Past Studies

Research Trials

Acute Stroke – 1997

Alzheimer’s Disease – 1998

Efficacy and long term tolerability of XXX in patients with moderately severe to severe Alzheimer’s Disease.

Epilepsy

XXX in combination with newer and older antiepileptic drugs and as mono-therapy.

Epilepsy -1999

Safety and Therapeutic Effect of XXX in patients with Partial Seizures.

Acute Stroke-1999

Phase IIa. Inpatient

HIV Neuropathy -1999

Stroke Prevention -1999

Phase III

Seizure Management -2000

Phase IV

Hypercholesterolemia-2001

Vascular Dementia -2002

Phase III

Hypercholesterolemia -2002

Migraine Disorder-2002

Phase II

Double-Blind Randomized Multi-center, Parallel Group Study to establish Dose     response, safety and efficacy of XXX as mono-therapy in patients with newly diagnosed epilepsy. 2002

A 6 week, open label, dose comparison study to evaluate the safety and efficacy of XXX versus XXX, XXX and XXX in subjects with Hypercholesterolemia. 2001

An open label, randomized, multi-center, Phase lllb, parallel group switching study to compare the efficacy and safety of lipid lowering agents XXX and XXX with XXX high risk subjects with type IIa and IIb Hypercholesterolemia. 2001

A randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and tolerability of XXX for a single moderate or severe headache in adults diagnosed with Migrainous disorder. 2002

A multi-center, double-blind, randomized study to evaluate the safety and efficacy of XXX compared with placebo in subjects with painful diabetic neuropathy. 2002

An open label study to evaluate the safety of XXX in subjects with Painful Diabetic Neuropathy. 2003

A multi-center, double-blind, randomized, placebo-controlled, parallel group trial to investigate the efficacy and safety of XXX as adjunctive therapy in subjects with partials seizures with or without secondary generalization. 2003

An open label extension trial to determine tolerability and efficacy of long-term oral XXX as adjunctive therapy in patients with Partial Seizures. 2003

Safety evaluation of XXX with opiod tolerant patients. 2003

A Phase III, randomized, double-blind, placebo-controlled, outpatient, safety and efficacy study of XXX in adults subjects with Chronic Insomnia. 2002

A Phase II Double-Blind, randomized, dose ranging, placebo-controlled , multi-center, safety and efficacy evaluation of three doses of XXX in patients with mild to moderate dementia of the Alzheimer’s Type. 2003

A Fourteen week placebo controlled dose response efficacy and safety study of XXX in early Parkinson’s Disease Patients. 2003

A randomized, double blind, placebo controlled, parallel-group, single attack study to evaluate the onset of efficacy of a new formulation of XXX in the acute treatment of Migraine. 2003

A dose-ranging, placebo controlled study of XXX at the dose of XXX for 12 weeks in patients with mild to moderate Alzheimer’s Disease. 2003

A randomized, double-blind, placebo controlled trial to evaluate the safety and efficacy of XXX in slowing the progression of Alzheimer’s Disease. 2003

A one year, multi-center, randomized, double-blind, placebo-controlled evaluation of efficacy and safety of XXX in subjects with Mild Cognitive Impairment. 2003

A 5-Week , randomized, Double-blind, placebo-controlled, placebo-controlled, multi-center study of XXX in patients with Postherpetic Neuralgia who are XXX treatment failures. 2004

A Multi-center, open-label trial to assess subject preference of XXX, orally disintegrating tablets, compared to conventional XXX in subjects with stable Parkinson’s Disease. 2004

A 4-Week randomized, Multi-center, double-blind, placebo-and-active-controlled, parallel-group, forced-titration Phase IIb study comparing efficacy and safety of ascending doses of XXX prolonged release up to 20mg BID to placebo in subjects with moderate to severe chronic pain due to Osteoarthritis of the knee. 2005

A Multi-center, randomized, double-blind, placebo controlled study assessing the safety and efficacy of XXX in patients in patients with Postherpetic Neuralgia. 2004

A randomized, parallel-design, multi-center study to evaluate the efficacy of XXX for the Treatment of Chronic Low Back Pain. 2004

