Abstract | STUDY OBJECTIVE: DESIGN: Randomized, open-label, active-treatment control, dosage-blinded study. SETTING: University-affiliated, tertiary-level care, Department of Veterans Affairs Medical Center. PATIENTS: Twenty-one healthy men and women outpatients suffering from traumatic SCI (14 tetraplegic, 7 paraplegic) for 2 years or more. INTERVENTIONS: Dosages of an immediate-release formulation of 4-AP were titrated. At 3 months, 16 subjects were receiving 4-AP 30 mg/day (high dose); 5 subjects were receiving 4-AP 6 mg/day (low dose) and served as an active-treatment control group. MEASUREMENTS AND MAIN RESULTS: Composite motor and sensory scores had statistically significant increases at 3 months. Maximal expiratory pressure, maximal inspiratory pressure, forced vital capacity, and forced expiratory volume in 1 second showed clinically meaningful and/or statistically significant increases among patients receiving 4-AP 30 mg/day. These subjects also had significant decreases in spasticity (modified Ashworth Scale). Serial biochemical profiles and electroencephalographs were unchanged from baseline, and no clinically significant drug toxicity was encountered. CONCLUSIONS: Long-term oral administration of immediate-release 4-AP was associated with improvement in and recovery of sensory and motor function, enhanced pulmonary function, and diminished spasticity in patients with long-standing SCI. 4-Aminopyridine appears to be safe and relatively free from toxicity when administered orally over 3 months. Each patient who received immediate-release 4-AP 30 mg/day showed a response in one or more of the outcome measures.
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Authors | J L Segal, M S Pathak, J P Hernandez, P L Himber, S R Brunnemann, R S Charter |
Journal | Pharmacotherapy
(Pharmacotherapy)
Vol. 19
Issue 6
Pg. 713-23
(Jun 1999)
ISSN: 0277-0008 [Print] United States |
PMID | 10391417
(Publication Type: Clinical Trial, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Potassium Channel Blockers
- 4-Aminopyridine
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Topics |
- 4-Aminopyridine
(administration & dosage, pharmacology)
- Administration, Oral
- Adult
- Aged
- Central Nervous System
(drug effects)
- Cohort Studies
- Double-Blind Method
- Female
- Humans
- Male
- Middle Aged
- Potassium Channel Blockers
- Psychomotor Performance
(drug effects)
- Spinal Cord Injuries
(drug therapy, physiopathology)
- Time Factors
- Treatment Outcome
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