Apr. 4, 2005 March 22, 2005 — Researchers at Washington University School of Medicine in St. Louis are testing the effectiveness of an investigational drug for the treatment of sciatica pain.
Sciatica involves pain in the lower back and hip that radiates down the thigh into the leg. It usually is caused by a combination of compressed nerve roots in the spinal cord and inflammation in the sciatic nerve. It often occurs with inflamed or herniated disks.
Pain from sciatica is called neuropathic pain because it is caused by damage to the nervous system. Many new therapies have been introduced to treat neuropathic pain, but not all patients benefit from existing therapies. This study is recruiting people with sciatica pain due to inflamed nerve roots in the lower back.
"Patients with sciatica often refer to their problem as a shooting pain like electricity down the leg," says anesthesiologist Rahul Rastogi, M.D., principal investigator, who sees patients at the Pain Management Center at Washington University and Barnes-Jewish Hospital. "Sometimes it also can be more of a burning pain or a tingling pain that resembles the feeling people get when their leg 'goes to sleep."
Rastogi and colleagues are studying the ability of the investigational drug REN-1654 to help control or eliminate that pain. The investigational medication is a novel, orally-active, small molecule inhibitor of TNF-alpha, a known proinflammatory cytokine which has been shown to be involved in neuropathology and pain associated with sciatica. REN-1654 is thought to have promise as a treatment for sciatica because it has been shown to interfere with communication between nerve cell receptors that may carry pain messages.
To be eligible for the study, volunteers must be between the ages of 18 and 55 and have leg pain radiating from the lower back to or below the knee that has been diagnosed as pain due to sciatica or to lumbar or lumbosacral radiculopathy. The onset of pain must have occurred two to 12 weeks prior to the initiation of study treatment.
Those who qualify for the study will receive a daily dose of either the study medication or an inactive placebo for three weeks. All participants will have their leg and back pain evaluated at one and three weeks after the start of treatment. Volunteers then will discontinue treatment and remain off medication for three weeks. At the end of those six weeks participants will be evaluated again.
Participation in the study is expected to last for about eight weeks Volunteers will receive free study-related physical exams, laboratory tests and investigational study medication. They will be compensated for time and travel.
The study will require five visits to the Pain Management Center, located in the Center for Advanced Medicine at Washington University and Barnes-Jewish Hospital.
For more information, call study coordinator Patty Suntrup at (314) 747-1709.
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