A randomized, double blind, placebo-controlled, parallel group Phase 2 Study to evaluate the Safety and Efficacy of XXXX in subjects with mild to moderate Alzheimer’s Disease. 2004

A multi-center double blind randomized parallel group evaluation of XXX extended release Adjunctive therapy in subjects with Partial Seizures. 2004

A multi-center double blind randomized parallel group evaluation of XXX extended release adjunctive therapy in patients with primary generalized Tonic- Clonic Seizures. 2004

A multi-center randomized double blind placebo-controlled, parallel group trial to assess the efficacy and safety of XXX in subjects with Painful Distal Diabetic Neuropathy. 2005

A randomized double blind parallel group, placebo controlled single –attack evaluation of the efficacy and tolerability of XXX verses Placebo when administered during the mild pain phase of a migraine. 2004

A multi-center, open label follow on trial to assess the long term safety and efficacy of XXX in subjects with Painful Distal Diabetic Neuropathy. 2004

A randomized double blind placebo controlled study to assess the subjective response to treatment with XXX in adult subjects with Chronic Insomnia by utilizing an interactive voice response system for collecting diary data. 2005

Phase 3 multi-center randomized double blind placebo controlled study of the effect of daily treatment with XXX on measures of cognitive and global function in subjects with mild to moderate dementia of the Alzheimer’s Type. 2005

A prospective multi-center randomized open label study with blinded raters to evaluate the effects of immediate versus delayed switch to XXX on motor function

And quality of life in patients with Parkinson’s disease with-end-of dose wearing off. 2005

A randomized multi-center double blind placebo-controlled, 18-month study of the efficacy of XXX in patients with mild to moderate dementia of the Alzheimer’s Type. 2005

A multi-center, randomized double blind placebo controlled Five arm parallel group trial to investigate the efficacy and safety of four different transdermal doses of XXX in subjects with Idiopathic Restless Legs Syndrome. 2005

A pilot randomized double blind placebo controlled study to evaluate the efficacy of XXX and XXX in the treatment of Chronic Lumbosacral  Radiculopathy. 2005

A randomized double blind double blind placebo-controlled study of the safety and efficacy of XXX extended release tablets in treatment of patients with Postherpetic Neuralgia. 2005

An open- label exploratory study with XXX of selective measures of volumetric MRI and cognition in patients with Moderate Dementia of the Alzheimer’s Type. 2005

Safety, tolerability and efficacy study of oral XXX administered for ninety days in subjects with Probable Alzheimer’s of mild to moderate Severity. 2005

A phase 2 double-blind randomized, placebo-controlled, parallel-group, multi-center proof-of-concept study to evaluate the safety and efficacy of XXX taken in combination with XXX for the treatment of subjects with Chronic Insomnia. 2005

A randomized, double- blind, multi-center, placebo-controlled, cross-over study to determine the consistency of response for XXX administered during the mild pain phase for the acute treatment of multiple migraine attacks. 2005

A randomized, double-blind, Placebo-controlled, Multi-center Phase 3 study to evaluate the safety and the safety of XXX once daily and XXX twice daily for 12 weeks for the treatment of Opiod-induced Bowel Dysfunction in Adults taking Opiod Theraphy for persistent Non-Cancer Pain. 2005

A randomized, double-blind, placebo-controlled, multi-center Phase 3 study to evaluate the Long-Term  Safety of XXX twice daily for 12 months for the treatment of Opiod-Induced Bowel Dysfunction in Adults taking Opiod Theraphy for Persistent Non-Cancer Pain. 2004

A multi-center study evaluating the efficacy and safety of XXX as headache prophylaxis in Migraine Patients with 15 or more headache days per 4-week  period in a 24-week, double blind, randomized, placebo-controlled, parallel-group phase followed by a 32-week open-label extension. 2006

A double-blind, randomized, placebo-controlled study of the efficacy, safety and tolerability of 8 week treatment of XXX in sleep disturbed community dwelling, mild to moderately severe Alzheimer’s Disease Subjects. 2006

A randomized, double-blind, placebo-controlled, parallel-group clinical trial to examine the efficacy and safety of early XXX treatment versus delayed XXX treatment in patients with new onset of Parkinson’s disease. 2006

