A PHASE III, MULTICENTRE, RANDOMISED, DOUBLE BLIND, PARALLEL GROUP, PLACEBO CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF ONE OR MORE INTRADETRUSOR TREATMENTS OF 600 OR 800 UNITS OF DYSPORT® FOR THE TREATMENT OF URINARY INCONTINENCE IN SUBJECTS WITH NEUROGENIC DETRUSOR OVERACTIVITY DUE TO SPINAL CORD INJURY OR MULTIPLE SCLEROSIS Save

Date Added
August 9th, 2016
PRO Number
Pro00058027
Researcher
Lindsey Cox

Silhouette
Keywords
Bladder, Multiple Sclerosis, Spinal Cord
Summary

The main objective of this study is to evaluate if Dysport® is effective and safe for the treatment of urinary incontinence due to NDO.

Dysport® contains a toxin that is produced from bacteria. The toxin is called Botulinum toxin A and it is known that this toxin causes muscles that are contracting too much to relax once the muscles are injected with the toxin. This relaxation usually lasts for several months before treatment needs to be given again.

Institution
MUSC
Recruitment Contact
Jessica Jenkins
843-876-0630
843792-2325

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 Save

Date Added
December 10th, 2015
PRO Number
Pro00048449
Researcher
Jagannadha Avasarala
Keywords
Multiple Sclerosis
Summary

The main purpose of this study in people with MS, either newly prescribed GILENYA or receiving another approved medication, is to evaluate long-term safety of Gilenya and to further explore the incidence of selected safety outcomes.
Patients eligible for participation in this study will, as part of their routine medical care, receive either fingolimod (fingolimod-cohort) or another approved disease-modifying therapy (parallel cohort). All patients will have 3 or 4 mandatory visits (Baseline, Month 3, change in MS therapy (if applicable) and end of study); beyond those, visits will be according to routine practice. Protocol recommended visits are aligned with patterns of care that most patients will receive in routine clinical practice.
The prescription of fingolimod or any other DMT is at the sole discretion of the prescribing physicians, is not part of the study plan and will not be provided by the study sponsor

Institution
Greenville
Recruitment Contact
Enrique Urrea Mendoza
864-454-5076
eurreamendoza@ghs.org

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) Save

Date Added
September 10th, 2015
PRO Number
Pro00044761
Researcher
Jagannadha Avasarala
Keywords
Multiple Sclerosis
Summary

The purpose of this study is to better characterize the long-term benefit-risk profile of DMF in patients with multiple sclerosis (MS) who are prescribed DMF under routine clinical care.
The primary objective of the study is to determine the incidence, type, and pattern of serious adverse events, including but not limited to serious infections (including opportunistic infections), hepatic events, malignancies, and renal events, and of adverse events leading to treatment discontinuation, in patients with MS treated with DMF. Secondary study objectives are to (1) determine DMF prescription and utilization patterns in routine clinical practice in patients with MS; (2) assess the effectiveness of DMF on MS disease activity and disability progression; and (3) assess the effect of DMF on health-related quality of life, healthcare resource consumption, and work productivity.

Institution
Greenville
Recruitment Contact
Enrique Urrea Mendoza
864-454-5076
eurreamendoza@ghs.org

A Multicenter, Global, Observational Study to Collect Information on Safety and to Document the Drug Utilization of TecfideraTM (Dimethyl Fumarate) When Used in Routine Medical Practice in the Treatment of Multiple Sclerosis (ESTEEM) Save

Date Added
June 5th, 2014
PRO Number
Pro00035485
Researcher
Davit Mrelashvili
Keywords
Multiple Sclerosis
Summary

The primary objective of the study is to determine the incidence, type, and pattern of serious adverse events, including but not limited to serious infections (including opportunistic infections), hepatic events, malignancies, and renal events, and of adverse events leading to treatment discontinuation, in patients with MS treated with DMF. Secondary study objectives are to (1) determine DMF prescription and utilization patterns in routine clinical practice in patients with MS; (2) assess the effectiveness of DMF on MS disease activity and disability progression; and (3) assess the effect of DMF on patient health-related quality of life, healthcare resource consumption, and work productivity.

Institution
USC
Recruitment Contact
Alyson Grant
803-545-6104
alyson.grant@uscmed.sc.edu

Regulation of Inflammatory T Cells and Neuroprotection by Calpain Inhibition in MS Save

Date Added
March 4th, 2014
PRO Number
Pro00028348
Researcher
Narendra Banik

Silhouette
Keywords
Inflammation, Multiple Sclerosis
Summary

A number of veterans suffer from multiple sclerosis (MS), a devastating and debilitating disease for which there is not cure or significant treatment. The only therapy available is immunomodulatory, but does not treat the neurodegeneration. The studies proposed in this application will develop therapeutic strategies and identify a drug that ameliorates inflammation as well as neurodegeneration in the disease. Thus, the effect of this drug will not only help veterans with MS, but will also benefit individuals with the disease in general.

Institution
MUSC
Recruitment Contact
Elizabeth Kau
789-6450
elizabeth.kau2@va.gov

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