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Evaluation of an Altered Peptide Ligand (NBI-5788) in Patients with Relapsing Multiple Sclerosis (MS) Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for proven healthcare advice, travels to or treatment by using a genuine medical doctor. We are not physicians. Always confer with your doctor on Evaluation of an Altered Peptide Ligand (NBI-5788) in Patients with Relapsing Multiple Sclerosis (MS) conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Evaluation of an Altered Peptide Ligand (NBI-5788) in Patients with Relapsing Multiple Sclerosis (MS) Clinical research trials and Evaluation of an Altered Peptide Ligand (NBI-5788) in Patients with Relapsing Multiple Sclerosis (MS) healthcare trials take place in many of cities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectiveness of new drugs. The function of the studies / undertakings is to answer specific human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector companies to find treatments for all forms of conditions, including Evaluation of an Altered Peptide Ligand (NBI-5788) in Patients with Relapsing Multiple Sclerosis (MS). Evaluation of an Altered Peptide Ligand (NBI-5788) in Patients with Relapsing Multiple Sclerosis (MS) Clinical Trials and other clinical trials allow for volunteers to access medical treatment alternatives before they are available to the masses. Many times the test subjects undergo treatment for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Evaluation of an Altered Peptide Ligand (NBI-5788) in Patients with Relapsing Multiple Sclerosis (MS) clinical trial. Test subjects oftentimes recieve the best healthcare possible for their Evaluation of an Altered Peptide Ligand (NBI-5788) in Patients with Relapsing Multiple Sclerosis (MS) condition. Hazards are a reality, nonetheless, and might include additional or frequent doctor trips, healthcare hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "E" Clinical Trials Conditions > Evaluation of an Altered Peptide Ligand (NBI-5788) in Patients with Relapsing Multiple Sclerosis (MS)  Evaluation of an Altered Peptide Ligand (NBI-5788) in Patients with Relapsing Multiple Sclerosis (MS)
Evaluation of an Altered Peptide Ligand (NBI-5788) in Patients with Relapsing Multiple Sclerosis (MS)
For Condition: Multiple Sclerosis
Status: Recruiting
Sponsor(s): Neurocrine Biosciences , Immune Tolerance Network
Synopsis: We are studying this investigational drug treatment, comparing it with placebo, to evaluate whether it is effective in reducing the number of MRI lesions with a minimum number of side effects. The investigational drug will be administered in the clinic weekly for 5 injections (induction phase) then monthly for 8 additional injections (maintenance phase). Approximately 150 male and female patients (100 active and 50 placebo), aged 18 to 55 years, with relapsing MS and at least one but no more than 10 total Gd-enhancing lesions on cranial MRI scans during the run-in phase will be randomized into this study.
Details: This is a multicenter, randomized, double-blind, placebo-controlled trial in which qualifying patients will be randomized 2:1 to receive active drug or placebo. Eligible patients must have MS with relapse, have had one or more relapses during the prior 2 years, 1-10 gadolinium (Gd)-enhancing lesions on the Run-in MRI, and an EDSS of 6.5 or less. There are exclusions for certain prior MS treatments and medical / psychiatric conditions. Following a 4-week run-in phase in which patients will have a baseline MRI, patients will enter a 4 week induction phase, during which they will be receive injections weekly (5 doses), then a 32-week maintenance phase during which injections are monthly (8 doses). A final follow-up visit will be conducted 4 weeks after the last injection. The primary efficacy parameter is a summary change score of the mean number of total Gd-enhancing lesions at weeks 36 and 40 minus the mean number for the two baseline scans. Safety monitoring will include AE/SAE reporting, physical exams, vital signs, ECG. CXR, laboratory tests, neurologic evaluations, and systemic hypersensitivity and injection site assessments. All study medications will be administered by study personnel and patients will remain under observation for a minimum of 2 hours post-injection. An independent Data Safety and Monitoring Board will oversee the safety of the trial.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/55 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: - Male or female, 18 to 55 years of age - Diagnosed with relapsing multiple sclerosis, with at least one relapse in the last two years - Females must not plan on becoming pregnant - Females must either be post-menopausal, surgically incapable of bearing children, or practicing an acceptable method of birth control and willing to continue birth control until 30 days after the last dose of study drug - Males must not intend to impregnate a partner during the study or for 30 days after the study and must also practice acceptable birth control with their partners Exclusion Criteria: - Significant long-lasting disease of the immune system other than multiple sclerosis - Past or current medical disease (heart, liver, kidney, etc.) including severe asthma, cancer or advancing brain or spinal cord disorder - Known or suspected long-lasting infectious disease including HIV, hepatitis B, or hepatitis C - Treatment with certain steroid or hormone medications within 30 days before the pre-study MRI scan - Treatment with other medications that suppress the immune system within 6 months before the pre-study MRI scan - Certain treatments and medications are not allowed - Laboratory and other tests will be performed to determine further eligibility - History of drug or alcohol abuse in the last year - History of medical or psychiatric condition that could pose a risk for participation in the study - Females who are pregnant or breast feeding - Participation in any other trial of an investigational agent within 90 days before the start of the study - History of not following instructions with past therapy.
