| Primary | Change From Baseline to Week 14 in the Numerical Rating Scale (NRS) Weekly Average of Daily Self-reported Average Pain Severity Scores. | Patients provide a daily numeric assessment of their average pain (24-hour recall), via an electronic diary, using an 11-point NRS. Scores range from 0 (no pain) to 10 (worst possible pain). | Intent to treat population (all patients who were randomized). Multiple imputation for missing data. | Posted | | Least Squares Mean | 95% Confidence Interval | score on a scale | | 14 weeks | | | | 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 patient 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 patient will have the dose increased to 2 tablets for 12 weeks. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG000-1.6(-1.8 to -1.3)
- OG001-1.3(-1.5 to -1.1)
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| | Mixed Model Repeated Measures | Multiple imputation used for missing data. | 0.115 | | LS Mean Difference | -0.2 | Standard Error of the Mean | 0.16 | 2-Sided | 95 | -0.6 | 0.1 | | | Treatment difference = TNX-102 SL - Placebo | | Superiority | | |
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| Secondary | Number of Patients With a Patient's Global Impression of Change (PGIC) Rating of "Very Much Improved" or "Much Improved" | 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. | Intent to Treat population (all patients who were randomized). Patients with missing data as non-responders. | Posted | | Count of Participants | | Participants | | 14 weeks | | | | 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 patient 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 patient will have the dose increased to 2 tablets for 12 weeks. |
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| Secondary | Change From Baseline to Week 14 in the Fibromyalgia Impact Questionnaire - Revised (FIQ-R) Symptoms Domain Score. | The FIQ-R is a validated questionnaire. Scores on the symptoms domain range from 0 to 100 where a higher score means worse outcome. | Intent to Treat population (all patients who were randomized). Multiple imputation for missing data. | Posted | | Least Squares Mean | 95% Confidence Interval | score on a scale | | 14 weeks | | | | 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 patient 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 patient will have the dose increased to 2 tablets for 12 weeks. |
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| Secondary | Change From Baseline to Week 14 in the FIQ-R Function Domain Score | The FIQ-R is a validated questionnaire. Score on the function domain range from 0 to 90 where a higher score means worse outcome. | Intent to Treat population (all patients who were randomized). Multiple imputation for missing data. | Posted | | Least Squares Mean | 95% Confidence Interval | score on a scale | | 14 weeks | | | | 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 patient 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 patient will have the dose increased to 2 tablets for 12 weeks. |
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| Secondary | Change From Baseline to Week 14 in the Patient Reported Outcomes Measurement Information System (PROMIS) Score for Sleep Disturbance | 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. | Intent to Treat population (all patients who were randomized). Multiple imputation for missing data. | Posted | | Least Squares Mean | 95% Confidence Interval | score on a scale | | 14 weeks | | | | 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 patient 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 patient will have the dose increased to 2 tablets for 12 weeks. |
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| Secondary | Change From Baseline to Week 14 in the PROMIS Score for Fatigue | The PROMIS fatigue short form 8a consist 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. | Intent to Treat population (all patients who were randomized). Multiple imputation for missing data. | Posted | | Least Squares Mean | 95% Confidence Interval | score on a scale | | 14 weeks | | | | 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 patient 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 patient will have the dose increased to 2 tablets for 12 weeks. |
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| Secondary | Change From Baseline to Week 14 in the Weekly Average of the Daily Diary Assessment of Sleep Quality | 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). | Intent to Treat population (all patients who were randomized). Multiple imputation for missing data. | Posted | | Least Squares Mean | 95% Confidence Interval | score on a scale | | 14 weeks | | | | 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 patient 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 patient will have the dose increased to 2 tablets for 12 weeks. |
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