Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study has been terminated.
(Financial Constraints)
Sponsor:
Information provided by (Responsible Party):
Opexa Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT00595920
First received: January 3, 2008
Last updated: February 16, 2016
Last verified: February 2014
Results First Received: January 13, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Multiple Sclerosis, Relapsing-Remitting
Clinically Isolated Syndrome
Intervention: Biological: Tovaxin

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Open Label Extension

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.


Participant Flow:   Overall Study
    Open Label Extension
STARTED   116 
Patients Dosed   38 [1] 
COMPLETED   0 
NOT COMPLETED   116 
The OLTERMS study was discontinued by th                116 
[1] 116 patients enrolled; however, only 38 received at least 1 dose.



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Randomized and received at least one dose.

Reporting Groups
  Description
Open Label Extension

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.


Baseline Measures
   Open Label Extension 
Overall Participants Analyzed 
[Units: Participants]
 38 
Age 
[Units: Years]
Mean (Full Range)
 39.98 
 (21 to 57) 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   38 
>=65 years   0 
Gender 
[Units: Participants]
 
Female   26 
Male   12 
Region of Enrollment 
[Units: Participants]
 
United States   38 


  Outcome Measures

1.  Primary:   Evaluate Changes in Number of Combined Unique Active Lesions on Brain Magnetic Resonance Imaging (MRI)   [ Time Frame: Annually ]

2.  Secondary:   Evaluate Changes in Rate and Severity of Multiple Sclerosis (MS) Progression   [ Time Frame: Annually ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

3.  Secondary:   Evaluate Changes in Annualized Relapse Rate   [ Time Frame: Annually ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI 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
e-mail: kfrazier@opexatherapeutics.com


Publications:

Responsible Party: Opexa Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT00595920     History of Changes
Other Study ID Numbers: 2007-00
Study First Received: January 3, 2008
Results First Received: January 13, 2014
Last Updated: February 16, 2016
Health Authority: United States: Food and Drug Administration