FibromyalgiaPhase 3RALLYNCT04508621

A Phase 3 Study To Evaluate The Efficacy And Safety Of TNX-102 SL In Patients With Fibromyalgia

A Phase 3 study testing TNX-102 SL in people with Fibromyalgia, run by Tonix Pharmaceuticals, Inc. at 36 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This is a Phase 3, randomized, parallel-group, double-blind, placebo-controlled, 14-week study designed to evaluate the efficacy and safety of TNX-102 SL 5.6 mg (2 x 2.8 mg tablets) taken daily at bedtime for the treatment of fibromyalgia. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Fibromyalgia
What is being tested?: TNX-102 SL
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 514 participants
Where: 36 sitesUnited States
Study dates: 22 Jul 2020to 1 Nov 2021
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

The patient is male or female 18 to 65 years of age, inclusive.
The patient has a diagnosis of primary FM as defined by the 2016 Revisions to the 2010/2011 fibromyalgia diagnostic criteria (American College of Rheumatology Preliminary Diagnostic Criteria)
The in clinic 7-day recall NRS average daily pain intensity score at Screening Visit within protocol defined range.

Who cannot join

History of or evidence for a diagnosis of borderline personality disorder (BPD).

Trial locations and contacts

36 sites in 1 country.

City, postcode or hospital

36 sites in 1 country

United States36 sites

Tonix Clinical Site
Albuquerque, New Mexico, 87109
Tonix Clinical Site
Alpharetta, Georgia, 30022
Tonix Clinical Site
Austin, Texas, 78737
Tonix Clinical Site
Birmingham, Alabama, 35216
Tonix Clinical Site
Boston, Massachusetts, 02131
Tonix Clinical Site
Charlottesville, Virginia, 22911
Tonix Clinical Site
Chattanooga, Tennessee, 37421
Tonix Clinical Site
Cincinnati, Ohio, 45219
Tonix Clinical Site
Cromwell, Connecticut, 06416
Tonix Clinical Site
Dallas, Texas, 75231
Tonix Clinical Site
Dayton, Ohio, 45417
Tonix Clinical Site
Evansville, Indiana, 47714
Tonix Clinical Site
Fort Myers, Florida, 33912
Tonix Clinical Site
High Point, North Carolina, 27262
Tonix Clinical Site
Jacksonville, Florida, 32256
Tonix Clinical Site
Kenosha, Wisconsin, 53144
Tonix Clinical Site
Memphis, Tennessee, 38119
Tonix Clinical Site
New Orleans, Louisiana, 70115
Tonix Clinical Site
North Canton, Ohio, 44720
Tonix Clinical Site
North Miami, Florida, 33161
Tonix Clinical Site
Ocala, Florida, 34470
Tonix Clinical Site
Oceanside, California, 92056
Tonix Clinical Site
Oklahoma City, Oklahoma, 73112
Tonix Clinical Site
Orlando, Florida, 32801
Tonix Clinical Site
Phoenix, Arizona, 85016
Tonix Clinical Site
Portland, Oregon, 97210
Tonix Clinical Site
Prairie Village, Kansas, 66208
Tonix Clinical Site
Raleigh, North Carolina, 27612
Tonix Clinical Site
Salt Lake City, Utah, 84102
Tonix Clinical Site
San Diego, California, 92103
Tonix Clinical Site
Santa Ana, California, 92705
Tonix Clinical Site
Temecula, California, 32591
Tonix Clinical Site
Tulsa, Oklahoma, 74133
Tonix Clinical Site
Warwick, Rhode Island, 02886
Tonix Clinical Site
West Des Moines, Iowa, 50265
Tonix Clinical Site
Williamsville, New York, 14221

Other trials in United States

About this study

Official title: A Phase 3, Double-Blind, Randomized, Multicenter, Placebo-Controlled Study To Evaluate The Efficacy And Safety Of TNX-102 SL Taken Daily At Bedtime In Patients With Fibromyalgia

Conditions: Fibromyalgia
Being tested: TNX-102 SL, Placebo SL Tablet
Keywords: Pain, Sleep, Fibromyalgia, FM
Medical subject headings: Fibromyalgia, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TNX-102 SLDrug
Also called Low dose cyclobenzaprine sublingual tablets
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.
Placebo SL TabletDrug
Also called Placebo sublingual tablets
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.

Study groups in NCT04508621
Study group	Role	What they receive
TNX-102 SL Tablet, 5.6 mg	Experimental	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. Receives: Drug: TNX-102 SL
Placebo SL Tablet	Placebo comparator	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. Receives: Drug: Placebo SL Tablet

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 14 weeks

Secondary outcomes (6)

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.
Measured: 14 weeks
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.
Measured: 14 weeks
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.
Measured: 14 weeks
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.
Measured: 14 weeks
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.
Measured: 14 weeks
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).
Measured: 14 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Jul 20201 Nov 2021

