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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00626418 | The Effects of Aplindore on the Treatment of Signs and Symptoms of Restless Legs Syndrome | PHASE2 | COMPLETED | 24 | — | — | Feb 1, 2008 | - | Oct 3, 2011 | 5 | United States |
| Arm | Type | Description |
|---|---|---|
| 1 | PLACEBO_COMPARATOR | This will be a crossover study. Ascending doses of active drug will be administered on study nights 3-5 with an option of 3 additional nights in an attempt to identify a tolerable efficacious dose. Night 1 will be an adaptation night and night two will be a placebo night. |
| 2 | ACTIVE_COMPARATOR | This will be a crossover study. Ascending doses of active drug will be administered on study nights 3-5 with an option of 3 additional nights in an attempt to identify a tolerable efficacious dose. Night 1 will be an adaptation night and night two will be a placebo night. |
| Name | Type | Description |
|---|---|---|
| Aplindore | DRUG | Tablets 0.05, 0.1, 0.2, 0.3, 0.5 and 0.7 mg QD for up to 6 nights |
| Placebo | DRUG | Placebo tablets |
Inclusion Criteria: * Aged 18 years or older; * Diagnosis of primary Restless Legs Syndrome (RLS) using ICSD-2 criteria: * The patient reports an urge to move the legs, usually accompanied or caused by uncomfortable and unpleasant sensations in the legs. * The urge to move or the unpleasant sensati...