Efficacy and safety of 4-aminopyridine in patients with chronic spinal cord injury (Eficacia y seguridad de la 4-aminopiridina en pacientes con lesión crónica de médula espinal)

Completed

Conditions: Spinal cord injury
Injury, Occupational Diseases, Poisoning
Other injuries of spine and trunk, level unspecified

Registration Number: ISRCTN81704322

Lead Sponsor: Mexican Social Security Institute (Instituto Mexicano del Seguro Social) (Mexico)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 60

Inclusion Criteria

Patients with SCI were eligible for the study if they met the following criteria:
1. Tetraplegia or paraplegia for more than 1.5 years before the study began,
2. Both males and females, aged 18-60 years
3. Neurologic injury level of C4-L1
4. Medically stable and able to breathe independently
5. Stable neurologic deficits for more than 90 days before the study
6. Absence of antiepileptic antecedent and electroencephalogram without epileptic activity, and paralysed extremities without passive limitations (healthy joints)
7. For females: postmenopausal or surgically sterile, or using an acceptable method of birth control

Exclusion Criteria

1. Pressure ulcers, skin infections, or phlebitis
2. History of cardiovascular disease (syncope, arrhythmia, or myocardial infarction within the last two years), systolic blood pressure greater than 150 or less than 70 mm Hg, diastolic blood pressure greater than 110 or less than 50 mm Hg, or heart rate greater than 110 or less than 50 beats/minute;
impaired hepatic function (total hepatic enzyme or bilirubin levels greater than 2 times the upper limits of normal) or impaired renal function (creatinine level greater than 2 times the upper limits of normal) less than 6 months before the study
3. Known allergy to pyridine-containing drugs
4. Neurologic, degenerative, or psychiatric disorders that would impair the patient's ability to complete the protocol
5. Any illness or abnormality that would jeopardize patients safety or interfere with the conduct of the study
6. History of substance abuse
7. Inability to discontinue excluded concomitant drug therapy