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Clinical Research & Trials

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At the Rocky Mountain MS Center, we know that clinical research is critical to understanding this diseases complex triggers and effects, and will lead to better treatments and ultimately the cure. The Rocky Mountain MS Center at Anschutz Medical Campus is the home of a world-class MS research program, with 22 clinical trials currently under way and many more in the planning stages. Other researchers in Colorado are also conducting vital clinical research in our community. The success of these clinical research programs depends on the broad support of the MS community in Colorado and Wyoming.

If you would like be notified when new clinical trials are added, please click HERE.

Please note that the studies listed below are being conducted at the Rocky Mountain MS Center, University of Colorado Denver Anschutz Medical Campus. You will be required to come to the study site for visits. Many of the studies are conducted at various sites around the United States and therefore if you do not reside in the Rocky Mountain Region, there may be a site in or near your area that would be more convenient. We will do our best to provide you with this information if available. You may be able to find this information using http://www.clinicaltrials.gov as well.

If you are interested in any of the studies listed below please call 303-724-4644 and provide your name, a phone number where you can be reached and the best time to reach you. Please allow 5-7 business days for a response.

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TRIALS

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Title: JCV Antibody Program in Patients with Relapsing Multiple Sclerosis Receiving or Considering Treatment with Tysabri®: STRATIFY-2

Purpose: To identify multiple sclerosis (MS) patients who have a specific antibody in their blood against the JC virus (JCV). The purpose of STRATIFY-2 is to gather more information about how many MS patients being treated with TYSABRI® or who are considering beginning Tysabri have the JCV antibody in their blood and to better understand whether antibodies to JCV may be used to predict whether a patient is at higher or lower risk for developing PML.

Main Eligibility Requirements:
  • Current treatment with Tysabri
OR
  • Considering treatment with Tysabri

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Title: A Longitudinal, Case-Control Study to Collect Medical and Epidemiological Data and Blood Samples for Research Into the Causes of Multiple Sclerosis and Selected Demyelinating Diseases (ACP)

Purpose: To establish a collection of blood samples and associated data from people whom have experienced at least one Central Nervous System (CNS) demyelinating event characteristic of the following syndromes or diseases: Multiple Sclerosis (MS),  Transverse Myelitis (TM), Acute Disseminated Encephalomyelitis (ADEM), Neuromyelitis Optica (NMO) or Optic Neuritis (ON). We will also collect blood samples from their blood relatives (those who have and have not experienced a CNS demyelinating event), and unrelated subjects who have not experienced any central nervous system event.  The samples and data will be made available to research scientists who are involved in the study of MS, TM, ADEM, NMO, and/or ON, and in particular, studies involved in determining the causes of these syndromes/diseases.

Main Eligibility Requirements:

  • Individuals at least 18 years old
  • Individuals with at least one CNS demyelinating event lasting at least 24 hours and not acute in onset
  • Willing and able to provide up to 110 ml blood via venipuncture

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Title:
A combination trial of Copaxone plus estriol in relapsing-remitting multiple sclerosis.

Purpose: To determine if the use of oral estriol (8mg/day) in combination with Copaxone injections (20mg/day) is an effective treatment for multiple sclerosis.

Main Eligibility Requirements:
  • Females age 18 to 50.
  • Diagnosis of active relapsing remitting multiple sclerosis as defined by either:
  • At least two clearly identified relapses within 24 months prior to study entry, OR
  • At least one clearly identified relapse within 24 months prior to study entry AND
  • have a history of at least one gadolinium enhancing lesion on a T1 brain or cord MRI
  • No relapse within 30 days before day of trial enrollment.
  • Cannot smoke at any time during the screening process or for the duration of the study
  • If post-menopausal, must be taking hormone replacement therapy or have been on hormone replacement therapy within 1 year.
Contact information:

UCLA; Dr. Barbara Giesser
Coordinator: Mike Montag
310-794-4020

Washington University, St. Louis; Dr. Anne Cross
Coordinator: Debbie Kemp
314-362-3839

