Post by grammy on Aug 22, 2013 20:04:08 GMT -8
For anyone watching the work of (CPG) Central Pattern Generator research with Dr. Guertin in Canada...
They are conducting a clinical trial in Quebec for the tri-therapy called "Spinalon" from the Nordic Life Science Company. The trial is registered HERE.
As a first-in-class (Central Pattern Generator or CPG activator) approach, this tritherapy candidate called SPINALON has been identified and is currently under development for its capacity to temporarily induce episodes of involuntary locomotor movements. The primary objective of this Phase I/IIa study is to assess safety and tolerability of a single escalating dose of SPINALON (levodopa + carbidopa + buspirone) in chronic spinal cord-injured patients. As a secondary objective, preliminary evidence of efficacy will also be sought.
SPINALON (levodopa + carbidopa + buspirone) was discovered by Dr. Guertin and colleagues as a drug treatment candidate that can acutely elicit temporarily (lasting approximately 30-60 minutes) episodes of CPG activity and corresponding powerful weight-bearing hindlimb stepping in completely SCI subjects (preclinical efficacy data obtained from mice and turtles completely spinal cord transected thoracically).
As such, SPINALON is currently being developed to become a chronic treatment (physical activity-based approach driven pharmacologically) against the multiple health problems or so-called 'secondary complications' associated specifically with the lack of physical activity (sarcopenia, osteoporosis, cardiovascular problems, dyslipidemia, obesity, type II diabetes, anemia, immune system deficiency, deep vein cloth, depression, etc.).
This study is a randomized, placebo-controlled, double-blind, single dose escalation study with fifty-one (51) patients who will receive either placebo capsules(starch) or capsules with buspirone only, levodopa/carbidopa only or buspirone/levodopa/carbidopa (SPINALON).
Inclusion Criteria:
•Clinical diagnosis of complete or motor-complete SCI (ASIA-A, ASIA-B)
•Chronically injured (at least 3 months post-injury)
•Paraplegic (within T1-T12) or tetraplegic (within C3-C8)
•In relatively good health condition (no significant bed sore, urinary tract infection)
•18-65 years of age
•Men and women
•Quebec Province residents only
