Studies Open at MSCA
Protocol # 25693 (ONWARD): A Phase II, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Safety, Tolerability and Efficacy Study of Add-on Cladribine Tablet Therapy with Interferon-beta (IFN-B) Treatment in Multiple Sclerosis Subjects with Active Disease. This 2 year study is evaluating the effects of adding on oral Cladribine therapy to patients currently on any of the FDA approved interferon therapies. The sponsor will provide any of the 3 interferon to the patient free of charge.
Protocol : 28821 (ORACLE MS) Trial: A Phase III, Randomized , Double-blind , placebo-controlled, Multicenter Clinical Trial of Oral Cladribine in Subjects with a First Clinical Event at High Risk of Converting to MS.
This 2 year study is for patients at risk for developing MS who would like a chance to be on the oral medication Cladribine. Patients have a 66% chance of being on drug. If they have a second attack, they are automatically placed on Rebif and followed for remainder of study.
Biogen105MS301: A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of PEGylated Interferon Beta-1a (BIIB017) in Subjects with Relapsing Multiple Sclerosis.
(ADVANCE Study) A new form of injectable Avonex which can be given monthly instead of weekly.
CTFY720D2309: A 24 Month, Double-blind, Randomized, Multicenter, Placebo-controlled, Parallel-group Study Comparing the Efficacy and Safety of 0.5mg and 1.25 mg Fingolimod (FTY720) Administered Orally Once Daily Versus Placebo in Patients with Relapsing Remitting Multiple Sclerosis (FREEDOMS II Study) with Extension Phase.
A 24 month study of an oral medication which is taken every day for patients with Relapsing Remitting MS. A three arm study, patients have 66% chance of being on active drug.
101-MS-402 TYGRIS: Tysabri Global Observational Program in Safety
A phase 4 study to follow patients already on Tysabri for a period of up to five years. Only patients in TOUCH program are eligible for this observational program. There are no free drugs or treatments.
SP902: A Historical controlled, Multicenter, Double-blind, Randomized Trial to Assess the Efficacy and Safety of Conversion to Lacosimide 400mg/day Monotherapy in Subjects with Partial-Onset Seizures.
Patients all will be on active drug, (no placebo arm), just different dosages. Goal is to wean them off of drugs they are currently on which may not be as effective as this new agent.
Protocol#ELN115727-301: A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Efficacy and Safety Trial of Bapineuzumab (AAB-001,ELN115727) in Patients with Mild to Moderate Alzheimer's Disease who are Apolipoprotein E 4 Non-carriers.
This 78 week study is 66% active drug vs. placebo. There will be 6 infusions and an extensive set of neuropsychological testing and questionnaires for patient and the caregiver over the 15 visits of study. All drug, labs, MD visits and MRI’s are provided by study.
Closed Enrollment Studies: Currently Being Monitored
Protocol#ELN115727-/302: A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Efficacy and Safety Trial of Bapineuzumab (AAB-001,ELN115727) in Patients with Mild to Moderate Alzheimer's Disease who are Apolipoprotein E 4 Carriers (Companion study to Elan 301).
This 78 week study is 66% active drug vs. placebo. There will be 6 infusions and an extensive set of neuropsychological testing and questionnaires for patient and the caregiver over the 15 visits of study. All drug, labs, MD visits and MRI’s are provided by study
CombiRX: A Multicenter, 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).
This two-year NIH (National Institutes of Health) sponsored study is studying the combination of using both Avonex and Copaxone versus using each drug alone. All drugs are provided free to study participants. 33% chance of being on both drugs, and 100% chance of being on active drug.
Protocol 109MS301: 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. (DEFINE Study).
This 2 year drug study is examining an oral drug currently available in Europe as an anti-psoriasis drug. Patients have a 66% chance of being on active drug. All study drug and MD visits are provided by the study. Patient is offered Avonex rescue therapy if meets criteria.
Protocol C32322: A Double-blind, Placebo-controlled, Randomized, Parallel-group, Phase II Study in Subjects with Relapsing forms of Multiple Sclerosis (MS) to Evaluate the safety, Tolerability, and Effects of Two doses of CDP323 over 24 Weeks
This 24 week study is examining an oral form of integrin.
Protocol: 27820 Clarity Extension: 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).
This trial has a predetermined enrollment for patients who completed the CLARITY trial. 4 out of our 5 patients elected to continue on trial with us. This is a cross-over trial for patients to begin Cladribine therapy until there is possible FDA approval.
Protocol 001-06-NAT: A Multi-Center, Open-Label Study to Evaluate the Effects of Natalizumab Treatment on Fatigue and Cognition in Subjects with Relapsing Forms of MS, (The ENER-G Study)
This phase 4 observational study is examining the reported effects of Tysabri on fatigue and mental cognition. Patients must be currently enrolled in the TOUCH program at the MS Center of Atlanta.