Multiple Sclerosis, Relapsing-RemittingPhase 2OLTERMSNCT00595920
Open Label Extension of Prior TERMS Study to Treat Relapsing Forms of Multiple Sclerosis
A Phase 2 study testing Tovaxin in people with Multiple Sclerosis, Relapsing-Remitting and Clinically Isolated Syndrome, run by Opexa Therapeutics, Inc. at 27 sites in United States.
Trial summary
The purpose of this study is to further evaluate the safety and efficacy of Tovaxin in the treatment of relapsing forms of multiple sclerosis. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Multiple Sclerosis, Relapsing-Remitting, Clinically Isolated Syndrome
- What is being tested?
- Tovaxin
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 27 sitesUnited States
- Study dates
- Nov 2007to Dec 2008
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subjects who completed the TERMS study and received at least 1 study treatment injection
- Signed and dated statement of informed consent
Who cannot join
- Pregnancy or breastfeeding
- Experienced a serious adverse drug reaction with confirmatory relationship to Tovaxin in the TERMS study.
- Withdrew from TERMS study and did not continue participating in the remaining 52-week core TERMS study assessments.
- Non-compliant with TERMS study.
- Diagnosis of progressive-relapsing, secondary progressive or primary progressive Multiple Sclerosis (MS) while enrolled in the TERMS study.
- Medical, psychiatric or other conditions that compromise the subject's ability to give informed consent, to understand the patient information, to comply with the study protocol, or to complete the study.
- Any significant change in the subject's medical condition after enrollment in the TERMS study which would have lead to his/her exclusion from participation in that study.
Trial locations and contacts
27 sites in 1 country.
27 sites in 1 country
United States27 sites
Neurology & Neuroscience Associates, Inc.
Akron, Ohio, 44302
Upstate Clinical Research, LLC
Albany, New York, 12205
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
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
Ayres & Associates Clinical Trials
Lebanon, New Hampshire, 03766
MidAmerica Neuroscience Institute
Lenexa, Kansas, 66214
Associates in Neurology
Lexington, Kentucky, 40503
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
About this study
Official title: An Open-Label Extension Study to Evaluate the Safety, Tolerability and Efficacy of Subcutaneous Tovaxin in Subjects Previously Treated in the TERMS Study 2005-00
The purpose of this study is to further evaluate the safety and efficacy of Tovaxin in the treatment of relapsing forms of multiple sclerosis.
Read the detailed description
The subjects with positive myelin-reactive T cells (MRTC) in their blood during the previous TERMS study will immediately be eligible for Tovaxin production and treatment in this open label extension study. The MRTC negative subjects will be monitored quarterly for safety, MRTC reactivity, paraclinical and clinical effect. Subjects who become MRTC positive during the monitoring phase will then be eligible for Tovaxin production and treatment in this study.
- Being tested
- Tovaxin
- Keywords
- Tovaxin, Autologous, T-cell vaccine (TCV)
- 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.
TovaxinBiological
Also called Autologous TCV, T Cell Vaccine
2 mL subcutaneous injections administered by a healthcare provider at weeks 0, 4, 8, 12, and 24 every year as required.
| Study group | Role | What they receive |
|---|---|---|
| Tovaxin, open-label | Experimental | Tovaxin; 30-45 million autologous myelin reactive T cells Receives: Biological: Tovaxin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate Changes in Number of Combined Unique Active Lesions on Brain Magnetic Resonance Imaging (MRI)
This extension study was discontinued due to financial constraints of the company. Of the 38 patients dosed, 32 did not complete all 5 doses. Of the 6 patients that completed the 5 doses, 5 patients did not have a Wk 52 MRI and therefore, no efficacy results are summarized as there is no comparison data.
Measured: Annually
Secondary outcomes (2)
Evaluate Changes in Rate and Severity of Multiple Sclerosis (MS) Progression
Measured: Annually
Evaluate Changes in Annualized Relapse Rate
Measured: Annually
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2008 (estimated)
- Study startNov 2007
- Primary completionDec 2008
- Study completionDec 2008
Why it stopped: Financial Constraints
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Multiple Sclerosis, Relapsing-RemittingStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Opexa Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Edward J Fox, MD, PhD, Principal investigator, Central Texas Neurology Consultants
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00595920
- Sponsor's protocol ID
- 2007-00
- Acronym
- OLTERMS
- Status last verified
- Feb 2014
- First submitted
- 3 Jan 2008
- Last updated
- 15 Mar 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Zhang J. T-cell vaccination in multiple sclerosis: immunoregulatory mechanism and prospects for therapy. Crit Rev Immunol. 2001;21(1-3):41-55.
