Combination Therapy With Dalfampridine and Locomotor Training for Chronic, Motor Incomplete Spinal Cord Injury

• Status: Completed
• Trial end date: 2017-10-16
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the efficacy, safety, and tolerability of treatment with dalfampridine in combination with locomotor training in persons with chronic, motor incomplete SCI.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kessler Foundation
• Collaborators: Acorda Therapeutics; National Institute on Disability, Independent Living, and Rehabilitation Research; U.S. Department of Education
• Treatments: 4-Aminopyridine

Criteria

Inclusion Criteria:

• Age 18 to 70 years, inclusive;

• Neurological impairment secondary to a traumatic spinal cord injury that occurred at least twelve (12) months prior to the screening visit;

• Neurological level of the injury between C4 and T10, inclusive;

• The injury is classified as motor incomplete (AIS grade C or D);

• Able and willing to comply with the study protocol, including availability for all scheduled clinic visits and locomotor training sessions.

Exclusion Criteria:

• The participant is a lactating female, or a female of childbearing potential who is sexually active, has not had a hysterectomy or oophorectomy, and is not using an approved birth control method (e.g. tubal ligation, implantable contraception device, oral or injectable contraceptive, barrier method, or sexual activity restricted to vasectomized partner);

• The participant has a history of seizures or treatment for seizure disorders;

• The participant has renal impairment (Creatinine Clearance < 80 mL/min);

• The participant has a known allergy to pyridine-containing substances or any of the inactive ingredients of the dalfampridine;

• The participant has a clinically significant abnormal laboratory values or an abnormal electrocardiogram (ECG);

• The participant has evidence of significant, diffuse, or generalized lower motor neuron damage;

• The participant has received new concomitant medication less than 3 weeks before the study or has a dose of current concomitant medication that is expected to change during study;

• The participant has received botulinum toxin injection for spasticity within 4 months of the screening visit;

• The participant has taken any other investigational drugs within 30 days before screening;

• The participant is known to have been treated previously with dalfampridine (4 aminopyridine) in any formulation, whether through participation in a previous fampridine study or by self-medication.

• The participant has received locomotor training therapy within 6 months of the screening visit;

• The participant has a history of alcohol or drug abuse in the previous year;

• The participant has a medical condition that would interfere with interpretation of study results or study conduct.

Note: Due to equipment and safety issues associated with locomotor training, participants must weigh less than 300 lbs.