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Open Label Extension of Prior TERMS Study to Treat Relapsing Forms of Multiple Sclerosis (OLTERMS)

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ClinicalTrials.gov Identifier: NCT00595920
Recruitment Status : Terminated (Financial Constraints)
First Posted : January 16, 2008
Results First Posted : March 15, 2016
Last Update Posted : March 15, 2016
Sponsor:
Information provided by (Responsible Party):
Opexa Therapeutics, Inc.

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Multiple Sclerosis, Relapsing-Remitting
Clinically Isolated Syndrome
Intervention Biological: Tovaxin
Enrollment 116
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Open Label Extension
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30-45 million autologous myelin reactive T cells

Tovaxin: 2 mL subcutaneous injections administered by a healthcare provider at weeks 0, 4, 8, 12, and 24 every year as required.

Period Title: Overall Study
Started 116
Patients Dosed 38 [1]
Completed 0
Not Completed 116
Reason Not Completed
The OLTERMS study was discontinued by th             116
[1]
116 patients enrolled; however, only 38 received at least 1 dose.
Arm/Group Title Open Label Extension
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30-45 million autologous myelin reactive T cells

Tovaxin: 2 mL subcutaneous injections administered by a healthcare provider at weeks 0, 4, 8, 12, and 24 every year as required.

Overall Number of Baseline Participants 38
Hide Baseline Analysis Population Description
Randomized and received at least one dose.
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 38 participants
39.98
(21 to 57)
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants
<=18 years
0
   0.0%
Between 18 and 65 years
38
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants
Female
26
  68.4%
Male
12
  31.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 38 participants
38
1.Primary Outcome
Title Evaluate Changes in Number of Combined Unique Active Lesions on Brain Magnetic Resonance Imaging (MRI)
Hide Description 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.
Time Frame Annually
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
This extension study was discontinued due to financial constraints. No efficacy results are summarized due to the small number of patients who received full treatment and follow-up.
Arm/Group Title Open Label Extension
Hide Arm/Group Description:

30-45 million autologous myelin reactive T cells

Tovaxin: 2 mL subcutaneous injections administered by a healthcare provider at weeks 0, 4, 8, 12, and 24 every year as required.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Evaluate Changes in Rate and Severity of Multiple Sclerosis (MS) Progression
Hide Description [Not Specified]
Time Frame Annually
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Evaluate Changes in Annualized Relapse Rate
Hide Description [Not Specified]
Time Frame Annually
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Open Label Extension
Hide Arm/Group Description

30-45 million autologous myelin reactive T cells

Tovaxin: 2 mL subcutaneous injections administered by a healthcare provider at weeks 0, 4, 8, 12, and 24 every year as required.

All-Cause Mortality
Open Label Extension
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Open Label Extension
Affected / at Risk (%) # Events
Total   1/38 (2.63%)    
Immune system disorders   
Multiple Sclerosis Relapse   1/38 (2.63%)  1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Open Label Extension
Affected / at Risk (%) # Events
Total   25/38 (65.79%)    
Gastrointestinal disorders   
Injection site reaction-Swelling   8/38 (21.05%)  8
General disorders   
Injection site reaction-Bruising   11/38 (28.95%)  11
Injection site reaction-Disomfort   7/38 (18.42%)  7
Injection site reaction-Induration   5/38 (13.16%)  5
Injection site reaction-Redness   24/38 (63.16%)  24
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Kenny Frazier, VP of Clinical Development and Regulatory Affairs
Organization: Opexa Therapeutics, Inc.
Phone: 281-775-0660
Responsible Party: Opexa Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT00595920     History of Changes
Other Study ID Numbers: 2007-00
First Submitted: January 3, 2008
First Posted: January 16, 2008
Results First Submitted: January 13, 2014
Results First Posted: March 15, 2016
Last Update Posted: March 15, 2016