XXX Dose-range finding trial: A 16-week, randomized, double-blind, placebo and XXX controlled, multi-center trial of XXX in patients with Post herpetic Neuralgia. 2006

A randomized , double-blind ,placebo-controlled , multi-center, phase 2 study designed to assess the efficacy and safety of XXX immediate release in subjects with Chronic pain from Low Back Pain or  Osteoarthritis of the Hip or Knee. 2006

A multi-center trial evaluating the efficacy of XXX for symptomatic treatment of pain in patients with Multiple Sclerosis. 2006

A multi-center trial evaluating the efficacy of XXX for the symptomatic treatment of pain in patients with Diabetic Peripheral Neuropathy. 2006

A prospective, Multi-center clinical evaluation of XXX in combination with a XXX for the management of chronic back pain with or without leg pain. 2006

A multi-center, randomized, double-blind, placebo-controlled, parallel group study of the efficacy, safety, and tolerability of XXX in XXX treated Parkinson’s disease patients with motor fluctuations. 2006

Phase 3 multinational, randomized, double-blind, placebo controlled study of the effect of daily treatment with XXX on measures of cognition, activities of daily living and global function in the subjects with mild dementia of the Alzheimer’s Type. 2006

A multi-center, randomized, double-blind, placebo-controlled, parallel- group study of oral XXX for the treatment of Opiod Induced bowel Dysfunction in subjects with chronic non malignant pain. 2006

Open-label, multi-center, effectiveness and safety study of once daily XXX as mono or adjunct therapy in patients with Idiopathic Parkinson’s Disease. 2006

Randomized evaluation of recurrent stroke comparing XXX closure to establish current standard of care treatment. 2006

A prospective, 5-week, open-label, randomized, multi-center, parallel-group study with a 20-week, open-label extension evaluating the tolerability and safety of switching from XXX to an initial dose of XXX patch formulation in patients with probable Alzheimer’s disease. 2006

An open-label extention trial assessing the safety and tolerability of XXX in patients with Postherpetic Neuralgia. 2006

Open label study of the effect of daily treatment with XXX in subjects with Dementia of the Alzheimer’s type. 2006

A randomized double-blind, placebo and active-control, parallel-arm, phase III trial with controlled adjustment of dose to evaluate the efficacy and safety of XXX extended release in subjects with moderate to severe chronic pain due to Osteoarthritis of the knee. 2007

An 18 month double blind monthly IV study to evaluate the safety and efficacy of a tau antibody in patients 60-85 years of age with memory loss. Patients need a study partner to attend some visits.  MMSE 20-28. 2019

A long term study to evaluate the effectiveness of an oral potential disease modifying therapy in patients 60-80 years of age, first part of screening is genotyping for Alzheimer’s disease.  MMSE 26-30 Patients need a study partner to attend some visits. 2019

A single attack randomized placebo controlled study to evaluate the safety and efficacy of an oral combination drug for the acute treatment of a migraine with nausea. 2019

An 18 month double blind monthly IV study to evaluate the safety and efficacy of a tau antibody in patients 60-85 years of age with memory loss. Patients need a study partner to attend some visits.  (MMSE 20-28) 2019

Randomized, Double-blind, Single-dose, Placebo-controlled Study to Assess the Efficacy and Safety of AXS-07 (meloxicam and rizatriptan) for the Acute Treatment of Migraine in Adults 2019

A 72 week open label study for patients currently on Tysabri for at least 12 months, comparing 4 week dosing to 6 week dosing. Participants must be 18-60 years old. 2019

A novel oral MS treatment study for 6 months (short placebo period of 4 weeks in either beginning or ending with 4 months on medication), then open label study to follow for up to 5 years, for patients 18-55 years old. For Relapsing Multiple Sclerosis (either RRMS or SPMS with relapses). 2019

Revance: ASPEN: Cervical Dystonia – A randomized double-blind study with an injectable investigational medication for Isolated Cervical Dystonia.  After the initial treatment, patients can enter an Open Label Extension for 52 weeks.

