| Primary | Change From Baseline to the Week 14 Endpoint in the Diary NRS Weekly Average of Daily Self Reported Average Pain Severity Scores. | Change from Baseline to the Week 14 endpoint in the diary Numerical Rating Scale (NRS) weekly average of daily self-reported average pain severity scores. Scores range from 0 to 10 where a higher score means worse outcome. | Intention-To-Treat (ITT) population: all patients who were randomized. This is the primary population for efficacy analyses, and patients will be analyzed based on their randomized treatment. | Posted | | Least Squares Mean | 95% Confidence Interval | score on a scale | | Baseline (Day -7 to Day -1), Week 14 | | | | ID | Title | Description |
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| OG000 | TNX-102 SL Tablet, 5.6 mg | 1 x TNX-102 SL 2.8 mg Tablet taken sublingually each day at bedtime for 2 weeks, then 2 x TNX-102 SL 2.8 mg (5.6 mg) Tablet taken sublingually each day at bedtime for 12 weeks. TNX-102 SL: Patients will take 1 tablet of randomly assigned study drug sublingually starting on Day 1 for 2 weeks. At the Week 2 visit, all patients will have the dose increased to 2 tablets for 12 weeks. | | OG001 | Placebo SL Tablet | 1 x Placebo Tablet taken sublingually each day at bedtime for 2 weeks, then 2 x Placebo Tablet taken sublingually each day at bedtime for 12 weeks. Placebo SL Tablet: Patients will take 1 tablet of randomly assigned study drug sublingually starting on Day 1 for 2 weeks. At the Week 2 visit, all patients will have the dose increased to 2 tablets for 12 weeks. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG000-1.8(-2.0 to -1.6)
- OG001-1.2(-1.4 to -0.9)
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| Secondary | Proportion of Patients With a Patient's Global Impression of Change (PGIC) Rating of "Very Much Improved" or "Much Improved" at the Week 14 Endpoint | The PGIC is a fibromyalgia specific validated instrument on a scale of 1 to 7, where a score of 1 indicates the highest level of improvement and a score of 7 indicates a much worse outcome. | Intention-To-Treat (ITT) population: all patients who were randomized. This is the primary population for efficacy analyses, and patients will be analyzed based on their randomized treatment. | Posted | | Count of Participants | | Participants | | Week 14 | | | | ID | Title | Description |
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| OG000 | TNX-102 SL Tablet, 5.6 mg | 1 x TNX-102 SL 2.8 mg Tablet taken sublingually each day at bedtime for 2 weeks, then 2 x TNX-102 SL 2.8 mg (5.6 mg) Tablet taken sublingually each day at bedtime for 12 weeks. TNX-102 SL Tablet, 5.6 mg: Patients will take 1 tablet of randomly assigned study drug sublingually starting on Day 1 for 2 weeks. At the Week 2 visit, all patients will have the dose increased to 2 tablets for 12 weeks. | | OG001 | Placebo SL Tablet | 1 x Placebo Tablet taken sublingually each day at bedtime for 2 weeks, then 2 x Placebo Tablet taken sublingually each day at bedtime for 12 weeks. Placebo SL Tablet: Patients will take 1 tablet of randomly assigned study drug sublingually starting on Day 1 for 2 weeks. At the Week 2 visit, all patients will have the dose increased to 2 tablets for 12 weeks. |
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| Secondary | Change From Baseline in the Fibromyalgia Impact Questionnaire - Revised (FIQ-R) Symptoms Domain Score at the Week 14 Endpoint | Change from Baseline in the FIQ-R Symptoms domain score at the Week 14 endpoint. Scores on the symptoms domain range from 0 to 90 where a higher score means worse outcome. | Intention-To-Treat (ITT) population: all patients who were randomized. This is the primary population for efficacy analyses, and patients will be analyzed based on their randomized treatment. | Posted | | Least Squares Mean | 95% Confidence Interval | score on a scale | | Day 1, Week 14 | | | | ID | Title | Description |
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| OG000 | TNX-102 SL Tablet, 5.6 mg | 1 x TNX-102 SL 2.8 mg Tablet taken sublingually each day at bedtime for 2 weeks, then 2 x TNX-102 SL 2.8 mg (5.6 mg) Tablet taken sublingually each day at bedtime for 12 weeks. TNX-102 SL: Patients will take 1 tablet of randomly assigned study drug sublingually starting on Day 1 for 2 weeks. At the Week 2 visit, all patients will have the dose increased to 2 tablets for 12 weeks. | | OG001 | Placebo SL Tablet | 1 x Placebo Tablet taken sublingually each day at bedtime for 2 weeks, then 2 x Placebo Tablet taken sublingually each day at bedtime for 12 weeks. Placebo SL Tablet: Patients will take 1 tablet of randomly assigned study drug sublingually starting on Day 1 for 2 weeks. At the Week 2 visit, all patients will have the dose increased to 2 tablets for 12 weeks. |
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| Secondary | Change From Baseline in the FIQ-R Function Domain Score at the Week 14 Endpoint | The FIQ-R is a validated questionnaire. Scores on the function domain range from 0 to 90 where a higher score means worse outcome. | Intention-To-Treat (ITT) population: all patients who were randomized. This is the primary population for efficacy analyses, and patients will be analyzed based on their randomized treatment. | Posted | | Least Squares Mean | 95% Confidence Interval | score on a scale | | Day 1, Week 14 | | | | ID | Title | Description |
