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 | CHRONIC PAIN | DIABETIC PERIPHERAL NEUROPATHY (DPN) | MIGRAINE | MULTIPLE SCLEROSIS | NONRESTORATIVE SLEEP (NRS) | PARKINSON'S DISEASE | POST HERPETIC NEURALGIA | RESTLESS LEGS SYNDROME
ALZHEIMER’S DISEASE
STUDY H6L-MC-LFAN is a multicenter, randomized, double-blind, placebo-controlled, Phase 3 study comparing LY450139 140 mg, LY450139 100 mg, and placebo in approximately 1500 patients with mild to moderate AD.
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
For more information, please contact Marilyn Yelton, RN, 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 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 Garriss, RN, Senior Clinical Research Coordinator at (919) 420-1658 or tsgarriss@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 Garriss, RN, Senior Clinical Research Coordinator at (919) 420-1658 or tsgarriss@raleighneurology.com.
ALZHEIMER’S DISEASE
A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Safety and Efficacy Study of Oral ELND005 (AZD-103) in Alzheimer’s Disease.
To be eligible to participate in the study the following criteria must be met:
- Age 50-85
- 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 Garriss, RN, Senior Clinical Research Coordinator at (919) 420-1658 or tsgarriss@raleighneurology.com.
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CHRONIC PAIN
Cephalon Protocol C25608/3055/BP/MN
A Randomized, Double-Blind, Active-Controlled Crossover Study to Evaluate the Efficacy and Safety of Fentanyl Buccal Tablets Compared With Immediate-Release Oxycodone for the Management of Breakthrough Pain in Opioid-Tolerant Patients With Chronic Pain.
To be eligible to participate, the following criteria must be met:
- Have chronic pain of at least 3 months duration associated with any of the following: diabetic peripheral neuropathy, postherpetic neuralgia, traumatic injury, complex regional pain syndrome, back pain, neck pain, fibromyalgia, chronic pancreatitis, osteoarthritis, or cancer; aged 18 - 80.
- Be currently taking and around-the-clock opioid pain treatment (at least 60 mg of oral morphine/day, or at least 25 mcg of transdermal fentanyl/hour, or at least 30 mg of oxycodone/day, or at least 8 mg of hydromorphone/day, or an equianalgesic dose of another opioid/day)
- Must have on average 1-4 episodes of Breakthrough Pain (BTP) per day
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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Study 034-01
A Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled, Crossover Study to Evaluate the Safety and Efficacy of MK-0974 in the Treatment of Acute Migraine in Patients With Stable Vascular Disease
To be eligible to participate, the following criteria must be met:
- Must be age 18 or older
- History of migraine for over one year
- Diagnosed with stable coronary artery disease (CAD) for more than 3 months prior to screening.
For more information, please contact Rick Allen, Clinical Research Coordinator at (919) 782-3456 ext. 8063 or rallen@raleighneurology.com
Study TXA107977
A Long-Term Safety Study of a Combination Product Containing Sumatriptan Succinate and Naproxen Sodium for the Treatment of Migraine in Adolescents.
To be eligible to participate, the following criteria must be met:
- Age 12-17
- Have migraine diagnosis with or without aura (a sensation preceding the migraine)
- Have 2-8 migraines per month for the last two months but no more than 15 total headache days per month
- Have a 6-month history of moderate to severe migraine attacks
- Weigh at least 75 lbs.
For more information, please contact Rick Allen, Clinical Research Coordinator at (919) 782-3456 ext. 8063 or rallen@raleighneurology.com
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MULTIPLE SCLEROSIS
Teva BRAVO
A Multinational, Multicenter, Randomized, Parallel-Group study performed in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) to assess the efficacy, safety and tolerability of laquinimod over placebo in a double-blind design and of a reference arm of Interferon B-1a (Avonex) in a rater-blinded design.
To be eligible to participate, the following criteria must be met:
- 18-55 years old
- Diagnosis of RRMS
- Documented relapse in past 12 months, or two documented relapses in 24 months
- Naïve to MS therapies with the exception of Copaxone, IVIG and Steroid treatment
For more information, please contact Shelly Griffin, EMT, Clinical Research Coordinator at (919) 420-1662 or sgriffin@raleighneurology.com
MULTIPLE SCLEROSIS
BioMS MAESTRO-03
A double-blind, placebo-controlled multi-center study to evaluate the efficacy and safety of MBP8298 in subjects with secondary progressive multiple sclerosis.
