Restoring Lost Functions After Spinal Cord Injury: Combination Therapy With Dalfampridine and Locomotor Training for Persons With Chronic, Motor Incomplete Spinal Cord Injury

Status: Completed
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: No
View:

• 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.

Locations
United States
New Jersey
Kessler Institute for Rehabilitation
West Orange
Time Frame
Start Date: June 2012
Completion Date: October 16, 2017
Participants
Target number of participants: 27
Treatments
Experimental: Locomotor Training + Dalfampridine
Subjects randomized to this group will undergo 10 weeks of double-blind treatment with extended release dalfampridine tablets (10 mg twice daily) while simultaneously receiving locomotor training therapy (5 sessions per week x 10 weeks = 50 sessions total).
Placebo Comparator: Locomotor Training + Placebo
Subjects randomized to this group will undergo identical treatment, but will take placebo tablets while simultaneously receiving locomotor training therapy (5 sessions per week x 10 weeks = 50 sessions total).
Authors
Steven C. Kirshblum, Trevor A. Dyson-Hudson, Monifa Brooks, Gail F. Forrest
Sponsors
Collaborators: Acorda Therapeutics, National Institute on Disability, Independent Living, and Rehabilitation Research
Leads: Kessler Foundation

This content was sourced from clinicaltrials.gov

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