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BEdtime Sublingual TNX-102 SL as Fibromyalgia Intervention Therapy (BESTFIT) (BESTFIT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Tonix Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01903265
First received: July 12, 2013
Last updated: October 31, 2016
Last verified: October 2016
Results First Received: July 15, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Primary Fibromyalgia
Interventions: Drug: TNX-102 SL 2.8mg
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
A total of 205 patients were randomized to either TNX-102 SL or placebo; however, one patient was randomized in error (to the placebo group) and was not dispensed any study drug. Therefore, all disposition and safety tables are based on the safety population of 204 patients. Of these, 174 patients completed the study.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Screening for eligibility and washout of restricted medications.

Reporting Groups
  Description
TNX-102 SL 2.8 mg 1 tablet of TNX-102 SL sublingually each day at bedtime for 12 weeks
Placebo 1 tablet of placebo sublingually each day at bedtime for 12 weeks.

Participant Flow:   Overall Study
    TNX-102 SL 2.8 mg   Placebo
STARTED   103   102 
COMPLETED   89   85 
NOT COMPLETED   14   17 



  Baseline Characteristics
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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.
No text entered.

Reporting Groups
  Description
TNX-102 SL 2.8 mg Tablets

1 x TNX-102 SL 2.8mg Tablet taken sublingually each day at bedtime for 12 weeks.

TNX-102 SL 2.8mg Tablets: Patients will take 1 tablet of randomly assigned study drug sublingually each day at bedtime starting on Day 0 for 12 weeks.

Placebo

1 x Placebo Tablet taken sublingually each day at bedtime for 12 weeks.

Placebo: Patients will take 1 tablet of randomly assigned study drug sublingually each day at bedtime starting on Day 0 for 12 weeks. (One patient randomized in error never received study drug and therefore is not included in this table.)

Total Total of all reporting groups

Baseline Measures
   TNX-102 SL 2.8 mg Tablets   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 103   101   204 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      103 100.0%      96  95.0%      199  97.5% 
>=65 years      0   0.0%      5   5.0%      5   2.5% 
Age 
[Units: Years]
Mean (Full Range)
 50.7 
 (20 to 64) 
 49.7 
 (19 to 65) 
 50.2 
 (19 to 65) 
Gender 
[Units: Participants]
Count of Participants
     
Female      96  93.2%      98  97.0%      194  95.1% 
Male      7   6.8%      3   3.0%      10   4.9% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Mean Change From Baseline in Weekly Average of Daily Pain Scores at Week 12   [ Time Frame: Baseline, Week 12 ]

2.  Secondary:   30% Responder Analysis of IVRS NRS Pain Assessments at Week 12   [ Time Frame: Baseline, Week 12 ]

3.  Secondary:   Change From Baseline to Week 12 in PROMIS T-score for Sleep Disturbance   [ Time Frame: Baseline, Week 12 ]

4.  Secondary:   Patient Global Impression of Change (PGIC) Responder Status (“Very Much Improved” or “Much Improved” vs All Other Categories) at Week 12   [ Time Frame: Week 12 ]

5.  Secondary:   Change From Baseline to Week 12 in FIQ-R Total Score   [ Time Frame: Baseline, Week 12 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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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 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 more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Gregory M. Sullivan, MD, Chief Medical Officer
Organization: Tonix Pharmaceuticals
phone: 212 980 9155 ext 117
e-mail: Gregory.Sullivan@TonixPharma.com



Responsible Party: Tonix Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01903265     History of Changes
Other Study ID Numbers: TNX-CY-F202
Study First Received: July 12, 2013
Results First Received: July 15, 2016
Last Updated: October 31, 2016