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Multiple Sclerosis (MS) - Completed Trials; for historical reference
| Antegren Phase II |
|
| Enrollment is CLOSED; completed in 2001 |
|
Results: Showed that 6 monthly infusions of the antibody to the VLA-4 adhesion molecule were safe and reduced attacks by 50% and enhancing lesions on MRI by 80%-90%. |
| Antiproliferative Therapy of MS (Paclitaxel) |
|
| Enrollment is CLOSED |
|
Results: Cancelled because Phase II trial showed no effect. |
| Aricept Trial in MS |
|
| Enrollment is CLOSED; study terminated |
|
Results: This study compared placebo with Aricept to see if memory and cognitive function improved over 12 weeks. In a related study, this drug improved memory and thinking speed in MS.
|
| Principle Investigator:
| Anthony Reder MD |
| Nurse Coordinator(s):
| Patricia Manning RN MSN, Bernadine Lake |
| ATM-027 Antibody to T Cell Receptor |
|
| Enrollment is CLOSED |
|
Results: Study was closed by sponsor before patient enrollment. |
| Avonex (IFN beta-1a) for First Attack of MS-like Illness (optic neuritis, transverse myelitis, etc.) |
|
| Enrollment is CLOSED |
|
Results: Reduced the number of patients who developed MS.
|
| Sponsor:
| Biogen |
| Principle Investigator:
| Anthony Reder MD |
| Sub-Investigator(s):
| Avertano Noronha MD |
| Betaseron (IFN beta-1b) for secondary-Progressive MS |
|
| Enrollment is CLOSED; study ended in 2000 |
|
Results: IFN reduced attacks and MRI lesions, yet had minimal effect on patients who had progression without concurrent attacks.
|
| Sponsor:
| Berlex Laboratories |
| Principle Investigator:
| Barry Arnason MD |
| Sub-Investigator(s):
| Avertano Noronha MD, Anthony Reder MD |
| Nurse Coordinator:
| Patricia Manning RN MSN |
| Betaseron (Interferon Beta-1b) for Relapsing/Remitting MS |
|
| Enrollment is CLOSED; study finished in 1993; Betaseron APPROVED by FDA in 1993 |
|
Results: Betaseron reduced relapses and active MRI lesions, and improved visual memory. This became the first biological agent to be approved by the FDA to treat MS.
|
| Sponsor:
| Berlex Laboratories |
| Principle Investigator:
| Barry Arnason MD |
| Sub-Investigator(s):
| Avertano Noronha MD, Anthony Reder MD |
| Betaseron: Prevention of Red Spots at Skin Injection Sites |
|
| Enrollment is CLOSED; completed in 2002; analysis is on-going |
|
Results: Trial looked at prevention of erythma (red spots) with steriod cream at site of Betaseron injection.
|
| Principle Investigator:
| Barry Arnason MD |
| Nurse Coordinator:
| Patricia Manning RN MSN |
| Copaxone (Cop1; Glatiramer acetate) in Primary progressive MS |
|
| Enrollment is CLOSED; study terminated |
|
Results: Subcutaneous injections of Copaxone are not effective in slowing the progression of primary progressive multiple sclerosis. The study lasted two and one half years. Later analysis suggested modest benefit in men but not women.
|
| Principle Investigator:
| Anthony Reder MD |
| Sub-Investigator(s):
| Barry Arnason MD, Avertano Noronha MD |
| Research Nurse:
| Patricia Manning RN MSN |
| Study Coordinator:
| Lily Wong MA, Barbara Harding-Clay |
| Copaxone Oral |
|
| Enrollment is CLOSED |
|
The study evaluated the efficacy of oral Copaxone in reducing relapse rates and new MRI lesions. Results: No significant effect, just as with oral myelin. A high-dose repeat trial is under consideration.
|
| Principle Investigator:
| Anthony Reder MD |
| Sub-Investigator(s):
| Barry Arnason MD, Avertano Noronha MD |
| Research Nurse:
| Patricia Manning RN MSN |
| Study Coordinator:
| Lily Wong MA |
| Cyclosporin for MS |
|
| Enrollment is CLOSED; study terminated by sponsor due to renal toxicity, 1986 |
|
Results: Some slowing of MS progression.
|
| Sponsor:
| Sandoz |
| Principle Investigator:
| Barry Arnason MD |
| Sub-Investigator(s):
| Mark Aguis MD, Anthony Reder MD |
| Cytotek (Misoprostol) for MS |
|
| Enrollment is CLOSED; study finished in 1997 |
|
Results: This drug is approved for other indications and is available for use in MS. Cytotek significantly reduces pain from trigeminal neuralgia (tic douloureux) in MS in patients who have failed all other drug therapies.
|
| Sponsor:
| G.D. Searle |
| Principle Investigator:
| Anthony Reder MD |
| Resident:
| Debra Babcock MD |
| Hu23F2G for Acute Exacerbation of MS |
|
| Enrollment is CLOSED; study ended in 1999 |
|
Monoclonal antibody against the LFA-1 adhesion molecule - to stop homing of lymphocytes to the brain. Results: No effect on MS.
|
| Sponsor:
| ICOS |
| Principle Investigator:
| Anthony Reder MD |
| Sub-Investigator(s):
| Avertano Noronha MD |
| Nurse Coordinator:
| Patricia Manning RN |
| (IFN-beta 1b) Betasron Double-Dose (Phase II) |
|
| Enrollment is CLOSED; completed in 2005 |
|
Results: This two year study determined that a very high dose of interferon reduced MRI lesions in relapsing/remitting MS by 40% compared to the FDA approved dose of Betaseron.
