Trial Outcomes & Findings for 12-Month Open-Label Long-term Safety Study of TNX-102 SL Tablets in Fibromyalgia Patients (NCT NCT02015234)
NCT ID: NCT02015234
Last Updated: 2017-07-07
Results Overview
NEAEs and Serious Adverse events (SAEs) were collected and are coded using the latest version of the Medical Dictionary for Regulatory Activities (MedDRA).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
158 participants
Primary outcome timeframe
Up to 12 months
Results posted on
2017-07-07
Participant Flow
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.
Restricted to patients who completed the lead-in double-blind study and continued to meet the inclusion/exclusion criteria.
Participant milestones
| Measure |
Placebo - TNX-102 SL 2.8 mg
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.
|
TNX-102 SL 2.8mg - TNX-102 SL 2.8 mg
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 Study
STARTED
|
79
|
79
|
|
Overall Study
COMPLETED
|
43
|
54
|
|
Overall Study
NOT COMPLETED
|
36
|
25
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
12-Month Open-Label Long-term Safety Study of TNX-102 SL Tablets in Fibromyalgia Patients
Baseline characteristics by cohort
| Measure |
Placebo - TNX-102 SL 2.8 mg
n=79 Participants
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.
|
TNX-102 SL 2.8 mg - TNX-102 SL 2.8 mg
n=79 Participants
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
n=158 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
75 Participants
n=5 Participants
|
79 Participants
n=7 Participants
|
154 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Age, Continuous
|
50.2 Years
n=5 Participants
|
51.7 Years
n=7 Participants
|
50.9 Years
n=5 Participants
|
|
Sex: Female, Male
Female
|
78 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
153 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 12 monthsPopulation: All of the 158 enrolled patients took at least 1 dose of study drug and were included in the safety analysis population.
NEAEs and Serious Adverse events (SAEs) were collected and are coded using the latest version of the Medical Dictionary for Regulatory Activities (MedDRA).
Outcome measures
| Measure |
Placebo - TNX-102 SL 2.8 mg
n=79 Participants
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.
|
TNX-102 SL 2.8 mg - TNX-102 SL 2.8 mg
n=79 Participants
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.
|
|---|---|---|
|
Newly-emergent Adverse Events (NEAEs) During Treatment With TNX-102 SL Tablets Taken Daily at Bedtime Over 12 Months in Patients With Fibromyalgia.
Patient with at least 1 NEAE reported
|
60 Participants
|
54 Participants
|
|
Newly-emergent Adverse Events (NEAEs) During Treatment With TNX-102 SL Tablets Taken Daily at Bedtime Over 12 Months in Patients With Fibromyalgia.
Patients withdrew due to NEAE
|
18 Participants
|
9 Participants
|
|
Newly-emergent Adverse Events (NEAEs) During Treatment With TNX-102 SL Tablets Taken Daily at Bedtime Over 12 Months in Patients With Fibromyalgia.
Patient with at least 1 SAE
|
3 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Months 1, 3, 6, 9 and 12.Population: 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.
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.
Outcome measures
| Measure |
Placebo - TNX-102 SL 2.8 mg
n=79 Participants
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.
|
TNX-102 SL 2.8 mg - TNX-102 SL 2.8 mg
n=79 Participants
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.
|
|---|---|---|
|
Change From Baseline in Numerical Rating Scale (NRS) Assessments of Average Pain Based on 24 Hour Recall
Baseline
|
5.6 Scores on a scale
Standard Deviation 2.29
|
5.0 Scores on a scale
Standard Deviation 2.52
|
|
Change From Baseline in Numerical Rating Scale (NRS) Assessments of Average Pain Based on 24 Hour Recall
Change at Month 1
|
-0.5 Scores on a scale
Standard Deviation 1.96
|
-0.2 Scores on a scale
Standard Deviation 1.75
|
|
Change From Baseline in Numerical Rating Scale (NRS) Assessments of Average Pain Based on 24 Hour Recall
Change at Month 3
|
-0.5 Scores on a scale
Standard Deviation 1.86
|
-0.3 Scores on a scale
Standard Deviation 1.92
|
|
Change From Baseline in Numerical Rating Scale (NRS) Assessments of Average Pain Based on 24 Hour Recall
Change at Month 6
|
-0.7 Scores on a scale
Standard Deviation 2.18
|
-0.2 Scores on a scale
Standard Deviation 2.32
|
|
Change From Baseline in Numerical Rating Scale (NRS) Assessments of Average Pain Based on 24 Hour Recall
Change at Month 9
|
-0.6 Scores on a scale
Standard Deviation 2.36
|
0.0 Scores on a scale
Standard Deviation 1.91
|
|
Change From Baseline in Numerical Rating Scale (NRS) Assessments of Average Pain Based on 24 Hour Recall
Change at Month 12
|
0.1 Scores on a scale
Standard Deviation 2.08
|
-0.0 Scores on a scale
Standard Deviation 2.26
|
SECONDARY outcome
Timeframe: Month 1, 3, 6, 9, 12Population: 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.
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.
Outcome measures
| Measure |
Placebo - TNX-102 SL 2.8 mg
n=79 Participants
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.
|
TNX-102 SL 2.8 mg - TNX-102 SL 2.8 mg
n=79 Participants
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.
|
|---|---|---|
|
Change From Baseline in Numerical Rating Scale (NRS) Assessments of Average Pain Based on a 7 Day Recall
Baseline
|
5.7 Scores on a scale
Standard Deviation 2.09
|
4.8 Scores on a scale
Standard Deviation 2.18
|
|
Change From Baseline in Numerical Rating Scale (NRS) Assessments of Average Pain Based on a 7 Day Recall
Change at Month 1
|
-0.8 Scores on a scale
Standard Deviation 1.68
|
0.1 Scores on a scale
Standard Deviation 1.13
|
|
Change From Baseline in Numerical Rating Scale (NRS) Assessments of Average Pain Based on a 7 Day Recall
Change at Month 3
|
-0.6 Scores on a scale
Standard Deviation 1.67
|
0.1 Scores on a scale
Standard Deviation 1.85
|
|
Change From Baseline in Numerical Rating Scale (NRS) Assessments of Average Pain Based on a 7 Day Recall
Change at Month 6
|
-0.7 Scores on a scale
Standard Deviation 2.06
|
0.2 Scores on a scale
Standard Deviation 2.11
|
|
Change From Baseline in Numerical Rating Scale (NRS) Assessments of Average Pain Based on a 7 Day Recall
Change at Month 9
|
-0.4 Scores on a scale
Standard Deviation 2.33
|
0.0 Scores on a scale
Standard Deviation 2.07
|
|
Change From Baseline in Numerical Rating Scale (NRS) Assessments of Average Pain Based on a 7 Day Recall
Change at Month 12
|
0.0 Scores on a scale
Standard Deviation 1.72
|
0.2 Scores on a scale
Standard Deviation 1.84
|
SECONDARY outcome
Timeframe: Months 1, 3, 6, 9, 12Population: 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.
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
Outcome measures
| Measure |
Placebo - TNX-102 SL 2.8 mg
n=79 Participants
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.
|
TNX-102 SL 2.8 mg - TNX-102 SL 2.8 mg
n=79 Participants
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.
|
|---|---|---|
|
Responder Analysis of Patient's Global Impression of Change (PGIC)
Month 1 · Score 1 or 2
|
16 Participants
|
25 Participants
|
|
Responder Analysis of Patient's Global Impression of Change (PGIC)
Month 1 · Scores 3 to 7
|
63 Participants
|
54 Participants
|
|
Responder Analysis of Patient's Global Impression of Change (PGIC)
Month 3 · Score 1 or 2
|
23 Participants
|
29 Participants
|
|
Responder Analysis of Patient's Global Impression of Change (PGIC)
Month 9 · Score 1 or 2
|
21 Participants
|
27 Participants
|
|
Responder Analysis of Patient's Global Impression of Change (PGIC)
Month 9 · Scores 3 to 7
|
58 Participants
|
52 Participants
|
|
Responder Analysis of Patient's Global Impression of Change (PGIC)
Month 12 · Score 1 or 2
|
17 Participants
|
32 Participants
|
|
Responder Analysis of Patient's Global Impression of Change (PGIC)
Month 3 · Scores 3 to 7
|
56 Participants
|
50 Participants
|
|
Responder Analysis of Patient's Global Impression of Change (PGIC)
Month 12 · Scores 3 to 7
|
62 Participants
|
47 Participants
|
|
Responder Analysis of Patient's Global Impression of Change (PGIC)
Month 6 · Score 1 or 2
|
22 Participants
|
26 Participants
|
|
Responder Analysis of Patient's Global Impression of Change (PGIC)
Month 6 · Scores 3 to 7
|
57 Participants
|
53 Participants
|
Adverse Events
Placebo - TNX-102 SL 2.8 mg
Serious events: 3 serious events
Other events: 43 other events
Deaths: 0 deaths
TNX-102 SL 2.8mg - TNX-102 SL 2.8 mg
Serious events: 5 serious events
Other events: 39 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo - TNX-102 SL 2.8 mg
n=79 participants at risk
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.
