharospasm may be focal (i.e. Benign essential blepharospasm), associated with non-drug-induced secondary cause (e.g., typical or atypical parkinsonism) or as part of a diagnosis of segmental or generalized dystonia involving the upper cranial region, if blepharospasm is the only indication requiring botulinum toxin injections.

Currently receiving onabotulinumtoxinA or incobotulinumtoxinA for the treatment of blepharospasm with: 1) documented duration of benefit \<12 weeks from most recent injection; and 2) no further dose escalation possible or advised due to side effect risk (e.g., ptosis, diplopia, etc.), as determined by treating neurologist; and 3) ability to provide informed consent and comply with study procedures, or subject has a reliable caregiver/proxy.

Written informed consent including authorization to release health information.

Exclusion

Tardive or medication-induced blepharospasm, as well as psychogenic/functional blepharospasm.

Active ocular pathology interfering with evaluation or injection safety.

Neuromuscular junction or motor neuron disorders (e.g., myasthenia gravis, Lambert-Eaton Myasthenic Syndrome, Amyotrophic Lateral Sclerosis, etc.).

Known hypersensitivity to botulinum toxin or formulation components.

Pregnant or breastfeeding women (including those who are found to be pregnant after a positive pregnancy test at Screening), women who are hoping to get pregnant over the upcoming 15 months, or women of childbearing potential who are unwilling to use contraception while enrolled in the BLEXI study.

Any signal suggestive of active suicidality, as per C-SSRS at screening.

Subjects who have undergone Deep Brain Stimulation (DBS) surgery for the management of blepharospasm and are not willing to keep the DBS settings unchanged for the duration of the trial.

History of primary or secondary non-response to BoNT-A injections, particularly those known to have neutralizing antibodies to BoNT-A.

Subjects on oral medications for dystonia (e.g., anticholinergics, muscle relaxants, benzodiazepines, dopamine depleter) who have not been stable on their regimen for at least 4 weeks prior to Screening, or who are not willing to keep them stable for the duration of the trial.

Use of aminoglycoside antibiotics, polymyxins, lincosamides (e.g., clindamycin), or other agents that might interfere with neuromuscular transmission (e.g., curare-like drugs, quinidine, magnesium sulfate, anticholinesterases, succinylcholine chloride) within 14 days prior to Screening.

History of severe (stage 3) chronic obstructive pulmonary disease, or unstable pulmonary disease within 30 days prior to Screening.

History of chronic or recurrent hypokalemia.

History of congestive heart failure (New York Heart Association Class III or IV), Torsade de Pointe (TdP), and/or Long QT Syndrome.

Subjects in an investigational drug or device study within the last 30 days prior to Screening.

Active skin infections at the injection sites which would put the subject at increased risk of morbidity with BoNT injections

History of blood coagulation disorder that makes facial injection an absolute contraindication

Any acute illnesses or medical conditions including cognitive impairment (e.g., dementia), significant psychiatric illnesses (e.g., major depressive or bipolar disorder) or symptoms (e.g., suicidal ideation, psychosis) that are not stable, and in the Investigator's opinion, could put the subject at increased risk of morbidity, confound the study results, or interfere significantly with the subject's participation in the study.

What this trial measures

First time to retreatmentOutcome will be assessed during Visit 5 (2nd study injection visit) and reported at study conclusion. Visit 5 will take place for each individual subject between days 180 and 280.
Time to retreatment (in days) with DAXI between the first and second study injection cycle.
Final time to retreatmentOutcome will be assessed during Visit 7 (3rd study injection visit) and reported at study conclusion. Visit 7 will take place for each individual study subject between days 270 and 280.
For patients who receive 3 study injection cycles with DAXI over 12 months, a second primary endpoint will be the time to retreatment (in days) between the second-to-last and last injection cycle (i.e., between DAXI cycles 2 and 3).

Trialytics