We are currently enrolling for the following studies. If you have interest in one of them, please contact the proper person listed with the study.
ALZHEIMER'S DISEASE | EPILEPSY | MIGRAINE | MULTIPLE SCLEROSIS | PARKINSON'S DISEASE | RESTLESS LEGS SYNDROME| STROKE
ALZHEIMER’S DISEASE
Toyama: AA4437420
A Phase 2a multi-center, randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of T-817MAa in patients with mild to moderate Alzheimer’s disease
To be included in the study patients must meet the following criteria:
- 50-90 years of age
- Must be receiving Aricept only for Alzheimer’s treatment
- MMSE score of 15-24
- Be able to swallow 2 capsules each morning
- Must have an eligible caregiver who is willing to oversee the patient’s compliance with study medication and participate on the patient’s clinical assessment
For more information, please contact Beth Jackson, Certified Clinical Research Coordinator at (919) 782-3456 ext. 8264 or bjackson@raleighneurology.com.
ALZHEIMER’S DISEASE
Wyeth 3133K1-3001-US
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Efficacy and Safety Trial of Bapineuzumab (AAB-001, ELN115727) in Subjects With Mild to Moderate Alzheimer’s Disease Who Are Apolipoprotein E4 Carriers.
To be eligible to participate in the study the following criteria must be met:
- Age 50-88
- MMSE 16 – 26
- Has caregiver that lives with the patient or visits at least 5 times a week
- Can successfully complete an MRI without sedation
- Has adequate venous access for study drug administration
For more information, please contact Tippi Hales, RN, Senior Clinical Research Coordinator at (919) 420-1658 or thales@raleighneurology.com.
ALZHEIMER’S DISEASE
Study H8A-MC-LZAM: Effects of LY2062430, an anti-amyloid beta monoclonal antibody, on the progression of Alzheimer’s Disease as compared with Placebo.
To be eligible to participate in the study the following criteria must be met:
- MMSE score of 16 through 26
- Is at least 55 years old
- Has reliable caregiver who is with patient at least 10 hours a week and can attend all study visits with the patient
For more information, please contact Chester Farley, LPN/Clinical Research Coordinator at (919)782-3456 ext. 8136 or cfarley@raleighneurology.com.
PRODROMAL ALZHEIMER’S DISEASE
STUDY CN156-018 is a multicenter, randomized, double-blind, placebo-controlled, Phase II study of the safety, tolerability, pharmacodynamic and pharmacokinetic effects of BMS-708163 in the treatment of patients with Prodromal Alzheimer’s Disease, Bristol Myers-Squibb.
To be eligible to participate in the study the following criteria must be met:
- Memory complaint by patient or study partner
- MMSE score between 24 and 30 (inclusive)
- Age criteria 45 to 90 years old
- Has reliable caregiver who is with patient at least 10 hours a week
- The following treatments are allowed as long as stable times 3 months prior: Aricept/donepezil, Razadyne/galantamine, Exelon/rivastigmine, vitamin E, fish oil, or estrogen (Namenda/memantine not allowed)
For more information, please contact Marilyn Yelton, RN, BSW, Clinical Research Coordinator at (919)420-1657 or myelton@raleighneurology.com.
ALZHEIMER’S DISEASE
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Efficacy and Safety Trial of Bapineuzumab (AAB-001, ELN115727) In Patients With Mild to Moderate Alzheimer’s Disease Who Are Apolipoprotein E4 Non-Carriers.
To be eligible to participate in the study the following criteria must be met:
- Age 50-88
- MMSE 16 – 26
- Has caregiver that lives with the patient or visits at least 5 times a week
- Can successfully complete an MRI without sedation
For more information, please contact Tippi Hales, RN, Senior Clinical Research Coordinator at (919) 420-1658 or thales@raleighneurology.com.
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K826-05-3001 “A Phase 3, Randomized, Double-Blind, Parallel, Placebo-Controlled, Multicenter Study, with Optional Open-Label Continuation, of the Efficacy and Safety of Vanquix Auto Injector ™ (Diazepam Injection) for the Management of Selected, Refractory, Patients with Epilepsy who Require Intermittent Medical Intervention to Control Episodes of Acute Repetitive Seizures.”
To be eligible to participate in the study the following criteria must be met:
- Patient must be 2 years or older
- Must have a diagnosis of epilepsy
- Must require intermittent medical intervention to control episodes of ARS (Acute Repetitive Seizures)
- Has been on a stable antiepileptic drug regimen for at least 2 weeks prior to enrollment
- Has experienced at least 2 episodes of repetitive seizures in the year prior to enrollment, one of which must have occurred in the previous 6 months
- Patient must have a caregiver 18 years or older, who is able to recognize an episode of repetitive seizures and able to administer study medication
For more information, please contact Richard Allen, Clinical Research Coordinator
(919) 782-3456 ext. 8063 or rallen@raleighneurology.com.
