Shepherd Center - A Catastrophic Care Hospital

Here is a list of current studies/initiatives that Shepherd Center is participating in to help increase our understanding of MS. These studies are not recruiting volunteers at the present time.

A phase 3, randomized, rater and dose-blinded study comparing two annual cycles of intravenous low and high dose Alemtuzumab to three-times weekly subcutaneous Interferon Beta-1a (Rebif®) in patients with Relapsing-Remitting Multiple Sclerosis who have relapsed on therapy. [438]

Principal Investigator: Ben Thrower, MD

Study Description: The purpose of this study is to evaluate the safety, tolerability, and effect of IV Alemtuzumab compared to Rebif in Relapsing Remitting MS. 

Contact: Email Marsha Hanson or call 404-367-1317.

A Dose-Blind, Multicenter, Extension Study to Determine the Long-Term Safety and Efficacy of Two Doses of BG00012 Monotherapy in Subjects with Relapsing-Remitting Multiple Sclerosis

Principal Investigator: Ben Thrower, MD

Study Description: To assess the safety, tolerability, and efficacy of Nerispirdine in patients with Multiple Sclerosis who have difficulty walking. This will also assess walking ability, fatigue, and muscle strength in the legs.

Contact: Email Alison Akard or call 404-350-3099.

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. (439)

Principal Investigator: Ben Thrower, MD

Study Description: The purpose of this study to test oral Laquinimod verses placebo and Avonex for its safety, tolerability, and efficacy.

Contact: Email Carlyn Kappy or call 404-367-1375.

A phase II, multicenter, randomized, parallel-group, partially blinded, placebo and Avonex controlled dose finding study to evaluate the efficacy, as measured by brain MRI lesions, and safety of two dose regimens of an experimental drug in patients with Relapsing-Remitting Multiple Sclerosis [447]

Principal Investigator: Ben Thrower, MD

Study Description: The purpose of this study is to compare the efficacy of two doses of an IV (intravenous) experimental drug versus an inactive drug (placebo) and a drug currently approved for the treatment of RRMS called Avonex® (interferon beta-1a,).
People age 18 to 55 who are diagnosed with relapsing-remitting MS may be eligible to participate in this study.

Contact: Email Alison Akard, RN, CCRP, or call  404-350-3099.

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 [428]

Study Description: The purpose of this study is to find out if treatment with BG00012 can decrease the number of MS relapses during a given time period. Other goals of the study are to find out if, over time, BG00012 can decrease the number of certain types of brain lesions commonly seen in MS and slow down the time it takes for the disease to get worse.

Principal Investigator: Ben Thrower, MD

Contact: Email Alison Akard, RN, CCRP, or call  404-350-3099.

Effect of Training and Education on Functional Outcomes and Quality of Life in Persons with MS [458]

Study Description: The purpose of this study is to determine whether a carefully guided and monitored protocol of upper and lower extremity stregthening, cardiovascular endurance training, and education regarding how to facilitate one’s optimal health and wellness will significantly improve overall functioning and quality of life for persons with MS.

Principal Investigator: Candy Tefertiller, PT

Contact: Email Candy Tefertiller, MPT, or call  404-742-9762.

Correlation of Cognitive Dysfunction and MRI T1 Hypointensities and Corpus Callosum Atrophy in MS Patients

Principle Investigator: Ben Thrower, MD

Contact: Email Ismari Clesson, RN, MSCN, CCRP, or call 404-350-7651.

A multi-center, double-blind, randomized study comparing the combined use of Interferon Beta-1a and Glatiramer Acetate to either agent alone in patients with Relapsing Remitting Multiple Sclerosis (CombiRx-Phase III)

Study Description: The purpose of this study is to determine wheather the combination of interferon beta-1a (Avonex) and glatiramer acetate (Copaxone) is an effective therapy for Relapsing-Remitting Multiple Sclerosis (RRMS).

Priniciple Investigator: Ben Thrower, MD

Contact: Email Nell Klein, RN, CCRP, or call 404-367-1307.

MS-F202 EXT Open label extension study to evaluate the safety, tolerability and activity of oral Fampridine-SR in subjects with Multiple Sclerosis who participated in the MS-F202 Trial (307)

Prinicipal Investigator: Ben Thrower, MD

Contact: Email Marsha Hanson, RN, BSN, MCSN, CCRP, or call 404-367-1317.

MS-F203 EXT Open label extension study to evaluate the safety, tolerability and activity of oral Fampridine-SR in subjects with Multiple Sclerosis who participated in the MS-F203 Trial (334)

Prinicipal Investigator: Ben Thrower, MD

Contact: Email Marsha Hanson, RN, BSN, MCSN, CCRP, or call 404-367-1317.

MS-F204 EXT Open label extension study for subjects who participated in the MS-F204 trial to evaluate the safety, tolerability and activity of oral Fampridine-SR in subjects with Multiple Sclerosis [427]

Study Description: The purpose of this series of extension studies (202, 203, & 204) is to further examine the effects of Fampridine-SR on the walking ability of subjects with MS, as well as to examine the effects on muscle strength and spasticity.

Prinicipal Investigator: Ben Thrower, MD

Contact: Email Marsha Hanson, RN, BSN, MCSN, CCRP, or call 404-367-1317.

A phase IIIb, double-blind, placebo-controlled, multicenter, parallel group, extension trial to evaluate the safety and tolerability of oral Cladribine in subjects with Relapsing-Remitting Multiple Sclerosis who have completed trial 25643 (CLARITY) [442]

Study Description: Trial subjects who have completed two years of treatment with Cladribine in an earlier trial will b given either placebo or will continue with Cladribine to evaluate the duration of treatment effects over a two year period.

Principal Investigator: Ben Thrower, MD

Contact: Email Nell Klein, RN, CCRP, or call 404-367-1307.

Nab Prevalence and Inadequate Treatment Responses to Beta IFN Therapy in RRMS – A Retrospective Review of Patients Tested 2001 – 2005 [451]

Study Description: Neutralizing Antibody(NAb) testing is obtained clinically on MS patients who are on Interferons (Avonex, Betaseron, or Rebif) and have breakthrough relapses, new MRI lesions, or progression of disability. Interferons (INFs) are manufactured by gene recombinant technology to produce large quantities of the drug. Because the cells are not human, the protein is recognized as foreign by our body and antibodies are formed. When a patient develops NAbs, an immune response is created against the medication, rendering the therapy less effective. Development of NAbs depends on the dose, frequency, and route, and is most commonly seen with subcutaneous injections, higher frequency, and higher doses (Betaseron and Rebif).. NAbs typically appear within 6-24 months after the start of the high dose therapy. NAb testing remains controversial in the treatment of MS even though it is agreed that Nabs reduce the biologic and clinical efficacy of IFNs.

Principal Investigator: Ben Thrower, MD

Contact: Email Marsha Hanson, RN, BSN, MCSN, CCRP, or call 404-367-1317.