FibromyalgiaGraliseNCT02052414
Study of Gralise to Treat Fibromyalgia Patients
A study testing Gabapentin ER in people with Fibromyalgia, run by The Center for Clinical Research, Winston-Salem, NC at 1 site in United States.
Trial summary
To determine Gralise in treating fibromyalgia pain: efficacy safety Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Gabapentin ER
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2012to Nov 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Clinical Research
Winston-Salem, North Carolina, 27103
About this study
Official title: Open Labeled, Non-randomized, Study of Efficacy and Safety of Gralise in Fibromyalgia Patients.
To determine Gralise in treating fibromyalgia pain:
- efficacy
- safety
Read the 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.
- Conditions
- Fibromyalgia
- Being tested
- Gabapentin ER
- Keywords
- side effects, safety, efficacy, Gralise, Fibromyalgia, gabapentin
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gabapentin ERDrug
Also called Gralise
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Gabapentin ER |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 15 weeks
Secondary outcomes (3)
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).
Measured: 15 weeks
Self Reported Side Effects.
Side / adverse effects were assessed at each follow up visits and resulted are as follows.
Measured: 15 Weeks
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.
Measured: 15 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2014 (estimated)
- Study startJul 2012
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Center for Clinical Research, Winston-Salem, NC
- Sponsor type
- University, hospital or other
- Collaborators
- Depomed
- Responsible party
- Sponsor
- Investigators
- James North, MD, Principal investigator, Center for Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02052414
- Sponsor's protocol ID
- IIR 2012-01
- Acronym
- Gralise
- Status last verified
- Sep 2016
- First submitted
- 2 Aug 2013
- Last updated
- 19 Oct 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No: 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.
Publications
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.
PubMed 2306288Hudson 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.
PubMed 8860800Wolfe 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.
PubMed 7818567Arnold 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.
PubMed 10749947Arnold 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.
PubMed 16298061Pillemer 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.
PubMed 9365080Lautenbacher 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.
PubMed 9303250Bennett 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.
PubMed 10221469Staud 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.
PubMed 12126581Baranauskas 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.
PubMed 9481803Arnold 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.
PubMed 17393438Gidal 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.
PubMed 9714500
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Labeled, Non-randomized, Study of Efficacy and Safety of Gralise in Fibromyalgia Patients.
- ClinicalTrials.gov ID
- NCT02052414
- Acronym / sponsor ID
- Gralise / IIR 2012-01
- Conditions
- Fibromyalgia
- Keywords
- side effects, safety, efficacy, Gralise, Fibromyalgia, gabapentin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- The Center for Clinical Research, Winston-Salem, NCUniversity, hospital or other
- Collaborators
- Depomed
- Study start
- Jul 2012
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 3 Feb 2014 (estimated)
- Results
- Posted 9 Oct 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gralise (Gabapentin ER) | Experimental | Drug: Gabapentin ERAll 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gabapentin ERAlso: GralisePatient 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. | Drug | Gralise (Gabapentin ER) |
Primary outcome
Numeric Pain Rating System (NPRS)
Time frame: 15 weeks
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).
3 secondary outcomes
Medical Outcome Study (MOS) Sleep Questionnaires
Time frame: 15 weeks
Self Reported Side Effects.
Time frame: 15 Weeks
Fibromyalgia Impact Questionnaire (FIQ)
Time frame: 15 weeks.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 2306288Wolfe 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.
- Background: PubMed 8860800Hudson 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.
- Background: PubMed 7818567Wolfe 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.
- Background: PubMed 10749947Arnold 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.
- Background: PubMed 16298061Arnold 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.
- Background: PubMed 9365080Pillemer 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.
- Background: PubMed 9303250Lautenbacher 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.
- Background: PubMed 10221469Bennett 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.
- Background: PubMed 12126581Staud 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.
- Background: PubMed 9481803Baranauskas 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.
- Background: PubMed 17393438Arnold 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.
- Background: PubMed 9714500Gidal 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.
- Drug manufacturer's websiteLink provided by the sponsor.
- website for center for clinical researchLink provided by the sponsor.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James North, MD principal investigator
Center for Clinical Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gabapentin ER in people with Fibromyalgia, run by The Center for Clinical Research, Winston-Salem, NC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Oct 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric Pain Rating System (NPRS) (time frame: 15 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02052414, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2016.