MULTIPLE SCLEROSIS RESEARCH STUDIES

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

Dr. Yelena Usmanova is involved in numerous research trials related to advances in the treatment of Multiple Sclerosis.

WA21092 (“Opera”)

Study Overview

A Randomized, Double-Blind, Double-Dummy, Parallel-Group Study to Evaluate the Efficacy and Safety of Ocrelizumab In Comparison To Interferon Beta-1a (Rebif ®) In Patients with Relapsing Multiple Sclerosis

Study Duration–96 Weeks

Phase-III

Enrollment Closed

Principle Investigator

Jessica Stulc, MD

Sponsor

F.Hoffmann-La Roche Ltd

Research Contact

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

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.

Principle 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.

Principle 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.

Principle 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.

Principle Investigator

Jessica Stulc, MD

Sponsor

Teva Pharmaceuticals

Research Contact

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

OBS14527 Sanofi/Genzyme “LEM-COG”:

A Prospective 24-Month Observational Study to Evaluate Neurocognitive Function and Safety in Patients with Relapsing Multiple Sclerosis Who Are Initiating LEMTRADA® Treatment in Routine Clinical Practice.  Enrolling

Principle Investigator

Jonathan Calkwood, M.D.

Please contact Dr. Calkwood’s Clinical Research Coordinator at 763-302-4126.

MA30143 “ENSEMBLE”:

An open-label, single-arm study to evaluate the effectiveness and safety of Ocrelizumab in patients with early stage relapsing remitting multiple sclerosis. Currently Enrolling.

Principle Investigator

Jonathan Calkwood, M.D.

Please contact Dr. Calkwood’s Clinical Research Coordinator at 763-302-4126.

MN30035 “CHORDS”:

An open-label study to evaluate the effectiveness and safety of Ocrelizumab in patients with relapsing remitting multiple sclerosis who have had a suboptimal response to an adequate course of disease-modifying treatment. Enrollment closed.

Principle Investigator

Jonathan Calkwood, M.D.

Please contact Dr. Calkwood’s Clinical Research Coordinator at 763-302-4126.

COMB157G2302 “ASCLEPIOS”:

A randomized, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing multiple sclerosis.  Enrollment Closed.

Principle Investigator

Jonathan Calkwood, M.D.

Please contact Dr. Calkwood’s Clinical Research Coordinator at 763-302-4126.

OBS13434 Sanofi/Genzyme “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. Enrolling

Principle Investigator

Jonathan Calkwood, M.D.

Please contact Dr. Calkwood’s Clinical Research Coordinator at 763-302-4126.

OBS14448 Sanofi/Genzyme “PRO-ACT”:

A Prospective, 24-Month Observational Study to Evaluate Patient Reported Outcomes and Safety After LEMTRADA® Treatment In Patients With Relapsing Multiple Sclerosis Switching From A Prior Disease Modifying Therapy.  Enrollment closed.

Principle Investigator

Jonathan Calkwood, M.D.

Please contact Dr. Calkwood’s Clinical Research Coordinator at 763-302-4126.

CFTY720D2403 Novartis “PASSAGE”

Long-term, prospective, multinational, parallel-cohort study monitoring safety in patients with MS newly started on fingolimod once daily or treated  with another approved disease-modifying therapy. Enrollment closed.

Principle Investigator

Jonathan Calkwood, M.D.

Please contact Dr. Calkwood’s Clinical Research Coordinator at 763-302-4126.

109MS401 Biogen Idec “ESTEEM”

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 (ESTEEM).  Enrollment closed.

Principle Investigator

Jonathan Calkwood, M.D.

Please contact Dr. Calkwood’s Clinical Research Coordinator at 763-302-4126.

DWA21092 Roche “OPERA”

A Randomized, Double-Blind, Double-Dummy, Parallel-Group Study to Evaluate The Efficacy and Safety of Ocrelizumab In Comparison To Interferon Beta-1a (Rebif ®) In Patients With Relapsing Multiple Sclerosis (96 weeks). Enrollment closed

Principle Investigator

Jonathan Calkwood, M.D.

