NeuroSearch USANeurosearch is a research company that for years has done observational, phase II and III clinical trials in the Southern California area in Parkinson's disease, epilepsy, multiple sclerosis and other movement disorders. They have programs in Reseda, Ventura, and Pasadena, California, where Dr. Jerome Lisk participates. Their goals are to provide local, focused patient care that includes more one-on-one time with physicians and staff and provide resources that will help advance the cause of clinical research. Neurosearch has established their reputation as a highly competent research site with extremely positive patient and clinical trial sponsor feedback. |
Open Trials (2012-2013)
1. A Fixed Dose, Dose Response Study for Ropinirole Prolonged Release in Patients With Early Stage Parkinson's Disease (TANDEM-662)
This study is a fixed dose, dose response study to characterize the dose response for ropinirole PR in early stage PD patients (Hoehn & Yahr stages I-III). After screening and baseline assessments, subjects will be randomized to one of six final target treatment groups (placebo, 2, 4, 8, 12 or 24mg/day ropinirole PR). The study will consist of a screening period, an up-titration period, a maintenance period, a down titration period and a follow up period. This study utilizes change from baseline in the UPDRS motor score as the primary endpoint, in line with that used in the ropinirole PR monotherapy pivotal study (SK&F101468/168). Clinical review of the primary and secondary endpoints will be performed in order to establish the lowest maximally effective therapeutic dose.
2. Extended Release Amantadine Safety and Efficacy Study in Levodopa-induced Dyskinesia (EASED Study) — Completed & Not Recruiting
The EASED study will evaluate four treatments (three dose levels of ADS-5102 and placebo capsules which contain no active study drug). Assignment to treatment groups will be randomized (as in a flip of the coin), and there is a 25 percent (one in four) chance that participants will be assigned to a particular treatment group. This is a double-blind study, which means that neither the participants nor the study staff will know the group to which participants are assigned. Study medication will be taken as three capsules each night for eight weeks. All participants will continue their current PD medications during study treatment. Study visits will include assessments of PD and dyskinesia, safety and tolerability, and participants will complete one or more questionnaires (fatigue, quality of life). Participants will also complete PD home diaries before certain visits.
3. A Study of the Safety and Tolerability of Pimavanserin (ACP-103) in Patients With Parkinson's Disease Psychosis — Completed & Not Recruiting
To assess the long-term safety and tolerability of ACP-103 in subjects with Parkinson's disease psychosis.
Primary & Secondary Outcome Measures: Safety
Study start date: July 2007
Study completion date: December 2012
Drug intervention: pimavanserin
Ages Eligible for Study: 40 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
This study is a fixed dose, dose response study to characterize the dose response for ropinirole PR in early stage PD patients (Hoehn & Yahr stages I-III). After screening and baseline assessments, subjects will be randomized to one of six final target treatment groups (placebo, 2, 4, 8, 12 or 24mg/day ropinirole PR). The study will consist of a screening period, an up-titration period, a maintenance period, a down titration period and a follow up period. This study utilizes change from baseline in the UPDRS motor score as the primary endpoint, in line with that used in the ropinirole PR monotherapy pivotal study (SK&F101468/168). Clinical review of the primary and secondary endpoints will be performed in order to establish the lowest maximally effective therapeutic dose.
2. Extended Release Amantadine Safety and Efficacy Study in Levodopa-induced Dyskinesia (EASED Study) — Completed & Not Recruiting
The EASED study will evaluate four treatments (three dose levels of ADS-5102 and placebo capsules which contain no active study drug). Assignment to treatment groups will be randomized (as in a flip of the coin), and there is a 25 percent (one in four) chance that participants will be assigned to a particular treatment group. This is a double-blind study, which means that neither the participants nor the study staff will know the group to which participants are assigned. Study medication will be taken as three capsules each night for eight weeks. All participants will continue their current PD medications during study treatment. Study visits will include assessments of PD and dyskinesia, safety and tolerability, and participants will complete one or more questionnaires (fatigue, quality of life). Participants will also complete PD home diaries before certain visits.
3. A Study of the Safety and Tolerability of Pimavanserin (ACP-103) in Patients With Parkinson's Disease Psychosis — Completed & Not Recruiting
To assess the long-term safety and tolerability of ACP-103 in subjects with Parkinson's disease psychosis.
Primary & Secondary Outcome Measures: Safety
Study start date: July 2007
Study completion date: December 2012
Drug intervention: pimavanserin
Ages Eligible for Study: 40 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
4. A Fixed Dose Study of Ropinirole Prolonged Release as Adjunctive Treatment in Patients With Advanced Parkinson's Disease (TANDEM-569)
This is a double blind, fixed dose, parallel group study to characterize the dose response of ropinirole PR as adjunctive therapy to L-dopa in patients with late stage Parkinson's disease. The primary endpoint of this study, mean change from baseline in total awake time spent "off' is the same endpoint as used in the ropinirole PR pivotal study for advanced Parkinson's disease patients. This study includes a wide range of ropinirole doses (4-24mg) with the 8mg, 12mg, and 16mg per day doses powered to detect a 1.7 hour difference in total awake time spent "off" compared with placebo. The dose of Ldopa will remain stable through the study, unless the subject experiences tolerability issues that require an L-dopa dose reduction. Up to three L-dopa dose reductions are allowed, making a total reduction of up to approximately 30%. Keeping the L-dopa dose constant where possible is important to avoid confounding the efficacy data. Clinical review of the primary and secondary endpoints will be performed in order to establish the lowest maximally effective therapeutic dose.
