High Doses of 4-aminopyridine in Clinically Complete Chronic Spinal Cord Injury Patients.
Status:
Active, not recruiting
Trial end date:
2023-12-01
Target enrollment:
Participant gender:
Summary
150 patients with clinically complete chronic spinal cord Injury will be included in a
randomized, parallel, placebo controlled, multi-centric, phase III trial. Patients will be
evaluated before starting the medication, and at the end of the treatment in the locomotor,
sensory, grade of independence, sensitivity and control of bladder and anal sphincters,
quality of life, and psychogenic erection in males. Patients will be divided randomly into
two groups where one will receive placebo and the other one 4-Aminopyridine (4-AP) in a
maximum of 30 weeks in increasing doses.