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12-Month Open-Label Long-term Safety Study of TNX-102 SL Tablets in Fibromyalgia Patients (BESTFIT-OLE)

Primary Purpose

Primary Fibromyalgia

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
TNX-102 SL
Sponsored by
Tonix Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Fibromyalgia focused on measuring TNX-102 SL, bedtime, sublingual, 12-month, long term safety, long term efficacy, Fibromyalgia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. The patient met all prior inclusion and exclusion requirements for Study F202 (NCT01903265) originally, and has had no intervening medical conditions, increased suicidal ideation, or requirements for concomitant medications that preclude exposure to TNX-102 SL or enrollment in the extension study.
  2. The patient completed expected dosing in F202 (NCT01903265) defined as taking study medication up to Week 12, with at least 70% compliance with medication usage (based on responses from daily IVRS calls recorded during the F202 study (NCT01903265)) and no major protocol violations.
  3. The patient has provided written informed consent to participate in this extension protocol.

Exclusion Criteria:

None

Sites / Locations

  • Denver
  • 16176 Cortez Boulevard
  • 100 West Gore Street
  • 71 Thomas Johnson Drive
  • 370 Faunce Corner Road
  • Worcester
  • Jackson
  • Cincinnati
  • 1275 Olentangy River Road
  • 18660 Bagley Road
  • 1001 South Market Street
  • 322 Memorial Drive
  • 601 Broadway

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

TNX-102 SL

Arm Description

1x TNX-102 SL 2.8 mg sublingual tablet taken daily at bedtime for 12 months

Outcomes

Primary Outcome Measures

Newly-emergent Adverse Events (NEAEs) During Treatment With TNX-102 SL Tablets Taken Daily at Bedtime Over 12 Months in Patients With Fibromyalgia.
NEAEs and Serious Adverse events (SAEs) were collected and are coded using the latest version of the Medical Dictionary for Regulatory Activities (MedDRA).

Secondary Outcome Measures

Change From Baseline in Numerical Rating Scale (NRS) Assessments of Average Pain Based on 24 Hour Recall
The NRS for average pain was an 11-point scale (0=no pain → 10=worst pain imaginable) that was assessed on a 24-hour recall basis.
Change From Baseline in Numerical Rating Scale (NRS) Assessments of Average Pain Based on a 7 Day Recall
The NRS for average pain over the past 7 days was an 11-point scale (0=no pain → 10=worst pain imaginable) that was assessed on a 7-day recall basis.
Responder Analysis of Patient's Global Impression of Change (PGIC)
PGIC is a fibromyalgia-specific validated instrument to gauge the patient's assessment of change in condition.The scores are categorized as provided below. A responder was defined by a score of 1 (very much improved), or 2 (much improved). = Very much improved = Much improved = Minimally improved = No change = Minimally worse = Much worse = Very much worse

Full Information

First Posted
December 9, 2013
Last Updated
June 8, 2017
Sponsor
Tonix Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02015234
Brief Title
12-Month Open-Label Long-term Safety Study of TNX-102 SL Tablets in Fibromyalgia Patients
Acronym
BESTFIT-OLE
Official Title
A 12-Month, Multicenter, Open-Label Extension Study (F202) to Evaluate the Long-term Safety of TNX-102 SL Tablets Taken Daily at Bedtime in Patients With Fibromyalgia
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
December 2013 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (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
This was an open-label, extension trial designed to evaluate the long-term safety over 12 months of TNX-102 SL tablets taken daily at bedtime for the treatment of fibromyalgia. Patients recruited into this trial were those who had successfully completed the double-blind study, TNX-CY-F202 (F202) (NCT01903265). Patients were not made aware of the therapy they received during the double-blind study.
Detailed Description
The study consisted of 7 clinic visits, including Screening/Baseline Visit 1 (Day 0 which was typically the same date as Visit 6 of the double-blind lead-in study), visits after 1, 3, 6, 9, and 12 months of treatment (Visits 2-6), and a Follow-up Visit (Visit 7) scheduled within one month after stopping study drug treatment. Primary: The primary objective of the study was to evaluate the long-term safety of TNX-102 SL tablets taken daily at bedtime over 12 months in patients with fibromyalgia who have completed Study TNX-CY-F202 (NCT01903265) Secondary: The secondary objective was to evaluate the long-term efficacy of TNX-102 SL tablets taken daily at bedtime to control symptoms of fibromyalgia

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Fibromyalgia
Keywords
TNX-102 SL, bedtime, sublingual, 12-month, long term safety, long term efficacy, Fibromyalgia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
158 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TNX-102 SL
Arm Type
Experimental
Arm Description
1x TNX-102 SL 2.8 mg sublingual tablet taken daily at bedtime for 12 months
Intervention Type
Drug
Intervention Name(s)
TNX-102 SL
Other Intervention Name(s)
cyclobenzaprine HCl
Intervention Description
TNX-102 SL 2.8 mg taken daily at bedtime.
Primary Outcome Measure Information:
Title
Newly-emergent Adverse Events (NEAEs) During Treatment With TNX-102 SL Tablets Taken Daily at Bedtime Over 12 Months in Patients With Fibromyalgia.
Description
NEAEs and Serious Adverse events (SAEs) were collected and are coded using the latest version of the Medical Dictionary for Regulatory Activities (MedDRA).
Time Frame
Up to 12 months
Secondary Outcome Measure Information:
Title
Change From Baseline in Numerical Rating Scale (NRS) Assessments of Average Pain Based on 24 Hour Recall
Description
The NRS for average pain was an 11-point scale (0=no pain → 10=worst pain imaginable) that was assessed on a 24-hour recall basis.
Time Frame
Months 1, 3, 6, 9 and 12.
Title
Change From Baseline in Numerical Rating Scale (NRS) Assessments of Average Pain Based on a 7 Day Recall
Description
The NRS for average pain over the past 7 days was an 11-point scale (0=no pain → 10=worst pain imaginable) that was assessed on a 7-day recall basis.
Time Frame
Month 1, 3, 6, 9, 12
Title
Responder Analysis of Patient's Global Impression of Change (PGIC)
Description
PGIC is a fibromyalgia-specific validated instrument to gauge the patient's assessment of change in condition.The scores are categorized as provided below. A responder was defined by a score of 1 (very much improved), or 2 (much improved). = Very much improved = Much improved = Minimally improved = No change = Minimally worse = Much worse = Very much worse
Time Frame
Months 1, 3, 6, 9, 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: The patient met all prior inclusion and exclusion requirements for Study F202 (NCT01903265) originally, and has had no intervening medical conditions, increased suicidal ideation, or requirements for concomitant medications that preclude exposure to TNX-102 SL or enrollment in the extension study. The patient completed expected dosing in F202 (NCT01903265) defined as taking study medication up to Week 12, with at least 70% compliance with medication usage (based on responses from daily IVRS calls recorded during the F202 study (NCT01903265)) and no major protocol violations. The patient has provided written informed consent to participate in this extension protocol. Exclusion Criteria: None
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gregory Sullivan
Organizational Affiliation
Tonix Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Denver
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
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
Worcester
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01605
Country
United States
Facility Name
Jackson
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39202
Country
United States
Facility Name
Cincinnati
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
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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12-Month Open-Label Long-term Safety Study of TNX-102 SL Tablets in Fibromyalgia Patients

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