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Botulinum Neurotoxin Type A · 1 trial · 5 indications
Time to retreatment (in days) with DAXI between the first and second study injection cycle.
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).
| Arm | Type | Description |
|---|---|---|
| Open label arm | EXPERIMENTAL | The study cohort will consist of adults with blepharospasm who previously received onabotulinumtoxinA or incobotulinumtoxinA and will transition to DAXI 12 weeks after their last botulinum toxin treatment. Each participant will receive a DAXI dose equivalent to their prior therapy, using a 1:1 conversion for onabotulinumtoxinA or a 1.5:1 conversion for incobotulinumtoxinA, adjusted if prior treatment caused excessive weakness or other side effects. Injections will be limited to muscles directly involved in blepharospasm (the orbicularis oculi, corrugators, procerus, and nasalis) and will use a dilution of 10 units per 0.1 mL. Subjects may use topical anesthetics to reduce injection pain, and efforts will ensure the same injector administers all treatments to maintain consistency. |
| Name | Type | Description |
|---|---|---|
| Botulinum Neurotoxin Type A | DRUG | DaxibotulinumtoxinA (DAXI) for injection is a sterile, lyophilized powder containing 100 units of active daxibotulinumtoxinA per vial, along with inactive ingredients including RTP004, trehalose dihydrate, L-histidine, L-histidine hydrochloride, and polysorbate 20. It is reconstituted with Bacteriostatic Sodium Chloride Injection 0.9% (Pfizer) and stored at 2-8°C. DAXI will be prepared by trained injectors or staff, with all preparations documented. Experienced movement disorder neurologists will administer injections, primarily from UPenn's Parkinson's Disease and Movement Disorders Center. Dosing will follow prior treatment patterns using a 1:1 conversion from onabotulinumtoxinA or 1.5:1 from incobotulinumtoxinA, adjusted for prior adverse effects. Injection sites will be selected based on clinical presentation, with optional EMG or imaging guidance. |
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 w...
Botulinum Neurotoxin Type A is being developed for the treatment of blepharospasm of both eyelids, a neurological condition causing involuntary eyelid spasms. It is currently in Phase 2 clinical development as an investigational therapy. The drug is also known as DaxibotulinumtoxinA.
Botulinum Neurotoxin Type A targets the neuromuscular junction by inhibiting the release of acetylcholine, which temporarily paralyzes muscles. This mechanism is intended to reduce the involuntary muscle contractions associated with blepharospasm. The drug is being studied specifically for its effects on eyelid muscles.
Botulinum Neurotoxin Type A is being developed by Revance Therapeutics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker RVNC. The company is conducting clinical trials to evaluate the drug's safety and efficacy for blepharospasm.
Botulinum Neurotoxin Type A is currently in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The ongoing Phase 2 trial is designed to assess its effects in patients with blepharospasm of both eyelids.
Botulinum Neurotoxin Type A is being evaluated in a Phase 2 clinical trial with the identifier NCT07489430, titled 'DaxibotulinumtoxinA for Blepharospasm.' The trial is not yet recruiting and plans to enroll 20 participants in the United States. It is an uncontrolled, open-label study.
Yes, Botulinum Neurotoxin Type A is also known as DaxibotulinumtoxinA. The clinical trial NCT07489430 uses the name DaxibotulinumtoxinA to refer to the same investigational drug being developed by Revance Therapeutics for blepharospasm.