As of December 10, 2012
New Studies:
Efficacy and Safety of Baclofen ER Capsules (GRS) in Subjects With Spasticity Due to Multiple Sclerosis
Title: A Placebo-controlled Randomized Withdrawal Evaluation of the Efficacy and Safety of Baclofen ER Capsules (GRS) in Subjects With Spasticity Due to Multiple Sclerosis
Purpose: The purpose of this study is to assess whether baclofen ER capsules demonstrate efficacy and safety in the treatment of spasticity.
Coordinator – Leigh Kreshel
http://www.clinicaltrials.gov/ct2/show/NCT01457352?term=Sun+Pharma+CLR_09_21&rank=1
The Efficacy and Safety and Tolerability of Laquinimod in Subjects With Relapsing Remitting Multiple Sclerosis (RRMS) (CONCERTO)
Title: A Multinational, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-Controlled Study Followed by an Active Treatment Period, to Evaluate the Efficacy, Safety and Tolerability of Two Oral Doses of Laquinimod (0.6 mg/d or 1.2 mg/d) in Subjects With Relapsing Remitting Multiple Sclerosis (RRMS)
Purpose: This is a multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study followed by active treatment, to evaluate the efficacy, safety and tolerability of two doses of oral administration of laquinimod 0.6 mg/day or 1.2 mg/day in subjects with RRMS.
Coordinator – Shannon Cone
http://www.clinicaltrials.gov/ct2/show/NCT01707992?term=Teva+LAQ-MS-305&rank=1
Title: A Randomized, Double-Blind, Parallel Group Study to Compare the Safety and Efficacy of Increasing Doses of Arbaclofen Extended Release Tablets to Placebo and Baclofen Tablets, USP for the Treatment of Spasticity in Patients with Multiple Sclerosis
Coordinator – Shannon Cone
Contact coordinator for more details
Title: Validation of the Fatigue Symptoms and Impacts Questionnaire-Relapsing Multiple Sclerosis (FSIQ-RMS)
Coordinator – LeAnn Cannon
Contact coordinator for more details
Title: TRANSITION: A two-year observational study to evaluate the safety profile of fingolimod in patients with multiple sclerosis who switched from natalizumab to fingolimod
Purpose: The purpose of this world-wide prospective observational single-cohort study is to evaluate, over a period of two years, the overall safety profile of fingolimod as well as the incidence of selected safety outcomes in patients previously exposed to natalizumab under the conditions of routine medical practice.
Coordinator – LeAnn Cannon
Clinic patient observation, contact coordinator for more details
Ongoing Studies:
Efficacy and Safety of Arbaclofen Placarbil in Subjects With Spasticity Due to Multiple Sclerosis
Title: A Randomized, Double Blind, Placebo-Controlled Efficacy and Safety Study of Arbaclofen Placarbil in Subjects With Spasticity Due to Multiple Sclerosis
Purpose: To evaluate the efficacy of three doses of XP19986 (arbaclofen placarbil) compared to placebo for the treatment of spasticity in subjects with multiple sclerosis (MS).
Coordinator – Shannon Cone
http://www.clinicaltrials.gov/ct2/show/NCT01359566?term=xenoport+ms&rank=2
Safety and Efficacy of AVP-923 in the Treatment of Central Neuropathic Pain in Multiple Sclerosis
Title: A Phase 2, Double-blind, Randomized, Placebo-controlled, Four-arm, Multicenter, Dose-finding Study to Assess the Safety and Efficacy of Three Dose Levels of AVP-923 (Dextromethorphan/Quinidine) in the Treatment of Central Neuropathic Pain in Patients With Multiple Sclerosis
Purpose: The objectives of the study are to evaluate the safety, tolerability, and efficacy of 3 doses of AVP-923 capsules in the treatment of central neuropathic pain in patients with multiple sclerosis.
Coordinator – Leigh Kreshel
http://www.clinicaltrials.gov/ct2/show/NCT01324232?term=avanir&rank=3
Evaluation of Patient Retention of Fingolimod vs. Currently Approved Disease Modifying Therapy in Patients With Relapsing Remitting Multiple Sclerosis (PREFERMS)
Title: A 12-month, Prospective, Randomized, Active-controlled, Open-label Study to Evaluate the Patient Retention of Fingolimod vs. Approved First-line Disease Modifying Therapies in Adults Who Are in Early Stages of Treatment for Relapsing Remitting Multiple Sclerosis
Purpose: A 12 month study where 1000 patients with relapsing remitting MS will be randomized 1:1 to fingolimod or approved disease modifying therapy. Patients will be in early stages of the disease and be treatment naïve or have only been treated with one class of DMT (Intereferon beta preparation or glatiramer acetate) for no more than 5 years total exposure. Patients will be able to switch to different treatment for safety, efficacy, tolerability or convenience during the study. Primary objective is to evaluate efficacy of fingolimod by assessing patients retention on treatment. Secondary objectives are to compare reasons for discontinuation, adverse events, cognitive impairment, medication satisfaction and change in brain volume measured by MRI.
Coordinator – LeAnn Cannon
http://clinicaltrials.gov/ct2/show/NCT01623596?term=novartis+CFTY720DUS09&rank=1
MS Study Evaluating Safety and Efficacy of Two Doses of Fingolimod Versus Copaxone
Title: A 12-month, Randomized, Rater- and Dose-blinded Study to Compare the Efficacy and Safety of Fingolimod 0.25 mg and 0.5 mg Administered Orally Once Daily With Glatiramer Acetate 20 mg Administered Subcutaneously Once Daily in Patients With Relapsing-remitting Multiple Sclerosis
Purpose: The purpose of this study is to compare 2 doses (0.25 mg and 0.50 mg) of fingolimod to glatiramer acetate (20 mg) and to evaluate the efficacy of fingolimod 0.25 mg for the treatment of patients with relapsing-remitting MS (RRMS)
Coordinator – LeAnn Cannon
http://clinicaltrials.gov/ct2/show/NCT01633112?term=novartis+CFTY720D2312&rank=1
Title: Long-term, prospective, observational, multinational, parallel-cohort study monitoring safety in patients with MS newly started with fingolimod once daily or treated with another approved disease-modifying therapy
Coordinator – LeAnn Cannon
Clinic patient observation, contact coordinator for more details
***Restless Legs Study***
Title: Study RXP114025: A Randomized, Double-Blind, Placebo-Controlled, Fixed-Dose, Parallel-Group Study to Compare the Efficacy, Tolerability, and Safety of 3 Doses of Gabapentin Enacarbil (GSK1838262) With Placebo in the Treatment of Subjects With Moderate-to-Severe Primary Restless Legs Syndrome (RLS)
Coordinator – Shannon Cone
Contact coordinator for more details
