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Trial record 32 of 46 for:    CYCLOBENZAPRINE

12-Month Open-Label Long-term Safety Study of TNX-102 SL Tablets in Fibromyalgia Patients (BESTFIT-OLE)

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ClinicalTrials.gov Identifier: NCT02015234
Recruitment Status : Completed
First Posted : December 19, 2013
Results First Posted : July 7, 2017
Last Update Posted : July 7, 2017
Sponsor:
Information provided by (Responsible Party):
Tonix Pharmaceuticals, Inc.

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Primary Fibromyalgia
Intervention Drug: TNX-102 SL
Enrollment 158
Recruitment Details One hundred fifty-eight (158) of the 174 patients who completed 12 weeks of treatment in Study F202 were eligible and consented to participate in the 12-month safety extension study.
Pre-assignment Details Restricted to patients who completed the lead-in double-blind study and continued to meet the inclusion/exclusion criteria.
Arm/Group Title Placebo - TNX-102 SL 2.8 mg TNX-102 SL 2.8mg - TNX-102 SL 2.8 mg
Hide Arm/Group Description These patients received placebo during the lead-in study (F202), followed by 1 x TNX-102 SL 2.8 mg tablet taken daily at bedtime for 12 months during the open-label study. These patients received 1 x TNX-102 SL 2.8 mg tablet taken daily at bedtime during both the lead-in study (F202) as well as the open-label study, for a total treatment duration of up to 15 months.
Period Title: Overall Study
Started 79 79
Completed 43 54
Not Completed 36 25
Arm/Group Title Placebo - TNX-102 SL 2.8 mg TNX-102 SL 2.8 mg - TNX-102 SL 2.8 mg Total
Hide Arm/Group Description

1x TNX-102 SL 2.8 mg sublingual tablet taken daily at bedtime for 12 months

TNX-102 SL: TNX-102 2.8 mg SL taken daily at bedtime.

1x TNX-102 SL 2.8 mg sublingual tablet taken daily at bedtime for 12 months

TNX-102 SL: TNX-102 2.8 mg SL taken daily at bedtime.

Total of all reporting groups
Overall Number of Baseline Participants 79 79 158
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 79 participants 79 participants 158 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
75
  94.9%
79
 100.0%
154
  97.5%
>=65 years
4
   5.1%
0
   0.0%
4
   2.5%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 79 participants 79 participants 158 participants
50.2
(19 to 65)
51.7
(20 to 64)
50.9
(19 to 65)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 79 participants 79 participants 158 participants
Female
78
  98.7%
75
  94.9%
153
  96.8%
Male
1
   1.3%
4
   5.1%
5
   3.2%
1.Primary Outcome
Title Newly-emergent Adverse Events (NEAEs) During Treatment With TNX-102 SL Tablets Taken Daily at Bedtime Over 12 Months in Patients With Fibromyalgia.
Hide Description NEAEs and Serious Adverse events (SAEs) were collected and are coded using the latest version of the Medical Dictionary for Regulatory Activities (MedDRA).
Time Frame Up to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
All of the 158 enrolled patients took at least 1 dose of study drug and were included in the safety analysis population.
Arm/Group Title Placebo - TNX-102 SL 2.8 mg TNX-102 SL 2.8 mg - TNX-102 SL 2.8 mg
Hide Arm/Group Description:
These patients received placebo during the lead-in study (F202), followed by 1 x TNX-102 SL 2.8 mg tablet taken daily at bedtime for 12 months during the open-label study.
These patients received 1 x TNX-102 SL 2.8 mg tablet taken daily at bedtime during both the lead-in study (F202) as well as the open-label study, for a total treatment duration of up to 15 months.
Overall Number of Participants Analyzed 79 79
Measure Type: Count of Participants
Unit of Measure: Participants
Patient with at least 1 NEAE reported
60
  75.9%
54
  68.4%
Patients withdrew due to NEAE
18
  22.8%
9
  11.4%
Patient with at least 1 SAE
3
   3.8%
5
   6.3%
2.Secondary Outcome
Title Change From Baseline in Numerical Rating Scale (NRS) Assessments of Average Pain Based on 24 Hour Recall
Hide Description The NRS for average pain was an 11-point scale (0=no pain → 10=worst pain imaginable) that was assessed on a 24-hour recall basis.
Time Frame Months 1, 3, 6, 9 and 12.
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who took at least 1 dose of study drug prior to study discontinuation were included in the efficacy analysis. By the end of the study, 36 patients from the Placebo - TNX-102 SL group and 25 patients from the TNX-102 SL - TNX-102 SL group had discontinued the study.
Arm/Group Title Placebo - TNX-102 SL 2.8 mg TNX-102 SL 2.8 mg - TNX-102 SL 2.8 mg
Hide Arm/Group Description:
These patients received placebo during the lead-in study (F202), followed by 1 x TNX-102 SL 2.8 mg tablet taken daily at bedtime for 12 months during the open-label study.
These patients received 1 x TNX-102 SL 2.8 mg tablet taken daily at bedtime during both the lead-in study (F202), as well as the open-label study, for a total treatment duration of up to 15 months.
Overall Number of Participants Analyzed 79 79
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
Baseline Number Analyzed 79 participants 79 participants
5.6  (2.29) 5.0  (2.52)
Change at Month 1 Number Analyzed 65 participants 75 participants
-0.5  (1.96) -0.2  (1.75)
Change at Month 3 Number Analyzed 56 participants 63 participants
-0.5  (1.86) -0.3  (1.92)
Change at Month 6 Number Analyzed 50 participants 58 participants
-0.7  (2.18) -0.2  (2.32)
Change at Month 9 Number Analyzed 46 participants 55 participants
-0.6  (2.36) 0.0  (1.91)
Change at Month 12 Number Analyzed 43 participants 54 participants
0.1  (2.08) -0.0  (2.26)
3.Secondary Outcome
Title Change From Baseline in Numerical Rating Scale (NRS) Assessments of Average Pain Based on a 7 Day Recall
Hide Description The NRS for average pain over the past 7 days was an 11-point scale (0=no pain → 10=worst pain imaginable) that was assessed on a 7-day recall basis.
Time Frame Month 1, 3, 6, 9, 12
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who took at least 1 dose of study drug prior to study discontinuation were included in the efficacy analysis. By the end of the study, 36 patients from the Placebo - TNX-102 SL group and 25 patients from the TNX-102 SL - TNX-102 SL group had discontinued the study.
Arm/Group Title Placebo - TNX-102 SL 2.8 mg TNX-102 SL 2.8 mg - TNX-102 SL 2.8 mg
Hide Arm/Group Description:
These patients received placebo during the lead-in study (F202), followed by 1 x TNX-102 SL 2.8 mg tablet taken daily at bedtime for 12 months during the open-label study.
These patients received 1 x TNX-102 SL 2.8 mg tablet taken daily at bedtime during both the lead-in study (F202), as well as the open-label study, for a total treatment duration of up to 15 months.
Overall Number of Participants Analyzed 79 79
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
Baseline Number Analyzed 79 participants 79 participants
5.7  (2.09) 4.8  (2.18)
Change at Month 1 Number Analyzed 65 participants 75 participants
-0.8  (1.68) 0.1  (1.13)
Change at Month 3 Number Analyzed 56 participants 63 participants
-0.6  (1.67) 0.1  (1.85)
Change at Month 6 Number Analyzed 50 participants 58 participants
-0.7  (2.06) 0.2  (2.11)
Change at Month 9 Number Analyzed 46 participants 55 participants
-0.4  (2.33) 0.0  (2.07)
Change at Month 12 Number Analyzed 43 participants 54 participants
0.0  (1.72) 0.2  (1.84)
4.Secondary Outcome
Title Responder Analysis of Patient's Global Impression of Change (PGIC)
Hide Description

PGIC is a fibromyalgia-specific validated instrument to gauge the patient's assessment of change in condition.The scores are categorized as provided below. A responder was defined by a score of 1 (very much improved), or 2 (much improved).

