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New injection study aims to ease uncontrollable eye blinking

NCT ID NCT07489430

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 25, 2026 · Updated 2 times

Summary

This study tests a botulinum toxin called DaxibotulinumtoxinA (DAXI) for adults with blepharospasm, a condition causing uncontrollable blinking or eye muscle spasms. Twenty participants will receive up to three injection cycles over 12 months. The goal is to measure how long symptom relief lasts and track safety. This is an early-phase study, not a cure, but aims to improve daily life.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 20 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Criteria: * 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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

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Contacts and locations

Locations

  • Parkinson Disease and Movement Disorders Center at the University of Pennsylvania

    Philadelphia, Pennsylvania, 19107, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.