CLINICAL TRIALS PROFILE FOR APLINDORE

Clinical Trials for Aplindore

Trial ID	Title	Status	Sponsor	Phase	Summary
NCT00623324 ↗	The Effects of Aplindore on the Treatment of Signs and Symptoms of Parkinson's Disease	Completed	Ligand Pharmaceuticals	Phase 2	The purpose of this study is to demonstrate the safety, tolerability, efficacy and pharmacokinetics of aplindore in patients with early stage Parkinson's Disease (PD) who are not currently taking any dopamine agonists or who are able to wash off dopamine agonists for 14 days prior to baseline. Efficacy will be assessed using the UPDRS questionnaire including part 3 of the UPDRS (Motor). their level of sleepiness on a standardized rating scale (Epworth Sleepiness Scale) and their level of nausea daily. Safety endpoints will include adverse events (AEs), clinical laboratory data, vital signs (blood pressure, orthostatic blood pressure and heart rate), ECGs, physical examinations and self rated scales.
NCT00626418 ↗	The Effects of Aplindore on the Treatment of Signs and Symptoms of Restless Legs Syndrome	Completed	Ligand Pharmaceuticals	Phase 2	The purpose of this study is to assess the efficacy and tolerability of single doses of aplindore compared to placebo in RLS. Patients will be required to spend 5-8 nights in a sleep laboratory. This includes 1 adaptation night, 1 placebo night, and 3-6 drug treatment nights. Ascending doses of active drug will be administered on study nights 3 through 5 to determine the maximum well tolerated efficacious dose (defined as a decrease in Periodic Limb Movement Index (PLMI) of at least 50% from placebo baseline). If an efficacious dose cannot be identified the Investigator in consultation with the sponsor may decide to examine higher doses in up to 3 additional PSG nights in an attempt to identify a tolerable efficacious dose. This study will utilize up to 24 evaluable patients, each meeting International Classification of Sleep Disorders (ICSD-2) diagnostic criteria for primary RLS who are not currently taking any RLS medication including DAs ( and L-dopa) or who are able to discontinue their RLS medication at least 5 half-lives prior to the adaptation night.
NCT00809302 ↗	Efficacy and Safety Study of Aplindore in Patients With Early Parkinson Disease	Terminated	Neurogen Corporation	Phase 2	This is a clinical trial to be conducted at multiple Parkinson Study Group (PSG) sites in the USA. Patients with early Parkinson disease will be randomly allocated to one of 4 arms in the study. The 4 arms include 3 arms with different doses of aplindore MR tablets and 1 placebo arm. The study drug will be taken twice a day (BID). The study is blinded and neither subjects, nor the investigators, will know what treatment the subject is receiving. Investigational study drug will be adjusted to the assigned dosage and then maintained at that dosage for the balance of the 12 week follow-up period. The entire study will take about 13 weeks. The study will assess the safety and tolerability of aplindore and measure how effective aplindore is in improving movement and other effects of Parkinson disease.
NCT00834327 ↗	Efficacy and Safety Study of Aplindore in Patients With Restless Legs Syndrome	Terminated	Neurogen Corporation	Phase 2	This is a clinical trial to be conducted at multiple sites in the USA. Patients diagnosed with moderate to severe Restless Legs Syndrome will be randomly allocated to one of 5 treatment arms in the study. The 5 arms include 4 arms with different doses of aplindore MR tablets and 1 placebo arm. The treatment will be taken once a day. The study is blinded and neither patients, nor the investigators, will know what treatment the patient is receiving. Patients will be assigned a dose and will be maintained at that dose for several weeks (2 treatment arms include a short titration period). The entire study will take about 6 weeks. The study will measure how effective aplindore is in decreasing symptoms of Restless Legs Syndrome, and will also assess the safety and tolerability of aplindore.

Clinical Trial Conditions for Aplindore

Condition Name

Condition Name for
Intervention	Trials
Restless Legs Syndrome	2
Early Stage Parkinson's Disease	1
Early Parkinson Disease	1

Condition MeSH

Condition MeSH for
Intervention	Trials
Syndrome	2
Restless Legs Syndrome	2
Psychomotor Agitation	2
Parkinson Disease	2

Clinical Trial Locations for Aplindore

Trials by Country

Trials by Country for
Location	Trials
United States	39

Trials by US State

Trials by US State for
Location	Trials
Florida	4
Kentucky	3
Colorado	2
Georgia	2
New York	2

Clinical Trial Progress for Aplindore

Clinical Trial Phase

Clinical Trial Phase for
Clinical Trial Phase	Trials
Phase 2	4

Clinical Trial Status

Clinical Trial Status for
Clinical Trial Phase	Trials
Terminated	2
Completed	2

Clinical Trial Sponsors for Aplindore

Sponsor Name

Sponsor Name for
Sponsor	Trials
Ligand Pharmaceuticals	2
Neurogen Corporation	2

Sponsor Type

Sponsor Type for
Sponsor	Trials
Industry	4