Study of Gralise to Treat Fibromyalgia Patients - Clinical Trial for Fibromyalgia | NCT02052414

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Gabapentin ER

About this trial

This is an interventional treatment trial for Fibromyalgia focused on measuring side effects, safety, efficacy, Gralise, Fibromyalgia, gabapentin

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Center for Clinical Research

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Gralise (Gabapentin ER)

Arm Description

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Medical Outcome Study (MOS) Sleep Questionnaires

Medical Outcomes Study (MOS) sleep questionnaires to assess how Fibromyalgia impacts patients' sleep in various areas. Specifically, Data reported below measured number of hours subjects spent per night sleeping. MOS sleep questionnaires were assessed at each follow up visits. (visits 1, 2, 3, 4, and 5).

Self Reported Side Effects.

Side / adverse effects were assessed at each follow up visits and resulted are as follows.

Fibromyalgia Impact Questionnaire (FIQ)

The Fibromyalgia Impact Questionnaire (FIQ) is an instrument designed to quantitate the overall impact of fibromyalgia over many dimensions (e.g. function, pain level, fatigue, sleep disturbance, psychological distress etc.). It is scored from 0 to 100 with the latter number being the worst case. The average score for patients seen in tertiary care settings is about 50. The FIQ is widely used to assess change in fibromyalgia status.

Full Information

NCT ID

NCT02052414

First Posted

August 2, 2013

Last Updated

September 1, 2016

Sponsor

The Center for Clinical Research, Winston-Salem, NC

Collaborators

Depomed

1. Study Identification

Unique Protocol Identification Number

NCT02052414

Brief Title

Study of Gralise to Treat Fibromyalgia Patients

Acronym

Gralise

Official Title

Open Labeled, Non-randomized, Study of Efficacy and Safety of Gralise in Fibromyalgia Patients.

Study Type

Interventional

2. Study Status

Record Verification Date

September 2016

Overall Recruitment Status

Completed

Study Start Date

July 2012 (undefined)

Primary Completion Date

November 2013 (Actual)

Study Completion Date

November 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

The Center for Clinical Research, Winston-Salem, NC

Collaborators

Depomed

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Fibromyalgia

Keywords

side effects, safety, efficacy, Gralise, Fibromyalgia, gabapentin

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

34 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Gralise (Gabapentin ER)

Arm Type

Experimental

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

Gabapentin ER

Other Intervention Name(s)

Gralise

Intervention Description

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.

Primary Outcome Measure Information:

Title

Numeric Pain Rating System (NPRS)

Description

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).

Time Frame

15 weeks

Secondary Outcome Measure Information:

Title

Medical Outcome Study (MOS) Sleep Questionnaires

Description

Medical Outcomes Study (MOS) sleep questionnaires to assess how Fibromyalgia impacts patients' sleep in various areas. Specifically, Data reported below measured number of hours subjects spent per night sleeping. MOS sleep questionnaires were assessed at each follow up visits. (visits 1, 2, 3, 4, and 5).

Time Frame

15 weeks

Title

Self Reported Side Effects.

Description

Side / adverse effects were assessed at each follow up visits and resulted are as follows.

Time Frame

15 Weeks

Title

Fibromyalgia Impact Questionnaire (FIQ)

Description

The Fibromyalgia Impact Questionnaire (FIQ) is an instrument designed to quantitate the overall impact of fibromyalgia over many dimensions (e.g. function, pain level, fatigue, sleep disturbance, psychological distress etc.). It is scored from 0 to 100 with the latter number being the worst case. The average score for patients seen in tertiary care settings is about 50. The FIQ is widely used to assess change in fibromyalgia status.

Time Frame

15 weeks.

Other Pre-specified Outcome Measures:

Title

Patient Global Impression of Change (PGIC)

Description

Patient Global impression of Change (PGIC) is an outcome commonly used measure of the efficacy of treatments. PGIC is a 7 point scale that requires the subjects to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. and rated as: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse.

Time Frame

15 Weeks.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

James North, MD

Organizational Affiliation

Center for Clinical Research

Official's Role

Principal Investigator

Facility Information:

Facility Name

Center for Clinical Research

City

Winston Salem

State/Province

North Carolina

ZIP/Postal Code

27103

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

No

IPD Sharing Plan Description

No individual participants data will be shared with anyone who is not a member of the study staff, and all records containing individual data and their protected health information will remain confidential in accordance with the HIPAA rules.

Citations:

PubMed Identifier

2306288

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.

Results Reference

background

PubMed Identifier

8860800

Citation

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.

Results Reference

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PubMed Identifier

7818567

Citation

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.

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PubMed Identifier

10749947

Citation

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.

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16298061

Citation

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PubMed Identifier

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Citation

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.

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PubMed Identifier

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Citation

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.

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PubMed Identifier

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Citation

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.

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Citation

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.

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Citation

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.

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Citation

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.

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Results Reference

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Links:

URL

http://depomed.com/

Description

Drug manufacturer's website

URL

http://www.centerforclinicalresearch.com/

Description

website for center for clinical research

Study of Gralise to Treat Fibromyalgia Patients (Gralise)

Fibromyalgia

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial