Relapsing-Remitting Multiple SclerosisPhase 2TERMSNCT00245622
Autologous T Cell Vaccine (TCV) for Multiple Sclerosis
A Phase 2 study testing Tovaxin Autologous T cell vaccine in people with Relapsing-Remitting Multiple Sclerosis, run by Opexa Therapeutics, Inc. at 33 sites in United States.
Trial summary
This is a 1 year study to evaluate the efficacy, safety, and tolerability of Tovaxin T cell therapy in subjects with a clinically isolated syndrome (CIS) and relapse-remitting multiple sclerosis (RR-MS). Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Relapsing-Remitting Multiple Sclerosis
- What is being tested?
- Tovaxin Autologous T cell vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 33 sitesUnited States
- Study dates
- May 2006to Sep 2008
- Phase
- Phase 2
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Aged 18 to 55 years old
- Presence of myelin reactive T cells at screening
- Diagnosis of CIS with screening MRI that fulfils the Barkhof criteria - dissemination in space
- Diagnosis of MS within the past 10 years according to the McDonald criteria (2005)
- Baseline EDSS score between 0 and 5.5 inclusively
Who cannot join
- Unable to produce T cell vaccine
- Disease-modifying treatment for MS during the last 30 days and 60 days for steroidal treatments
- Diagnosis of progressive-relapsing, secondary progressive, or primary progressive MS
- Planned pregnancy, currently pregnant, or breastfeeding
- Any prior treatment with total lymphoid irradiation, cladribine, T cell or T cell receptor vaccination
Trial locations and contacts
33 sites in 1 country.
33 sites in 1 country
United States33 sites
Neurology & Neuroscience Associates, Inc.
Akron, Ohio, 44302
Upstate Clinical Research, LLC
Albany, New York, 12205
Shepherd Center
Atlanta, Georgia, 30309
Medical College of Georgia - Department of Neurology
Augusta, Georgia, 30912
Alta Bates Summit Medical Center - East Bay Physicians Medical Group
Berkeley, California, 94705
Bradenton Neurology
Bradenton, Florida, 34205
Capitol Neurology
Charleston, West Virginia, 25301
Neurology Consultants of the Carolinas, PA
Charlotte, North Carolina, 28204
Patricia A Fodor, PC
Colorado Springs, Colorado, 80919
Neurological Research Institute
Columbus, Ohio, 43221
North Central Neurology Associates, PC
Cullman, Alabama, 35058
Neurology Specialists, Inc
Dayton, Ohio, 45408
Allied Physicians Inc
Fort Wayne, Indiana, 46805
The Maxine Mesinger MS Clinic/Baylor College of Medicine
Houston, Texas, 77030
MS Center at Evergreen
Kirkland, Washington, 98101
Research Nurse Specialists
Lafayette, Louisiana, 70503
Ayres & Associates Clinical Trials
Lebanon, New Hampshire, 03766
MidAmerica Neuroscience Institute
Lenexa, Kansas, 66214
Associates in Neurology
Lexington, Kentucky, 40503
University of Louisville Hospital
Louisville, Kentucky, 40202
Winthrop University Hospital - Clinical Trials Unit
Mineola, New York, 11501
Consultants in Neurology, Ltd.
Northbrook, Illinois, 60062
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Xenoscience - 21st Century Neurology
Phoenix, Arizona, 85013
HOPE Research Institute
Phoenix, Arizona, 85050
Neurological Associates
Pompano Beach, Florida, 33060
Providence St. Vincent Medical Center - Northwest MS Center
Portland, Oregon, 97225
Raleigh Neurology Associates
Raleigh, North Carolina, 27607
Central Texas Neurology
Round Rock, Texas, 78681
St Mary's of Michigan - Field Neuroscience Institute
Saginaw, Michigan, 48604
Integra Clinical Research, LLC
San Antonio, Texas, 78229
Lovelace Scientific Resources
Sarasota, Florida, 34233
University Hospital and Medical Center Stony Brook New York
Stony Brook, New York, 11794-8121
About this study
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Subcutaneous Tovaxin in Subjects With CIS or RR-MS
This is a 1 year study to evaluate the efficacy, safety, and tolerability of Tovaxin T cell therapy in subjects with a clinically isolated syndrome (CIS) and relapse-remitting multiple sclerosis (RR-MS).
