MS - Completed Studies for Historical Reference
- Antegren Phase II
Completed in 2001.
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)
Cancelled. Phase II trial showed no effect.
- Aricept Trial in MS
Study terminated. 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.
Selection criteria include:
25 - 60 years old
Able to walk a few steps with support
Moderate memory/cognitive problems
On no drugs that could interfere with mental function
Principal investigator: Anthony Reder, MD
Nurse coordinators: Patricia Manning, RN and Bernadine Lake
- ATM-027 Antibody to T Cell Receptor
Study was closed by sponsor before patient enrollment.
- Avonex (IFN beta-1a) for First Attack of MS-like Illness
(optic neuritis, transverse myelitis, etc.)
Results: Reduced the number of patients who developed MS.
Principal investigator: Anthony Reder, MD
Sub-investigator: Avertano Noronha, MD
Sponsor: Biogen
- Betaseron (IFN beta-1b) for secondary-Progressive MS
Study ended in 2000.
Results: IFN reduced attacks and MRI lesions, yet had minimal effect on patients who had progression without concurrent attacks.
Principal investigator: Barry G.W. Arnason, MD
Sub-investigators: Avertano Noronha, MD; Anthony Reder, MD
Nurse coordinator: Patricia Manning, RN MSN (773) 702-9812
Sponsor: Berlex Laboratories
- Copaxone (Cop1; Glatiramer acetate) in primary progressive MS
Study terminated.
Finding: Subcutaneous injections of Copaxone are not effective in slowing the
progression of primary progressive multiple sclerosis. The study lasted two
and one half years. Analysis is in progress to see if a subgroup of patients responded.
Selection criteria include:
Primary progressive MS
No history of prior attacks of neurological disease (no relapses
or exacerbation)
30 - 65 years old
Kurtzke score in the range of 3.0 - 6.5 (walk 20 yards with
support)
Principal investigator: Anthony Reder, MD
Sub-investigator: Barry G.W. Arnason, MD;
Avertano Noronha, MD
Research nurse:
Patricia Manning, RN, MSN (773) 702-9812
Study cordinator: Lily Wong, MA (773-834-4654)
Barbara Harding-Clay (773-702-9812)
- Cyclosporin for MS
Study terminated by sponsor due to renal toxicity, 1986.
Results: Some slowing of MS progression
Principal investigator: Barry G.W. Arnason
Sub-investigator: Anthony Reder, MD and Mark Aguis, MD
Sponsor: Sandoz
- Cytotek (Misoprostol) for MS
Study finished, 1997. Drug is approved for other indications and is available for use in MS.
Results: Cytotek reduces pain from trigeminal neuralgia (tic douloureux) in MS.
in patients who have failed all other drug therapies.
Principal investigator: Anthony Reder, MD
Resident: Debra Babcock, MD
Sponsor: G.D. Searle
- Double-Dose IFN-beta 1b (Phase II)
Enrollment closed. Completed 2005.
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.
Selection criteria:
18 - 55 years old
Not on therapy for MS
Relapsing/remitting MS
Principal investigator: Barry G.W. Arnason, MD
Sub-investigators: Anthony Reder, MD;
Avertano Noronha, MD, and Adil Javed, MD
- Hu23F2G for Acute Exacerbation of MS
Study ended in 1999. Enrollment closed. Monoclonal antibody against the LFA-1 adhesion
molecule - to stop homing of lymphocytes to the brain.
Results: No effect on MS.
Principal investigator: Anthony Reder, MD
Sub-investigator: Avertano Noronha, MD
Nurse Coordinator: Patricia Manning, RN
Sponsor: ICOS
- Interferon Beta-1b (Betaseron) for Relapsing/Remitting MS
Study finished, 1993. Betaseron approved by FDA, 1993
Results: Betaseron reduced relapses and active MRI lesions, and improved visual memory.
Principal investigator: Barry G.W. Arnason, MD
Sub-investigator: Avertano Noronha, MD, and Anthony Reder, MD
Sponsor: Berlex Laboratories
- Linomide for Secondary Progressive MS
Study terminated in 1997 due to side effects.
Results: Linomide reduced clinical and MRI activity in MS,
but caused heart attacks.
Principal investigator: Anthony Reder, MD
Sub-investigator: Barry G.W. Arnason, MD; Avertano Noronha, MD
Sponsor: Pharmacia
- Natalizumab (Tysabri) Antibody to Adhesion Molecules VLA-4
(See results of Phase II trial above.)
This 2 1/2 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.