First posted11 Aug 2020
Study start22 Jul 2020
Primary completion1 Nov 2021
Study completion1 Nov 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for FibromyalgiaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 514 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04508621
Sponsor's protocol ID: TNX-CY-F306
Acronym: RALLY
Status last verified: Dec 2023
First submitted: 7 Aug 2020
Last updated: 18 Dec 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Fibromyalgia trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3, Double-Blind, Randomized, Multicenter, Placebo-Controlled Study To Evaluate The Efficacy And Safety Of TNX-102 SL Taken Daily At Bedtime In Patients With Fibromyalgia
ClinicalTrials.gov ID: NCT04508621
Acronym / sponsor ID: RALLY / TNX-CY-F306
Conditions: Fibromyalgia
Keywords: Pain, Sleep, Fibromyalgia, FM
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 514 participants (actual)
Lead sponsor: Tonix Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
Study start: 22 Jul 2020 (actual)
Primary completion: 1 Nov 2021 (actual)
Study completion: 1 Nov 2021 (actual)
First posted: 11 Aug 2020 (actual)
Results: Posted 2 Dec 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
TNX-102 SL Tablet, 5.6 mg	Experimental	Drug: TNX-102 SL1 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.
Placebo SL Tablet	Placebo comparator	Drug: Placebo SL Tablet1 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.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

The patient is male or female 18 to 65 years of age, inclusive.
The patient has a diagnosis of primary FM as defined by the 2016 Revisions to the 2010/2011 fibromyalgia diagnostic criteria (American College of Rheumatology Preliminary Diagnostic Criteria)
The in clinic 7-day recall NRS average daily pain intensity score at Screening Visit within protocol defined range.

Key exclusion criteria (1 listed)

History of or evidence for a diagnosis of borderline personality disorder (BPD).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
TNX-102 SLAlso: Low dose cyclobenzaprine sublingual tabletsPatients 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.	Drug	TNX-102 SL Tablet, 5.6 mg
Placebo SL TabletAlso: Placebo sublingual tabletsPatients 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.	Drug	Placebo SL Tablet

Primary outcome

Change From Baseline to Week 14 in the Numerical Rating Scale (NRS) Weekly Average of Daily Self-reported Average Pain Severity Scores.
Time frame: 14 weeks
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).

6 secondary outcomes

Number of Patients With a Patient's Global Impression of Change (PGIC) Rating of "Very Much Improved" or "Much Improved"
Time frame: 14 weeks
Change From Baseline to Week 14 in the Fibromyalgia Impact Questionnaire - Revised (FIQ-R) Symptoms Domain Score.
Time frame: 14 weeks
Change From Baseline to Week 14 in the FIQ-R Function Domain Score
Time frame: 14 weeks
Change From Baseline to Week 14 in the Patient Reported Outcomes Measurement Information System (PROMIS) Score for Sleep Disturbance
Time frame: 14 weeks
Change From Baseline to Week 14 in the PROMIS Score for Fatigue
Time frame: 14 weeks
Change From Baseline to Week 14 in the Weekly Average of the Daily Diary Assessment of Sleep Quality
Time frame: 14 weeks

Results and safety

Results posted to the registry on 2 Dec 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
TNX-102 SL Tablet, 5.6 mg	256	189
Placebo SL Tablet	258	210

Primary outcome: Change From Baseline to Week 14 in the Numerical Rating Scale (NRS) Weekly Average of Daily Self-reported Average Pain Severity Scores.

Time frame: 14 weeks. Least squares mean (95% Confidence Interval). Unit: score on a scale

Measure	TNX-102 SL Tablet, 5.6 mg n = 256	Placebo SL Tablet n = 258
Value	-1.6 (-1.8 to -1.3)	-1.3 (-1.5 to -1.1)

TNX-102 SL Tablet, 5.6 mg vs Placebo SL Tablet: LS Mean Difference: -0.2 (95% CI -0.6 to 0.1), p = 0.115, Mixed Model Repeated Measures

Population analysed: Intent to treat population (all patients who were randomized). Multiple imputation for missing data.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: 14 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
TNX-102 SL Tablet, 5.6 mg	6 of 256 (2.3%)	80 of 256 (31.3%)	0 of 256
Placebo SL Tablet	0 of 258 (0%)	5 of 258 (1.9%)	0 of 258

Limitations and caveats (from the sponsor): Recruitment during COVID-19 pandemic

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Fibromyalgia

Active, not recruiting
PEACE: Comparing Chronic Pain Treatment Options
Chronic Pain, Musculoskeletal Pain
Not yet recruiting
Effects of Adding Vagal Neuromodulation to Manual Therapy in Women With Fibromyalgia
Fibromyalgia (FM) OR Fibromyalgia Syndrome, Manuel Therapy
Active, not recruiting
Relationships of Affect and Neuroinflammation With Clinical Pain in Veterans With Fibromyalgia
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Enrolling by invitation
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Gregory Sullivan, MD study director

Tonix Pharmaceuticals, Inc.

36 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing TNX-102 SL in people with Fibromyalgia, run by Tonix Pharmaceuticals, Inc. at 36 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 36 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Dec 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline to Week 14 in the Numerical Rating Scale (NRS) Weekly Average of Daily Self-reported Average Pain Severity Scores. (time frame: 14 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04508621.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2023.