Read the detailed description
A 2 arm, 52 week parallel-group of Tovaxin versus placebo in subjects with CIS or RR-MS. Subjects who provide written, informed consent will complete screening and procurement assessments and provide blood to be used for vaccine production. Eligible subjects will be enrolled to receive either Tovaxin or placebo and will complete baseline assessments. Randomization and enrolled subjects will receive study treatment by subcutaneous injections at weeks 0, 4, 8, 12, and 24. Subjects will be monitored by CBC, serum chemistries, urinalysis, Expanded Disability Status Scale (EDSS), MSFC, MSQLI, magnetic resonance imaging (MRI), and monitor myelin reactive T cells for safety, efficacy, and tolerability of Tovaxin.
- Conditions
- Relapsing-Remitting Multiple Sclerosis
- Being tested
- Tovaxin Autologous T cell vaccine, Placebo
- Keywords
- Phase 2b Tovaxin, Clinically Isolated Syndrome (CIS), Relapse-Remitting Multiple Sclerosis (RR-MS)
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tovaxin Autologous T cell vaccineBiological
subcutaneous injections administered by healthcare provider at weeks 0, 4, 8, 12, and 24
PlaceboBiological
subcutaneous injections administered by healthcare provider at weeks 0, 4, 8, 12, and 24
| Study group | Role | What they receive |
|---|---|---|
| Tovaxin Autologous T cell vaccine | Experimental | 2.0 mL subcutaneous formulated with 30-45 million autologous myelin reactive T cells Receives: Biological: Tovaxin Autologous T cell vaccine |
| Placebo | Placebo comparator | 2.0 mL subcutaneous injections without autologous myelin reactive T cells Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the efficacy, safety, and tolerability of Tovaxin TCV in subjects with CIS or RR-MS
Measured: 1 year
Secondary outcomes (1)
To evaluate biomarkers of efficacy of Tovaxin TCV and effects of Tovaxin TCV on epitope spreading
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2005 (estimated)
- Study startMay 2006
- Primary completionSep 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Relapsing-Remitting 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Opexa Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Edward J Fox, M.D., Ph.D., Study chair, Central Texas Neurology ConsultantsJaye Thompson, Ph.D., Study director, Opexa Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00245622
- Sponsor's protocol ID
- 2005-00
- Acronym
- TERMS
- Status last verified
- Feb 2014
- First submitted
- 20 Oct 2005
- Last updated
- 10 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Fox E, Markowitz C, Cohan S, Wynn D. TERMS Trial TCV Secondary Analysis of Clinical and Immunological Outcoms in Patients with Relapsing Remitting MS. Poster presentation P06.132 at the 61st Annual Meeting of the American Academy of Neurology (AAN) on 01 May 2009.
Fox E, Wynn D, Cohan S, Rill D, McGuire D, Markowitz C. A randomized clinical trial of autologous T-cell therapy in multiple sclerosis: subset analysis and implications for trial design. Mult Scler. 2012 Jun;18(6):843-52. doi: 10.1177/1352458511428462. Epub 2011 Nov 6.
PubMed 22065170
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Subcutaneous Tovaxin in Subjects With CIS or RR-MS
- ClinicalTrials.gov ID
- NCT00245622
- Acronym / sponsor ID
- TERMS / 2005-00
- Conditions
- Relapsing-Remitting Multiple Sclerosis
- Keywords
- Phase 2b Tovaxin, Clinically Isolated Syndrome (CIS), Relapse-Remitting Multiple Sclerosis (RR-MS)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Opexa Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2006
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 28 Oct 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 is a 1 year study to evaluate the efficacy, safety, and tolerability of Tovaxin T cell therapy in subjects with a clinically isolated syndrome (CIS) and relapse-remitting multiple sclerosis (RR-MS).