Selection criteria include:
Relapsing/remitting MS
One exacerbation in the last 12 months
18 - 50 years old
Kurtze score in the range of 0 - 5.0
(able to walk 200 meters
without support)
No IFNs or Copaxone for at least six months
Principal investigator: Anthony Reder, MD
Sub-investigator: Barry G.W. Arnason, MD;
Avertano Noronha, MD, Adil Javed, MD
Coordinator: Mildred Valentine
- Oral Copaxone
The study evaluated the efficacy of oral Copaxone in reducing relapse rates
and new MRI lesions.
Findings: No significant effect, just as with oral myelin. A high dose
repeat trial is under consideration.
Principal investigator: Anthony Reder, MD
Sub-investigator: Barry G.W. Arnason, MD; Avertano Noronha, MD
Research nurse: Patricia Manning, RN, MSN
Study coordinator: Lily Wong, MA
- PPAR-gamma agonists in Remitting/Relapsing MS (Avandia)
Enrollment closed. Completed 2004.
This one year showed no effect of an oral diabetes pill on
reducing MRI lesions, MS attacks, and MS progression.
Selection criteria:
18 - 55 years old
Not on therapy for MS
Relapsing/remitting MS
Principal investigator: Anthony Reder, MD
Sub-investigators: Barry G.W. Arnason, MD;
Avertano Noronha, MD
Study coordinator: Mildred Valentine - 773-702-9812
- Prevention of Red Spots on Skin with Betaseron
Analysis ongoing. Enrollment is closed. Completed 2002.
Trial looked at prevention of erythma (red spots) with steriod cream at
site of Betaseron injection.
Prinicipal investigator: Barry G.W. Arnason, MD
Nurse coordinator: Patricia Manning, RN, MSN
- Rebif vs Avonex Trial
Study ongoing. Enrollment is closed.
This study compares the therapeutic effect of two IFN beta-1 therapies
for relapsing-remitting multiple sclerosis. Participants will receive
monthly MRI exams.
Finding: Rebif reduced the attack rate and MRI lesions faster than Avonex
Selection criteria include:
Relapsing/remitting or Secondary progresssive MS
Two exacerbations in the last two years
18 - 55 years old
Kurtzke score in the range of 0 - 5.5 (walk 100 meters without
aid)
No prior IFNs
Principal investigator:
Anthony Reder, MD
Sub-investigator: Barry G.W. Arnason, MD; Avertano Noronha, MD
Research nurse:
Patricia Manning, RN, MSN,(773-702-9812)
Study coordinator: Lily Wong, MA (773-834-4654)
- Rebiject Trial in MS
Study ended. Enrollment closed.
Completed 2004. Rebiject was effective.
Principal investigator: Anthony Reder, MD
Nurse coordinator: Patricia Manning, RN
- T-Cell Receptor Vaccine for MS
A phase II study of a peptice vaccine to inhibit brain-reactive cells.
Principal investigator: Anthony Reder, MD
Sponsor: Connective Therapeutics. Contact sponsor for results of this trial.
- Tegison (Vitamin A) for MS
Study ended. Enrollment closed.
Data being analyzed.
Principal investigator: Barry G.W. Arnason, MD
Nurse coordinator: Patricia Manning, RN, MSN (773) 702-9812
Sponsor: Berlex Laboratories
- Terbutaline in Chronic Progressive MS
Study completed, 1995. Drug is available.
Results: Terbutaline may reduce fatigue in MS and correct immune abnormalities.
Principal investigator: Eva Chelmicka-Schorr, MD
Sub-investigator: Barry G.W. Arnason, MD and Anthony Reder, MD
Sponsor: The University of Chicago
- Tizanidine for Spasticity in MS
Study finished, 1995. Drug approved by FDA, 1997
Principal investigator: Anthony Reder, MD
Sub-investigator: Barry G.W. Arnason, MD
Sponsor: Athena Neurosciences.
Contact Athena Neurosciences for drug information.
- TNFR-IgG (Lenercept; RO45-2081) for Relapsing/Remitting MS
Study terminated, 1997. Drug appeared to worsen MS.
Principal investigator: Barry G.W. Arnason, MD
Sub-investigator: Avertano Noronha, MD
Sponsor: Hoffman LaRoche
- Zanaflex for Spasticity in MS and Spinal Cord Damage
Study ongoing. Enrollment is closed.
Trial will look at the effects of Zanaflex on spasticity and blood pressure.
Principal investigator: Anthony Reder, MD
Nurse Coordinator: Patricia Manning, RN
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