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Dipraglurant · 1 trial · 2 indications
The primary outcome will be testing the safety and tolerability of dipraglurant in patients with blepharospasm based on the incidence of adverse events reported by patients and/or as identified by the Investigator based on clinical assessments conducted during the study.
Video analysis, by an independent rater, of the mean proportion of eye closure time, severity of periocular spasms, and blink rate. Decreased eye closure time, severity of periocular spasms and blink rate indicates improvement of blepharospasm symptoms.
Analysis of blinking activity as recorded on the Skintronics wearable device. Decreased blink activity indicates improvement of blepharospasm symptoms.
| Arm | Type | Description |
|---|---|---|
| Dipraglurant 50 mg | EXPERIMENTAL | - |
| Dipraglurant 100 mg | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Dipraglurant | DRUG | Oral tablet |
| Placebo | DRUG | Oral matching placebo tablet |
Inclusion Criteria: * Patients with an established diagnosis of idiopathic benign essential blepharospasm * Must have had prior response to to botulinum toxin (BoNT) reported on last 2 consecutive injection cycles * Last injection of BoNT at least 8 weeks prior to Screening assessments * Patient is...
Dipraglurant is an investigational small molecule being studied for the treatment of blepharospasm, a type of focal dystonia characterized by involuntary eyelid spasms. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities.
Dipraglurant is being developed by Addex Therapeutics Ltd, a biopharmaceutical company listed on the stock exchange under the ticker ADXN. The company is conducting clinical research to evaluate the drug's safety and efficacy in patients with blepharospasm.
Dipraglurant is in Phase 2 clinical development. A Phase 2 exploratory study has been completed, and the drug remains investigational, meaning it has not yet received regulatory approval for any use.
Dipraglurant has been studied in one completed Phase 2 clinical trial with the identifier NCT05027997. This randomized, double-blind, placebo-controlled study enrolled 15 participants with blepharospasm or dystonia in the United States.
Yes, Dipraglurant is also known as ADX48621. The clinical trial NCT05027997 refers to the drug as Dipraglurant (ADX48621), confirming that both names refer to the same investigational compound.