Revance: JUNIPER: Upper Limb Spasticity-A randomized double-blind study with an injectable investigational medication for upper limb spasticity after a stroke or Traumatic Brian Injury, ages 18-70.

Roche – GRADUATE 2: Early Alzheimer’s Disease – 2 YEAR study to evaluate a potential disease modifying therapy, monthly subcutaneous injections versus placebo in patients between 50 and 90 years old with memory loss with 24-month open label extension. Patients need a study partner to attend some visits. (MMSE 22-28)

PrileniaParkinson’s Disease – Study to Assess the Efficacy and Safety of Two Doses of Pridopidine versus Placebo for the Treatment of Levodopa Induced Dyskinesia.

Satsuma: Acute MigraineA randomized study to evaluate the Efficacy, Safety and Tolerability of inhaled Single Doses of STS101 in the Acute treatment of Migraine.

Eisai-CLARITY: Early Alzheimer’s Disease – An 18-month randomized study to evaluate the safety and efficacy of an infused investigational medication vs. placebo in subjects 50-90 years of age with Mild Cognitive Impairment or early Alzheimer’s Disease. Visits are every 2 weeks, must have a study partner. 2-year Open label extension to follow for patients completing the double-blind study. (MMSE 22-30)

Impax: Parkinson’s Disease – A Randomized controlled study to compare the safety and efficacy of an oral drug with Immediate Release-Carbidopa-Levodopa in Parkinson’s disease patients with motor fluctuations.

Sage: Essential Tremor-A 6 week double-blind, placebo controlled, randomized study evaluating the efficacy, safety and tolerability of Sage-324 in the treatment of individuals with essential tremor who are ages 18-80.

Lilly-Trailblazer 2-AACI-Alzheimer’s Disease: A Phase 2, Multicenter, Randomized, Double-Blind Placebo-Controlled, Study to Evaluate the Safety, Efficacy and Tolerability of donanemab in participants with early symptomatic Alzheimer’s Disease. Study partner is required.

Novartis: EXCHANGE – Advancing Relapsing-Remitting MS – A 6 month open label study for a new oral medication for MS, patients wanting to switch from taking beta-interferons, glatiramer acetate, fingolimod, dimethyl fumarate, or teriflunomide (must have been on these medications for at least 3 months). Patients must have had a relapse in the last 12 months. Extension study to follow, for patients completing the 6-month study. Participants must be between 18-65 years old.

Lilly: Trailblazer 3-AACM Preclinical Memory Loss – Phase 3 Study Assessing the Efficacy, Safety, and Tolerability of Donanemab in Preclinical Alzheimer’s Disease for people 55-80 years of age, not yet diagnosed with memory problems.

Jazz: EveresT Essential Tremor – A Phase 2b, 12-week, Double-blind, Placebo-controlled, Randomized, Parallel-group, Multicenter Study of the Safety and Efficacy of JZP385 in the Treatment of Adults with Moderate to Severe Essential Tremor for people 18-80 years of age.

Novartis: COMB157GUS12 – An open-label multicenter study to assess response to influenza vaccine in participants with multiple sclerosis treated with ofatumumab 20 mg subcutaneously for people 18-55 years of age.

HOLLYWOOD NEUROLOGY

T3D PIONEER: Mild to moderate Alzheimer’s Disease – A 28-week randomized study to evaluate the efficacy, safety and tolerability of an oral investigational medication vs. placebo in subjects with mild to moderate Alzheimer’s Disease, must have a study partner, ages 50-90. (MMSE 16-26)

Neuraly: Early Parkinson’s Disease – A 36-week randomized double-blind study to evaluate the efficacy, safety and tolerability of an oral medication vs. placebo in Early Parkinson’s Disease, ages 30-80.

Satsuma Migraine: A Randomized, Double Blind, Parallel group, Placebo controlled, Multicenter Study to Evaluate the Efficacy, Safety and Tolerability of STS101 (Dihydroergotamine Nasal Powder) in Acute Treatment of Migraine.

Aeon-Cervical Dystonia: A Phase 2, Randomized, Double-Blind, Multicenter, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Intramuscular ABP-450 (prabotulinumtoxinA) Injection for the Treatment of Cervical Dystonia. Followed by an open label extension for 1 year for those who complete the Double-Blind study.

