Study of Gralise to Treat Fibromyalgia Patients

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.

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.