Recruiting

Twice-Daily 4-AP for Spinal Cord Injury Recovery

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Dalfampridine

+ STDP stimulation

+ Exercise training

DrugOtherBehavioral
Who is being recruted

Central Nervous System Diseases+3

+ Nervous System Diseases

+ Spinal Cord Diseases

From 18 to 85 Years
+19 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 1 & 2
Interventional
Study Start: February 2025
See protocol details

Summary

Principal SponsorShirley Ryan AbilityLab
Study ContactMonica Perez, PT, PhDMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: February 1, 2025

Actual date on which the first participant was enrolled.

This study is looking into how a drug called 4-AP can help people recover better after a spinal cord injury. The focus is on individuals with chronic spinal cord injuries who experience problems with movement and sensation. Previous research suggests that 4-AP can improve both sensory and motor functions, reduce muscle stiffness, increase sensation, and lessen pain. The study is particularly interested in seeing if taking this medication twice a day can keep the drug levels in the body steady, which might improve its benefits. By combining the drug with specific limb training techniques, researchers hope to enhance the body's ability to recover movement by promoting changes in the brain and spinal cord pathways that control movement. Participants in the study will receive 4-AP in a sustained release form, meaning it is designed to be taken orally twice a day to maintain consistent drug levels in the blood. Alongside taking the medication, they will undergo specialized exercises aimed at improving limb movement. The study will look at how these treatments together can improve lower limb motor function. There are no specified outcomes listed, but the main focus is to observe any improvements in movement and sensation, and how these changes relate to the body's pathways for movement. As with any medical study, there is a possibility of risks, but the goal is to find out if the benefits of 4-AP can be maximized when combined with targeted limb training.

Official TitleEffects of Twice-daily Dosing 4-AP on Functional Recovery After Spinal Cord Injury
NCT06853015
Principal SponsorShirley Ryan AbilityLab
Study ContactMonica Perez, PT, PhDMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

27 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 85 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Central Nervous System DiseasesNervous System DiseasesSpinal Cord DiseasesSpinal Cord InjuriesWounds and InjuriesTrauma, Nervous System

Criteria

5 inclusion criteria required to participate
Male and females between ages 18-85 years

SCI 6 months post injury

Spinal Cord injury at or above L2

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

Show More Criteria

14 exclusion criteria prevent from participating
Uncontrolled medical problems including pulmonary, cardiovascular or orthopedic disease

Any history of renal impairment

Any debilitating disease prior to the SCI that caused exercise intolerance

Premorbid, ongoing major depression or psychosis, altered cognitive status

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

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

Group II

Placebo
The effects of the functional recovery of the lower-limb muscles will be determined after 40 sessions of twice-daily-dosing Placebo, STDP stimulation and training.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Shirley Ryan Abilitylab

Chicago, United StatesOpen Shirley Ryan Abilitylab in Google Maps
Recruiting
One Study Center