Current | Ongoing Studies - Hollywood

SUNRISE CLINICAL RESEARCH

4925 Sheridan Street, Suite 200     Hollywood, Fl 33021

Telephone:  (954) 366-0277     Fax: (954) 981-9306

researchcures@yahoo.com

Physicians Fax referrals or contact Lutheria Hollis @ (954) 981-3850 Ext 302

Alzheimer Trials:

A Phase 3 Multicenter, Randomized, Double Blind, Placebo Controlled Study of the Effect of Daily Treatment with MPC-7689 on Measures of Cognitive and Global Function in Subjects with Mild Dementia of the Alzheimer’s Type.  Age > 55years. MMSE 20-26. Can be taking an Ache or memantine. 18 month trial. (Visits every 3 months). Dr. Schwartz is the Principal Investigator.

A randomized, prospective, multicenter, open label, parallel-group rivastigmine patch. The study is designed to estimate the tolerability of switching patients from donzepil to rivastigmine patch formulation.  The study will last approximately 9 weeks.  Dr Schwartz is the Principal investigator.

Parkinson’s Trials:

 A prospective, multicenter, randomized, open label study with blinded raters to evaluate the effects of immediate versus delayed switch to Stalevo on motor function and quality of life in patients with Parkinson’s disease with end-of-dose wearing off. Age 30-80. Must be on stable dose of carbidopa/levodopa. Hoehn & Yahr less than or equal to 2.5. Dr. Ginsberg is the Principal Investigator.

A randomized, double-blind, placebo-controlled, parallel-group clinical trial to examine the efficacy and safety of early pramipexole treatment versus delayed pramipexole treatment in patients with new onset Parkinson’s disease. Age 30-75. Newly diagnosed with PD within past 2 years.  Hoehn & Yahr Stage I-II. Not currently taking L-dopa. Dr Schwartz is the Principal Investigator.

A multi-center, randomized, double-blind, placebo-controlled, parallel group study of the efficacy, safety, and tolerability of XXXX in Levodopa treated Parkinson’s disease patients with motor fluctuations.  Hoehn & Yahr stage II-IV off. Must have at least 2 hours of off time during the waking day. Dr Ginsberg is the PI.

A multi-center open label Phase IV Azilect. Dr Ginsberg is the PI.

Alzheimer’s/Insomnia:

A Double-Blind, Randomized, Placebo-controlled study of the efficacy, safety and tolerability of 8 week treatment of Rozerem 8mg (qhs) in sleep disturbed, community dwelling, mild to moderately severe Alzheimer’s disease subjects.  Age 55 and over. Probable AD. Must have caregiver. MMSE 10-26. HX of greater than 2 sleep disorder behaviors. No RLS. 8 visits over 8 weeks.  Dr Steinberg is the Principal Investigator.

Migraine:

A mutlicenter study evaluating the efficacy and safety of BOTOX 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, parrellel-group phase followed by a 32 week open label extension.  Age 18-65. Hx of migraine.

At least 15 headache days per month, half being probable migraine. No prophylaxis therapy for 28 days prior to screening. BOTOX naïve.  Dr Schwartz is the Principal Investigator.

A Prospective Randomized investigation to Evaluate incidence of headache reduction in subjects with Migraine and PFO using the XXXXX PFO Occluder compared to Medical Management. (The PREMIUM Trial). Age 18 – 55.  Documented history of > 6 migraine headache days and no greater than 14 total migraine headache days for weeks prior to randomization.  No history of TIA or stroke.  No contraindication to aspirin or Plavix.  No allergy to nickel. No treatment with BOTOX for at least 4 month prior.  No History of CAD. Dr Schwartz is the PI.

Stroke:

Randomized Evaluation of Recurrent Stroke comparing PFO Closure to Established Current Standard of Care Treatment. Patients with PFO who have had a cryptogenic stroke within the last 270 days. Patients will be randomized to the PFO occluder or standard of care. 2 year study. Dr Schwartz is the PI.

Diabetic Neuropathy:

A Randomized Double-Blind, Placebo-Controlled, Multi-Center, Phase 2 Study Designed to assess the Efficacy and Safety of XXX in Subjects with Painful Diabetic Neuropathy. Dr Seliger is the PI.

Multiple Sclerosis:

A Multicenter Trial evaluating the safety and efficacy of XXXXXX for symptomatic treatment of pain in patients with Multiple Sclerosis Age 18-75. Consistent pain for 2 months.  Baseline pain score > 40mm. On stable therapies for MS.  Dr Seliger Is the PI>

Opiod Induced Constipation:

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of XXX in the Treatment of Opiod Induced Constipation in Subjects with Non-Malignant Pain.  Dr Steinberg is the PI.

Chronic Pain:

A Randomized, Double-Blind, Active Control, Parallel Group, 90 day safety Study for Subjects with Chronic pain from Low Back Pain or Osteoarthritis of the Hip or Knee. Dr Steinberg is the PI.

A prospective, Multicenter clinical evaluation of XXX channel implantable pulse generator (IPG) in combination with a lead tripole array for the management of chronic back pain with or without leg pain.  Dr Schou is the PI.

Non-treatment:

A Multi-Site, Cross- Sectional, Non-treatment, prospective trial to collect bio-fluids and neuropsychiatric data from cognitive normal elderly subjects.  1 Visit study. Dr Schwartz is the Principal Investigator.