Since 1993, 4-aminopyridine (4-AP) has been giving hope to patients with spinal injuries, according to a study at the Specialties Hospital in Mexico City. Twenty-seven patients were randomly assigned to receive either oral 4-AP 5 mg/day, increased to a maximum of 30 mg/day, or placebo for 12 weeks. Patients were then switched to the opposite treatment for 12 weeks.
The results from the first 12 weeks were used to test efficacy. Improved motor function, sensation, and independence were observed more often in the patients receiving 4-AP (69%) than in the placebo patients (46%). When each scale was considered separately, motor function was the only marker that improved significantly (92% in the drug group but only 46% in the placebo group).
The researchers also measured whether the drug’s effects persisted after therapy was stopped. At week 24, they found lasting effects in sensation (in 67%) and independence (in 83%) of the 25 patients who finished the study. Five patients experienced a small loss of 4-AP improvements beginning three to four days after they started taking placebo and mainly one week after discontinuing treatment, but no other patients experienced this change.
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One patient who had received 4-AP was partially impaired during the first two weeks of placebo treatment but then improved progressively to reach higher scores on both motor and sensory tests at the end of his placebo treatment— significant differences were seen in his scores at the end of the 4-AP treatment.
Fourteen patients had adverse reactions, which were mostly mild to moderate and transitory.
Although 4-AP is safe, the researchers suggest that patients be monitored for possible peripheral vasospasm and, at the highest dose, for changes in enzyme levels and platelet counts.