NCT00103974

Brief Summary

This research study is being done to evaluate the safety of BHT-3009 alone and when combined with atorvastatin (Lipitor) in patients with multiple sclerosis (MS).

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P50-P75 for phase_1 multiple-sclerosis

Timeline
Completed

Started Jul 2004

Geographic Reach
2 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2004

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 17, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 18, 2005

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
Last Updated

April 7, 2008

Status Verified

February 1, 2008

First QC Date

February 17, 2005

Last Update Submit

April 4, 2008

Conditions

Multiple Sclerosis

Keywords

multiple sclerosisrelapsing-remittingsecondary progressive

Outcome Measures

Primary Outcomes (2)

  • Evaluate safety of BHT-3009 alone and when combined with atorvastatin in patients with multiple sclerosis.

  • Determine dose of BHT-3009 and regimen for phase II testing.

Secondary Outcomes (3)

  • Describe effect of treatment on antibody and T cell responses to myelin basic protein (MBP).

  • Describe clinical course of treated patients.

  • Explore biomarkers of MS activity

Interventions

BHT-3009-01BIOLOGICAL

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Definite diagnosis of multiple sclerosis by the McDonald criteria.
  • Patients with relapsing remitting MS or secondary progressive MS are eligible.
  • gadolinium enhancing (Gd+) lesions on the first Screening MRI or relapse in the previous 2 years, or disease worsening in the previous 2 years
  • Clinically stable for \> 1 month before screening evaluation and during screening. Patients who are stable on approved therapy are eligible only if they have intolerable side effects or other medical reasons for discontinuing approved therapy.
  • Off interferon for \> 1 month before screening evaluation.
  • Off immunosuppressive and cytotoxic therapy (e.g. mitoxantrone, cladrabine) \>12 months or \> 6 months with CD4 count \> 400.
  • EDSS ≥ 2.5 and \< 7.0.
  • Female or male, age \> 18 years.
  • Able to give informed consent.
  • WBC and platelets in normal range, hemoglobin \> 10.0 g/dl.
  • AST, ALT, bilirubin \< upper limit of normal.
  • Creatinine \< upper limit of normal.
  • CPK \< upper limit of normal.

You may not qualify if:

  • High-dose corticosteroids (e.g. \>500 mg methylprednisolone or equivalent) within previous month.
  • \>5 Gd+ lesions on the first Screening MRI.
  • Previous vaccine therapy, stem cell transplantation or total lymphoid radiation.
  • Glatiramer within previous 12 months.
  • Treatment with any statin in the previous 6 months or elevated cholesterol that requires treatment with a statin.
  • Pregnant or lactating women.
  • Unwilling to use a medically acceptable form of birth control.
  • History of positive test for HIV, hepatitis B or hepatitis C.
  • Clinically significant ECG abnormalities.
  • 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 pacemakers, defibrillators or other metallic objects on or inside the body that limit performing MRI scans.
  • History of intolerable adverse events with statin therapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Barrow Neurology Clinics

Phoenix, Arizona, 85013, United States

Location

USC, LAC & USC Medical Center

Los Angeles, California, 90033, United States

Location

University of British Columbia, MS Research

Vancouver, British Columbia, V6T 2B5, Canada

Location

Montreal Neurological Institute, Clinical Research Unit and MS clinic

Montreal, Quebec, H3A 2B4, Canada

Location

Related Publications (1)

  • Bar-Or A, Vollmer T, Antel J, Arnold DL, Bodner CA, Campagnolo D, Gianettoni J, Jalili F, Kachuck N, Lapierre Y, Niino M, Oger J, Price M, Rhodes S, Robinson WH, Shi FD, Utz PJ, Valone F, Weiner L, Steinman L, Garren H. Induction of antigen-specific tolerance in multiple sclerosis after immunization with DNA encoding myelin basic protein in a randomized, placebo-controlled phase 1/2 trial. Arch Neurol. 2007 Oct;64(10):1407-15. doi: 10.1001/archneur.64.10.nct70002. Epub 2007 Aug 13.

    PMID: 17698695DERIVED

Related Links

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Frank Valone, MD

    Bayhill Therapeutics

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 17, 2005

First Posted

February 18, 2005

Study Start

July 1, 2004

Study Completion

March 1, 2007

Last Updated

April 7, 2008

Record last verified: 2008-02

Locations

CA(2)US(2)