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Trial record 26 of 46 for:    CYCLOBENZAPRINE

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

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ClinicalTrials.gov Identifier: NCT01903265
Recruitment Status : Completed
First Posted : July 19, 2013
Results First Posted : December 23, 2016
Last Update Posted : December 23, 2016
Sponsor:
Information provided by (Responsible Party):
Tonix Pharmaceuticals, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Primary Fibromyalgia
Interventions Drug: TNX-102 SL 2.8mg
Drug: Placebo
Enrollment 205
Recruitment Details 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 Screening for eligibility and washout of restricted medications.
Arm/Group Title TNX-102 SL 2.8 mg Placebo
Hide Arm/Group Description 1 tablet of TNX-102 SL sublingually each day at bedtime for 12 weeks 1 tablet of placebo sublingually each day at bedtime for 12 weeks.
Period Title: Overall Study
Started 103 102
Completed 89 85
Not Completed 14 17
Arm/Group Title TNX-102 SL 2.8 mg Tablets Placebo Total
Hide Arm/Group Description

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.

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 of all reporting groups
Overall Number of Baseline Participants 103 101 204
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 103 participants 101 participants 204 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, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 103 participants 101 participants 204 participants
50.7
(20 to 64)
49.7
(19 to 65)
50.2
(19 to 65)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 103 participants 101 participants 204 participants
Female
96
  93.2%
98
  97.0%
194
  95.1%
Male
7
   6.8%
3
   3.0%
10
   4.9%
1.Primary Outcome
Title Mean Change From Baseline in Weekly Average of Daily Pain Scores at Week 12
Hide Description Daily pain scores were assessed using a 24-hour recall response provided by each patient via an interactive voice response system (IVRS) daily telephone diary. Average daily pain was measured using an 11-point (0-10) numerical rating scale (NRS), with higher scores representing worse pain. Jump to control was used to replace missing data in each treatment arm.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Patients in the Intention-to-treat (ITT) population: all randomized patients
Arm/Group Title TNX-102 SL 2.8 mg Tablets Placebo
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 103 102
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-1.39  (0.253) -0.95  (0.271)
2.Secondary Outcome
Title 30% Responder Analysis of IVRS NRS Pain Assessments at Week 12
Hide Description

The weekly averages of daily pain scores were calculated using the daily, 24-hour-recall, IVRS NRS pain assessments.

Patients who had at least a 30% improvement from baseline to week 12 in weekly average of daily pain scores were considered responders.

Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Patients in the Intention-to-treat (ITT) population: all randomized patients.
Arm/Group Title TNX-102 SL 2.8 mg Tablets Placebo
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 103 102
Measure Type: Number
Unit of Measure: percentage of participants
34 20.6
3.Secondary Outcome
Title Change From Baseline to Week 12 in PROMIS T-score for Sleep Disturbance
Hide Description The Patient-Reported Outcome Measurement Information System (PROMIS) sleep disturbance instrument consists of 8 items in which responses are scored 1 to 5 for each item. A higher score on 5 of the 8 items reflects a worse outcome, whereas a higher score on 3 items reflects an improved outcome; therefore, the directionality of the 8 item scores are first synchronized prior to calculation of the total raw score. PROMIS scores are presented as T-scores in which the raw score has been rescaled into a standardized score with a mean of 50 and a standard deviation of 10. Higher T-scores represent more of the concept being measured (in this case, sleep disturbance).
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Patients in the Intention-to-treat (ITT) population: all randomized patients
Arm/Group Title TNX-102 SL 2.8 mg Tablets Placebo
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 103 102
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-8.96  (0.993) -5.13  (1.029)
4.Secondary Outcome
Title Patient Global Impression of Change (PGIC) Responder Status (“Very Much Improved” or “Much Improved” vs All Other Categories) at Week 12
Hide Description The PGIC is a 7-point scale (1=very much improved; 7=very much worse) that assesses the patient's perception of the overall change in his/her fibromyalgia symptoms since entering the study. Scores of 1 and 2 were considered responders.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Patients in the Intention-to-treat (ITT) population: all randomized patients
Arm/Group Title TNX-102 SL 2.8 mg Tablets Placebo
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 103 102
Measure Type: Number
Unit of Measure: percentage of participants
30.1 16.7
5.Secondary Outcome
Title Change From Baseline to Week 12 in FIQ-R Total Score
Hide Description The Fibromyalgia Impact Questionnaire (revised) FIQ-R is made up of 3 domains: functional (9 questions), overall (2 questions) and symptoms (10 questions). All questions are based on an 11-point numerical rating scale (NRS) of 0-10, with 10 being "worst." Total FIQ-R scores can range from 0-100, with higher scores reflecting worsening status. The patient's total score on the FIQ-R was assessed at Visits 2, 3, 4, 5, and 6 (Week 12). Jump to control was used to replace missing data in each treatment arm.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Patients in the Intention-to-treat (ITT) population: all randomized patients
Arm/Group Title TNX-102 SL 2.8 mg Tablets Placebo
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 103 102
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-15.59  (2.079) -8.54  (2.133)
Time Frame 12 weeks
Adverse Event Reporting Description One placebo patient was never assigned study drug, thereby reducing the placebo group for safety analyses to 101 patients.
 
Arm/Group Title TNX-102 SL 2.8 mg Tablets Placebo
Hide Arm/Group Description

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.

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.

All-Cause Mortality
TNX-102 SL 2.8 mg Tablets Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
TNX-102 SL 2.8 mg Tablets Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/103 (0.00%)      1/101 (0.99%)    
Hepatobiliary disorders     
CHOLECYSTITIS * 1  0/103 (0.00%)  0 1/101 (0.99%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (16.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
TNX-102 SL 2.8 mg Tablets Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   65/103 (63.11%)      14/101 (13.86%)    
Gastrointestinal disorders     
hypoaesthesia oral * 1  45/103 (43.69%)  2/101 (1.98%) 
Nausea * 1  5/103 (4.85%)  2/101 (1.98%) 
General disorders     
Product taste abnormal * 1  8/103 (7.77%)  0/101 (0.00%) 
Musculoskeletal and connective tissue disorders     
Back pain * 1  5/103 (4.85%)  3/101 (2.97%) 
Nervous system disorders     
Somnolence * 1  2/103 (1.94%)  7/101 (6.93%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (16.0)
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.
An industry standard NDA in place with all study investigators.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Gregory M. Sullivan, MD, Chief Medical Officer
Organization: Tonix Pharmaceuticals
Phone: 212 980 9155 ext 117
EMail: Gregory.Sullivan@TonixPharma.com
Layout table for additonal information
Responsible Party: Tonix Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01903265     History of Changes
Other Study ID Numbers: TNX-CY-F202
First Submitted: July 12, 2013
First Posted: July 19, 2013
Results First Submitted: July 15, 2016
Results First Posted: December 23, 2016
Last Update Posted: December 23, 2016