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TXA107979 “A Randomized, Multicenter, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of a Combination Product Containing Sumatriptan and Naproxen Sodium for the Acute Treatment of Migraine in Adolescents”
To be eligible to participate in the study the following criteria must be met:
- Age 12-17
- Must have moderate to severe migraine headaches
- Must be able to distinguish migraine from other headaches
- Able to read, comprehend, and complete migraine diaries
For more information, please contact Richard Allen, Clinical Research Coordinator
(919) 420-1658 or rallen@raleighneurology.com.
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MULTIPLE SCLEROSIS (MS)
Actelion Pharmaceuticals: Protocol AC-058B201: A Multicenter, Randomized, Double-Blind,Placebo-Controlled,Parallel-Group, Dose-finding study to evaluate the efficacy, safety, and tolerability of three doses of ACT-128800, an oral S1P1 receptor agonist, administered for twenty-four weeks in patients with relapsing-remitting multiple sclerosis.
To be included in this study patients must meet the following criteria:
1) Diagnosed with relapsing remitting MS (RRMS)
2) Must be ambulatory and with an EDSS score between 0 and 5.5
3) Must have at least one of the following characteristics of RRMS:
- One or more documented relapse(s) within 12 months prior to the screening visit
- Two or more documented relapses within 24 months prior to the screening visit
- At least one gadolinium-enhancing lesion detected on T1 weighted MRI at the screening visit (based on central reading)
4) In a stable clinical condition
- Without a clinical exacerbation of MS for at least 30 days prior to randomization
For more information, please contact Penni Bye, RN, BSN, Certified Clinical Research Coordinator at (919) 782-3456 x 8197 or email at pbye@raleighneurology.com.
MULTIPLE SCLEROSIS (MS)
Novartis CBAF312A2201
A phase II, double-blind, randomized, multi-center, adaptive dose-ranging, placebo-controlled, parallel-group study evaluating safety, tolerability and efficacy on MRI lesion parameters and determining the dose response curve of BAF312 given orally once daily in patients with relapsing-remitting multiple sclerosis
To be eligible to participate in this study the following criteria must be met:
- 18-55 years old
- Diagnosis of relapsing-remitting multiple sclerosis
- Documented relapse in past 12 months, or two documented relapses in 24 months, or positive Gd-enhanced MRI at screening
- No history of diabetes, substance abuse, or immunosuppressive treatments such as rituxamab
For more information, please contact Keisha Fuller, RN, BSN, Clinical Research Coordinator at (919) 782-3456 x8254 or kfulller@raleighneurology.com.
MULTIPLE SCLEROSIS (MS)
Protocol # H9B-MC-BCDJ (a): Multiple Subcutaneous Doses of LY2127399, and Anti-BAFF Human Antibody, in Subjects with Relapsing-Remitting Multiple Sclerosis. EliLilly,2009.
To be eligible to participate in this study the following criteria must be met:
- Relapsing Remitting Multiple Sclerosis
- EDSS score between 0 through 5.0
- Have at least 1 documented clinical relapse within 12 months prior to visit 2; OR show evidence of Gd-enhancing lesion(s) of the brain or spine within the last 12 months
- Are 18 to 64 years of age
For further information please contact Penni Bye, RN, BSN at (919) 782-3456 x8197 or email at pbye@raleighneurology.com.
MULTIPLE SCLEROSIS (MS)
Protocol #105MS301; A Multicenter, Randomized, Double-blind, Parallel-Group, Placebo-controlled Study to Evaluate the Efficacy and Safety of PEGylated Interferon Beta-1a (B11B017) in Subjects with Relapsing Multiple Sclerosis. Biogen Idec, 2009.
To be eligible to participate in this study the following criteria must be met:
- Relapsing Remitting Multiple Sclerosis
- 18 to 55 years of age
- EDSS score between 0 and 5.0
- Must have experienced at least 2 relapses that have been medically documented within the last 3 years with at least one of these relapses having occurred within the past 12 months prior to randomization
For further information please contact Penni Bye, RN, BSN at (919) 782-3456 x8197 or email at pbye@raleighneurology.com.