Detailed description
A 2 arm, 52 week parallel-group of Tovaxin versus placebo in subjects with CIS or RR-MS. Subjects who provide written, informed consent will complete screening and procurement assessments and provide blood to be used for vaccine production. Eligible subjects will be enrolled to receive either Tovaxin or placebo and will complete baseline assessments. Randomization and enrolled subjects will receive study treatment by subcutaneous injections at weeks 0, 4, 8, 12, and 24. Subjects will be monitored by CBC, serum chemistries, urinalysis, Expanded Disability Status Scale (EDSS), MSFC, MSQLI, magnetic resonance imaging (MRI), and monitor myelin reactive T cells for safety, efficacy, and tolerability of Tovaxin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tovaxin Autologous T cell vaccine | Experimental | Biological: Tovaxin Autologous T cell vaccine2.0 mL subcutaneous formulated with 30-45 million autologous myelin reactive T cells |
| Placebo | Placebo comparator | Biological: Placebo2.0 mL subcutaneous injections without autologous myelin reactive T cells |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Aged 18 to 55 years old
- Presence of myelin reactive T cells at screening
- Diagnosis of CIS with screening MRI that fulfils the Barkhof criteria - dissemination in space
- Diagnosis of MS within the past 10 years according to the McDonald criteria (2005)
- Baseline EDSS score between 0 and 5.5 inclusively
Key exclusion criteria (5 listed)
- Unable to produce T cell vaccine
- Disease-modifying treatment for MS during the last 30 days and 60 days for steroidal treatments
- Diagnosis of progressive-relapsing, secondary progressive, or primary progressive MS
- Planned pregnancy, currently pregnant, or breastfeeding
- Any prior treatment with total lymphoid irradiation, cladribine, T cell or T cell receptor vaccination
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 |
|---|---|---|
| Tovaxin Autologous T cell vaccinesubcutaneous injections administered by healthcare provider at weeks 0, 4, 8, 12, and 24 | Biological | Tovaxin Autologous T cell vaccine |
| Placebosubcutaneous injections administered by healthcare provider at weeks 0, 4, 8, 12, and 24 | Biological | Placebo |
Primary outcome
To evaluate the efficacy, safety, and tolerability of Tovaxin TCV in subjects with CIS or RR-MS
Time frame: 1 year
1 secondary outcome
To evaluate biomarkers of efficacy of Tovaxin TCV and effects of Tovaxin TCV on epitope spreading
Time frame: 1 year
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 10 Mar 2014.
- Results publicationFox E, Markowitz C, Cohan S, Wynn D. TERMS Trial TCV Secondary Analysis of Clinical and Immunological Outcoms in Patients with Relapsing Remitting MS. Poster presentation P06.132 at the 61st Annual Meeting of the American Academy of Neurology (AAN) on 01 May 2009.
- Derived from this study: PubMed 22065170Fox E, Wynn D, Cohan S, Rill D, McGuire D, Markowitz C. A randomized clinical trial of autologous T-cell therapy in multiple sclerosis: subset analysis and implications for trial design. Mult Scler. 2012 Jun;18(6):843-52. doi: 10.1177/1352458511428462. Epub 2011 Nov 6.
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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.
Edward J Fox, M.D., Ph.D. study chair
Central Texas Neurology Consultants
Jaye Thompson, Ph.D. study director
Opexa Therapeutics, Inc.
33 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tovaxin Autologous T cell vaccine in people with Relapsing-Remitting Multiple Sclerosis, run by Opexa Therapeutics, Inc. at 33 sites in United States.
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 5 inclusion and 5 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 10 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in United States. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
To evaluate the efficacy, safety, and tolerability of Tovaxin TCV in subjects with CIS or RR-MS (time frame: 1 year). 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 NCT00245622, which also lists 2 linked publications.
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 10 Mar 2014.