Back to resultsBEdtime Sublingual TNX-102 SL as Fibromyalgia Intervention Therapy (BESTFIT) (BESTFIT)
Primary Purpose
Primary Fibromyalgia
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
TNX-102 SL 2.8mg
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Primary Fibromyalgia focused on measuring pain, sleep
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of primary Fibromyalgia (ACR criteria)
- Male or female 18-65 years old
- For patients with major depressive disorders only: clinically stable, no suicidal risk and stable anti-depressent therapy
- Willing and able to withdraw specific therapies (ask PI)
- Medically acceptable form of contraception (female only)
- Signed informed consent
Exclusion Criteria:
- Arthritis, lupus and other systemic auto-immune diseases
- Regional or persistent pain that could interfere with assessment of fibromyalgia pain
- Bipolar and psychotic disorders
- Increased risk of suicide
- Significant clinical (cardiac, systemic infection, systemic corticosteroid requirement, drug/alcohol abuse) or laboratory abnormalities.
- Inability to wash-off specific medications (ask PI)
- Known hypersensitivity to cyclobenzaprine
- Others: seizure disorders, sleep apnea, continuous positive airway pressure (CPAP) use, BMI>40
Sites / Locations
- 107 Scripps Drive
- Radiant Research, Inc.
- 16176 Cortez Boulevard
- 100 West Gore Street
- 3401 North Central Avenue
- 71 Thomas Johnson Drive
- 370 Faunce Corner Road
- Clinical Pharmacology Study Group
- CRC of Jackson, LLC
- University of Cincinnati College of Medicine
- 1275 Olentangy River Road
- 18660 Bagley Road
- 1001 South Market Street
- 322 Memorial Drive
- 1002 E. South Temple
- 1951 152nd Place NE
- 601 Broadway
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
TNX-102 SL 2.8 mg
Placebo
Arm Description
Patients will take 1 tablet of TNX-102 SL sublingually each day at bedtime for 12 weeks.
Patients will take 1 tablet of placebo sublingually each day at bedtime for 12 weeks.
Outcomes
Primary Outcome Measures
Mean Change From Baseline in Weekly Average of Daily Pain Scores at 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 Outcome Measures
30% Responder Analysis of IVRS NRS Pain Assessments at 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.
Change From Baseline to Week 12 in PROMIS T-score for Sleep Disturbance
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).
Patient Global Impression of Change (PGIC) Responder Status ("Very Much Improved" or "Much Improved" vs All Other Categories) at 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.
Change From Baseline to Week 12 in FIQ-R Total Score
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.
Full Information
NCT ID
NCT01903265
First Posted
July 12, 2013
Last Updated
October 31, 2016
Sponsor
Tonix Pharmaceuticals, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01903265
Brief Title
BEdtime Sublingual TNX-102 SL as Fibromyalgia Intervention Therapy (BESTFIT)
Acronym
BESTFIT
Official Title
A Phase 2b, Double-Blind, Randomized, Multicenter, Placebo-Controlled Study to Evaluate the Efficacy and Safety of TNX-102 SL Tablets Taken at Bedtime in Patients With Fibromyalgia
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
September 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tonix Pharmaceuticals, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
TNX-102 capsules [formerly known as very low dose (VLD) cyclobenzaprine] at bedtime have shown promise as a treatment of fibromyalgia, but the drug required new formulation technology for bedtime use. The present trial was designed to assess the safety and efficacy of TNX-102 SL 2.8 mg tablets, taken daily at bedtime over 12 weeks to treat fibromyalgia.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Fibromyalgia
Keywords
pain, sleep
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
205 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TNX-102 SL 2.8 mg
Arm Type
Experimental
Arm Description
Patients will take 1 tablet of TNX-102 SL sublingually each day at bedtime for 12 weeks.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients will take 1 tablet of placebo sublingually each day at bedtime for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
TNX-102 SL 2.8mg
Other Intervention Name(s)
Low dose cyclobenzaprine sublingual tablets
Intervention Description
Patients will take 1 tablet of randomly assigned study drug sublingually each day at bedtime starting on Day 0 for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Placebo sublingual tablets
Intervention Description
Patients will take 1 tablet of randomly assigned study drug sublingually each day at bedtime starting on Day 0 for 12 weeks.
