Study of Gralise to Treat Fibromyalgia Patients

NCT02052414 | Completed Results DMC

• 1 other identifier: IIR 2012-01
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

To determine Gralise in treating fibromyalgia pain:

• efficacy
• safety

Conditions

Fibromyalgia

Keywords

side effects; safety; efficacy; Gralise; Fibromyalgia; gabapentin

Outcome Measures

Primary Outcomes (1)

• Numeric Pain Rating System (NPRS)

  Fibromyalgia pain experienced by study subjects will be captured using NPRS at baseline visit, at each follow visits that are scheduled to occur every 4 weeks over 12 weeks of treatment period, and at the end of treatment visit that will occur 3 weeks after treatment period (12 weeks treatment period + 3 weeks = 15 weeks). Any difference in NPRS scores between baseline and any subsequent visits will indicate the magnitude of pain relief as reflected in digital scale of 0-10 (0=no pain, 10=worst pain imaginable).

  15 weeks

Secondary Outcomes (3)

• Medical Outcome Study (MOS) Sleep Questionnaires

  15 weeks

• Self Reported Side Effects.

  15 Weeks

• Fibromyalgia Impact Questionnaire (FIQ)

  15 weeks.

Other Outcomes (1)

• Patient Global Impression of Change (PGIC)

  15 Weeks.

Study Arms (1)

Gralise (Gabapentin ER)

EXPERIMENTAL

All patients will be treated with Gralise. Patients who are on pregabalin or gabapentin (lyrica or neurontin) will need to wash off the medication before starting Gralise. Patients who are ready to take Gralise will start with starter pack, and will gradually titrate the dose up to 1800mg per day. After that, patient will take 1800mg per day out of the bottle. Patient will be seen in clinic at 4weeks intervals for first 4 visits, and then there will be end of the study visit on week 15. On visit 4, week 12 of treatment, patients will be taught to taper off the study medication.

Drug: Gabapentin ER

Interventions

Gabapentin ER DRUG

Patient who are on gralise will report efficacy by rating his or her pain rating on a digital pain scale (11 points) from 0 to 10 on each scheduled clinical visits, which will be compared to their pain level at baseline. In addition, patients will also record the doses and any adverse effects that might arise during the trial in a diary provided by the study. All information will be recorded in a paper diary that will be followed by coordinator during each follow up visits.

Also known as: Gralise

Gralise (Gabapentin ER)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.
• Subject who are on more than one additional class of concomitant fibromyalgia medications i.e. non-selective serotonin reuptake inhibitor (SSRI) antidepressants, topicals, opioids.

Sponsors & Collaborators

• The Center for Clinical Research, Winston-Salem, NC: lead
• Depomed: collaborator

Study Sites (1)

Center for Clinical Research

Winston-Salem, North Carolina, 27103, United States

Location

Related Publications (12)

• 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.

  PMID: 2306288 BACKGROUND

• Hudson JI, Pope HG Jr. The relationship between fibromyalgia and major depressive disorder. Rheum Dis Clin North Am. 1996 May;22(2):285-303. doi: 10.1016/s0889-857x(05)70273-8.

  PMID: 8860800 BACKGROUND

• Wolfe F, Ross K, Anderson J, Russell IJ, Hebert L. The prevalence and characteristics of fibromyalgia in the general population. Arthritis Rheum. 1995 Jan;38(1):19-28. doi: 10.1002/art.1780380104.

  PMID: 7818567 BACKGROUND

• Arnold LM, Keck PE Jr, Welge JA. Antidepressant treatment of fibromyalgia. A meta-analysis and review. Psychosomatics. 2000 Mar-Apr;41(2):104-13. doi: 10.1176/appi.psy.41.2.104.

  PMID: 10749947 BACKGROUND

• Arnold LM, Rosen A, Pritchett YL, D'Souza DN, Goldstein DJ, Iyengar S, Wernicke JF. A randomized, double-blind, placebo-controlled trial of duloxetine in the treatment of women with fibromyalgia with or without major depressive disorder. Pain. 2005 Dec 15;119(1-3):5-15. doi: 10.1016/j.pain.2005.06.031. Epub 2005 Nov 17.

  PMID: 16298061 BACKGROUND

• Pillemer SR, Bradley LA, Crofford LJ, Moldofsky H, Chrousos GP. The neuroscience and endocrinology of fibromyalgia. Arthritis Rheum. 1997 Nov;40(11):1928-39. doi: 10.1002/art.1780401103. No abstract available.

  PMID: 9365080 BACKGROUND

• Lautenbacher S, Rollman GB. Possible deficiencies of pain modulation in fibromyalgia. Clin J Pain. 1997 Sep;13(3):189-96. doi: 10.1097/00002508-199709000-00003.

  PMID: 9303250 BACKGROUND

• Bennett RM. Emerging concepts in the neurobiology of chronic pain: evidence of abnormal sensory processing in fibromyalgia. Mayo Clin Proc. 1999 Apr;74(4):385-98. doi: 10.4065/74.4.385.

  PMID: 10221469 BACKGROUND

• Staud R. Evidence of involvement of central neural mechanisms in generating fibromyalgia pain. Curr Rheumatol Rep. 2002 Aug;4(4):299-305. doi: 10.1007/s11926-002-0038-5.

  PMID: 12126581 BACKGROUND

• Baranauskas G, Nistri A. Sensitization of pain pathways in the spinal cord: cellular mechanisms. Prog Neurobiol. 1998 Feb;54(3):349-65. doi: 10.1016/s0301-0082(97)00067-1.

  PMID: 9481803 BACKGROUND

• Arnold LM, Goldenberg DL, Stanford SB, Lalonde JK, Sandhu HS, Keck PE Jr, Welge JA, Bishop F, Stanford KE, Hess EV, Hudson JI. Gabapentin in the treatment of fibromyalgia: a randomized, double-blind, placebo-controlled, multicenter trial. Arthritis Rheum. 2007 Apr;56(4):1336-44. doi: 10.1002/art.22457.

  PMID: 17393438 BACKGROUND

• Gidal BE, DeCerce J, Bockbrader HN, Gonzalez J, Kruger S, Pitterle ME, Rutecki P, Ramsay RE. Gabapentin bioavailability: effect of dose and frequency of administration in adult patients with epilepsy. Epilepsy Res. 1998 Jul;31(2):91-9. doi: 10.1016/s0920-1211(98)00020-5.

  PMID: 9714500 BACKGROUND

Related Links

• Drug manufacturer's website
• website for center for clinical research

MeSH Terms

Conditions

Fibromyalgia

Interventions

Gabapentin

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins

Limitations and Caveats

small sample size, geographical bias, relatively short duration of treatment, open label, single arm study without a control group.

Results Point of Contact

• Title: James M. North MD
• Organization: The Center for Clinical Research

jnorth1@ccrpain.com

3367656181

Study Officials

• James North, MD

  Center for Clinical Research

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2013
• First Posted: February 3, 2014
• Study Start: July 1, 2012
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: October 19, 2016
• Results First Posted: October 9, 2015

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)