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.
Pfizer 3133K1-3000-US/B2521001
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 Eε4 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
- 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
Protocol #: ABE4869g
A Randomized, Double-blind, Placebo controlled, Parallel-group, Multicenter, Phase II Study To Evaluate the Efficacy and Safety of MABT5102A in Patients with Mild to Moderate Alzheimer’s Disease
To be eligible to participate in the study the following criteria must be met:
- Diagnosis of probable Alzheimer’s Disease
- 50 – 80 years of age
- MMSE 18 – 26
- Completion of 6 years of education
- If receiving concurrent AD treatment, patient must be on the medication for at least 3 months at a stable dose at least 2 months prior to enrolling in the study
For more information, please contact Tonisha Brown, RN, BSN, CRC at (919) 782-3456 x 8316 or tbrown@raleighneurology.com.
EPILEPSY STUDY FOR PATIENTS WITH EPISODES OF ACUTE REPETITIVE SEIZURES (ARS)
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 Penni Bye, RN Certified Clinical Research Coordinator
(919) 782-3456 ext. 8197 or pbye@raleighneurology.com.
DECIDE MS STUDY: 205MS301
Double-blind, Randomized, Parallel-Group, Monotherapy, Active-Control Study to determine the Efficacy and Safety of Daclizumab High Yield Process (DAC HYP) versus Avonex (Interferon B-1a) in Patients with Relapsing-Remitting Multiple Sclerosis.
To be included patients must meet the following criteria:
- 18-55 years of age, inclusive
- EDSS score between 0-5
- History of Relapsing Remitting MS
- Must meet one of the following disease activity-related criteria:
- Two or more clinical relapses within the previous 3 years with at least 1 clinical relapse in the 12 months prior to randomization.
OR
- One or more Clinical relapses and 1 or more new MRI lesions within the previous 2 years with at least one of these events in the 12 months prior to randomization. The new MRI lesion must be distinct from the one associated with the clinical relapse. The baseline MRI may be used to satisfy this criterion.
For more information please contact Penni Bye, RN, Certified Clinical Research Coordinator at pbye@raleighneurology.com or (919) 782-3456 x 8197.
MULTIPLE SCLEROSIS (MS)
Acorda DER-401
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Safety and Efficacy of Two Doses of Oral Dalfampridine Extended Release Tablets (5mg and 10mg twice daily) in Patients with Multiple Sclerosis.
To be eligible to participate in the study the following criteria must be met:
- Has clinically definite multiple sclerosis
- Age 18-70
- Patient who has previously taken Ampyra must have withdrawn from the drug for at least one month prior to screening
- Patient who is female of childbearing potential must have a negative urine pregnancy urine test at the Screening Visit.
For more information, please contact Julie Shah RN, BSN, Clinical Research Coordinator at (919) 782-3456 ext. 8265 or jshah@raleighneurology.com
MULTIPLE SCLEROSIS (MS)
Roche Pharmaceuticals WA 21093/A
A Randomized, Double-Blind, Double Dummy, Parallel Group Study to Evaluate the Efficacy and Safety of Ocrelizumab In Comparison To Interferon Beta-1a (Rebif) In Patients with Relapsing Multiple Sclerosis
To be eligible to participate in this study you must meet the following criteria:
● Be between the ages of 18-55 at screening
● Have had at least 2 clinical attacks within the last two years prior to screening or one attack in the year prior to screening (but not within the 30 days prior to screening)
● EDSS range at screening between 0 to 5.5
● Have Relapsing Remitting or secondary progressive MS
● No other major medical problems that would impede participation in the trial
Please contact Penni Bye, RN, BSN, MSCN at (919) 782-3456 x 8197 or email at
pbye@raleighneurology.com for more information.
MULTIPLE SLEROSIS (MS)
Biogen Ascend 101MS326 Study
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy of Natalizumab on Reducing Disability Progression in Subjects With Secondary Progressive Multiple Sclerosis
To be included in this study, patients must meet the following criteria:
- 18-58 years of age inclusive
- Onset of SPMS at least 2 years prior to enrollment
- Have documented confirmed evidence of disease progression independent of clinical relapses over the 1 year prior to enrollment.
- Have a Timed 25 foot walk <30 seconds.
- No prior exposure to natalizumab (Tysabri)
For more information, please contact Beth Jackson, LPN, CCRC, MSCS at bjackson@raleighneurology.com or (919) 782-3456 ext 8264
P05664-Phase 3 Trial
A Phase3, Double-Blind, Double-Dummy, Placebo-and Active-Controlled Dose-Range-Finding Efficacy and Safety Study of Preladenant in Subjects With Early Parkinson’s Disease
To be eligible to participate in the study the following criteria must be met:
• Diagnosis of idiopathic Parkinson’s Disease for less than 5 years
• Must be between 30 and 85 years of age
• Must not be taking levodopa or any dopamine agonists medications, such as Requip or Mirapex
For more information, please contact Keisha Fuller, RN, BSN, Research Manager at (919) 782-3456 x8254 or kfuller@raleighneurology.com.
