- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00382629
BHT-3009 Immunotherapy in Relapsing Remitting Multiple Sclerosis
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
People with multiple sclerosis are thought to have abnormal immunity. Usually the body's immune system attacks only foreign substances, but people with MS have abnormal immunity, where the immune system attacks normal proteins, one of which is a protein found in the brain called MBP (myelin basic protein). This abnormal immunity causes inflammation in the brain resulting in nerve damage. BHT-3009 is a drug that is designed to decrease this abnormal immunity to MBP. BHT-3009 is a DNA plasmid that contains the gene for MBP. Plasmids are circular pieces of DNA that are being tested in clinical trials for their ability to alter patients' immune systems. Two different doses of BHT-3009 will be tested to determine if there are any differences in their safety or effects on inflammation.
Treatment in this study is 3 doses every two weeks for 6 weeks, followed by a dose every 4 weeks for a total of 13 doses in 44 weeks.
Study Type
Enrollment
Phase
- Phase 2
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Definite diagnosis of multiple sclerosis by the McDonald criteria.
- Screening cranial MRI demonstrating lesions consistent with MS.
- One or more relapses within the previous year.
- Clinically stable (no relapses) for > 50 days before beginning screening procedures and during the screening period.
- EDSS 0 to 3.5 inclusive.
- Age > 17 years and < 56 years.
- Willing and able to give informed consent.
- WBC >3,000; platelets >100,000; hemoglobin > 10.0 g/dl.
- AST, ALT, bilirubin < 2.0 x upper limit of normal.
- Creatinine < 2.0 x upper limit of normal.
- Negative test for HIV.
Exclusion Criteria:
- Primary progressive, secondary progressive or progressive relapsing MS.
- More than 5 gadolinium-enhancing lesions on the first screening MRI.
- High-dose corticosteroids (e.g. > 500 mg methylprednisolone or equivalent per day for 3 or more days) within 50 days prior to beginning screening procedures.
- Previous stem cell transplantation, total lymphoid radiation, or cytotoxic therapy.
- Treatment with interferon, glatiramer acetate or other approved disease-modifying agent for > 180 days (lifetime total of all agents).
- Treatment with an approved disease modifying agent within 180 days of beginning screening procedures.
- Previous treatment of MS with an experimental agent including off-label use of approved drugs. (Allowed with approval of the Medical Monitor.)
- Prior therapy with natalizumab (Tysabri).
- Pregnant or lactating women.
- Unwilling to use a medically acceptable form of birth control (e.g. hormonal contraception, intrauterine device, double barriers, sterilization of self or partner).
- Clinically significant ECG abnormalities (e.g. acute ischemia or life-threatening arrhythmia).
- Medical condition or social circumstances that would in the opinion of the investigator prevent full participation in the trial or evaluation of study endpoints.
- Implanted pace makers, defibrillators or other metallic objects on or inside the body that limit performing MRI scans.
- Known hypersensitivity or allergy to gadolinium.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Evaluate the effect of BHT-3009 on the mean four-week rate of occurrence of new gadolinium (Gd) enhancing MRI lesions in relapsing remitting MS.
|
Secondary Outcome Measures
Outcome Measure |
---|
Evaluate the safety and tolerability of intramuscular injections of BHT-3009 given for a total of one year.
|
Evaluate the effect of BHT-3009 on other cranial MRI measures.
|
Describe the effect of BHT-3009 therapy on relapse rate.
|
Describe the effect of BHT-3009 on subject disability scores.
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Nervous System Diseases
- Immune System Diseases
- Demyelinating Autoimmune Diseases, CNS
- Autoimmune Diseases of the Nervous System
- Demyelinating Diseases
- Autoimmune Diseases
- Multiple Sclerosis
- Sclerosis
- Multiple Sclerosis, Relapsing-Remitting
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Protective Agents
- Antioxidants
- Butylated Hydroxytoluene
Other Study ID Numbers
- BHT-3009-03
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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