Study of Gralise to Treat Fibromyalgia Patients
Last updated on April 2022Recruitment
- Recruitment Status
- Completed
Inclusion Criteria
- Subject carries Fibromyalgia diagnosis based on American College of Rheumatology criteria.
- 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)
- 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).
- ...
- Subject carries Fibromyalgia diagnosis based on American College of Rheumatology criteria.
- 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)
- 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).
- Subject must be 18 years and older.
- Subject pain scores >4 on Numeric pain rating scale (NPRS)
Exclusion Criteria
- Pain from Traumatic injury or structural or regional rheumatic disease
- Lifetime history of psychosis, hypomania, or mania.
- Epilepsy, or dementia
- ...
- Pain from Traumatic injury or structural or regional rheumatic disease
- Lifetime history of psychosis, hypomania, or mania.
- Epilepsy, or dementia
- Concomitant medication exclusions consisted of medications or herbal agents with Central Nervous System (CNS) effects with exception of episodic use of sedating antihistamines
- Creatinine clearance of < 30mg/ml
- Unstable medical or psychiatric illness
- Pregnant or breastfeeding
- Subjects who are, in the opinion of the principle investigator, are treatment refractory
- Substance abuse in the last 6 months
- Subject who are on more than one additional class of concomitant fibromyalgia medications i.e. non-selective serotonin reuptake inhibitor (SSRI) antidepressants, topicals, opioids.
- Suicidal tendencies
- Not on contraception for those of childbearing age. (Barrier methods, oral contraception, hormone injections, or surgical sterilization)
- Treatment with investigational drug within 30 days of screening.
Summary
- Conditions
- Fibromyalgia
- Type
- Interventional
- Design
- Allocation: N/A
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 70 years
- Gender
- Both males and females
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 ...
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 carries Fibromyalgia diagnosis based on American College of Rheumatology criteria.
- 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)
- 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).
- ...
- Subject carries Fibromyalgia diagnosis based on American College of Rheumatology criteria.
- 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)
- 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).
- Subject must be 18 years and older.
- Subject pain scores >4 on Numeric pain rating scale (NPRS)
Exclusion Criteria
- Pain from Traumatic injury or structural or regional rheumatic disease
- Lifetime history of psychosis, hypomania, or mania.
- Epilepsy, or dementia
- ...
- Pain from Traumatic injury or structural or regional rheumatic disease
- Lifetime history of psychosis, hypomania, or mania.
- Epilepsy, or dementia
- Concomitant medication exclusions consisted of medications or herbal agents with Central Nervous System (CNS) effects with exception of episodic use of sedating antihistamines
- Creatinine clearance of < 30mg/ml
- Unstable medical or psychiatric illness
- Pregnant or breastfeeding
- Subjects who are, in the opinion of the principle investigator, are treatment refractory
- Substance abuse in the last 6 months
- Subject who are on more than one additional class of concomitant fibromyalgia medications i.e. non-selective serotonin reuptake inhibitor (SSRI) antidepressants, topicals, opioids.
- Suicidal tendencies
- Not on contraception for those of childbearing age. (Barrier methods, oral contraception, hormone injections, or surgical sterilization)
- Treatment with investigational drug within 30 days of screening.
Tracking Information
- NCT #
- NCT02052414
- Collaborators
- Depomed
- Investigators
- Principal Investigator: James North, MD Center for Clinical Research
- James North, MD Center for Clinical Research
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