UMDNJ, New Brunswick; Dr. Suhayl Dhib-Jalbut
Coordinator: Yaritza Rosario
732-235-7099

OSU, Columbus; Dr. M. Racke
Coordinator: Lisa Hafer
614-293-7877

University of Chicago; Dr. Anthony Reder
Coordinator: Mildred Valentine
773-702-9812

University of Utah, Salt Lake; Dr. John Rose
Coordinator: Julia Klein
801-582-1565 X2014

U. of Texas Southwestern, Dallas; Dr. A. Courtney
Coordinator: Gina Remington
214-645-0560

Johns Hopkins U., Baltimore; Dr. John Ratchford
Coordinator: Stephanie Syc
410-502-2488

University of Colorado, Aurora; Dr. John Corboy
Coordinator: Caitlin Pattamasaevi
303-724-8905

U. of New Mexico, Albuquerque; Dr. Corey Ford
Coordinator: Lori Bachert
505-272-8905

U. of Pennsylvania, Philadelphia; Dr. Dina Jacobs
Coordinator: Vanessa Zimmerman
215-349-5162

Dartmouth Med. Sch., Lebanon, NH; Dr. L. Kasper
Coordinator: Kathleen Ryan
603-653-9919

U. of Kansas, Kansas City; Dr. Sharon Lynch
Coordinator: Kelly Dickerson
913-588-0080

U. of Minnesota, Minneapolis; Dr. Gareth Parry
Coordinator: Susan Rolandelli
612-624-5978

Mayo Clinic Arizona, Scottsdale; Dr. D. Wingerchuk
Coordinator: Irene Galasky
480-301-6104
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The following study does not have a research location at the Rocky Mountain MS Center at Anschutz Medical Campus
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DELIVER Study
A study to evaluate delivery of Natalizumab (Tysabri®)

Study Rationale:
While other Multiple Sclerosis medications can be administered at home, Natalizumab is given through IV at infusion centers. This can be costly and inconvenient to patients, especially if there is not an infusion center nearby.

Study Objective:
The objective of the study is to determine if Natalizumab can be given by subcutaneous (SC) injection (under the skin). This will be accomplished through laboratory blood work, clinical assessments, and MRI scans.

Study Description:
The study is sponsored by Biogen Idec. Neurologist Dr. Ronald Murray will oversee all study activities at IMMUNOe Health Centers.

New participants will be assigned to either Group D or Group E:

Group A IV    Group B SC   Group C IM   Group D SC   Group E IV   Group F Reference    

Participation in Groups D or E will last approximately 8 months and will include 22 office visits and 8 MRIs.

Eligibility will be assessed at the first visit (Screening Visit).
If qualified, the patient will receive either an infusion or injection of Natalizumab (Baseline visit)
Following the Baseline treatment, patients will return for 10 blood draws.
The blood draws will occur daily for the next four days post treatment (treatment is usually on Mon and blood draws are sch. for Tues, Wed, Thurs, Fri).
The next 6 blood draws will occur weekly for the following 2 months after treatment.
After 2 months, patients will resume a monthly schedule of treatment visits for the next 6 months.  

Patient Profile (for Groups D and E):
•    Male and Females between 18 to 65
•    Diagnosed with Relapsing Forms MS (No SPMS or PPMS patients)
•    Must be Tysabri Naïve
•    EDSS between 0 and 6.5 (wheel chair bound = 7 and these patients are excluded)
•    No other conflicting medical condition which would jeopardize the patient or study data
•    Able to undergo an MRI (lasting an hour)

Costs:
There is no cost to participate. You may be reimbursed for any reasonable travel costs as a result of your participation in this study.

Information: contact Lauren Friedman at 303-224-4671 or This e-mail address is being protected from spambots. You need JavaScript enabled to view it

For more information on various clinical trials throughout the United States please visit:
www.clinicaltrials.gov


Receive monthly updates on current clinical trials via email.