5. Effect of Rotigotine on Motor Symptoms in Patients With Advanced Parkinson's Disease (PD) With Motor Fluctuations and Gastroparesis (ROADMAP)
A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Assess the Effect of Rotigotine on Motor Symptoms in Patients With Advanced Parkinson’s Disease With Motor Fluctuations and Gastroparesis
Primary Outcome Measures:
Change in Rotigotine versus Placebo in the absolute time spent “off” from Baseline to the end of the 7-week Maintenance Period
Time Frame: Baseline to 9 weeks
Designated as safety issue: No
Mean number of hours marked “off” during a 24-hour period.
Estimated Enrollment: 190
Study Start Date: January 2012
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Ages Eligible for Study: 30 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
This is a double blind, fixed dose, parallel group study to characterize the dose response of ropinirole PR as adjunctive therapy to L-dopa in patients with late stage Parkinson's disease. The primary endpoint of this study, mean change from baseline in total awake time spent "off' is the same endpoint as used in the ropinirole PR pivotal study for advanced Parkinson's disease patients. This study includes a wide range of ropinirole doses (4-24mg) with the 8mg, 12mg, and 16mg per day doses powered to detect a 1.7 hour difference in total awake time spent "off" compared with placebo. The dose of Ldopa will remain stable through the study, unless the subject experiences tolerability issues that require an L-dopa dose reduction. Up to three L-dopa dose reductions are allowed, making a total reduction of up to approximately 30%. Keeping the L-dopa dose constant where possible is important to avoid confounding the efficacy data. Clinical review of the primary and secondary endpoints will be performed in order to establish the lowest maximally effective therapeutic dose.
5. Effect of Rotigotine on Motor Symptoms in Patients With Advanced Parkinson's Disease (PD) With Motor Fluctuations and Gastroparesis (ROADMAP)
A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Assess the Effect of Rotigotine on Motor Symptoms in Patients With Advanced Parkinson’s Disease With Motor Fluctuations and Gastroparesis
Primary Outcome Measures:
Change in Rotigotine versus Placebo in the absolute time spent “off” from Baseline to the end of the 7-week Maintenance Period
Time Frame: Baseline to 9 weeks
Designated as safety issue: No
Mean number of hours marked “off” during a 24-hour period.
Estimated Enrollment: 190
Study Start Date: January 2012
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Ages Eligible for Study: 30 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
7. Study to Assess Droxidopa in Treatment of Neurogenic Orthostatic Hypotension in Patients With Parkinson's Disease (NOH306) — Completed & Not Recruiting
This is a study to evaluate the effects of an investigational drug, Droxidopa, in participants with neurogenic orthostatic hypotension (NOH), associated with Parkinson's disease. Droxidopa is being studied to determine the effects on blood pressure changes upon standing up (orthostatic challenge). Symptoms and activity measurements, including patient reported falls, will be evaluated to determine the effectiveness of the study drug.
Symptoms of NOH may include any of the following:
The study duration is a maximum of approximately 14 weeks including up to 2 weeks for screening, up to 2 weeks for proper dose finding, followed by an 8 week treatment period and a follow-up visit after 2 weeks. A sufficient number of patients will be screened to allow approximately 211 randomized patients. An extension study is also available to continue treatment if determined appropriate by the study doctor. This Study is NCT01132326 sponsored by Chelsea Therapeutics and is enrolling by invitation only.
A Phase 3, 12-week, Double-Blind, Placebo-Controlled, Randomized, Multicenter Study to Evaluate the Efficacy of Oral Istradefylline 20 and 40 mg/day as Treatment for Subjects with Moderate to Severe Parkinson’s Disease
More details coming soon.
This is a study to evaluate the effects of an investigational drug, Droxidopa, in participants with neurogenic orthostatic hypotension (NOH), associated with Parkinson's disease. Droxidopa is being studied to determine the effects on blood pressure changes upon standing up (orthostatic challenge). Symptoms and activity measurements, including patient reported falls, will be evaluated to determine the effectiveness of the study drug.
Symptoms of NOH may include any of the following:
- Dizziness, light-headedness, feeling faint or feeling like you may blackout
- Problems with vision (blurring, seeing spots, tunnel vision, etc.)
- Weakness
- Fatigue
- Trouble concentrating
- Head & neck discomfort (the coat hanger syndrome)
- Difficulty standing for a short time or a long time
- Trouble walking for a short time or a long time
The study duration is a maximum of approximately 14 weeks including up to 2 weeks for screening, up to 2 weeks for proper dose finding, followed by an 8 week treatment period and a follow-up visit after 2 weeks. A sufficient number of patients will be screened to allow approximately 211 randomized patients. An extension study is also available to continue treatment if determined appropriate by the study doctor. This Study is NCT01132326 sponsored by Chelsea Therapeutics and is enrolling by invitation only.
A Phase 3, 12-week, Double-Blind, Placebo-Controlled, Randomized, Multicenter Study to Evaluate the Efficacy of Oral Istradefylline 20 and 40 mg/day as Treatment for Subjects with Moderate to Severe Parkinson’s Disease
More details coming soon.
