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BEdtime Sublingual TNX-102 SL as Fibromyalgia Intervention Therapy (BESTFIT)

Tonix Pharmaceuticals logo

Tonix Pharmaceuticals

Status and phase

Completed
Phase 3
Phase 2

Conditions

Primary Fibromyalgia

Treatments

Drug: TNX-102 SL 2.8mg
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01903265
TNX-CY-F202

Details and patient eligibility

About

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.

Enrollment

205 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

205 participants in 2 patient groups, including a placebo group

TNX-102 SL 2.8 mg
Experimental group
Description:
Patients will take 1 tablet of TNX-102 SL sublingually each day at bedtime for 12 weeks.
Treatment:
Drug: TNX-102 SL 2.8mg
Placebo
Placebo Comparator group
Description:
Patients will take 1 tablet of placebo sublingually each day at bedtime for 12 weeks.
Treatment:
Drug: Placebo

Trial contacts and locations

17

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Data sourced from clinicaltrials.gov

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