Pregabalin, a potentially habit-forming anticonvulsant drug, is being used in an US Government-approved adolescent fibromyalgia study to test its efficiency in alleviating pain and improving sleep quality, the two primary symptoms of the disorder.
The study, which started in May 2010, has an estimated completion date of April 2014. Its official title is A 15 Week, Randomized, Double Blind, Parallel-Group, Placebo-Controlled, Flexible Dose, Safety And Efficacy Study of Pregabalin In Adolescents (12-17 Years Old) With Fibromyalgia, and it is classified as a safety/efficiency study with the primary purpose of treatment.
The US National Institutes of Health (NIH) is currently recruiting participants for clinical trials that are sponsored by pharmaceutical giant, Pfizer. They are taking place throughout the US, at Pfizer Investigational Sites, as well as in India, the Czech Republic and in Taiwan. While some parts of the study are already complete, recruits are still required for testing in California, Florida, Georgia, Kentucky, Ohio, South Carolina, Utah, as well as India.
According to the study outline on the ClinicalTrials.gov website, it was hoped when the study that involves this habit-forming anticonvulsant drug was launched, that about 162 adolescents would enroll and participate in the experiment. Half of them were to be given 75-450 mg of Pregabalin daily for 15 days. The other half was to be given matching placebo capsules.
Volunteers must have been diagnosed with fibromyalgia, but must not have been previously treated with the drug. Patients with other pain conditions are excluded from joining the study.
In addition to determining daily pain thresholds and nightly sleep quality, various other factors are tracked. These include noting any adverse events suffered, and any suicidal tendencies. Physical and neurological examinations are done, vital signs are checked, the reproductive hormones in females are monitored, as well as their “pubertal status”, and a 12-lead electrocardiogram is undertaken. Various laboratory tests enable researchers to monitor and track things like hematology, serum pregnancy, and urinalysis.
Fibromyalgia, defined by the NIH as “a common chronic pain disorder,” is an emotionally charged and frequently misunderstood condition. Treatments range from drugs to sleep therapy, and include supplements like vitamin D that is thought to have the potential to reduce pain and tiredness.
Pregabalin for Fibromyalgia
The drug Pregabalin, which is also known as Lyrica, is commonly used to alleviate neuropathic pain caused by damaged nerves. However, because it is a type of anticonvulsant, it is frequently used to treat seizures suffered by individuals with epilepsy. It is also a well-known prescription for fibromyalgia (which is why it is being used in this study). According to the NIH’s MedicinePlus Drug Information data, Pregabalin must be taken “exactly as directed” because it can be a habit-forming anticonvusant. They warn that patients must not take doses larger than prescribed, or take it for longer or more frequently than advised to do.
The NIH also warns that Pregabalin “may help control your symptoms but will not cure your condition.”
Patients coming off the drug must be weaned slowly. If they stop taking it suddenly, it is likely that they will suffer from withdrawal symptoms ranging from nausea, headaches and diarrhea, to an inability to sleep or even seizures. While it is not considered to be a controversial drug, the NIH warns that there can also be a wide range of side effects.
Savella for Fibromyalgia
Milnacipran or Savella is another drug that is used to treat fibromyalgia. Approved by the FDA several years ago after successful clinical studies, it has a totally different action to Pregabalin, raising the levels of serotonin in the brain to help the patient sleep, and norepinephrine to minimize pain signals coming from the brain. Both are natural substances normally found in the body.
Like Pregabalin, this drug won’t cure fibromyalgia, but it will control symptoms. The possibility of withdrawal symptoms is also a risk, as are side effects.
Milnacipran is an antidepressant that is never used to treat depression!
Children, teenagers and young adults (up to 24 years) were all involved in the clinical trials. Because it is a type of mood elevator, it resulted in a number of participants becoming suicidal. For this reason, anyone who has any type of mental health change when they take the drug should stop immediately and see a doctor.
Furthermore, it is not to be prescribed to anyone under the age of 18 years.
With this in mind, it will be interesting to see what the results of the Pregabalin anticonvulsant-type drug will be once the current adolescent fibromyalgia study is complete. Presumably the researchers will keep track of any habit-forming instances, and include any suicidal tendencies in their final report.
By Penny Swift