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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 studied for the treatment of early stage Parkinson's disease and restless legs syndrome. It has been evaluated in Phase 2 clinical trials in both indications. It is not approved for any use and remains in clinical development.
Aplindore targets the dopamine D2 receptor, also known as DRD2, where it acts as a partial agonist. This target class places it among compounds that modulate dopaminergic signaling, a pathway relevant to movement disorders such as Parkinson's disease and restless legs syndrome.
Aplindore is being developed by Ligand Pharmaceuticals Incorporated, which trades under the ticker LGND. The company has sponsored the clinical research conducted on the compound to date.
Aplindore is in Phase 2 clinical development. It has not been approved by the FDA for any indication and remains an investigational agent. Both of its recorded Phase 2 studies have completed, and no trials are currently active.
Aplindore has been evaluated in two completed Phase 2 trials. NCT00626418 tested it in restless legs syndrome with 24 participants, and NCT00623324 tested it in early stage Parkinson's disease with 40 participants. Both were randomized, double-blind, placebo-controlled studies conducted in the United States.