CBAF312A2304 Novartis “EXPAND”

A multicenter, randomized, double-blind, parallel-group, placebo-controlled variable treatment duration study evaluating the efficacy and safety of Siponimod (BAF312) in patients with secondary progressive multiple sclerosis (SPMS). Enrollment closed

Principle Investigator

Jonathan Calkwood, M.D.

RPC01-3001 Receptos “DAYBREAK”

A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis. Enrollment closed

Principle Investigator

Jonathan Calkwood, M.D.

BN29739 Roche/Genzyme “VELOCE”

A PHASE IIIB, MULTICENTER, RANDOMIZED, PARALLEL-GROUP, OPEN-LABEL STUDY TO EVALUATE THE EFFECTS OF OCRELIZUMAB ON IMMUNE RESPONSES IN PATIENTS WITH RELAPSING FORMS OF MULTIPLE SCLEROSIS. Enrollment closed

Principle Investigator

Jonathan Calkwood, M.D.                                   

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.

Principle Investigator

Jessica Stulc, M.D,

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.

Principle Investigator

Jessica Stulc, M.D,

Research Contact

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

SP12 “MedDay 229829”

Effect of MD1003 in progressive multiple sclerosis: a randomized double blind placebo controlled study. Enrollment closed.

Principle Investigator

Jonathan Calkwood, M.D.

Please contact Dr. Calkwood’s Clinical Research Coordinator at 763-302-4126.

Corrona MS Registry

Corrona Multiple Sclerosis (MS) Registry. The Corrona MS Registry is a prospective, non-interventional, research study for patients with MS under the care of a board-certified neurologist. Currently enrolling

Principle Investigator

Jonathan Calkwood, M.D.

Please contact Dr. Calkwood’s Clinical Research Coordinator at 763-302-4126.

215MS202 “AFFINITY”:

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study in Subjects With Relapsing Multiple Sclerosis to Evaluate the Efficacy and Safety of BIIB033 as an Add-On Therapy to Anti-Inflammatory Disease-Modifying Therapies. Enrollment closed.

Principle Investigator

Jonathan Calkwood, M.D.

Please contact Dr. Calkwood’s Clinical Research Coordinator at 763-302-4126.

101MS329 “NOVA”

A Randomized, Controlled, Open-Label, Rater-Blinded, Phase 3b Study of the Efficacy, Safety, and Tolerability of 6-Week Extended Interval Dosing of Natalizumab (BG00002) in Subjects With Relapsing-Remitting Multiple Sclerosis Switching From Treatment With 4-Week Natalizumab standard Interval Dosing (SID) in Relation to Continued SID Treatment.  Currently Enrolling.

Principle Investigator

Jonathan Calkwood, M.D.

Please contact Dr. Calkwood’s Clinical Research Coordinator at 763-302-4126.

COMB157G2399 “ALITHIOS”

An open label, single arm, multi-center extension study evaluating long-term safety, tolerability and effectiveness of ofatumumab in subjects with relapsing multiple sclerosis. Currently enrolling only subjects who complete the COMB157G2302 study.

Please contact Dr. Calkwood’s Clinical Research Coordinator at 763-302-4126 with any questions.

ADS-AMT-MS301

A 3-ARM, MULTICENTER, DOUBLE-BLIND, PLACEBO-CONTROLLED, RANDOMIZED STUDY TO ASSESS THE EFFICACY AND SAFETY OF ADS-5102 AMANTADINE EXTENDED RELEASE CAPSULES IN MULTIPLE SCLEROSIS PATIENTS WITH WALKING IMPAIRMENT.  Currently enrolling.

Principle Investigator

Jonathan Calkwood, M.D.

Please contact Dr. Calkwood’s Clinical Research Coordinator at 763-302-4126.

ADS-AMT-MS303

A MULTICENTER, OPEN-LABEL SAFETY AND EFFICACY STUDY OF ADS-5102  AMANTADINE EXTENDED RELEASE CAPSULES IN PATIENTS WITH MULTIPLE SCLEROSIS AND WALKING IMPAIRMENT.  Currently enrolling only subjects who complete the ADS-AMT-MS301 study.

Please contact Dr. Calkwood’s Clinical Research Coordinator at 763-302-4126 with any questions.