|
| Principle Investigator:
| Barry Arnason MD |
| Sub-Investigator(s):
| Adil Javed MD, Avertano Noronha MD, Anthony Reder MD |
| Linomide for Secondary Progressive MS |
|
| Enrollment is CLOSED; study terminated in 1997 due to side effects |
|
Results: Linomide reduced clinical and MRI activity in MS, but caused heart attacks.
|
| Sponsor:
| Pharmacia |
| Principle Investigator:
| Anthony Reder MD |
| Sub-Investigator(s):
| Barry Arnason MD, Avertano Noronha MD |
| Natalizumab (Tysabri) Antibody to Adhesion Molecules VLA-4 |
|
| Enrollment is CLOSED |
|
This two and a half year study looked at a new method for blocking the VLA-4 adhesion molecule that allows white blood cells to stick to blood vessels in the brain. Monthly infusions of the monoclonal antibody reduced relapses by 66% and slowed progressions. (See results of Phase II trial above.)
|
| Principle Investigator:
| Anthony Reder MD |
| Sub-Investigator(s):
| Barry Arnason MD, Adil Javed MD, Avertano Noronha MD |
| Study Coordinator:
| Mildred Valentine |
| (Avandia) PPAR-gamma agonists in Remitting/Relapsing MS |
|
| Enrollment is CLOSED; completed in 2004 |
|
Results: This one year showed no effect of an oral diabetes pill on reducing MRI lesions, MS attacks, and MS progression.
|
| Principle Investigator:
| Anthony Reder MD |
| Sub-Investigator(s):
| Barry Arnason MD, Avertano Noronha MD |
| Study Coordinator:
| Mildred Valentine |
| MBP8298-SP-03 |
|
| Enrollment is CLOSED; completed in 2009 |
|
|
A double-blind, placebo-controlled, multi-center study to evaluate the efficacy and safety of MBP8298 in subjects withi secondary progressive Multiple Sclerosis. |
|
|
Drug: MBP8298 is given intravenously (i.v.). |
|
|
Duration: Study treatment for 24 months, and follow-up visits. |
|
|
Primary Objective: To compare the clinical efficacy and safety of 500mg MBP8298 given i.v. every six months, to placebo. |
|
|
Eligibility Criteria:
- Male or Female, 18 to 65 years of age.
- Test Positive for HLA (DR2 or DR4) blood group protein.
- Documented history of Secondary Progressive Multiple Sclerosis. Not RRMS or PPMS.
- Subjects must have had an absence of relapses in the 3 months prior to the baseline visit.
- EDSS score of 3.0 - 6.5
|
|
| Principle Investigator:
| Anthony Reder MD |
|
| Study Coordinator:
| Ismael Gutierrez, 773-834-4654 (Office), 773-834-7663 (Fax) |
| Rebif vs. Avonex Trial |
|
| Enrollment is CLOSED; study is on-going |
|
This six month study compared the therapeutic effect of two IFN beta-1 therapies for relapsing-remitting multiple sclerosis. Participants will receive monthly MRI exams. Results: Rebif reduced the attack rate and MRI lesions faster than Avonex.
|
| Principle Investigator:
| Anthony Reder MD |
| Sub-Investigator(s):
| Barry Arnason MD, Avertano Noronha MD |
| Nurse Coordinator:
| Patricia Manning RN MSN |
| Rebiject Trial in MS |
|
| Enrollment is CLOSED; study ended in 2004 |
|
Results: Rebiject device was effective.
|
| Principle Investigator:
| Anthony Reder MD |
| Nurse Coordinator:
| Patricia Manning RN MSN |
| T Cell Receptor Vaccine for MS |
|
| Enrollment is CLOSED |
|
A phase II study of a peptide vaccine to inhibit brain-reactive cells. Results: Contact sponsor for the results of this trial.
|
| Sponsor:
| Connective Therapeutics |
| Principle Investigator:
| Anthony Reder MD |
| Tegison (Vitamin A) for MS |
|
| Enrollment is CLOSED; data being analyzed
|
| Sponsor:
| Berlex Laboratories |
| Principle Investigator:
| Barry Arnason MD |
| Nurse Coordinator:
| Patricia Manning RN MSN |
| Terbutaline in Chronic Progressive MS |
|
| Enrollment is CLOSED; study completed in 1995; drug is available |
|
Results: Terbutaline may reduce fatigue in MS and correct immune abnormalities.
|
| Sponsor:
| The University of Chicago Medical Center |
| Principle Investigator:
| Ewa Chelmicka-Schorr MD |
| Sub-Investigator(s):
| Barry Arnason MD, Anthony Reder MD |
| Tizanidine for Spasticity in MS |
|
| Enrollment is CLOSED; study finished in 1995; drug approved by FDA in 1997 |
|
Results: Contact Athena Neurosciences for drug information.
|
| Sponsor:
| Athena Neurosciences |
| Principle Investigator:
| Anthony Reder MD |
| Sub-Investigator(s):
| Barry Arnason MD |
| TNFR-IgG (Lenercept; RO45-2081) for Relapsing/Remitting MS |
|
| Enrollment is CLOSED; study terminated in 1997 |
|
Results: Drug caused more MS attacks, despite reducing MRI lesions.
|
| Sponsor:
| Hoffman LaRoche |
| Principle Investigator:
| Anthony Reder MD |
| Sub-Investigator(s):
| Avertano Noronha MD |
| Zanaflex for Spasticity in MS and Spinal Cord Damage |
|
| Enrollment is CLOSED; study is on-going |
|
Results: Trial will look at the effects of Zanaflex on spasticity and blood pressure.
|
| Principle Investigator:
| Anthony Reder MD |
| Nure Coordinator:
| Patricia Manning RN MSN |
|