N/A
Completed N=34
Study of Gralise to Treat Fibromyalgia Patients
Source: ClinicalTrials.gov NCT02052414 ↗Enrolled (actual)
34
Serious AEs
6.5%
Results posted
Oct 2015
Primary outcomePrimary: Numeric Pain Rating System (NPRS) — 7.29; 4.72; 3.95; 3.83 units on a scale
Summary
To determine Gralise in treating fibromyalgia pain:
* efficacy
* safety
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Numeric Pain Rating System (NPRS) |
7.29; 4.72; 3.95; 3.83; 6.94 | — |
| SECONDARY Medical Outcome Study (MOS) Sleep Questionnaires |
5.86; 7.17; 6.81; 7.04; 6.23 | — |
| SECONDARY Self Reported Side Effects. |
2; 2; 8; 3; 3; 2 | — |
| SECONDARY Fibromyalgia Impact Questionnaire (FIQ) |
71.04; 41.82; 40.79; 39.27; 61.86 | — |
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.
Data sourced from ClinicalTrials.gov (NCT02052414). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.