| Primary | Proportion of Patients With ≥30% Pain Improvement | The primary efficacy endpoint is the proportion of patients with a ≥30% improvement (responder criteria) from baseline to Week 12 in the weekly mean of the daily self-reported 24-hour recall average pain intensity score using an 11-point (0-10) NRS. Scores range from 0 (no pain) to 10 (worst possible pain). | Results are reported for the ITT population which includes all patients who were randomized. | Posted | | Count of Participants | | Participants | | Day 1, Week 12 | | | | ID | Title | Description |
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| OG000 | Placebo SL Tablet | 1 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 each day at bedtime starting on Day 1 for 12 weeks. | | OG001 | TNX-102 SL Tablet, 2.8 mg | 1 x TNX-102 SL 2.8mg Tablet taken sublingually each day at bedtime for 12 weeks TNX-102 SL Tablet, 2.8mg: Patients will take 1 tablet of randomly assigned study drug sublingually each day at bedtime starting on Day 1 for 12 weeks. |
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| Secondary | Patient's Global Impression of Change (PGIC) | Proportion of patients with a PGIC rating of 1 ("very much improved") or 2 ("much improved") at Week 12. 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 the highest level of worsening. | Results are reported for the ITT population which includes all patients who were randomized. | Posted | | Count of Participants | | Participants | | Week 12 | | | | ID | Title | Description |
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| OG000 | Placebo SL Tablet | 1 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 each day at bedtime starting on Day 1 for 12 weeks. | | OG001 | TNX-102 SL Tablet, 2.8 mg | 1 x TNX-102 SL 2.8mg Tablet taken sublingually each day at bedtime for 12 weeks TNX-102 SL Tablet, 2.8mg: Patients will take 1 tablet of randomly assigned study drug sublingually each day at bedtime starting on Day 1 for 12 weeks. |
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| Secondary | Change From Baseline to Week 12 in the Fibromyalgia Impact Questionnaire - Revised (FIQR) Symptoms Domain Score | The FIQR is a validated questionnaire. Scores on the symptoms domain range from 0 to 100 where a higher score means worse outcome. | Results are reported for the ITT population which includes all patients who were randomized. | Posted | | Least Squares Mean | Standard Error | units on a scale | | Day 1, Week 12 | | | | ID | Title | Description |
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| OG000 | Placebo SL Tablet | 1 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 each day at bedtime starting on Day 1 for 12 weeks. | | OG001 | TNX-102 SL Tablet, 2.8 mg | 1 x TNX-102 SL 2.8mg Tablet taken sublingually each day at bedtime for 12 weeks TNX-102 SL Tablet, 2.8mg: Patients will take 1 tablet of randomly assigned study drug sublingually each day at bedtime starting on Day 1 for 12 weeks. |
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| Secondary | Change From Baseline to Week 12 in the FIQR Function Domain Score | The FIQR is a validated questionnaire. Scores on the function domain range from 0 to 90 where a higher score means worse outcome. | Results are reported for the ITT population which includes all patients who were randomized. | Posted | | Mean | Standard Error | units on a scale | | Day 1, Week 12 | | | | ID | Title | Description |
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| OG000 | Placebo SL Tablet | 1 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 each day at bedtime starting on Day 1 for 12 weeks. | | OG001 | TNX-102 SL Tablet, 2.8 mg | 1 x TNX-102 SL 2.8mg Tablet taken sublingually each day at bedtime for 12 weeks TNX-102 SL Tablet, 2.8mg: Patients will take 1 tablet of randomly assigned study drug sublingually each day at bedtime starting on Day 1 for 12 weeks. |
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| Secondary | Patient Reported Outcomes Measurement System (PROMIS) Sleep Disturbance | Change from baseline in the PROMIS score for sleep disturbance at Week 12. 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. Lower T-scores indicate less sleep disturbance. | Results are reported for the ITT population which includes all patients who were randomized. | Posted | | Least Squares Mean | Standard Error | T-score | | Day 1, Week 12 | | | | ID | Title | Description |
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| OG000 | Placebo SL Tablet | 1 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 each day at bedtime starting on Day 1 for 12 weeks. | | OG001 | TNX-102 SL Tablet, 2.8 mg | 1 x TNX-102 SL 2.8mg Tablet taken sublingually each day at bedtime for 12 weeks TNX-102 SL Tablet, 2.8mg: Patients will take 1 tablet of randomly assigned study drug sublingually each day at bedtime starting on Day 1 for 12 weeks. |
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| Secondary | Weekly Average of Daily Sleep Quality Diary | Change from Baseline in the weekly average of the daily diary assessment of sleep quality at Week 12. 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). | Results are reported for the ITT population which includes all patients who were randomized. | Posted | | Least Squares Mean | Standard Error | units on a scale | | Baseline (Day -7 to Day -1), Week 12 | | | | ID | Title | Description |
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| OG000 | Placebo SL Tablet | 1 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 each day at bedtime starting on Day 1 for 12 weeks. | | OG001 | TNX-102 SL Tablet, 2.8 mg | 1 x TNX-102 SL 2.8mg Tablet taken sublingually each day at bedtime for 12 weeks TNX-102 SL Tablet, 2.8mg: Patients will take 1 tablet of randomly assigned study drug sublingually each day at bedtime starting on Day 1 for 12 weeks. |
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| Secondary | Patient Reported Outcomes Measurement System (PROMIS) Fatigue | Change from Baseline in the PROMIS score for fatigue at Week 12. 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. Lower T-scores indicate less fatigue. | Results are reported for the ITT population which includes all patients who were randomized. | Posted | | Least Squares Mean | Standard Error | T-score | | Day 1, Week 12 | | | | ID | Title | Description |
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| OG000 | Placebo SL Tablet | 1 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 each day at bedtime starting on Day 1 for 12 weeks. | | OG001 | TNX-102 SL Tablet, 2.8 mg | 1 x TNX-102 SL 2.8mg Tablet taken sublingually each day at bedtime for 12 weeks TNX-102 SL Tablet, 2.8mg: Patients will take 1 tablet of randomly assigned study drug sublingually each day at bedtime starting on Day 1 for 12 weeks. |
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| Secondary | Weekly Average of Daily Pain Diary | Change from baseline to Week 12 in the weekly average of the daily self-reported average pain severity score using an 11-point (0-10) NRS. Scores range from 0 (no pain) to 10 (worst possible pain). | Results are reported for the ITT population which includes all patients who were randomized. | Posted | | Least Squares Mean | Standard Error | units on a scale | | Baseline (Day -7 to Day -1), Week 12 | | | | ID | Title | Description |
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| OG000 | Placebo SL Tablet | 1 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 each day at bedtime starting on Day 1 for 12 weeks. | | OG001 | TNX-102 SL Tablet, 2.8 mg | 1 x TNX-102 SL 2.8mg Tablet taken sublingually each day at bedtime for 12 weeks TNX-102 SL Tablet, 2.8mg: Patients will take 1 tablet of randomly assigned study drug sublingually each day at bedtime starting on Day 1 for 12 weeks. |
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