To be eligible to participate, the following criteria must be met:
- 18-65 years old
- Diagnosis of SPMS
- Absence of relapse in 3 months prior to baseline
- Must be able to walk with or without aid
- Not currently taking MS medications
For more information, please contact Shelly Griffin, EMT, Clinical Research Coordinator at (919) 420-1662 or sgriffin@raleighneurology.com
MULTIPLE SCLEROSIS
Biogen Idec 109-MS-301
A randomized, multicenter, double –blind, placebo-controlled, dose-comparison study to determine the efficacy and safety of BG00012 in subjects with relapsing remitting multiple sclerosis.
To be eligible to participate, the following criteria must be met:
- 18-55 years old
- Must have confirmed diagnosis of RRMS
- Must have 1 relapse in last 12 months.
For more information, please contact Shelly Griffin, EMT, Clinical Research Coordinator at (919) 420-1662 or sgriffin@raleighneurology.com
MULTIPLE SCLEROSIS
Novartis Protocol CFTY720D2309 (Fingolimod)
A 24-Month Double-Blind, Randomized, Multicenter, Placebo-Controlled, Parallel-Group Study Comparing the Efficacy and Safety of 0.5 mg and 1.25 mg Fingolimod (FTY720) Administered Orally Once Daily versus Placebo in Patients with Relapsing-Remitting Multiple Sclerosis
To be eligible to participate in the study the following criteria must be met:
- A diagnosis of relapsing-remitting MS with at least 1 documented relapse during the previous year, OR 2 documented relapses in during the previous 2 years; prior to randomization
- Age 18-55
- EDSS 0-5.5
- Neurologically stable with no evidence of relapse or corticosteroid treatment within 30 days of randomization
For more information, please contact Shelly Griffin, EMT, Clinical Research Coordinator at (919) 420-1662 or SGriffin@raleighneurology.com
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Neuropathic Pain Associated with Diabetic Peripheral Neuropathy (DPN)
Study PXN110448:
A Dose-response Study of XP13512, Compared with Concurrent Placebo Control and Lyrica (Pregabalin), In Subjects With Neuropathic Pain Associated With Diabetic Peripheral Neuropathy (DPN)
A Phase IIb multicenter, randomized, double-blind, double-dummy, parallel group, placebo-controlled and active-controlled study
To be eligible to participate, the following criteria must be met:
- Must be age 18 or older
- Have diagnosis of Type 1 or Type 2 diabetes
- Must have diagnosis of Diabetic Peripheral Neuropathy (DPN)
For more information, please contact Rick Allen, Clinical Research Coordinator at (919) 782-3456 ext. 8063 or rallen@raleighneurology.com
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Nonrestorative Sleep (NRS)
Pfizer Protocol A4251033
A randomized, double-blind, parallel group, placebo-controlled, multicenter outpatient trial of PD 0200390 in adults with Nonrestorative sleep.
To be eligible to participate in this study, you must:
- Be aged 18 – 64 who wakes up unrestored or unrefreshed with significant daytime impairment for the past 3 months
- Have a general bedtime between 9 PM and midnight and get 6.5 – 9 hours of sleep each night for the past month
- Have no medical condition that could interfere with sleep
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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A randomized, double-blind, placebo-controlled, 5-arm, parallel-group trial to assess rotigotine transdermal system dose response in subjects with advanced Parkinson’s disease.
To be eligible to participate in this study, the following criteria must be met:
- Patients must have advanced Parkinson’s disease for at least 3 years.
- Must be on carbidopa/levodopa (Sinemet)
- Patients must experience the fluctuation of “On” and “Off” symptoms of Parkinson’s disease.
For more information, please contact Heidi Butler, EMT-I Clinical Research Coordinator, at (919)-782-3456 ext 8059 or hbutler@raleighneurology.com
None
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RESTLESS LEGS SYNDROME
Pfizer A0081183
A Randomized, Double-Blind, 6 Week Study of Pregabalin In patients With Restless Leg Syndrome
To be eligible to participate in this study, the following criteria must be met:
Have uncomfortable and unpleasant sensations in the legs.
Sensations worse at night
Sleep interference on 15 or more nights per month for the last 6 months Age range 18 to 65 years.
For more information, please contact Heidi Butler, EMT-I Clinical Research Coordinator, at (919)782-3456 ext 8059 or hbutler@raleighneurology.com
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