Comparison · NCT02436096-27dff9a7
TNX-102 SL Tablet, 2.8 mg vs Placebo SL Tablet: Patient's Global Impression of Change (PGIC)
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. TNX-102 SL Tablet, 2.8 mg vs Placebo SL Tablet: Patient's Global Impression of Change (PGIC). Trial comparisons, record NCT02436096-27dff9a7. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02436096-27dff9a7
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.237 | 0.189 | 0.292 | wilson | |
| Risk in group 2 | 0.163 | 0.123 | 0.214 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0732 | 0.00423 | 0.141 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.45 | 1.02 | 2.06 | log | |
| Odds ratio, group 1 over group 2 | 1.59 | 1.03 | 2.46 | log | |
| Number needed to treat, for one more participant with the outcome on TNX-102 SL Tablet, 2.8 mg than on Placebo SL Tablet | 13.7 | 7.07 | 237 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | 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. | 62 | 262 | OG001 |
| Group 2 | 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. | 42 | 257 | OG000 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Patient's Global Impression of Change (PGIC)
- Description
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.
- Time frame
- Week 12
- Population
- Results are reported for the ITT population which includes all patients who were randomized.
Source ClinicalTrials.gov
Trial
- Title
- A Study to Evaluate eFFIcacy and Safety of Sublingual TNX-102 SL Tablet Taken at Bedtime in Patients With fibRoMyalgia
- NCT number
- NCT02436096
- Phases
- PHASE3
- Conditions
- Fibromyalgia, Myofascial Pain Syndromes, Muscular Diseases, Musculoskeletal Diseases, Nervous System Diseases, Neuromuscular Diseases, Rheumatic Diseases
- Interventions
- TNX-102 SL Tablet, 2.8mg, Placebo SL Tablet
- Lead sponsor
- Tonix Pharmaceuticals, Inc.
- Results first posted
- 2025-02-07
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02436096?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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