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Aplindore · 2 trials · 2 indications
| 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...
Aplindore is an investigational small molecule being developed for Restless Legs Syndrome and Early Stage Parkinson's Disease. It is in Phase 2 clinical development and is not approved by the FDA. Two Phase 2 trials have been completed to evaluate its effects on the signs and symptoms of these neurological conditions.
Aplindore is being developed by Ligand Pharmaceuticals Incorporated, a biopharmaceutical company traded on the NASDAQ under the ticker symbol LGND. The company is conducting clinical research to evaluate the drug's safety and efficacy in treating Restless Legs Syndrome and Early Stage Parkinson's Disease.
Aplindore is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. Two Phase 2 clinical trials have been completed, one for Early Stage Parkinson's Disease and one for Restless Legs Syndrome, but the drug remains under investigation.
Aplindore has been studied in two completed Phase 2 clinical trials. NCT00623324 evaluated its effects on signs and symptoms of Early Stage Parkinson's Disease with 40 participants, and NCT00626418 evaluated its effects on Restless Legs Syndrome with 24 participants. Both trials were randomized, double-blind, and placebo-controlled, conducted in the United States.
No alternative names for Aplindore have been reported. It is identified by its generic name Aplindore in clinical trial registries and scientific literature. The drug is a small molecule being investigated for neurological conditions, but no other names or brand names have been associated with it in available information.