Multiple Sclerosis Research Studies

Dr. Gary Birnbaum, retired MCN MS specialist, offers updates about Multiple Sclerosis research on his new blog:  www.MSResearchUpdate.com

109MS401 (“ESTEEM”)
Study Overview
A Multicenter, Global, Observational Study to Collect Information on Safety and to Document the Drug Utilization of Tecfidera™ (Dimethyl Fumarate) When Used in Routine Medical Practice in the Treatment of Multiple Sclerosis.
Principal Investigator: Jessica Stulc, MD
Sponsor: Biogen Idec

Research Contact: If interested please contact Dr. Stulc’s Clinical Research Coordinator at 763-302-4072.

Protocol No.:  CLR_09_21
Study Overview
A Placebo-Controlled Randomized Withdrawal Evaluation of the Efficacy and Safety of Baclofen ER Capsules (GRS) in Subjects with Spasticity Due to Multiple Sclerosis.
Principal Investigator: Jessica Stulc, MD
Sponsor: Sun Pharmaceuticals

Research Contact: If interested please contact Dr. Stulc’s Clinical Research Coordinator at 763-302-4072.

105MS401 (“POP”)
Study Overview
Plegridy™ (peginterferon β 1a) Real World Effectiveness and Safety Observational Program.
Principal Investigator: Jessica Stulc, MD
Sponsor: Biogen Idec

Research Contact: If interested please contact Dr. Stulc’s Clinical Research Coordinator at 763-302-4072.

TV5600-CNS-200006: ARPEGGIO
Study Overview
A Multinational, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Once Daily Oral Administration of Laquinimod (0.6 or 1.5 mg) in Patients with Primary Progressive Multiple Sclerosis.
Principal Investigator: Jessica Stulc, MD
Sponsor: Teva Pharmaceuticals

Research Contact: If interested please contact Dr. Stulc’s Clinical Research Coordinator at 763-302-4072.

TV44400-CNS-40083 (CONFIDENCE)
Study Overview
A Multinational, Multicenter, Randomized, Parallel Group, Open-Label Study to Assess Medication Satisfaction in Patients with Relapsing Remitting Multiple Sclerosis (RRMS) Treated with Subcutaneous Injections of Copaxone® (Glatiramer Acetate) 40 mg/mL Three Times a Week Compared to 20 mg/mL Daily.
Principal Investigator: Jessica Stulc, MD

Research Contact: If interested please contact Dr. Stulc’s Clinical Research Coordinator at 763-302-4072.

Alkermes ALK8700-A301 (EVOLVE)
Study Overview
A Phase 3 Open Label Study to Evaluate the Long-term Safety and Tolerability of ALKS 8700 in Adults with Relapsing Remitting Multiple Sclerosis.
Principal Investigator: Jessica Stulc, MD

Research Contact: If interested please contact Dr. Stulc’s Clinical Research Coordinator at 763-302-4072.

Enrolling Trials
TG1101-RMS401/Enhance: Evaluating efficacy when transitioning from a current Disease Modifying Therapy {DMT} to ublituximab {ENHANCE}
Sponsor: TG Therapeutics, Inc.
Phase 3b
Active Subjects: O
Principal Investigator: Dr. Stulc

Studies in Follo’w-Up

GN41791/Fentrepid: A Phase III Multicenter, Randomized, Double-Blind, Double-Dummy, Parallel-Group Study to Evaluate the Efficacy and Safety ofFenebrutinib Compared with Ocrelizumab in Adult Patients with Primary Progressive Multiple Sclerosis
Sponsor: F. Hoffman-La-Roche
Phase: 3
Active Subjects: 5
Principal Investigator: Dr. Stulc

OBS13434/Lemtrada Pass: A prospective, Multicenter, Observational, Post-Authorization Safety Study to Evaluate the Long-Term Safety Profile of LEMTRADA® (Alemtuzumab) Treatment in Patients with Relapsing Forms of Multiple Sclerosis
Sponsor: Sanofi
Phase: 4
Active Subjects: 2
Principal Investigator: Dr. Stulc

BA39731Nerismo: An Observational Study of Ocrelizumab Treated Patients with Multiple Sclerosis to Determine the Incidence and Mortality Rates of Breast Cancer and all Malignancies
Sponsor: F. Hoffman-La-Roche
Phase: 4
Active Subjects: 45
Principal Investigator: Dr. Stulc

MS700568_0079/Master 2: An Observational Evaluation of Effectiveness and Patient-Reported Outcomes in Suboptimally Controlled Patients Previously Taking Oral or Infusion Disease-Modifying Drugs for Relapsing Forms of Multiple Sclerosis
Sponsor: EMD Serano
Phase: 4
Active Subjects: 1
Principal Investigator: Dr. Stulc

EFC16645/Hercules: A Phase 3, Randomized, Double-Blind, Efficacy and Safety Study Comparing SAR442168 To Placebo in Participants with Non-Relapsing Secondary Progressive Multiple Sclerosis
Sponsor: Sanofi
Phase: 3
Active Subjects: 3
Principal Investigator: Dr. Stulc

MN43964/0lero: A Multicenter, Single-Arm, Open-Label, Extension, Rollover Study to Evaluate the Long­ Term Safety and Efficacy of Ocrelizumab in Patients with Multiple Sclerosis
Sponsor: F. Hoffman-La-Roche
Phase: 3
Active Subjects: 3
Principal Investigator: Dr. Stulc

Closing Studies

MS700568_0078/Click-MS: Cladribine Tablets; Observational evaluation of effectiveness and patient-reported outcomes (PROs) in sub optimally Controlled patients previously taking injectable disease-modifying drugs (DMDs) for relapsing forms of Multiple Sclerosis (RMS)
Sponsor: EMO Serano
Phase: 4
Active Subjects: 4
Closing date: In June, still confirming date with sponsor
Principal Investigator: Dr. Stulc

OMB157GUS07 /OLll
Sponsor: Novartis
Phase 3b
Active Subjects: 0
Principal Investigator: Dr. Stulc

Note: If you have any patients that could potentially qualify for any enrolling trials, please contact Jenna Skinner Jenna.skinner@Mpls-clinic.com or Dr. Jessica Stulc.