Clinical trial NCT02015234: 12-Month Open-Label Long-term Safety Study of TNX-102 SL Tablets in Fibromyalgia Patients
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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Primary Fibromyalgia
Keywords: TNX-102 SL
bedtime
sublingual
12-month
long term safety
long term efficacy
Fibromyalgia
Lead sponsor: Tonix Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2013-12-19
Enrollment: 158
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Newly-emergent Adverse Events (NEAEs) During Treatment With TNX-102 SL Tablets Taken Daily at Bedtime Over 12 Months in Patients With Fibromyalgia.
timeFrame: Up to 12 months
Secondary outcomes:
measure: Change From Baseline in Numerical Rating Scale (NRS) Assessments of Average Pain Based on 24 Hour Recall
timeFrame: Months 1, 3, 6, 9 and 12.
measure: Change From Baseline in Numerical Rating Scale (NRS) Assessments of Average Pain Based on a 7 Day Recall
timeFrame: Month 1, 3, 6, 9, 12
measure: Responder Analysis of Patient's Global Impression of Change (PGIC)
timeFrame: Months 1, 3, 6, 9, 12
Other outcomes:
Locations:
city: Denver
country: United States
facility: Denver
state: Colorado
city: Brooksville
country: United States
facility: 16176 Cortez Boulevard
state: Florida
city: Orlando
country: United States
facility: 100 West Gore Street
state: Florida
city: Frederick
country: United States
facility: 71 Thomas Johnson Drive
state: Maryland
city: North Dartmouth
country: United States
facility: 370 Faunce Corner Road
state: Massachusetts
city: Worcester
country: United States
facility: Worcester
state: Massachusetts
city: Jackson
country: United States
facility: Jackson
state: Mississippi
city: Cincinnati
country: United States
facility: Cincinnati
state: Ohio
city: Columbus
country: United States
facility: 1275 Olentangy River Road
state: Ohio
city: Middleburg Heights
country: United States
facility: 18660 Bagley Road
state: Ohio
city: Mechanicsburg
country: United States
facility: 1001 South Market Street
state: Pennsylvania
city: Greer
country: United States
facility: 322 Memorial Drive
state: South Carolina
city: Seattle
country: United States
facility: 601 Broadway
state: Washington
Study officials:
affiliation: Tonix Pharmaceuticals
name: Gregory Sullivan
role: STUDY_DIRECTOR
References: