NCT02015234

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
158

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Dec 2013

Geographic Reach
1 country

13 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2013

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

December 9, 2013

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 19, 2013

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

July 7, 2017

Completed
Last Updated

July 7, 2017

Status Verified

June 1, 2017

Enrollment Period

1.7 years

First QC Date

December 9, 2013

Results QC Date

May 22, 2017

Last Update Submit

June 8, 2017

Conditions

Primary Fibromyalgia

Keywords

TNX-102 SLbedtimesublingual12-monthlong term safetylong term efficacyFibromyalgia

Outcome Measures

Primary Outcomes (1)

  • 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).

    Up to 12 months

Secondary Outcomes (3)

  • Change From Baseline in Numerical Rating Scale (NRS) Assessments of Average Pain Based on 24 Hour Recall

    Months 1, 3, 6, 9 and 12.

  • Change From Baseline in Numerical Rating Scale (NRS) Assessments of Average Pain Based on a 7 Day Recall

    Month 1, 3, 6, 9, 12

  • Responder Analysis of Patient's Global Impression of Change (PGIC)

    Months 1, 3, 6, 9, 12

Study Arms (1)

TNX-102 SL

EXPERIMENTAL

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

Drug: TNX-102 SL

Interventions

TNX-102 SLDRUG

TNX-102 SL 2.8 mg taken daily at bedtime.

Also known as: cyclobenzaprine HCl
TNX-102 SL

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Denver

Denver, Colorado, 80239, United States

Location

16176 Cortez Boulevard

Brooksville, Florida, 34601, United States

Location

100 West Gore Street

Orlando, Florida, 32806, United States

Location

71 Thomas Johnson Drive

Frederick, Maryland, 21702, United States

Location

370 Faunce Corner Road

North Dartmouth, Massachusetts, 02747, United States

Location

Worcester

Worcester, Massachusetts, 01605, United States

Location

Jackson

Jackson, Mississippi, 39202, United States

Location

Cincinnati

Cincinnati, Ohio, 45219, United States

Location

1275 Olentangy River Road

Columbus, Ohio, 43212, United States

Location

18660 Bagley Road

Middleburg Heights, Ohio, 44130, United States

Location

1001 South Market Street

Mechanicsburg, Pennsylvania, 17055, United States

Location

322 Memorial Drive

Greer, South Carolina, 29650, United States

Location

601 Broadway

Seattle, Washington, 98122, United States

Location

MeSH Terms

Conditions

Fibromyalgia

Interventions

cyclobenzaprine

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System Diseases

Results Point of Contact

Title
Gregory M. Sullivan, Chief Medical Officer
Organization
Tonix Pharmaceuticals
greg.sullivan@tonixpharma.com
212 980 9155

Study Officials

  • Gregory Sullivan

    Tonix Pharmaceuticals

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 9, 2013

First Posted

December 19, 2013

Study Start

December 1, 2013

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

July 7, 2017

Results First Posted

July 7, 2017

Record last verified: 2017-06

Locations

US(13)