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Potassium Channel Blocker

Dalfampridine + Stimulation/Exercise for Spinal Cord Injury

Phase < 1

Recruiting

Led By Monica A Perez, PT, PhD

Research Sponsored by Shirley Ryan AbilityLab

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Spinal Cord injury at or above L2

ASIA A,B,C, or D, complete or incomplete

Must not have

Individuals taking Bupropion, Dolutegravir, Lacosamide, Trilaciclib, or PR Interval prolonging drugs

History of head injury or stroke

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 10-m walk measured at baseline and 3 weeks (10 sessions) for dalfampridine+stdp+training and placebo+stdp+training groups. 10-m walk measured at baseline, 6 weeks (20 sessions), and 12 weeks (40 sessions) for extended sessions group.

Awards & highlights

All Individual Drugs Already Approved

Approved for 5 Other Conditions

Summary

This trial will test if a combination of the drug 4-AP and two types of stimulation can help improve lower limb motor function in people with SCI.

Who is the study for?

This trial is for men and women aged 18-85 with spinal cord injury (SCI) at or above L2, who are at least 4 weeks post-injury. They must be able to slightly move their hip flexor or dorsiflexion muscles. Excluded are those with a history of head injury, stroke, seizures, epilepsy, renal impairment, certain medication use (affecting the CNS), metal in the skull, uncontrolled medical issues, pre-existing debilitating diseases or mental health conditions.

What is being tested?

The study tests Dalfampridine (FDA approved drug) combined with STDP stimulation and limb training to enhance lower limb motor function recovery in SCI patients. Participants will receive either this combination therapy or a placebo alongside exercise training to compare effectiveness.

What are the potential side effects?

Dalfampridine can cause side effects such as urinary tract infections, insomnia, dizziness, headache, nausea; it may also increase seizure risk. Exercise might lead to muscle soreness and fatigue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My spinal cord injury is at or above the L2 level.

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My spinal cord injury level is graded ASIA A, B, C, or D.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently taking Bupropion, Dolutegravir, Lacosamide, Trilaciclib, or drugs that prolong the PR Interval.

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I have had a head injury or stroke in the past.

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I had a condition before my spinal cord injury that made it hard for me to exercise.

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I do not have unmanaged heart, lung, or bone problems.

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I am taking medication that could increase my risk of seizures.

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I have had kidney problems in the past.

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I have a history of seizures or epilepsy.

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I have a brain condition not caused by seizures and I'm not on seizure medication.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 10-m walk measured at baseline and 3 weeks (10 sessions) for dalfampridine+stdp+training and placebo+stdp+training groups. 10-m walk measured at baseline, 6 weeks (20 sessions), and 12 weeks (40 sessions) for extended sessions group.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~10-m walk measured at baseline and 3 weeks (10 sessions) for dalfampridine+stdp+training and placebo+stdp+training groups. 10-m walk measured at baseline, 6 weeks (20 sessions), and 12 weeks (40 sessions) for extended sessions group.

This trial's timeline: 3 weeks for screening, Varies for treatment, and 10-m walk measured at baseline and 3 weeks (10 sessions) for dalfampridine+stdp+training and placebo+stdp+training groups. 10-m walk measured at baseline, 6 weeks (20 sessions), and 12 weeks (40 sessions) for extended sessions group. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in MVC

Change in TMEPs

Secondary study objectives

Change in 10-meter walk test

Change in 6-minute walk test

Spinal Cord

+3 more

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: Dalfampridine (4-AP)+STDP+training for extended sessionsExperimental Treatment3 Interventions

The long-term effects of the functional recovery of the lower-limb muscles will be determined after 40 sessions of 4-AP, STDP stimulation and training.

Group II: Dalfampridine (4-AP)+STDP+trainingActive Control3 Interventions

The effects of the functional recovery of the lower-limb muscles will be determined after 10 sessions of 4-AP, STDP stimulation and training.

Group III: Placebo+STDP+trainingPlacebo Group3 Interventions

The effects of the functional recovery of the lower-limb muscles will be determined after 10 sessions of placebo drug, STDP stimulation and training.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dalfampridine

FDA approved

Exercise training

2019