Total Enrollment: 150
Location and Contact Information:
Overall Study Official:
MichaelSkinner, Study Director, Neurocrine Biosciences
Henry Ford Hospital and Health System *Recruiting*
Detroit, Michigan, 48202
United States
Recruiting Toll Info Line 800-972-2505
Foothills Medical Centre *Recruiting*
Calgary, Alberta, T2N 2T9
Canada
Recruiting Toll Info Line 1-800-972-2505
University of Kansas Medical Center *Recruiting*
Kansas City, Kansas, 66160
United States
Recruiting Toll Info Line 800-972-2505
North Texas Neurology *Recruiting*
Wichita Falls, Texas, 76301
United States
Recruiting Toll Info Line 800-972-2505
Indiana University *Recruiting*
Indianapolis, Indiana, 46202
United States
Recruiting Toll Info Line 800-972-2505
Washington University MS Center *Recruiting*
St. Louis, Missouri, 63110
United States
Recruiting Toll Info Line 800-972-2505
University of Pennsylvania MS Center *Recruiting*
Philadelphia, Pennsylvania, 19104
United States
Recruiting Toll Info Line 800-972-2505
Texas Neurology *Recruiting*
Dallas, Texas, 75214
United States
Recruiting Toll Info Line 800-972-2505
Multiple Sclerosis Institute *Recruiting*
Philadelphia, Pennsylvania, 19146
United States
Recruiting Toll Info Line 800-972-2505
University of British Columbia *Recruiting*
Vancouver, British Columbia, V6T 2B5
Canada
Recruiting Toll Info Line 1-800-972-2505
Montreal Neurological Institute *Recruiting*
Montreal, Quebec, H3A 2B4
Canada
Recruiting Toll Info Line 1-800-972-2505
Barrow Neurological Institute *Recruiting*
Phoenix, Arizona, 85013
United States
Recruiting Toll Info Line 800-972-2505
University of California at Irvine *Recruiting*
Irvine, California, 92697
United States
Recruiting Toll Info Line 800-972-2505
Sheperd Center *Recruiting*
Atlanta, Georgia, 30309
United States
Recruiting Toll Info Line 800-972-2505
UC Davis *Recruiting*
Sacramento, California, 95817
United States
Recruiting Toll Info Line 800-972-2505
Integra Clinical Research *Recruiting*
San Antonio, Texas, 78229
United States
Recruiting Toll Info Line 800-972-2505
University of Washington *Recruiting*
Seattle, Washington, 98195
United States
Recruiting Annette Wundes 206-616-7104
Yale Center for MS Treatment and Research *Recruiting*
New Haven, Connecticut, 06510
United States
Recruiting Toll Info Line 800-972-2505
University of New Mexico *Recruiting*
Albuquerque, New Mexico, 87131
United States
Recruiting Toll Info Line 800-972-2505
Dalhousie Multiple Sclerosis Research Unit *Recruiting*
Halifax, Nova Scotia, B3H 1V7
Canada
Recruiting Toll Info Line 1-800-972-2505
The Ottawa Hospital - General Campus *Recruiting*
Ottawa, Ontario, K1H 8L6
Canada
Recruiting Toll Info Line 1-800-972-2505
Wake Forest University *Recruiting*
Winston Salem, North Carolina, 27157
United States
Recruiting Toll Info Line 800-972-2505
Stony Brook University Hospital *Recruiting*
Stony Brook, New York, 11794
United States
Recruiting Toll Info Line 800-972-2505
Ohio State University *Recruiting*
Columbus, Ohio, 43210
United States
Recruiting Toll Info Line 800-972-2505
Additional Information:
Study ID Numbers: NBI-5788-0201; Neurocrine,MS APL
Study Start Date: July 2003
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00079495
Other Multiple Sclerosis Studies:
1. Treatment of Multiple Sclerosis with Copaxone and Albuterol
2. A 48-Week (24-Week Baseline Followed by a 24-Week Treatment) Phase II Pilot Study of the Tolerability and Effect/Efficacy of Subcutaneously Administered Insulin-Like Growth Factor-1 (rhIGF) (CEP-151) in Multiple Sclerosis (MS) Patients
3. Phase I Pilot Study of Total-Body Irradiation, Anti-Thymocyte Globulin and Cyclophosphamide Followed By Syngeneic or Autologous Peripheral Blood Stem Cell Transplantation in Patients With Multiple Sclerosis
4. Safety testing of AVP-923 in the Treatment of Emotional Lability (Uncontrolled Laughter & Crying)
5. Induction Therapy with a Single High Dose Bolus of Intravenous Methotrexate with Leucovorin Rescue, Prior to Initiation of AVONEX® Treatment, in Patients Presenting with a First Acute Demyelinating Event.
Related Studies:
Other Multiple Sclerosis Clinical Trials
Other Ohio Clinical Trials
Other Columbus Clinical Trials
Evaluation of an Altered Peptide Ligand (NBI-5788) in Patients with Relapsing Multiple Sclerosis (MS)
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