View clinical trials related to Parkinson's Disease.
Filter by:Many patients with Parkinson's disease (PD) have sleep problems, including excessive sleepiness during the day. This is probably due to degeneration of sleep-regulating areas in the brain. At present, the only treatment for sleepiness in PD is modafinil, which is expensive and only partially effective. There is another potential treatment for sleepiness that is used worldwide, is inexpensive, well tolerated and safe - namely, caffeine. There have also been suggestions that caffeine may slow the progression of degeneration in PD, since coffee non-drinkers are at higher risk of developing PD. PD patients, even with severe sleepiness often do not use caffeine. It is unclear whether this is because their PD makes their sleepiness unresponsive to caffeine, because they cannot tolerate it, or whether this reflects their lifelong habit of non-use. This proposal outlines a trial in which patients with excessive sleepiness will be given caffeine or placebo (no therapy) in a blinded fashion. In this way, the effect of caffeine on sleepiness and motor symptoms can be directly analyzed. In addition, these findings can be used to test the tolerability of caffeine, to help plan a larger-scale study testing whether caffeine can slow the progression of PD
A 12-week, multicenter, double-blind, randomized study designed to evaluate the safety and efficacy of 20 and 60 mg/day istradefylline compared with placebo in subjects with OFF-time phenomena and advanced Parkinson's disease treated with levodopa/carbidopa.
12-week, double-blind, placebo-controlled, multicenter, randomized study designed to evaluate the safety and efficacy of 40 mg/day istradefylline compared with placebo in subjects with OFF phenomena advanced PD who were treated with levodopa/carbidopa.
The purpose of this study is to establish the efficacy of 20 mg/day and 40 mg/day doses of istradefylline for reducing the mean total hours of awake time per day spent in the OFF state in patients with advanced Parkinson's disease (PD) treated with levodopa.
The purpose of the study is to determine if reducing or eliminating a dopamine agonist (DA) causing one of the side effects of daytime sleepiness, swelling of the lower legs or feet, hallucinations or impulsive behaviors while adding orally disintegrating selegiline can eliminate the adverse effect and maintain control of Parkinson's disease (PD) symptoms.
To identify patients within the community taking anti-parkinson medications in whom the diagnosis of Parkinson's disease is incorrect and to supervise and clinically monitor the withdrawal of anti-parkinson medications in this patient group
The main purpose of this study is to determine the safety of BIIB014 and how well BIIB014 is tolerated when given at different doses to patients with early-stage Parkinson's Disease. This study will also explore: - How BIIB014 is affected when given to patients with early-stage Parkinson's Disease (this will be done by measuring the levels of BIIB014 in the blood at several different times during the study), and - The activity of BIIB014 when given to early Parkinson's patients (this will be done by performing different Parkinson's Disease assessments and other tests during the study). Patients who enter this study will be randomly assigned to receive either BIIB014 or a placebo but because the study is blinded, neither they nor their study doctor will know which study treatment they are taking.
The main purpose of this study is to determine the safety of BIIB014 and how well BIIB014 is tolerated when given at different doses to patients with moderate to late-stage Parkinson's Disease who are also taking the Parkinson's medication, levodopa (L-DOPA). This study will also explore: 1. the pharmacokinetics of BIIB014 in Parkinson's patients who are also taking L-DOPA (this will be done by measuring the levels of BIIB014 in the blood at several different times during the study), and 2. the activity of BIIB014 when given to Parkinson's patients who are also taking L-DOPA (this will be done by performing different Parkinson's Disease assessments during the study to examine change in waking OFF time, change in time with troublesome dyskinesia, change in Unified PD Rating Scale (UPDRS) scores, and Clinical Global Improvement). Patients who enter this study will be randomly assigned to receive either BIIB014 or a placebo but because the study is blinded, neither they nor their study doctor will know which study treatment they are taking. The study will be divided into 2 parts: - Part A: a, rapid, sequential cohort, dose escalation to establish MTD, followed by - Part B: a parallel-group exploration of the two highest tolerated doses versus placebo. Note: As Part A of the study is now concluded, some of the study design information presented below (e.g., number of study arms) pertains only to Part B.
This study will explore sequence effect, a fatigue or tiredness commonly seen in patients with Parkinson's disease after they have been doing the same thing for a while. The study will use a new device called a modified peg board test (see description below) to measure whether antiparkinsonian medications (levodopa/carbidopa or dopamine) and repetitive transcranial magnetic stimulation (rTMS, see description below) of the brain can improve the symptoms of sequence effect. Patients with early-stage Parkinson's disease who have never taken antiparkinsonian medications and patients with advanced disease may be eligible for this study. Candidates must be 18 years of age or older and right-handed. Participants have five visits to the NIH Clinical Center as follows: - Visit 1 (baseline): Patients have a neurological examination, including brief cognitive function tests, a rating for depression, and two types of ratings for fatigue severity. - Visits 2 through 5 (experimental sessions): Patients who have been taking antiparkinson medication for a long time are asked to not take their medication for about 12 hours (overnight withdrawal) before visits 2 through 5. They are off medication for about 14 hours total (until after the experiments are done). Patients may be admitted to the NIH Clinical Center for the overnight drug withdrawal if necessary. At the start of each session, participants are given either levodopa/carbidopa tablets or placebo (tablets identical in appearance but with no active medication). They perform the modified pegboard test before medication, after medication, and after brain stimulation with rTMS. During two of the sessions, they receive actual brain stimulation, and during the other two sessions they receive sham stimulation, which does not actually stimulate the brain. The modified pegboard test is a computer-based machine with eight pegs. Subjects transfer each peg from a line of holes on the right side to a line of holes on the left side using their right hand and moving as quickly as possible. After they finish moving all pegs to the left line of holes, they wait for a beep and then transfer the pegs from left line to right line of holes. They do this six times, three times with their right hand and three times with their left. rTMS involves repeated magnetic pulses delivered in trains or short bursts of impulses. A brief electrical current is passed through a wire coil held on the scalp. The current creates a magnetic pulse that stimulates the brain. The subject hears a click and may feel a pulling sensation on the skin under the coil. There may be a twitch in muscles of the face, arm or leg. During the stimulation, the subject may be asked to tense certain muscles slightly or perform other simple actions. The effect of TMS on the muscles is detected with small metal disk electrodes taped onto the skin of the right hand. Subjects receive four rTMS blocks per 10 minutes. Each block consists of a total of 375 pulses.
The aim of the study is to evaluate the long-term efficacy, local tolerability and safety of Lisuride applied as subcutaneous infusion compared to placebo in patients with advanced Parkinson's disease with motor fluctuations and "OFF" periods refractory to conventional treatment.