Trial · NCT01903265

BEdtime Sublingual TNX-102 SL as Fibromyalgia Intervention Therapy (BESTFIT)

NCT01903265, Phase 2, Phase 3, Completed, Tonix Pharmaceuticals, Inc.; results first posted 2016-12-23

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. BEdtime Sublingual TNX-102 SL as Fibromyalgia Intervention Therapy (BESTFIT). Trials, record NCT01903265. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01903265

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: BEdtime Sublingual TNX-102 SL as Fibromyalgia Intervention Therapy (BESTFIT)
NCT number: NCT01903265
Status: Completed
Phases: Phase 2, Phase 3
Enrollment: 205 participants, actual
Lead sponsor: Tonix Pharmaceuticals, Inc.
Conditions: Primary Fibromyalgia
Interventions: TNX-102 SL 2.8mg, Placebo
First posted: 2013-07-19
Last updated: 2016-12-23
Results first posted: 2016-12-23

Source ClinicalTrials.gov

Registered outcomes5

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Mean Change From Baseline in Weekly Average of Daily Pain Scores at Week 12	Baseline, 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.
Secondary	30% Responder Analysis of IVRS NRS Pain Assessments at Week 12	Baseline, 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.
Secondary	Change From Baseline to Week 12 in PROMIS T-score for Sleep Disturbance	Baseline, Week 12	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).
Secondary	Patient Global Impression of Change (PGIC) Responder Status ("Very Much Improved" or "Much Improved" vs All Other Categories) at Week 12	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.
Secondary	Change From Baseline to Week 12 in FIQ-R Total Score	Baseline, Week 12	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.

Source ClinicalTrials.gov

Outcomes5

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Mean Change From Baseline in Weekly Average of Daily Pain Scores at Week 12	Baseline, Week 12	Patients in the Intention-to-treat (ITT) population: all randomized patients	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	30% Responder Analysis of IVRS NRS Pain Assessments at Week 12	Baseline, Week 12	Patients in the Intention-to-treat (ITT) population: all randomized patients.	percentage of participants	NUMBER
SECONDARY	Change From Baseline to Week 12 in PROMIS T-score for Sleep Disturbance	Baseline, Week 12	Patients in the Intention-to-treat (ITT) population: all randomized patients	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Patient Global Impression of Change (PGIC) Responder Status (Very Much Improved or Much Improved vs All Other Categories) at Week 12	Week 12	Patients in the Intention-to-treat (ITT) population: all randomized patients	percentage of participants	NUMBER
SECONDARY	Change From Baseline to Week 12 in FIQ-R Total Score	Baseline, Week 12	Patients in the Intention-to-treat (ITT) population: all randomized patients	units on a scale	LEAST_SQUARES_MEAN

Source ClinicalTrials.gov

Results by group10

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Mean Change From Baseline in Weekly Average of Daily Pain Scores at Week 12	TNX-102 SL 2.8 mg Tablets	-1.39	Standard Error 0.253	units on a scale
Mean Change From Baseline in Weekly Average of Daily Pain Scores at Week 12	Placebo	-0.95	Standard Error 0.271	units on a scale
30% Responder Analysis of IVRS NRS Pain Assessments at Week 12	TNX-102 SL 2.8 mg Tablets	34		percentage of participants
30% Responder Analysis of IVRS NRS Pain Assessments at Week 12	Placebo	20.6		percentage of participants
Change From Baseline to Week 12 in PROMIS T-score for Sleep Disturbance	TNX-102 SL 2.8 mg Tablets	-8.96	Standard Error 0.993	units on a scale
Change From Baseline to Week 12 in PROMIS T-score for Sleep Disturbance	Placebo	-5.13	Standard Error 1.029	units on a scale
Patient Global Impression of Change (PGIC) Responder Status (Very Much Improved or Much Improved vs All Other Categories) at Week 12	TNX-102 SL 2.8 mg Tablets	30.1		percentage of participants
Patient Global Impression of Change (PGIC) Responder Status (Very Much Improved or Much Improved vs All Other Categories) at Week 12	Placebo	16.7		percentage of participants
Change From Baseline to Week 12 in FIQ-R Total Score	TNX-102 SL 2.8 mg Tablets	-15.59	Standard Error 2.079	units on a scale
Change From Baseline to Week 12 in FIQ-R Total Score	Placebo	-8.54	Standard Error 2.133	units on a scale

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	TNX-102 SL 2.8 mg	103
Overall Study	STARTED	Placebo	102
Overall Study	COMPLETED	TNX-102 SL 2.8 mg	89
Overall Study	COMPLETED	Placebo	85
Overall Study	NOT COMPLETED	TNX-102 SL 2.8 mg	14
Overall Study	NOT COMPLETED	Placebo	17

Source ClinicalTrials.gov

Adverse events12

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	hypoaesthesia oral	Gastrointestinal disorders	TNX-102 SL 2.8 mg Tablets	45	103
other	hypoaesthesia oral	Gastrointestinal disorders	Placebo	2	101
other	Nausea	Gastrointestinal disorders	TNX-102 SL 2.8 mg Tablets	5	103
other	Nausea	Gastrointestinal disorders	Placebo	2	101
other	Somnolence	Nervous system disorders	TNX-102 SL 2.8 mg Tablets	2	103
other	Somnolence	Nervous system disorders	Placebo	7	101
other	Back pain	Musculoskeletal and connective tissue disorders	TNX-102 SL 2.8 mg Tablets	5	103
other	Back pain	Musculoskeletal and connective tissue disorders	Placebo	3	101
other	Product taste abnormal	General disorders	TNX-102 SL 2.8 mg Tablets	8	103
other	Product taste abnormal	General disorders	Placebo	0	101

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	TNX-102 SL 2.8 mg Tablets
Total, all-cause mortality	Placebo
Total, other adverse events	TNX-102 SL 2.8 mg Tablets	65	103
Total, other adverse events	Placebo	14	101
Total, serious adverse events	TNX-102 SL 2.8 mg Tablets	0	103
Total, serious adverse events	Placebo	1	101

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
TNX-102 SL 2.8 mg Tablets vs Placebo: serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

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
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01903265

GET https://conductscience.org/api/trials/v1/NCT01903265/registered

API reference For AI assistants