PARKINSON'S DISEASE
TEVA TVP-1012/PM103
A Double-blind, Placebo Controlled, Randomized, Multicenter Study to Assess the Safety and Clinical Benefit of Rasagiline as an Add on Therapy to Stable Dose of Dopamine Agonists in the Treatment of Early Parkinson’s Disease
To be eligible to participate in the study the following criteria must be met:
- Diagnosis of early Parkinson’s Disease
- Treating with Requip or Mirapex
For more information, please contact Keisha Fuller, RN, BSN, Research Manager at (919) 782-3456 x8254 or kfuller@raleighneurology.com.
PARKINSON'S DISEASE
Protocol: ACP-103-020
A Multi-Center, Placebo Controlled, Double-Blind Trial to Examine the Safety and Efficacy of Primavanserin in the Treatment of Psychosis in Parkinson’s Disease
To be eligible to participate in the study the following criteria must be met:
- ≥ 1 year since Diagnosis Parkinson’s Disease
- ≥ 40 years of age
- Actively experiencing hallucinations and/or delusions related to PD
- ≥ 1 month on a stable dose of anti-Parkinson’s medication
- No severe dementia present
For more information, please contact Tonisha Brown, RN, BSN, CRC at (919) 782-3456 x8316 or tbrown@raleighneurology.com
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 Keisha Fuller, RN, BSN, Clinical Research Coordinator at (919) 782-3456 x8254 or kfuller@raleighneurology.com
DIABETIC PERIPHERAL NEUROPATHY
Study A0081242
Study of pregabalin (Lyrica) in the treatment of patients with inadequately treated painful diabetic peripheral neuropathy.
To be eligible to participate in the study the following criteria must be met:
- Men or women at least 18 years of age
- Diagnosis of Type I or Type II diabetes mellitus with current hemoglobin A1C levels of < 11% and on stable antidiabetic medication regimen
- Cannot currently be receiving opioids or pregabalin (Lyrica) for the treatment of painful DPN
- Must have inadequate pain control on current medications
For more information, please contact Keisha Fuller, RN, BSN, Clinical Research Coordinator at (919) 782-3456 x8254 or kfuller@raleighneurology.com
IDIOPATHIC INTRACRANIAL HYPERTENSION WITH MILD VISION LOSS
NORDIC1
A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of Weight-Reduction and/or Low Sodium Diet plus Acetazolamide vs. Diet plus Placebo in Subjects with Idiopathic Intracranial Hypertension with Mild Visual Loss
- Men or women age 18-60
- Diagnosis of Idiopathic Intracranial Hypertension (aka: pseudotumor cerebri) for 6 weeks or less
- Mild visual loss present
For more information, please contact Tippi Hales, RN, Senior Clinical Research Coordinator at (919)420-1658 or
thales@raleighneurology.com.
ADOLESCENT MIGRAINE
AZ - D1220C00001
A Multicenter, Double-blind, Randomized, Placebo-controlled, 4-Armed Parallel Group Study to Evaluate the Efficacy of Zolmitriptan 0.5-, 2.5- and 5-mg Nasal Spray in the Treatment of Acute Migraine Headache in Adolescents
To be eligible to participate in the study the following criteria must be met:
- Age 12-17
- 1 year history of diagnosis of migraine with or without aura
- At least 2 migraines per month, considering to be moderately or severely disabling
For more information, please contact Tippi Hales, RN, Senior Clinical Research Coordinator at (919) 420-1658 or thales@raleighneurology.com
CERVIAL DYSTONIA
Registry Protocol
Protocol #: A-TL-52120-156
Dysport for Injection AbobotulinumtoxinA Neurotoxin Clinical and Health Economics Outcomes Registry in Cervical Dystonia (ANCHOR-CD)
To be eligible to participate in the study the following criteria must be met:
- A diagnosis of idiopathic Cervical Dystonia as determined by the enrolling Investigator
- ≥ 18 years of age
- If previously treated with a neurotoxin for Cervical Dystonia, at least a 12-week interval must have elapsed between the last injection of BoNT-A or BoNT-B and the first dose of Dysport injected in this study.
For more information, please contact Tonisha Brown, RN, BSN, CRC at (919) 782-3456 x8316 or tbrown@raleighneurology.com
RESTLESS LEGS SYNDROME
IPX159-B11-02
A Randomized, Double-Blind, Placebo-Controlled Safety and Efficacy Study of IPX159 in the Treatment of Moderate to Severe Restless Legs Syndrome (RLS)
To be eligible to participate in the study the following criteria must be met:
- Age 18-70 with primary RLS ≥ 6 months
- BMI 18.5 – 32
- No other primary sleep disorder
For more information, please contact Tippi Hales, RN, Senior Clinical Research Coordinator at (919) 420-1658 or
thales@raleighneurology.com
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