Cassava: Alzheimer’s Disease – A Phase 3, Double-blind, Placebo controlled  52-Week study evaluating the safety and efficacy of Simufilam 100 mg tablets in subjects with Mild to Moderate Alzheimer’s Disease in patients age 50-87

SUNRISE OFFICE NEUROLOGY

Aptinyx: Parkinson’s Disease – A study to evaluate NYX-458 in subjects with Mild Cognitive Impairment associated with Parkinson’s Disease, must have a study partner and be between 50-80 years of age.

SUNRISE OFFICE NEUROLOGY – MS STUDIES

Novartis-Artios: –Relapsing MS— (SPMS or RRMS) A single-arm, prospective, open-label study to evaluate ofatumumab treatment effectiveness and patient reported outcomes in patients with relapsing multiple sclerosis transitioning from dimethyl fumarate or fingolimod therapy. Participants must be 18-60 years old.

Novartis: Multiple Sclerosis – A randomized, open label, multi-center, active-comparator study to assess the efficacy, safety and tolerability of ofatumumab 20mg sc monthly versus continued current therapy in relapsing-remitting multiple sclerosis after elevation of serum neurofilament light levels (SOSTOS).

Takeda: Parkinson’s Disease-A Randomized, Double-Blind, Placebo-Controlled, 2-Period Crossover, Phase 2 Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral TAK-071 in Parkinson’s patients with Cognitive Impairment and an Elevated Risk of Falls for people 40-75 years of age.

Axsome-Alzheimer’s with Agitation: A Phase 3, 12-Week, Multicenter, Randomized, Double-blind, Placebo-controlled, 2-Arm, Fixed-dose Trial to Evaluate the Efficacy, Safety, and Tolerability of Brexpiprazole (OPC-34712) in the Treatment of Subjects With Agitation Associated With Dementia of the Alzheimer’s Type

Sanofi- Gemini 2: Relapsing MS— (SPMS or RRMS) A Phase 3, randomized, double-blind efficacy and safety study comparing SAR442168 to teriflunomide (Aubagio®) in participants with relapsing forms of multiple sclerosis (GEMINI 2). Participants must be 18-55 years old.

Novartis: OLIKOS--Relapsing MS (SPMS or RRMS) A 12 month, single-arm, multi-center study to explore maintained efficacy with ofatumumab therapy in patients with relapsing Multiple Sclerosis who discontinue intravenously delivered anti-CD20 monoclonal antibody (aCD2mAb) therapy (Ocrelizumab or Rituximab) Participants must be 18-55 years old.

Novartis-COMB157GUS16: An open-label multicenter study to assess response to COVID-19 vaccine in participants with multiple sclerosis treated with ofatumumab 20 mg subcutaneously

Sanofi: Secondary Progressive Non-Relapsing MS – A Phase 3, Randomized, Double-Blind, Efficacy and Safety Study comparing SAR442168 to Placebo in Participants with nonrelapsing Secondary Progressive Multiple Sclerosis (HERCULES)

Lilly: Trailblazer 3-AACM Preclinical Memory Loss – Phase 3 Study Assessing the Efficacy, Safety, and Tolerability of Donanemab in Preclinical Alzheimer’s Disease for people 55-80 years of age, not yet diagnosed with memory problems.

Lilly: 15T-MC-AACQ Alzheimer’s Disease – Investigating the effect of different Donanemab dosing regimens on ARIA-E and amyloid lowering in adults with early symptomatic Alzheimer’s Disease. Ages 60-85.

Novartis: COMB157GUS12 – An open-label multicenter study to assess response to influenza vaccine in participants with multiple sclerosis treated with ofatumumab 20 mg subcutaneously for people 18-55 years of age.

Biogen: Fusion-RMS – A two-part, multicenter, randomized, blinded, active-controlled Phase 2 study to sequentially evaluate the safety and efficacy of BIIB091 (BTK inhibitor) Monotherapy and BII091 Combination Therapy with Diroximel Fumarate in participants with relapsing forms of Multiple Sclerosis. Ages 18-55.