Clinical trial NCT02052414: Study of Gralise to Treat Fibromyalgia Patients
Official title: Open Labeled, Non-randomized, Study of Efficacy and Safety of Gralise in Fibromyalgia Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Keywords: side effects
safety
efficacy
Gralise
Fibromyalgia
gabapentin
Lead sponsor: The Center for Clinical Research, Winston-Salem, NC
Sponsor class: OTHER
Collaborators: name: Depomed
First posted: 2014-02-03
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To determine Gralise in treating fibromyalgia pain:

* efficacy
* safety

Detailed description: Subject must carry a diagnosis of fibromyalgia based on American College of Rheumatology (ACR) criteria for fibromyalgia

* Patient may be gaba-analogue (Pregabalin, trade name: lyrica, or Gabapentin, trade name: Neurontin) naïve, or had been on other gaba analogue before, and discontinued for lack of efficacy.
* Patient who had allergic reaction or serious adverse reactions will not be included in this study.
* Patient will start with starter pack of Gralise and will reach therapeutic dose of 1800 mg per day by end of 2 weeks.
* Drug is to be taken with meal, once a day in the evening; once patient has reached the therapeutic dose of 1800 mg, patient will come in for visit, at which point the PI will evaluate the patient and may increase or decrease the dosage, but patient may not increase or decrease the dose of medication at his /her discretion.
* During study, patient will have total of 5 visits, 4 of which will be for duration patient will be on Gralise, and the last visit will be for tapering off the medication.
* During study, patient is asked keep a paper diary on which patient will record the numeric pain scale from Fibromyalgia, time the medication was taken, dose of medication, and any side effects.

Eligibility criteria: Inclusion Criteria:

* Subject must be 18 years and older.
* Subject carries Fibromyalgia diagnosis based on American College of Rheumatology criteria.
* Fibromyalgia patients who are gamma-aminobutyric acid (GABA)-analogue (gabapentin or pregabalin) naïve, or those who have been on gamma-aminobutyric acid (GABA)-analogue, but discontinued due to side effects or having difficulty maintaining dosing schedule due to multiple doses per day, or those who are currently on immediate release gamma-aminobutyric acid-analogue (GABA).
* Able to distinguish pain from fibromyalgia and pain from other sources. (subjects with other rheumatic disease or medical conditions that contributed to the symptoms of fibromyalgia will be excluded)
* Subject pain scores \>4 on Numeric pain rating scale (NPRS)

Exclusion Criteria:

* Creatinine clearance of \< 30mg/ml
* Pain from Traumatic injury or structural or regional rheumatic disease
* Unstable medical or psychiatric illness
* Lifetime history of psychosis, hypomania, or mania.
* Epilepsy, or dementia
* Substance abuse in the last 6 months
* Suicidal tendencies
* Pregnant or breastfeeding
* Not on contraception for those of childbearing age. (Barrier methods, oral contraception, hormone injections, or surgical sterilization)
* Subjects who are, in the opinion of the principle investigator, are treatment refractory
* Treatment with investigational drug within 30 days of screening.
* Concomitant medication exclusions consisted of medications or herbal agents with Central Nervous System (CNS) effects with exception of episodic use of sedating antihistamines
* Subject who are on more than one additional class of concomitant fibromyalgia medications i.e. non-selective serotonin reuptake inhibitor (SSRI) antidepressants, topicals, opioids.

Primary outcomes:
measure: Numeric Pain Rating System (NPRS)
timeFrame: 15 weeks
Secondary outcomes:
measure: Medical Outcome Study (MOS) Sleep Questionnaires
timeFrame: 15 weeks
measure: Self Reported Side Effects.
timeFrame: 15 Weeks
measure: Fibromyalgia Impact Questionnaire (FIQ)
timeFrame: 15 weeks.
Other outcomes:
measure: Patient Global Impression of Change (PGIC)
timeFrame: 15 Weeks.
Locations:
city: Winston Salem
country: United States
facility: Center for Clinical Research
state: North Carolina
Study officials:
affiliation: Center for Clinical Research
name: James North, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wolfe F, Smythe HA, Yunus MB, Bennett RM, Bombardier C, Goldenberg DL, Tugwell P, Campbell SM, Abeles M, Clark P, et al. The American College of Rheumatology 1990 Criteria for the Classification of Fibromyalgia. Report of the Multicenter Criteria Committee. Arthritis Rheum. 1990 Feb;33(2):160-72. doi: 10.1002/art.1780330203.
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