  1. = Very much improved
  2. = Much improved
  3. = Minimally improved
  4. = No change
  5. = Minimally worse
  6. = Much worse
  7. = Very much worse
Time Frame Months 1, 3, 6, 9, 12
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who took at least 1 dose of study drug prior to study discontinuation were included in the efficacy analysis. Overall, 36 patients from the Placebo - TNX-102 SL group and 25 patients from the TNX-102 SL - TNX-102 SL group had discontinued the study early. Any missing PGIC responses were included in the “scores 3-7” for that visit.
Arm/Group Title Placebo - TNX-102 SL 2.8 mg TNX-102 SL 2.8mg - TNX-102 SL 2.8 mg
Hide Arm/Group Description:
These patients received placebo during the lead-in study (F202), followed by 1 x TNX-102 SL 2.8 mg tablet taken daily at bedtime for 12 months during the open-label study.
These patients received 1 x TNX-102 SL 2.8 mg tablet taken daily at bedtime during both the lead-in study (F202), as well as the open-label study, for a total treatment duration of up to 15 months.
Overall Number of Participants Analyzed 79 79
Measure Type: Count of Participants
Unit of Measure: Participants
Month 1 Score 1 or 2
16
  20.3%
25
  31.6%
Scores 3 to 7
63
  79.7%
54
  68.4%
Month 3 Score 1 or 2
23
  29.1%
29
  36.7%
Scores 3 to 7
56
  70.9%
50
  63.3%
Month 6 Score 1 or 2
22
  27.8%
26
  32.9%
Scores 3 to 7
57
  72.2%
53
  67.1%
Month 9 Score 1 or 2
21
  26.6%
27
  34.2%
Scores 3 to 7
58
  73.4%
52
  65.8%
Month 12 Score 1 or 2
17
  21.5%
32
  40.5%
Scores 3 to 7
62
  78.5%
47
  59.5%
Time Frame 12 months
Adverse Event Reporting Description 5% was used as the adverse event reporting cut-off
 
Arm/Group Title Placebo - TNX-102 SL 2.8 mg TNX-102 SL 2.8mg - TNX-102 SL 2.8 mg
Hide Arm/Group Description These patients received placebo during the lead-in study (F202), followed by 1 x TNX-102 SL 2.8 mg tablet taken daily at bedtime for 12 months during the open-label study. These patients received 1 x TNX-102 SL 2.8 mg tablet taken daily at bedtime during both the lead-in study (F202), as well as the open-label study, for a total treatment duration of up to 15 months.
All-Cause Mortality
Placebo - TNX-102 SL 2.8 mg TNX-102 SL 2.8mg - TNX-102 SL 2.8 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   0/79 (0.00%)   0/79 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo - TNX-102 SL 2.8 mg TNX-102 SL 2.8mg - TNX-102 SL 2.8 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   3/79 (3.80%)   5/79 (6.33%) 
Ear and labyrinth disorders     
Vertigo  1/79 (1.27%)  0/79 (0.00%) 
Gastrointestinal disorders     
Abdominal hernia  0/79 (0.00%)  1/79 (1.27%) 
Injury, poisoning and procedural complications     
Ankle fracture  0/79 (0.00%)  1/79 (1.27%) 
Pubic fracture  1/79 (1.27%)  0/79 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Intraductal proliferative breast lesion  0/79 (0.00%)  1/79 (1.27%) 
Brain stem glioma  0/79 (0.00%)  1/79 (1.27%) 
Malignant melanoma  1/79 (1.27%)  0/79 (0.00%) 
Psychiatric disorders     
Anxiety  0/79 (0.00%)  1/79 (1.27%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo - TNX-102 SL 2.8 mg TNX-102 SL 2.8mg - TNX-102 SL 2.8 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   43/79 (54.43%)   39/79 (49.37%) 
Gastrointestinal disorders     
Hypoaesthesia oral  22/79 (27.85%)  1/79 (1.27%) 
Glossodynia  5/79 (6.33%)  2/79 (2.53%) 
Constipation  2/79 (2.53%)  4/79 (5.06%) 
General disorders     
Fatigue  3/79 (3.80%)  8/79 (10.13%) 
Product taste abnormal  9/79 (11.39%)  0/79 (0.00%) 
Infections and infestations     
Sinusitis  1/79 (1.27%)  10/79 (12.66%) 
Nervous system disorders     
Somnolence  1/79 (1.27%)  4/79 (5.06%) 
Paraesthesia  0/79 (0.00%)  4/79 (5.06%) 
Respiratory, thoracic and mediastinal disorders     
Upper respiratory tract infection  0/79 (0.00%)  6/79 (7.59%) 
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, Chief Medical Officer
Organization: Tonix Pharmaceuticals
Phone: 212 980 9155 ext 117
EMail: greg.sullivan@tonixpharma.com
Layout table for additonal information
Responsible Party: Tonix Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT02015234     History of Changes
Other Study ID Numbers: TNX-CY-F203
First Submitted: December 9, 2013
First Posted: December 19, 2013
Results First Submitted: May 22, 2017
Results First Posted: July 7, 2017
Last Update Posted: July 7, 2017