Clinical Trials
The Department of Neurology is actively involved in clinical trials to determine the effectiveness of new medications to treat neuromuscular diseases and disorders. If you are interested in receiving additional information or participating in a trial, please e-mail or call the persons listed below. Please note that enrollment is currently closed for some of the trials.


Multiple Sclerosis (MS) - Ongoing Trials


CBAF312A2201 (oral pill)
  Enrollment is OPEN
 


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.

Purpose: Compare safety, tolerability, efficacy of BAF312 vs. placebo on MRI lesions in relapsing-remitting MS.

 
Eligibility Criteria:
  • Must be 18-55 y/o, male or female
  • Must be diagnosed with relapsing remitting multiple sclerosis, with at least one documented relapse during the last year, or two documented relapses during the last two years, or have a positive Gadolinium-enhanced MRI scan during screening.
  • Must have an EDSS score of 0-5.0
  • Must be able to perform and complete all protocol visits and procedures.
 
Duration: 6 months
  Principle Investigator: Jacqueline Bernard MD
  Sr. Clinical Trials Coordinator: Mildred Valentine, 773-702-9812
  Research Support: Jessica Peyton, 773-702-0159

CFTY720D2306 (oral pill)
  Enrollment is OPEN
 


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

Purpose: The purpose of this study in patients with primary progressive multiple sclerosis (PPMS) is to evaluate whether FTY720 is effective in delaying MS disability progression in the absence of relapses compared to placebo.

 
Eligibility Criteria:
  • Male or female, 25-60 y/o
  • EDSS score of 3.5-6.0
  • Documented diagnosis of Primary Progressive Multiple Sclerosis
  • One year of disease progression
  • Two of the following:
    • a) positive brain MRI (nine T2 lesions or four or more T2 lesions with positive visual evoked potential);
    • b) positive spinal cord MRI (two focal T2 lesions);
    • c) positive CSF.
  • Central review of the evidence will be required to randomization. Patients who meet all three criteria (a, b & c) do not need to be submitted for central review.
 
Duration: up to three years.
  Principle Investigator: Anthony Reder MD
  Sr. Clinical Trials Coordinator: Mildred Valentine, 773-702-9812
  Study Coordinator: Ismael Gutierrez, 773-834-4654

Estriol Research Study for Relapsing/Remitting Multiple Sclerosis
  Enrollment is OPEN
 


A Combination trial of copaxone plus Estriol in relapsing remitting multiple sclerosis.

Purpose: The purpose of this two year study is to determine:

  1. If the use of oral estriol in combination with Copaxone injection is safe;
  2. If the use of combination treatment causes a decrease in relapse rates;
  3. If there is more rapid improvement on brain MRI withi the combination treatment; and
  4. If there is an improvement in disability measures with the combination.
 
Eligibility Criteria:
  • Only Females 18 to 50 years old.
  • Relapse/Remitting MS..
  • EDSS (expanded disability status scale) 0 to 4.5.
  • Not on any other therapy for MS.

It is hoped that patients taking Estriol in combination with Copaxone injections will do better with their MS. We hope the information learned from this study will benefit other individuals with MS in the future.

  Principle Investigator: Anthony Reder MD
  Sr. Clinical Trials Coordinator: Mildred Valentine, 773-702-9812
  Research Support: Jessica Peyton, 773-702-0159

FTY720 in Relapsing/Remitting MS (Oral Treatment)
  Enrollment is CLOSED
 
New experimental drug taken orally for relapsing/remitting MS. This two year research study will determine if a new experimental drug taken by mouth once daily can reduce the number of relapses in patients with relapsing/remitting MS compared to placebo. It will also evaluate how safe and well tolerated the experimental drug is when used for up to two years.
 
Eligibility Criteria:
  • 18 to 55 years old
  • Relapsing/Remitting MS
  • EDSS score: 0 to 5.5 (able to walk 100 meters without aids)
  • Must be available for clinic visits for the duration of the study
  Principle Investigator: Anthony Reder MD
  Sr. Clinical Trials Coordinator: Mildred Valentine, 773-702-9812

Single vs. Double-Dose Copaxone for Relapsing/Remitting MS
  Enrollment is CLOSED
 
This two-year study will determine if an experimental dose of Copaxone is safe, tolerable, and more effective than the currently approved dose.

  Principle Investigator: Adil Javed MD
  Sr. Clinical Trials Coordinator: Mildred Valentine, 773-702-9812