Clinical Trials

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There is a great deal of clinical research currently underway related to a variety of fibromyalgia aspects. In fact, a search of www.clinicaltrials.gov on December 12, revealed 99 open trials related to fibromyalgia.

www.clinicaltrials.gov is an Internet-based resource provided by the U.S. National Institutes of Health (NIH) for patients, their families, healthcare providers, researchers, and the general public. It is designed to provide ready access to information on both public and privately funded clinical trials, both in the U.S. and abroad. The information provided through www.clinicaltrials.gov can be easily obtained by searching the online database, which can provide information regarding specific clinical trial objectives, the eligibility criteria for enrolling in the trial, the locations where the trial is being offered, and contact information for the study staff. Each trial is also assigned a specific identifier, which begins with the three letter prefix NCT, followed by a series of eight numbers (ex. NCT01234567).

Although the website is maintained by the National Library of Medicine, individual study sponsors or the principal investigator (i.e., the lead researcher who heads up the study) are responsible for submitting and updating all study-specific information. As a result, some study information may be outdated at times. For example, some studies will have their status labeled as “unknown” if their information has not been updated for a period of time. Therefore it is always good to follow up on a particular trial of interest by utilizing the study team contact information provided for individual trials.

How to Find Trials on www.clinicaltrials.gov

When searching for clinical trials related to fibromyalgia, it is best to use the advanced search options on www.clinicaltrials.gov. This can be done by clicking on the Advanced Search link, which is located on the left side of the homepage, just beneath the Search for Studies field. After clicking on the advanced search options, select “Open Studies” from the pull-down menu in the Recruitment field. Then, type “fibromyalgia” into the Conditions field, and click on the “search” button. The screen will show you a listing of all fibromyalgia-related clinical trials that are planned or actively in progress. It is advisable to take some time to further explore the Advanced Search area of www.clinicaltrials.gov. You will find that you can search for trials by location, age criteria, funding source, and a variety of other variables.

Current Trials

Medications / Drugs

A number of trials continue to investigate the effectiveness of well-known fibromyalgia drug therapies. NCT01619566 is studying the nerve endings in biopsied skin samples to determine if fibromyalgia patients with specific nerve characteristics are more responsive to treatment with the antidepressant duloxetine (Cymbalta). Findings from a study like this one might help to better identify which patients will experience the greatest benefit from this drug and therefore allow more targeted treatment. NCT01288807 is evaluating how treatment with milnacipran (Savella) affects the release of specific neurotransmitters in the body of patients with fibromyalgia. The researchers conducting this study hope that the information learned will shed insight into how these neurotransmitters affect pain sensitization in fibromyalgia patients. Another trial, NCT01041495, is investigating the use of the muscle relaxant cyclobenzaprine to relieve fibromyalgia-related pain and improve fatigue, while NCT01387607 is evaluating the effectiveness and tolerability of pregabalin (Lyrica) on pain in fibromyalgia.

In addition, a number of other drugs – not commonly associated with the treatment of fibromyalgia – are also under investigation to determine their impact on a variety of fibromyalgia related symptoms. The drug memantine is commonly used to treat the symptoms associated with Alzheimer’s disease. A paper published in 2009 suggested that treatment with a combination of memantine and pregabalin might be beneficial to fibromyalgia patients from not only a pain-control standpoint, but also in terms of its potential ability to protect delicate brain tissue from degeneration, which is known to occur among individuals who suffer from chronic pain conditions (including fibromyalgia). Accordingly, a randomized controlled trial evaluating the use of memantine in fibromyalgia (NCT01653457) is currently planned to determine the effectiveness of memantine on fibromyalgia pain, as well as its effectiveness in preventing brain tissue atrophy. Another drug, etoricoxib, is commonly used to treat the symptoms that are associated with osteoarthritis, gout, and to relieve minor, short-term pain, such as that associated with menstruation. NCT00755521 is assessing whether etoricoxib is useful at improving pain and/or psychiatric endpoints associated with fibromyalgia. TD-9855 is a drug that is currently in the early stages of clinical research for use in treating both attention deficit hyperactivity disorder (ADHD) and fibromyalgia. At present, a randomized, placebo-controlled trial (NCT 01693692) is investigating whether or not TD-9855 might be effective at treating fibromyalgia. Finally, the drug neurotropin is being investigated through a randomized, placebo-controlled trial for its safety and effectiveness in preventing or relieving fibromyalgia-related pain. Neurotropin is not commercially available in the U.S., as it has not been approved by the U.S. Food and Drug Administration (FDA). Nevertheless, unapproved drugs can still be used for the purposes of clinical research as long as the study adheres to strict FDA-enforced rules and regulations governing its conduct, including intense patient safety monitoring and reporting. In such situations, the unapproved drug is referred to as an investigational drug.

