Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05027997 | Exploratory Study of Dipraglurant (ADX48621) for the Treatment of Patients With Blepharospasm | PHASE2 | COMPLETED | 15 | — | — | Oct 6, 2021 | Nov 27, 2022 | Oct 3, 2025 | 1 | United States |
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...