At the Rocky Mountain MS Center, we know that clinical research is bedrock upon 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 18 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.
Please help us get the word out about these studies. There is no direct expense involved for participants in the clinical trials listed below. Each of these studies can also provide an opportunity to receive expert MS care during the course of the study. Generally, only a handful of patients are needed for each trial.
From time to time, we will send out emails to notify people in the MS community of studies that are actively enrolling patients. If you would like to be added to this list so that you receive this and other information from the Rocky Mountain MS Center, please click HERE. If you add your name to our list and then decide you do not want to receive further emails, you can easily unsubscribe from this service; each email we send has a simple to use unsubscribe feature. Of course, we will never give third parties access to your email.
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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 or
email
This e-mail address is being protected from spambots. You need JavaScript enabled to view it
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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Title: Duloxetine in patients with central neuropathic (nerve) pain due to multiple sclerosis.
Purpose: This study is intended to determine whether duloxetine (also known as
Cymbalta®), a medication that is already FDA approved for the treatment of depression,
fibromyalgia, diabetic peripheral neuropathic pain and generalized anxiety disorder may
also be helpful in the management of some kinds of pain caused by multiple sclerosis.
Some patients will receive a placebo (a capsule that contains no active medication),
others will receive active medication.
Main Eligibility Requirements:
-Must be 18 years or older.
-Diagnosed with MS for at least 1 year.
-Have been experiencing nerve pain (numbness, tingling, burning, stabbing, shooting, prickly sensations) at least 4 days per week for the past 3 months.
-Are willing to make up to 6 office visits over the 5 months duration of the study.
-Stable on current pain meds for 1 month and willing to maintain that dose during the
study.
-Absence of relapse for 3 months.
-Stable on disease modifying therapy for 3 months.
-No previous treatment with duloxetine.
-No elective surgery planned during the course of the study.
Additional Sponsor Information:
Patients can go to the following website: http://www.mspainstudy.com/ for more information and to see if they qualify for the study.
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Title: A Phase III, randomized, double-blind, placebo-controlled, multicenter
clinical trial of oral cladribine in subjects with a first clinical event at high risk of
converting to multiple sclerosis.
Purpose: To study the effectiveness, safety, and tolerability of high-dose and low-dose
oral cladribine (cladribine tablets) versus placebo (tablets containing no active
medication) in the treatment of clinically isolated syndrome.
Main Eligibility Requirements:
1. Between 18 and 55 years old.
2. Has experienced a single, first clinical event suggestive of MS within 75 days.
3. Has no medical history or evidence of latent tuberculosis infection or active
tubercular disease.
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Title: A randomized, double-blind, placebo-controlled, escalating-dose study to
assess the safety, tolerability, pharmacokinetics and pharmacodynamics of
CS-0777, administered for 12 Weeks, in patients with multiple sclerosis.
Purpose: This is an early phase study designed to test the safety of the compound
CS-0777. This is one of the steps necessary before conducting a large clinical trial
to determine if the agent CS-0777 is beneficial in MS.
Main Eligibility Requirements:
- 18-65 years old with a diagnosis of clinically isolated syndrome or a relapsing
form of multiple sclerosis.
-Willing to have up to 13 study visits with 2 potential overnight stays required
at the Rocky Mountain MS Center at Anschutz Medical Campus in Aurora, CO.
-Not currently taking an FDA-approved MS medication or investigational MS medication.
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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.
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The following study does not take place 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
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