Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2025-12-25 @ 4:59 AM
NCT ID:
NCT00626418
Brief Summary:
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.
Detailed Description:
Restless legs syndrome (RLS) is a neurosensorimotor disorder of uncertain etiology that commonly disturbs sleep. The main feature of the disorder is paresthesia felt deep in the limbs that troubles the individual when he or she is at rest. The paresthesias of RLS commonly increase during the evening or the early part of the night. Patients are commonly less bothered by symptoms in the morning, unless they are severely affected. The repetitive movements that lead to arousal may also cause a subset of patients to become quite sleepy during the daytime. This sleepiness is usually not as severe as that found in patients with sleep apnea or narcolepsy but can be quite disruptive to quality of life and daytime functioning. Recent surveys indicate that RLS occurs in 10% to 15% of the North American population.
A common associated feature of RLS is Periodic Limb Movements during Sleep (PLMS). These are repetitive movements that typically occur as flexions of the foot, knee, and hip at intervals of 5 to 90 seconds. Most commonly, the interval is 20 to 40 seconds. The movements are present during non-rapid-eye-movement (REM) sleep and are less common during REM sleep. Population-based studies have found that RLS is associated with an increased risk for hypertension and coronary artery disease. Periodic leg movements -related repetitive nocturnal blood pressure fluctuations may contribute to this increased risk of cardiovascular disease especially in the elderly19. There is a possibility that dopamine agonist (DA) reduction of PLMS may mitigate the risk of the cardiovascular complications of RLS. The potential role of aplindore in reducing PLMS and nocturnal blood pressure fluctuations will be evaluated in this study.
Dopaminergic agents have become the most common medications used in the treatment of RLS and PLMS. Aplindore is an orally available, small molecule partial agonist of the D2 dopamine receptor. Preclinical in vitro and in vivo results have demonstrated the functional agonist selectivity of aplindore for supersensitive D2 receptors in the striatum, but not extra-striatal D2 receptors. Stimulation of D2 receptors in areas deficient in dopamine is attributed to aplindore's low intrinsic activity and high affinity for these receptors. Aplindore has been studied in preclinical toxicology studies in rats for up to 6 months and in monkeys for up to 1 year with safety margins in excess of 100-fold relative to projected human efficacious doses. The primary objective of this study is to assess the efficacy and tolerability of single doses of aplindore compared to placebo in RLS. The secondary objectives are to generate safety data with aplindore to support outpatient trials in RLS. b) To generate pilot data on the effects of aplindore on changes in blood pressure and heart rate associated with PLMS in patients with RLS. c) To understand the concentration-effect relationships of aplindore on RLS symptoms.
Study:
NCT00626418
Study Brief:
Protocol Section:
NCT00626418