MULTIPLE SCLEROSIS (MS)
Biogen Protocol 001-06-NAT (ENER-G)
Multi-center, Open-Label Study to Evaluate the Effects of Natalizumab Treatment on Fatigue and Cognition in Subjects with Relapsing Forms of MS.
To be eligible to participate in this study, you must:
- Be aged 18 – 55 with a diagnosis of relapsing forms of MS
- Be enrolled in the TOUCH prescribing program
- Be naïve to TYSABRI®
- History or presence of PML (progressive multifocal leukoencephalopathy)
- Have no problems with upper extremity dexterity
For more information, please contact Chester Farley, LPN, Clinical Research Coordinator at (919) 782-3456 ext 8136 or cfarley@raleighneurology.com
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PARKINSON'S DISEASE
SP921 - Phase 3 Trial
A multicenter, randomized, double-blind, placebo-controlled, 5-Arm, parallel-group trial to assess Rotigotine Transdermal system dose response in subjects with advanced-stage Parkinson’s Disease. Schwarz Biosciences, Inc.
To be eligible to participate in the study the following criteria must be met:
- Parkinson’s disease for greater than 3 years duration, as defined by the cardinal sign of bradykinesia plus the presence of at least 1 of the following: resting tremor, rigidity, impairment of postural reflexes, and without any other known or suspected cause of the Parkinsonism.
- PD characterized as Stage II through IV by the Hoehn & Yahr Scale in both the “on” and “off” state.
- Patient on stable dose of L-dopa, either short-acting or sustained release prior to baseline.
- Mini Mental State Examination MMSE of ≥ 25.
- Patient is aged ≥ 30 years.
- Excluded if patient has participated previously in a trial with rotigotine or received commercially available rotigotine.
- Excluded if patient is receiving therapy with a dopamine agonist such as, Mirapex or Requip currently or has done so within 28 days prior to visit 2.
For more information, please contact Marilyn Yelton, RN, Clinical Research Coordinator at (919)420-1657 or myelton@raleighneurology.com
PARKINSON'S DISEASE
IMPAX IPX066-B09-02
A Phase 3, randomized, double-blind, active-control, parallel-group 13-week comparison of IPX066 versus immediate-release (IR) carbidopa-levodopa (CD-LD). Prior to randomization, subjects on a stable IR LD regimen will enter a 3-week Dose-Adjustment period for IR CD-LD, followed by a 6-week Dose-Conversion period to IPX066.
To be eligible to participate in the study the following criteria must be met:
- Diagnosed with idiopathic Parkinson’s Disease
- At least 30 years old at time of PD diagnosis
- Mini Mental Status Exam > 26 at Screening
- Currently being treated with immediate-release Levodopa and on a stable dose for at least 4 weeks
- Total daily dose of IR LD of at least 400 mg and a minimum dosing frequency of 4 times per day
- Able to distinguish between “On” and “Off” times
For more information, please contact Chester Farley, LPN, Clinical Research Coordinator at (919) 782-3456 ext 8136 or cfarley@raleighneurology.com.
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RESTLESS LEGS SYNDROME
Pfizer A0081185
A Randomized, Double-Blind, Placebo-Controlled, 3-Way Crossover, Multicenter Polysomnography Study Of Pregabalin And Pramipexole In Adults With Restless Legs Syndrome
To be included in the study patients must meet the following criteria:
- 18-60 years of age
- Have history or presence of RLS symptoms interfering with sleep 3 or more nights/week
- Be willing to have 8 overnight sleep studies during 5 months of study participation
For more information, please contact Tippi Hales, RN, Senior Clinical Research Coordinator at (919) 420-1658 or thales@raleighneurology.com.
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INPATIENT STROKE
Study DG-AF1
Detection of intermittent atrial fibrillation in stroke patients
To be eligible to participate, the following criteria must be met:
- Age 40-80
- Have a diagnosis of a large vessel stroke
- No past history of atrial fibrillation or flutter
- No history of stroke within past 1 month
For more information, please contact Mary Allen, RN, Clinical Research Coordinator at (919) 782-3456, ext. 8265 or mallen@raleighneurology.com.
INPATIENT STROKE
ALIAS Study
A Phase III Randomized Multicenter Clinical Trial of High-Dose Human Albumin Therapy for Neuroprotection in Acute Ischemic Stroke
To be eligible to participate, the following criteria must be met:
- Have an acute ischemic stroke
- Age 19-83
- NIHSS of 6 or greater
- Be able to start albumin within 5 hours of stroke onset
For more information, please contact Mary Allen, RN, Clinical Research Coordinator at (919) 782-3456, ext. 8265 or mallen@raleighneurology.com.
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