Multiple SclerosisPhase 1NCT00103974
Immunotherapy With BHT-3009 Alone or Combined With Atorvastatin in Patients With Multiple Sclerosis
A Phase 1 study testing BHT-3009-01 in people with Multiple Sclerosis, run by Bayhill Therapeutics at 4 sites in 2 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- BHT-3009-01
- How many people
- 30 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Jul 2004to Mar 2007
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Definite diagnosis of multiple sclerosis by the McDonald criteria.
- Patients with relapsing remitting MS or secondary progressive MS are eligible.
- 1-5 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United States2 sites
USC, LAC & USC Medical Center
Los Angeles, California, 90033
Barrow Neurology Clinics
Phoenix, Arizona, 85013
Canada2 sites
Montreal Neurological Institute, Clinical Research Unit and MS clinic
Montreal, Quebec, H3A 2B4
University of British Columbia, MS Research
Vancouver, British Columbia, V6T 2B5
About this study
Official title: A Phase I Trial of Immunotherapy With BHT-3009 Alone or Combined With Atorvastatin in Patients With Multiple Sclerosis
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).
Read the detailed description
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).
Patients with MS are thought to have an immune response that attacks certain proteins in the brain, including myelin basic protein. (Myelin basic protein is a protein that makes up part of the outside layer of nerve cells.) BHT-3009 is an investigational immunotherapy product that is designed to alter the immune response to myelin basic protein and make the response less harmful. BHT-3009 contains the DNA (gene) for myelin basic protein.
Three different doses of BHT-3009 will be tested to determine if there are any differences in safety or effects on immunity. This is the first clinical research study of BHT-3009. Laboratory studies have shown that BHT-3009 and atorvastatin given together alters the immune response to myelin basic protein and makes the response less harmful.
- Conditions
- Multiple Sclerosis
- Being tested
- BHT-3009-01
- Keywords
- multiple sclerosis, relapsing-remitting, secondary progressive
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BHT-3009-01Biological
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2005 (estimated)
- Study startJul 2004
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- Bayhill Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Frank Valone, MD, Study director, Bayhill Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00103974
- Sponsor's protocol ID
- BHT-3009-01
- Status last verified
- Feb 2008
- First submitted
- 17 Feb 2005
- Last updated
- 7 Apr 2008
- Results posted
- No
Publications
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.
PubMed 17698695
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Trial of Immunotherapy With BHT-3009 Alone or Combined With Atorvastatin in Patients With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT00103974
- Acronym / sponsor ID
- BHT-3009-01
- Conditions
- Multiple Sclerosis
- Keywords
- multiple sclerosis, relapsing-remitting, secondary progressive
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants
- Lead sponsor
- Bayhill TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Jul 2004
- Study completion
- Mar 2007
- First posted
- 18 Feb 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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).
Patients with MS are thought to have an immune response that attacks certain proteins in the brain, including myelin basic protein. (Myelin basic protein is a protein that makes up part of the outside layer of nerve cells.) BHT-3009 is an investigational immunotherapy product that is designed to alter the immune response to myelin basic protein and make the response less harmful. BHT-3009 contains the DNA (gene) for myelin basic protein.
Three different doses of BHT-3009 will be tested to determine if there are any differences in safety or effects on immunity. This is the first clinical research study of BHT-3009. Laboratory studies have shown that BHT-3009 and atorvastatin given together alters the immune response to myelin basic protein and makes the response less harmful.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Definite diagnosis of multiple sclerosis by the McDonald criteria.
- Patients with relapsing remitting MS or secondary progressive MS are eligible.
- 1-5 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BHT-3009-01 | Biological | – |
Primary outcome
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.
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2008.
- Derived from this study: PubMed 17698695Bar-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frank Valone, MD study director
Bayhill Therapeutics
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BHT-3009-01 in people with Multiple Sclerosis, run by Bayhill Therapeutics at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate safety of BHT-3009 alone and when combined with atorvastatin in patients with multiple sclerosis.. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00103974, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2008.