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Pagoclone · 2 trials · 2 indications
Primary objective using a flexible dosing titration regimen from 0.15mg Pagocolne BID, titrated at 2 weeks to 0.30mg Pagaclone BID for an additional 6 weeks versus placebo, on persistent developmental stuttering in patients 18 to 65 years of age over an 8 week, double blind treatment period, followed by five 53 week open label treatment extension periods. The primary efficacy variables will be based on data collected on the stuttering Severity Instrument-3 (SSI-3) Frequency and Duration Subscore, the Subjective Screening of Stuttering (SSS) Severity Subscore, and the treatment and week 8 visits. All efficacy assessments will evaluate change from pre-treatment to each on-treatment week.
| Arm | Type | Description |
|---|---|---|
| 0.15 mg | EXPERIMENTAL | - |
| 0.30 mg | EXPERIMENTAL | - |
| 0.60 mg | EXPERIMENTAL | - |
| PBO | PLACEBO_COMPARATOR | - |
| Pagoclone | EXPERIMENTAL | .15mg, .30mg, .60mg |
| Placebo | PLACEBO_COMPARATOR | Placebo |
| Name | Type | Description |
|---|---|---|
| pagoclone | DRUG | - |
| Placebo | DRUG | - |
Inclusion Criteria: * A male regularly experiencing premature ejaculation * 18 to 55 yrs old * In a Stable relationship with one woman for at least 6 months
Pagoclone is an investigational small molecule being studied for the treatment of premature ejaculation. It is currently in Phase 2 clinical development and is not approved by the FDA. The drug is being evaluated for its potential to address this condition in men.
Pagoclone is being developed by BrainsWay Ltd., a company traded on the stock exchange under the ticker symbol BWAY. The company is conducting clinical research to evaluate the drug's safety and efficacy for premature ejaculation.
Pagoclone is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The drug is being studied for the treatment of premature ejaculation, with clinical trials currently ongoing or completed.
Pagoclone has one completed Phase 2 clinical trial registered under NCT00370981. This study, titled 'Exploratory Study of Pagoclone in Men With Premature Ejaculation,' enrolled 100 male participants in the United States. The trial was randomized, double-blind, and placebo-controlled.
No, pagoclone is not FDA approved. It is an investigational drug currently in Phase 2 clinical development for the treatment of premature ejaculation. The drug has not yet completed the clinical trials and regulatory review process required for approval.