Clinical Trials

Clinical Trials
What are clinical trials?

Clinical trials collect data on the safety and efficacy of a treatment and are regulated by the F.D.A. If a treatment passes a clinical trial with enough evidence to suggest it is safe and effective, it may then become eligible to be distributed by pharmaceutical companies.

The clinical trial is the last step in the development of a new pharmaceutical treatment. Potential drugs, for example, first have to be purified, characterized, and tested in labs with cell and animal subjects. Many years of development and research are needed before any drug can even begin its clinical trial. Even after a drug begins its clinical trials, years of review and data collection are needed before the drug can enter the market.

For a clinical trial to be successful, it needs to enroll exactly the right kind of study subject. Dr. Shubin is extremely successful at finding the appropriate subjects for clinical trials, and at working with those subjects and their families to create solutions for the needs and logistical complexities of everyone involved in the trial.
Dr. Shubin and Clinical Trials

Dr. Shubin is the director and founder of Neurotherapeutics Inc., a research company focused on conducting clinical trials for new pharmaceutical treatments. Neurotherapeutics Inc. specializes in conducting trials related to Multiple Sclerosis, Alzheimers, Parkinson’s, stroke, and Migraine. These trials are on the frontier of medicine, helping to get safe and effective treatments for some of the most complex and serious diseases in neurology.

Current Clinical Trials
43. Title: A randomized, double-blind, double-dummy, parallel-group study to evaluate the efficacy and safety of Ocrelizumab in comparison to Interferon beta la (Rebif) in patients with relapsing multiple sclerosis

Sponsor: Roche, Genentech

Dates of Participation: 
 August 2011 - present

Summary/Objective: to assess whether the efficacy of ocrelizumab 600 mg (given as dual infusions of 300 mg ocrelizumab 14 days apart) intravenously every 24 weeks is superior to Rebif as measured by the annualized protoco1—defmed relapse rate by two years in patients with relapsing MS.

Enrollment: 3
44. Title: A randomized, double-blind, placebo-controlled, parallel-group, 18-month
safety and efficacy study of Leuco-methylthioninium bis in subjects with mildAlzheimer’s disease

Sponsor: TauRx

Dates of Participation: 
September 2013 - present

Enrollment: 5
45. Title: A Phase 3, 12-week, double-Blind, Placebo-controlled, Randomized,
Multicenter Study to Evaluate the Efficacy of Oral Istradefylline 20 and 40 mg/day as Treatment for Subjects with Moderate to Severe Parkinson’s Disease

Sponsor: Kyowa

Dates of Participation: 
March 2014 - present

Enrollment: 6
46. Title: Efficacy and Safety of ADS-5102 (Amantadine HCL) Extended Release Capsules for the Treatment of Levodopa Induced Dyskinesia in Parkinson’s Disease Patients (Ease LID Study)

Sponsor: Adamas Pharmaceuticals, Inc.

Dates of Participation: 
October 2014 - present

Enrollment: 3
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