|
TNX-102 SL 2.8mg - TNX-102 SL 2.8 mg
n=79 participants at risk
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.
|
|---|---|---|
|
Psychiatric disorders
Anxiety
|
0.00%
0/79 • 12 months
5% was used as the adverse event reporting cut-off
|
1.3%
1/79 • 12 months
5% was used as the adverse event reporting cut-off
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intraductal proliferative breast lesion
|
0.00%
0/79 • 12 months
5% was used as the adverse event reporting cut-off
|
1.3%
1/79 • 12 months
5% was used as the adverse event reporting cut-off
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.00%
0/79 • 12 months
5% was used as the adverse event reporting cut-off
|
1.3%
1/79 • 12 months
5% was used as the adverse event reporting cut-off
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/79 • 12 months
5% was used as the adverse event reporting cut-off
|
1.3%
1/79 • 12 months
5% was used as the adverse event reporting cut-off
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain stem glioma
|
0.00%
0/79 • 12 months
5% was used as the adverse event reporting cut-off
|
1.3%
1/79 • 12 months
5% was used as the adverse event reporting cut-off
|
|
Injury, poisoning and procedural complications
Pubic fracture
|
1.3%
1/79 • 12 months
5% was used as the adverse event reporting cut-off
|
0.00%
0/79 • 12 months
5% was used as the adverse event reporting cut-off
|
|
Ear and labyrinth disorders
Vertigo
|
1.3%
1/79 • 12 months
5% was used as the adverse event reporting cut-off
|
0.00%
0/79 • 12 months
5% was used as the adverse event reporting cut-off
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
1.3%
1/79 • 12 months
5% was used as the adverse event reporting cut-off
|
0.00%
0/79 • 12 months
5% was used as the adverse event reporting cut-off
|
Other adverse events
| Measure |
Placebo - TNX-102 SL 2.8 mg
n=79 participants at risk
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.
|
TNX-102 SL 2.8mg - TNX-102 SL 2.8 mg
n=79 participants at risk
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.
|
|---|---|---|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
27.8%
22/79 • 12 months
5% was used as the adverse event reporting cut-off
|
1.3%
1/79 • 12 months
5% was used as the adverse event reporting cut-off
|
|
Infections and infestations
Sinusitis
|
1.3%
1/79 • 12 months
5% was used as the adverse event reporting cut-off
|
12.7%
10/79 • 12 months
5% was used as the adverse event reporting cut-off
|
|
General disorders
Fatigue
|
3.8%
3/79 • 12 months
5% was used as the adverse event reporting cut-off
|
10.1%
8/79 • 12 months
5% was used as the adverse event reporting cut-off
|
|
General disorders
Product taste abnormal
|
11.4%
9/79 • 12 months
5% was used as the adverse event reporting cut-off
|
0.00%
0/79 • 12 months
5% was used as the adverse event reporting cut-off
|
|
Gastrointestinal disorders
Glossodynia
|
6.3%
5/79 • 12 months
5% was used as the adverse event reporting cut-off
|
2.5%
2/79 • 12 months
5% was used as the adverse event reporting cut-off
|
|
Gastrointestinal disorders
Constipation
|
2.5%
2/79 • 12 months
5% was used as the adverse event reporting cut-off
|
5.1%
4/79 • 12 months
5% was used as the adverse event reporting cut-off
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract infection
|
0.00%
0/79 • 12 months
5% was used as the adverse event reporting cut-off
|
7.6%
6/79 • 12 months
5% was used as the adverse event reporting cut-off
|
|
Nervous system disorders
Somnolence
|
1.3%
1/79 • 12 months
5% was used as the adverse event reporting cut-off
|
5.1%
4/79 • 12 months
5% was used as the adverse event reporting cut-off
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/79 • 12 months
5% was used as the adverse event reporting cut-off
|
5.1%
4/79 • 12 months
5% was used as the adverse event reporting cut-off
|
Additional Information
Gregory M. Sullivan, Chief Medical Officer
Tonix Pharmaceuticals
Phone: 212 980 9155
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee An industry standard NDA in place with all study investigators.
- Publication restrictions are in place
Restriction type: OTHER