Complementary and Alternative Therapies

A number of complementary and alternative therapies are also being studied to gain further insight into their effectiveness on a variety of fibromyalgia-related factors. Cupping is an ancient Chinese therapy in which a partial vacuum is created (either by heat or suction) in cups that are then placed on the skin. This draws the underlying skin and tissues up into the cup and is believed to promote healing by improving the flow of energy throughout the body. NCT016635634 is a randomized controlled pilot trial designed to determine the effectiveness of cupping in relieving pain and fatigue, and improving sleep and overall quality of life in fibromyalgia patients. Magnet therapy has received some attention in past years as a treatment for fibromyalgia pain and a new study (NCT01308801) continues to evaluate its pain-relieving potential. A study conducted by Tufts Medical Center is currently recruiting patients to a large randomized clinical trial (NCT01420640) that will compare various frequencies and durations of Tai Chi mind-body exercise to conventional aerobic exercise in fibromyalgia patients. This study will measure data regarding each intervention’s impact on pain, overall functioning, depression, sleep, fitness level, physical strength, and a number of other variables. Other complementary therapies being investigated for their usefulness in fibromyalgia include relaxation (NCT01628822), transcutaneous electrical nerve stimulation (TENS) therapy (NCT00932360), dietary supplements such as omega-3 fatty acid (NCT01352013) and glutamine/curcumin (NCT01469936), and Qigong (NCT01333566).

Exercise

Exercise has been extensively studied for its role in improving fibromyalgia symptoms, and studies have repeatedly demonstrated exercise to be an essential component to an effective multi-disciplinary treatment regimen. Despite its proven track record, exercise is still an active area of investigation for fibromyalgia researchers, many of whom seek to refine specific details regarding the modes, intensity, and duration of exercise that are most effective. NCT01490281 is currently comparing water-based vs. land-based exercise to a control group to determine which has the greatest overall impact on fibromyalgia. Another study is attempting to determine why exercise is beneficial to some fibromyalgia patients but not to others by examining individual and biological factors (NCT01592916). Finally, NCT01547195 is evaluating the effects that swimming can have on pain and quality of life in fibromyalgia patients.

Miscellaneous

Other clinical trials are evaluating a variety of additional fibromyalgia-related topics of interest, including cognitive dysfunction (i.e. fibro fog; NCT01655537), the use of cognitive-behavioral therapy (NCT01287481; NCT01598753), and studies involving adolescent fibromyalgia patients (NCT01020474).

Recently Completed Clinical Trials

A number of clinical trials have recently completed their accrual and are currently in their follow-up phase, analyzing data, or preparing study results. Below is a list of selected trials that have been completed within the past two years.

  • Pregabalin for pain (NCT00760474; NCT01271933; NCT00830128)
  • Naltrexone for pain (NCT00568555)
  • T3 (thyroid hormone) for pain (NCT00903877)
  • Fluoxetine (Prozac) treatment for pain in adolescents (NCT00115804)
  • Art therapy vs. walking for pain (NCT01586637)
  • Qigong for pain (NCT00938834)
  • Acupuncture for pain (NCT00142597)
  • Dietary supplementation with creatine for pain (NCT00749983)
  • Mattress type and sleep outcomes (NCT01108718)

 

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References

1.        Recla JM, Sarantopoulos CD. Combined use of pregabalin and memantine in fibromyalgia syndrome treatment: a novel analgesic and neuroprotective strategy? Med Hypotheses. 2009;73(2):177-83.

 

 

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