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TNX-102 capsules [formerly known as very low dose (VLD) cyclobenzaprine] at bedtime have shown promise as a treatment of fibromyalgia, but the drug required new formulation technology for bedtime use. The present trial was designed to assess the safety and efficacy of TNX-102 SL 2.8 mg tablets, taken daily at bedtime over 12 weeks to treat fibromyalgia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TNX-102 SL 2.8 mg | Experimental | Patients will take 1 tablet of TNX-102 SL sublingually each day at bedtime for 12 weeks. |
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| Placebo | Placebo Comparator | Patients will take 1 tablet of placebo sublingually each day at bedtime for 12 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TNX-102 SL 2.8mg | Drug | Patients will take 1 tablet of randomly assigned study drug sublingually each day at bedtime starting on Day 0 for 12 weeks. |
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| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in Weekly Average of Daily Pain Scores at Week 12 | 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. | Baseline, Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 30% Responder Analysis of IVRS NRS Pain Assessments at Week 12 | 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. | Baseline, Week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark R. Schmal | Premier Research | Study Director |
| Daniel J. Clauw, MD | Ann Arbor, MI | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 107 Scripps Drive | Sacramento | California | 95825 | United States | ||
| Radiant Research, Inc. |
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Screening for eligibility and washout of restricted medications.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | TNX-102 SL 2.8 mg | 1 tablet of TNX-102 SL sublingually each day at bedtime for 12 weeks |
| FG001 | Placebo | 1 tablet of placebo sublingually each day at bedtime for 12 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Placebo | Drug | Patients will take 1 tablet of randomly assigned study drug sublingually each day at bedtime starting on Day 0 for 12 weeks. |
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| Change From Baseline to Week 12 in PROMIS T-score for Sleep Disturbance |
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). |
| Baseline, Week 12 |
| Patient Global Impression of Change (PGIC) Responder Status ("Very Much Improved" or "Much Improved" vs All Other Categories) at Week 12 | 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. | Week 12 |
| Change From Baseline to Week 12 in FIQ-R Total Score | 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. | Baseline, Week 12 |
| Denver |
| Colorado |
| 80239 |
| United States |
| 16176 Cortez Boulevard | Brooksville | Florida | 34601 | United States |
| 100 West Gore Street | Orlando | Florida | 32806 | United States |
| 3401 North Central Avenue | Chicago | Illinois | 60634 | United States |
| 71 Thomas Johnson Drive | Frederick | Maryland | 21702 | United States |
| 370 Faunce Corner Road | North Dartmouth | Massachusetts | 02747 | United States |
| Clinical Pharmacology Study Group | Worcester | Massachusetts | 01605 | United States |
| CRC of Jackson, LLC | Jackson | Mississippi | 39202 | United States |
| University of Cincinnati College of Medicine | Cincinnati | Ohio | 45219 | United States |
| 1275 Olentangy River Road | Columbus | Ohio | 43212 | United States |
| 18660 Bagley Road | Middleburg Heights | Ohio | 44130 | United States |
| 1001 South Market Street | Mechanicsburg | Pennsylvania | 17055 | United States |
| 322 Memorial Drive | Greer | South Carolina | 29650 | United States |
| 1002 E. South Temple | Salt Lake City | Utah | 84102 | United States |
| 1951 152nd Place NE | Bellevue | Washington | 98007 | United States |
| 601 Broadway | Seattle | Washington | 98122 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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.) |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Full Range | years |
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| Gender | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Change From Baseline in Weekly Average of Daily Pain Scores at Week 12 | 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. | Patients in the Intention-to-treat (ITT) population: all randomized patients | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Week 12 |
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| Secondary | 30% Responder Analysis of IVRS NRS Pain Assessments at Week 12 | 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. | Patients in the Intention-to-treat (ITT) population: all randomized patients. | Posted | Number | percentage of participants | Baseline, Week 12 |
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| Secondary | Change From Baseline to Week 12 in PROMIS T-score for Sleep Disturbance | 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). | Patients in the Intention-to-treat (ITT) population: all randomized patients | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Week 12 |
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| Secondary | Patient Global Impression of Change (PGIC) Responder Status ("Very Much Improved" or "Much Improved" vs All Other Categories) at Week 12 | 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. | Patients in the Intention-to-treat (ITT) population: all randomized patients | Posted | Number | percentage of participants | Week 12 |
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| Secondary | Change From Baseline to Week 12 in FIQ-R Total Score | 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. | Patients in the Intention-to-treat (ITT) population: all randomized patients | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Week 12 |
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12 weeks
One placebo patient was never assigned study drug, thereby reducing the placebo group for safety analyses to 101 patients.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 103 | 65 | 103 | ||
| EG001 | 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. | 1 | 101 | 14 | 101 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| CHOLECYSTITIS | Hepatobiliary disorders | MedDRA (16.0) | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| hypoaesthesia oral | Gastrointestinal disorders | MedDRA (16.0) | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (16.0) | Non-systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA (16.0) | Non-systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Non-systematic Assessment |
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| Product taste abnormal | General disorders | MedDRA (16.0) | Non-systematic Assessment |
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An industry standard NDA in place with all study investigators.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gregory M. Sullivan, MD, Chief Medical Officer | Tonix Pharmaceuticals | 212 980 9155 | 117 | Gregory.Sullivan@TonixPharma.com |
| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| D010146 | Pain |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| >=65 years |
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| Male |
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