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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
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

Study 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.Check my eligibility
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.See study design
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.

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.
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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in MVC
Change in TMEPs
Secondary outcome measures
Change in 10-meter walk test
Change in 6-minute walk test
Spinal Cord
+3 more

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
Completed Phase 1
~1170

Find a Location

Who is running the clinical trial?

Shirley Ryan AbilityLabLead Sponsor
192 Previous Clinical Trials
14,841 Total Patients Enrolled
National Institute of Neurological Disorders and Stroke (NINDS)NIH
1,337 Previous Clinical Trials
648,800 Total Patients Enrolled
Monica A Perez, PT, PhDPrincipal InvestigatorShirley Ryan Ability Lab
2 Previous Clinical Trials
250 Total Patients Enrolled

Media Library

Dalfampridine (Potassium Channel Blocker) Clinical Trial Eligibility Overview. Trial Name: NCT05447676 — Phase < 1
Spinal Cord Injury Research Study Groups: Dalfampridine (4-AP)+STDP+training for extended sessions, Dalfampridine (4-AP)+STDP+training, Placebo+STDP+training
Spinal Cord Injury Clinical Trial 2023: Dalfampridine Highlights & Side Effects. Trial Name: NCT05447676 — Phase < 1
Dalfampridine (Potassium Channel Blocker) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05447676 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are people still able to sign up for this test?

"That is correct. The clinicaltrials.gov website contains information suggesting that this study is still searching for subjects. This research was initially posted on 6/30/2022 and updated as recently as 7/6/2022. So far, 44 patients have been recruited from 1 site."

Answered by AI

Will this experiment be testing on any elderly individuals?

"For this specific trial, only patients aged 18 to 85 are eligible. However, there are a total of 39 clinical trials for minors and 324 trails available for elderly patients."

Answered by AI

What hope does this research bring for patients?

"The primary outcome of this trial, as evaluated over the change in MVC, will be measured at baseline and 3 weeks for Dalfampridine+STDP+training and Placebo+STDP+training groups. TMEPs will be measured at baseline, 6 weeks, and 12 weeks for extended sessions group. The secondary objectives include Change in surveys on ambulation, basic mobility, bowel and bladder management difficulties which is defined as The name of the questionnaire is Spinal cord injury Quality of Life (SCI-QOL) and we used four subdomains: ambulation, self-care, bowel management difficulties, and"

Answered by AI

What is the total number of volunteers for this research project?

"That is correct. The clinicaltrial.gov website has the most recent information on this topic and it states that the study was posted on 6/30/2022 and was last updated on 7/6/2022. The trial is looking for 44 individuals total, from 1 location."

Answered by AI

How can I join this clinical research?

"This study is looking for 44 participants, both male and female, who are between 18 and 85 years old. In order to be eligible, patients must have suffered a spinal cord injury (SCI) at least 4 weeks prior to enrolling in the trial, with the injury occurring at or above the L2 level on the spine. Additionally, participants must be classified as ASIA A, B, C, or D (complete or incomplete), and must be able to perform small muscle contractions in their dorsiflexion and hip flexor muscles."

Answered by AI

Who else is applying?

What state do they live in?
California
How old are they?
65+
What portion of applicants met pre-screening criteria?
Did not meet criteria
~5 spots leftby Jun 2024