Primary Outcome Measure Information:
Title
Mean Change From Baseline in Weekly Average of Daily Pain Scores at Week 12
Description
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.
Time Frame
Baseline, Week 12
Secondary Outcome Measure Information:
Title
30% Responder Analysis of IVRS NRS Pain Assessments at Week 12
Description
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.
Time Frame
Baseline, Week 12
Title
Change From Baseline to Week 12 in PROMIS T-score for Sleep Disturbance
Description
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).
Time Frame
Baseline, Week 12
Title
Patient Global Impression of Change (PGIC) Responder Status ("Very Much Improved" or "Much Improved" vs All Other Categories) at Week 12
Description
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.
Time Frame
Week 12
Title
Change From Baseline to Week 12 in FIQ-R Total Score
Description
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.
Time Frame
Baseline, Week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of primary Fibromyalgia (ACR criteria)
Male or female 18-65 years old
For patients with major depressive disorders only: clinically stable, no suicidal risk and stable anti-depressent therapy
Willing and able to withdraw specific therapies (ask PI)
Medically acceptable form of contraception (female only)
Signed informed consent
Exclusion Criteria:
Arthritis, lupus and other systemic auto-immune diseases
Regional or persistent pain that could interfere with assessment of fibromyalgia pain
Bipolar and psychotic disorders
Increased risk of suicide
Significant clinical (cardiac, systemic infection, systemic corticosteroid requirement, drug/alcohol abuse) or laboratory abnormalities.
Inability to wash-off specific medications (ask PI)
Known hypersensitivity to cyclobenzaprine
Others: seizure disorders, sleep apnea, continuous positive airway pressure (CPAP) use, BMI>40
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark R. Schmal
Organizational Affiliation
Premier Research Group plc
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Daniel J. Clauw, MD
Organizational Affiliation
Ann Arbor, MI
Official's Role
Study Chair
Facility Information:
Facility Name
107 Scripps Drive
City
Sacramento
State/Province
California
ZIP/Postal Code
95825
Country
United States
Facility Name
Radiant Research, Inc.
City
Denver
State/Province
Colorado
ZIP/Postal Code
80239
Country
United States
Facility Name
16176 Cortez Boulevard
City
Brooksville
State/Province
Florida
ZIP/Postal Code
34601
Country
United States
Facility Name
100 West Gore Street
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
3401 North Central Avenue
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60634
Country
United States
Facility Name
71 Thomas Johnson Drive
City
Frederick
State/Province
Maryland
ZIP/Postal Code
21702
Country
United States
Facility Name
370 Faunce Corner Road
City
North Dartmouth
State/Province
Massachusetts
ZIP/Postal Code
02747
Country
United States
Facility Name
Clinical Pharmacology Study Group
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01605
Country
United States
Facility Name
CRC of Jackson, LLC
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39202
Country
United States
Facility Name
University of Cincinnati College of Medicine
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
1275 Olentangy River Road
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43212
Country
United States
Facility Name
18660 Bagley Road
City
Middleburg Heights
State/Province
Ohio
ZIP/Postal Code
44130
Country
United States
Facility Name
1001 South Market Street
City
Mechanicsburg
State/Province
Pennsylvania
ZIP/Postal Code
17055
Country
United States
Facility Name
322 Memorial Drive
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29650
Country
United States
Facility Name
1002 E. South Temple
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84102
Country
United States
Facility Name
1951 152nd Place NE
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98007
Country
United States
Facility Name
601 Broadway
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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BEdtime Sublingual TNX-102 SL as Fibromyalgia Intervention Therapy (BESTFIT)
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