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| OG000 | TNX-102 SL Tablet, 5.6 mg | 1 x TNX-102 SL 2.8 mg Tablet taken sublingually each day at bedtime for 2 weeks, then 2 x TNX-102 SL 2.8 mg (5.6 mg) Tablet taken sublingually each day at bedtime for 12 weeks. TNX-102 SL tablet: Patients will take 1 tablet of randomly assigned study drug sublingually starting on Day 1 for 2 weeks. At the Week 2 visit, all patients will have the dose increased to 2 tablets for 12 weeks. | | OG001 | Placebo SL Tablet | 1 x Placebo Tablet taken sublingually each day at bedtime for 2 weeks, then 2 x Placebo Tablet taken sublingually each day at bedtime for 12 weeks. Placebo SL Tablet: Patients will take 1 tablet of randomly assigned study drug sublingually starting on Day 1 for 2 weeks. At the Week 2 visit, all patients will have the dose increased to 2 tablets for 12 weeks. |
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| Secondary | Change From Baseline in the Patient Reported Outcomes Measurement Information System (PROMIS) Score for Sleep Disturbance at the Week 14 Endpoint | The PROMIS Sleep disturbance short form 8a consists of 8 questions on a 5-point scale (1 to 5) where a higher score indicates a worse outcome. The total score is reported on a range of 8 to 40. Raw scores are converted to T-scores based on US population with score of 50 as average with a standard deviation of 10. | Intention-To-Treat (ITT) population: all patients who were randomized. This is the primary population for efficacy analyses, and patients will be analyzed based on their randomized treatment. | Posted | | Least Squares Mean | 95% Confidence Interval | T-score | | Day 1, Week 14 | | | | ID | Title | Description |
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| OG000 | TNX-102 SL Tablet, 5.6 mg | 1 x TNX-102 SL 2.8 mg Tablet taken sublingually each day at bedtime for 2 weeks, then 2 x TNX-102 SL 2.8 mg (5.6 mg) Tablet taken sublingually each day at bedtime for 12 weeks. TNX-102 SL tablet: Patients will take 1 tablet of randomly assigned study drug sublingually starting on Day 1 for 2 weeks. At the Week 2 visit, all patients will have the dose increased to 2 tablets for 12 weeks. | | OG001 | Placebo SL Tablet | 1 x Placebo Tablet taken sublingually each day at bedtime for 2 weeks, then 2 x Placebo Tablet taken sublingually each day at bedtime for 12 weeks. Placebo SL Tablet: Patients will take 1 tablet of randomly assigned study drug sublingually starting on Day 1 for 2 weeks. At the Week 2 visit, all patients will have the dose increased to 2 tablets for 12 weeks. |
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| Secondary | Change From Baseline in the PROMIS Score for Fatigue at the Week 14 Endpoint | The PROMIS fatigue short form 8a consists of 8 questions on a 5 point scale (1 to 5) where a higher score indicates a worse outcome. The total score is reported on a range of 8 to 40. Raw scores are converted to T-scores based on US population with score of 50 as average with a standard deviation of 10. | Intention-To-Treat (ITT) population: all patients who were randomized. This is the primary population for efficacy analyses, and patients will be analyzed based on their randomized treatment. | Posted | | Least Squares Mean | 95% Confidence Interval | T-score | | Day 1, Week 14 | | | | ID | Title | Description |
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| OG000 | TNX-102 SL Tablet, 5.6 mg | 1 x TNX-102 SL 2.8 mg Tablet taken sublingually each day at bedtime for 2 weeks, then 2 x TNX-102 SL 2.8 mg (5.6 mg) Tablet taken sublingually each day at bedtime for 12 weeks. TNX-102 SL tablet: Patients will take 1 tablet of randomly assigned study drug sublingually starting on Day 1 for 2 weeks. At the Week 2 visit, all patients will have the dose increased to 2 tablets for 12 weeks. | | OG001 | Placebo SL Tablet | 1 x Placebo Tablet taken sublingually each day at bedtime for 2 weeks, then 2 x Placebo Tablet taken sublingually each day at bedtime for 12 weeks. Placebo SL Tablet: Patients will take 1 tablet of randomly assigned study drug sublingually starting on Day 1 for 2 weeks. At the Week 2 visit, all patients will have the dose increased to 2 tablets for 12 weeks. |
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| Secondary | Change From Baseline in the Weekly Average of the Daily Diary Assessment of Sleep Quality at the Week 14 Endpoint | Patients provide a daily numeric assessment of their sleep quality for the previous night, via an electronic diary, using an 11-point NRS. Scores range from 0 (best possible sleep) to 10 (worst possible sleep). | Intention-To-Treat (ITT) population: all patients who were randomized. This is the primary population for efficacy analyses, and patients will be analyzed based on their randomized treatment. | Posted | | Least Squares Mean | 95% Confidence Interval | score on a scale | | Baseline (Day -7 to Day -1), Week 14 | | | | ID | Title | Description |
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| OG000 | TNX-102 SL Tablet, 5.6 mg | 1 x TNX-102 SL 2.8 mg Tablet taken sublingually each day at bedtime for 2 weeks, then 2 x TNX-102 SL 2.8 mg (5.6 mg) Tablet taken sublingually each day at bedtime for 12 weeks. TNX-102 SL tablet: Patients will take 1 tablet of randomly assigned study drug sublingually starting on Day 1 for 2 weeks. At the Week 2 visit, all patients will have the dose increased to 2 tablets for 12 weeks. | | OG001 | Placebo SL Tablet | 1 x Placebo Tablet taken sublingually each day at bedtime for 2 weeks, then 2 x Placebo Tablet taken sublingually each day at bedtime for 12 weeks. Placebo SL Tablet: Patients will take 1 tablet of randomly assigned study drug sublingually starting on Day 1 for 2 weeks. At the Week 2 visit, all patients will have the dose increased to 2 tablets for 12 weeks. |
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