PubMed 11642613Zhang JZ, Rivera VM, Tejada-Simon MV, Yang D, Hong J, Li S, Haykal H, Killian J, Zang YC. T cell vaccination in multiple sclerosis: results of a preliminary study. J Neurol. 2002 Feb;249(2):212-8. doi: 10.1007/pl00007867.
PubMed 11985389Zhang J. T-cell vaccination for autoimmune diseases: immunologic lessons and clinical experience in multiple sclerosis. Expert Rev Vaccines. 2002 Oct;1(3):285-92. doi: 10.1586/14760584.1.3.285.
PubMed 12901569
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Extension Study to Evaluate the Safety, Tolerability and Efficacy of Subcutaneous Tovaxin in Subjects Previously Treated in the TERMS Study 2005-00
- ClinicalTrials.gov ID
- NCT00595920
- Acronym / sponsor ID
- OLTERMS / 2007-00
- Keywords
- Tovaxin, Autologous, T-cell vaccine (TCV)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Financial Constraints
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Opexa Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2007
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 16 Jan 2008 (estimated)
- Results
- Posted 15 Mar 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to further evaluate the safety and efficacy of Tovaxin in the treatment of relapsing forms of multiple sclerosis.
Detailed description
The subjects with positive myelin-reactive T cells (MRTC) in their blood during the previous TERMS study will immediately be eligible for Tovaxin production and treatment in this open label extension study. The MRTC negative subjects will be monitored quarterly for safety, MRTC reactivity, paraclinical and clinical effect. Subjects who become MRTC positive during the monitoring phase will then be eligible for Tovaxin production and treatment in this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tovaxin, open-label | Experimental | Biological: TovaxinTovaxin; 30-45 million autologous myelin reactive T cells |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects who completed the TERMS study and received at least 1 study treatment injection
- Signed and dated statement of informed consent
Key exclusion criteria (7 listed)
- Pregnancy or breastfeeding
- Experienced a serious adverse drug reaction with confirmatory relationship to Tovaxin in the TERMS study.
- Withdrew from TERMS study and did not continue participating in the remaining 52-week core TERMS study assessments.
- Non-compliant with TERMS study.
- Diagnosis of progressive-relapsing, secondary progressive or primary progressive Multiple Sclerosis (MS) while enrolled in the TERMS study.
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 |
|---|---|---|
| TovaxinAlso: Autologous TCV, T Cell Vaccine2 mL subcutaneous injections administered by a healthcare provider at weeks 0, 4, 8, 12, and 24 every year as required. | Biological | Tovaxin, open-label |
Primary outcome
Evaluate Changes in Number of Combined Unique Active Lesions on Brain Magnetic Resonance Imaging (MRI)
Time frame: Annually
This extension study was discontinued due to financial constraints of the company. Of the 38 patients dosed, 32 did not complete all 5 doses. Of the 6 patients that completed the 5 doses, 5 patients did not have a Wk 52 MRI and therefore, no efficacy results are summarized as there is no comparison data.
2 secondary outcomes
Evaluate Changes in Rate and Severity of Multiple Sclerosis (MS) Progression
Time frame: Annually
Evaluate Changes in Annualized Relapse Rate
Time frame: Annually
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 11642613Zhang J. T-cell vaccination in multiple sclerosis: immunoregulatory mechanism and prospects for therapy. Crit Rev Immunol. 2001;21(1-3):41-55.
- Background: PubMed 11985389Zhang JZ, Rivera VM, Tejada-Simon MV, Yang D, Hong J, Li S, Haykal H, Killian J, Zang YC. T cell vaccination in multiple sclerosis: results of a preliminary study. J Neurol. 2002 Feb;249(2):212-8. doi: 10.1007/pl00007867.
- Background: PubMed 12901569Zhang J. T-cell vaccination for autoimmune diseases: immunologic lessons and clinical experience in multiple sclerosis. Expert Rev Vaccines. 2002 Oct;1(3):285-92. doi: 10.1586/14760584.1.3.285.
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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, MD, PhD principal investigator
Central Texas Neurology Consultants
27 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 in people with Multiple Sclerosis, Relapsing-Remitting and Clinically Isolated Syndrome, run by Opexa Therapeutics, Inc. at 27 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 2 inclusion and 7 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: stopped early, as of the sponsor's last update on 15 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 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. 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?
Yes. Results are posted in the registry (first posted 15 Mar 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Changes in Number of Combined Unique Active Lesions on Brain Magnetic Resonance Imaging (MRI) (time frame: Annually). 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 NCT00595920, which also lists 3 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 15 Mar 2016.