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.
Fund My Medical ResearchDr. Jerome Lisk is on the advisory board of Fund My Medical Research, a fundraising non-profit organization that utilizes crowd funding platforms and angel investors clubs for financing. Through generous donations, Fund My Medical Research can legally pass along the donations to the best Biotech companies so they can continue their search for disease cures. |
Open Trials
NOW RECRUITING - 12-week Randomized Study to Evaluate Oral Istradefylline in Subjects With Moderate to Severe Parkinson's Disease (KW-6002)
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. Patients will be randomized 1:1:1 to receive either Istradefylline 20 mg per day, or Istradefylline 40 mg per day or an equivalent placebo. Patients will be treated for a 12 week period to demonstrate the effectiveness of Istradefylline in improving Parkinson's disease symptoms (referred to as improvement in patient OFF time) and that Istradefylline has an acceptable safety profile in this group. Patients will continue on their existing Levodopa combination therapy throughout the study period.
Clinical Study of Patients With Symptomatic NOH to Assess Sustained Effects of Droxidopa Therapy
Evaluate the clinical efficacy and safety of droxidopa versus placebo over a 17 week (maximum) treatment period in patients with symptomatic NOH.
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. Patients will be randomized 1:1:1 to receive either Istradefylline 20 mg per day, or Istradefylline 40 mg per day or an equivalent placebo. Patients will be treated for a 12 week period to demonstrate the effectiveness of Istradefylline in improving Parkinson's disease symptoms (referred to as improvement in patient OFF time) and that Istradefylline has an acceptable safety profile in this group. Patients will continue on their existing Levodopa combination therapy throughout the study period.
Clinical Study of Patients With Symptomatic NOH to Assess Sustained Effects of Droxidopa Therapy
Evaluate the clinical efficacy and safety of droxidopa versus placebo over a 17 week (maximum) treatment period in patients with symptomatic NOH.
Apokyn for Motor IMProvement of Morning AKinesia Trial (AM IMPAKT)
This study is designed to assess the effect of APOKYN treatment in rapid and reliable improvement of motor symptoms in Parkinson's disease (PD) subjects suffering from delayed or unreliable onset of levodopa (L-dopa) action.
In the study, subjects will complete an L-Dopa Baseline Period in which they record daily "time to on" following their regularly scheduled L-Dopa morning dose for 7 days. At the end of the baseline period, patients will start trimethobenzamide therapy during a minimum 3-Day Anti-Emetic Pretreatment Period. Patients determined to remain eligible at the end of the required Anti-Emetic Pretreatmetn Period will be initiated on APOKYN therapy by an investigator. Once the appropriate dose is identified by a study investigator, patients will inject APOKYN at their regularly scheduled levodopa morning dose time (levodopa will be delayed by 40 minutes) daily during a 7-day APOKYN Treatment Period and record "time to on" following the APOKYN injection. For eligibility, visit the trial's page.
A Clinical Study of Patients With Symptomatic NOH to Assess Sustained Effects of Droxidopa Therapy
Purpose: Evaluate the clinical efficacy and safety of droxidopa versus placebo over a 17 week (maximum) treatment period in patients with symptomatic NOH.
This is a multi-center, multi-national, randomized, parallel-group, placebo-controlled, double-blind study with a 17 week (maximum) treatment period consisting of an initial, open-label dose titration (up to 2 weeks), followed by a washout period (up to 3 weeks), followed by a 12 week treatment period on a stable dose. For eligibility, visit the trial's page.
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 study is designed to assess the effect of APOKYN treatment in rapid and reliable improvement of motor symptoms in Parkinson's disease (PD) subjects suffering from delayed or unreliable onset of levodopa (L-dopa) action.
In the study, subjects will complete an L-Dopa Baseline Period in which they record daily "time to on" following their regularly scheduled L-Dopa morning dose for 7 days. At the end of the baseline period, patients will start trimethobenzamide therapy during a minimum 3-Day Anti-Emetic Pretreatment Period. Patients determined to remain eligible at the end of the required Anti-Emetic Pretreatmetn Period will be initiated on APOKYN therapy by an investigator. Once the appropriate dose is identified by a study investigator, patients will inject APOKYN at their regularly scheduled levodopa morning dose time (levodopa will be delayed by 40 minutes) daily during a 7-day APOKYN Treatment Period and record "time to on" following the APOKYN injection. For eligibility, visit the trial's page.
A Clinical Study of Patients With Symptomatic NOH to Assess Sustained Effects of Droxidopa Therapy
Purpose: Evaluate the clinical efficacy and safety of droxidopa versus placebo over a 17 week (maximum) treatment period in patients with symptomatic NOH.
This is a multi-center, multi-national, randomized, parallel-group, placebo-controlled, double-blind study with a 17 week (maximum) treatment period consisting of an initial, open-label dose titration (up to 2 weeks), followed by a washout period (up to 3 weeks), followed by a 12 week treatment period on a stable dose. For eligibility, visit the trial's page.
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.
Completed & Not Recruiting - Extended Release Amantadine Safety and Efficacy Study in Levodopa-induced Dyskinesia (EASED Study) —
The EASED study will evaluate four treatments (three dose levels of ADS-5102 and placebo capsules which contain no active study drug). Efficacy and Safety Study of ADS-5102 (Amantadine HCL) Extended Release (ER) Capsules for the Treatment of Levodopa Induced Dyskinesia in Parkinson Disease Patients. 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.
Completed & Not Recruiting - Study to Assess Droxidopa in Treatment of Neurogenic Orthostatic Hypotension in Patients With Parkinson's Disease (NOH306)
Completed in 2013. 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.
Completed & Not Recruiting - A Study of the Safety and Tolerability of Pimavanserin (ACP-103) in Patients With Parkinson's Disease Psychosis
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
(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
Completed & Not Recruiting - 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.
The EASED study will evaluate four treatments (three dose levels of ADS-5102 and placebo capsules which contain no active study drug). Efficacy and Safety Study of ADS-5102 (Amantadine HCL) Extended Release (ER) Capsules for the Treatment of Levodopa Induced Dyskinesia in Parkinson Disease Patients. 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.
Completed & Not Recruiting - Study to Assess Droxidopa in Treatment of Neurogenic Orthostatic Hypotension in Patients With Parkinson's Disease (NOH306)
Completed in 2013. 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.
Completed & Not Recruiting - A Study of the Safety and Tolerability of Pimavanserin (ACP-103) in Patients With Parkinson's Disease Psychosis
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
(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
Completed & Not Recruiting - 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.
Completed & Not Recruiting - 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.
Completed & Not Recruiting - 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.
Completed & Not Recruiting - 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
