BHT-3009 Immunotherapy in Relapsing Remitting Multiple Sclerosis

BHT-3009 Immunotherapy in Relapsing Remitting Multiple Sclerosis

CompletedPhase 2Relapsing MSNCT003826292005-001340-22

What it found

No results found

We found no results in the registry or in papers.

This trial finished 19 years ago. We found no results in the registry or in any paper that cites it.

What was tested

Treatment tested

  • BHT-3009 0.5 mg
  • BHT-3009 1.5 mg
  • BHT-3009

Placebo

  • Placebo

What it measured

Main measures

  • 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.

    MRI lesions

  • - The primary endpoint is the mean four-week rate of occurrence of new Gd-enhancing lesions on the cranial MRIs performed every 4 weeks from Week 28 through Week 48 (6 MRIs).

    MRI lesions

Other measures (4)

  • Evaluate the safety and tolerability of intramuscular injections of BHT-3009 given for a total of one year.

    Safety

  • Evaluate the effect of BHT-3009 on other cranial MRI measures.

    MRI lesions

  • Describe the effect of BHT-3009 therapy on relapse rate.

    Relapses

  • Describe the effect of BHT-3009 on subject disability scores.

Who could take part

Relapsing MS · 18 to 55 · EDSS 0 to 3.5

Show the full criteria

Inclusion criteria

1. Definite diagnosis of multiple sclerosis by the McDonald criteria. 2. Screening cranial MRI demonstrating lesions consistent with MS. 3. One or more relapses within the previous year. 4. Clinically stable (no relapses) for > 50 days before beginning screening procedures and during the screening period. 5. EDSS 0 to 3.5 inclusive. 6. Age > 17 years and \< 56 years. 7. Willing and able to give informed consent. 8. WBC >3,000; platelets >100,000; hemoglobin > 10.0 g/dl. 9. AST, ALT, bilirubin \< 2.0 x upper limit of normal. 10. Creatinine \< 2.0 x upper limit of normal. 11. Negative test for HIV.

Exclusion criteria

1. Primary progressive, secondary progressive or progressive relapsing MS. 2. More than 5 gadolinium-enhancing lesions on the first screening MRI. 3. 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. 4. Previous stem cell transplantation, total lymphoid radiation, or cytotoxic therapy. 5. Treatment with interferon, glatiramer acetate or other approved disease-modifying agent for > 180 days (lifetime total of all agents). 6. Treatment with an approved disease modifying agent within 180 days of beginning screening procedures. 7. Previous treatment of MS with an experimental agent including off-label use of approved drugs. (Allowed with approval of the Medical Monitor.) 8. Prior therapy with natalizumab (Tysabri). 9. Pregnant or lactating women. 10. Unwilling to use a medically acceptable form of birth control (e.g. hormonal contraception, intrauterine device, double barriers, sterilization of self or partner). 11. Clinically significant ECG abnormalities (e.g. acute ischemia or life-threatening arrhythmia). 12. Medical condition or social circumstances that would in the opinion of the investigator prevent full participation in the trial or evaluation of study endpoints. 13. Implanted pace makers, defibrillators or other metallic objects on or inside the body that limit performing MRI scans. 14. Known hypersensitivity or allergy to gadolinium.

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

The purpose of this study is to determine if BHT-3009 decreases inflammation (measured by gadolinium enhancing MRI lesions) in the brains of people with relapsing remitting multiple sclerosis.

Papers

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    History

      1. Started

        Feb 2006

      2. Finished

        Jun 2007

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