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NeuroLogic - Clinical Trials

Spring 2010

Clinical Trials

Date: March 1, 2010


The following clinical trials are actively recruiting patients.

Epilepsy

Double-blind, randomized, historical control study of the safety and efficacy of eslicarbezepine acetate monotherapy in subjects with partial epilepsy not well controlled by current antiepileptic drugs. Trial for subjects who experience partial seizures and are stable on no more than 1 and 2/3 (standard dose) of other antiepileptic drugs.

Info: Gregory Krauss, MD, P.I.; Amanda Cole, coordinator, acole12@jhmi.edu,410-614-8628.

Parkinson Disease

LCIG (Levodopa-Carbidopa Intestinal Gel)

We are enrolling patients in an open-label, multi-center safety and efficacy study of an investigational medication for patients with severe motor-fluctuations despite optimized treatment with available parkinson disease medications. Info:

Joseph Savitt, P.I., jsavitt@jhmi.edu; Melissa Gerstenhaber, coordinator, mgerste1@jhmi.edu; 410 614-1242.

Multiple Sclerosis

Relapsing Remitting MS(RRMS)-A multicenter trial evaluating whether oral treatment with estriol, the major estrogen of pregnancy, decreases relapses in relapsing remitting multiple sclerosis (RRMS) subjects when used in combination with injectable Copaxone®. Info: Peter Calabresi, MD, P.I.;

Stephanie Syc, coordinator, ssyc1@jhmi.edu, 410-502-2488.

RR MS

A multicenter trial evaluating whether the efficacy and safety of PEGylated Interferon Beta-1a (BIIB017) in subjects with RRMS when given either every 2 weeks or every 4 weeks versus placebo.

 Info: Peter Calabresi, MD, P.I.; Kristie Albright, research nurse, kalbrig2@jhmi.edu, 410-502-6867.

Primary Progressive Multiple Sclerosis

A double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing the efficacy and safety of 1.25mg fingolimod (FTY720) administered orally once daily versus placebo in patients with primary progressive multiple sclerosis (PPMS).

Info: Julius Birnbaum, MD, P.I.; Alpa Uchil, research nurse, apalich2@jhmi.edu, 443-287-6079, or Regina Brock-Simmons, research coordinator, rrock1@jhmi.edu, 410-502-7220.

Acute Optic Neuritis

A multicenter trial to determine whether Copaxone® is neuroprotective in Acute Optic Neuritis (AON). Participants must be randomized within 9 days of visual disturbance.

Info: Peter Calabresi, MD, P.I.; Stephanie Syc, coordinator,ssyc1@jhmi.edu, 410-502-2488.

Atkins Diet

Open-label trial of modified Atkins diet for adults (18 years of age and over) with at least weekly uncontrolled seizures. Study is done via the internet. Info: Eric Kossoff, MD, P.I.;

Mackenzie Cervenka, co-investigator, mcerven1@jhmi.edu, 410-955-1270.

Intracerebral Hemorrhage and Intraventricular Hemorrhage

A Phase III randomized clinical trial (RCT) to compare a policy of early extraventricular drain (EVD) use and recom binant tissue plasminogen activator (rt-PA, Cathflo® Activase ® Genentech, Inc., San Francisco, CA) with EVD use and placebo (normal saline) for the treatment of subjects with intracerebral hemorrhage (ICH) and intraventricular hemorrhage (IVH) with obstruction of the 3rd or 4th ventricles by blood.Info: Wendy Ziai, MD, and Daniel Hanley,

MD. PIs; Shannon LeDroux, study coordinator, 410-502-6367,sledrou1@jhmi.edu Study pager: 410-283-6772.

Intracerebral Hemorrhage

Phase II trial is to determine the safety of using a combination of minimally invasive surgery and clot lysis with rt-PA to remove ICH.

 Info: Judy Huang, MD, and Daniel Hanley,MD. PIs; Shannon LeDroux, study coordinator, 410-502-6367, sledrou1@jhmi.edu Study pager: 410-283-6772.

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