Trial Outcomes & Findings for A Single Dose Pharmaco-Diagnostic for Peripheral Nerve Continuity After Trauma (NCT NCT04026568)

Last Updated: 2022-10-18

Results Overview

Return of lost sensation after nerve injury attributable to circulating 4-AP. Subjective return of sensation in the injured limb or portion of the limb. Patients for this trial are not able to sense in portions of their limbs. The measure will be sensation, measured on the binary scale of yes or no (able to feel the extremity versus unable to feel) This is assessed through clinical examination of the injured limb.

Recruitment status

TERMINATED

Study phase

PHASE2/PHASE3

Target enrollment

1 participants

Primary outcome timeframe

During dosing of drug intervention (5 hours) and 2, 6, 9, 12, 15, 20 weeks post injury

Results posted on

2022-10-18

Participant Flow

Participant milestones

Participant milestones
Measure	Single Dose 4AP 15mm opaque capsule containing 10mg of 4-AP 4-Aminopyridine: Single drug test for nerve continuity	Placebo Opaque capsule identical looking to the 4AP placebo pill Placebo oral tablet: Placebo arm
Overall Study STARTED	0	1
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Single Dose 4AP 15mm opaque capsule containing 10mg of 4-AP 4-Aminopyridine: Single drug test for nerve continuity	Placebo Opaque capsule identical looking to the 4AP placebo pill Placebo oral tablet: Placebo arm
Overall Study study terminated	0	1

Baseline Characteristics

A Single Dose Pharmaco-Diagnostic for Peripheral Nerve Continuity After Trauma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Single Dose 4AP 15mm opaque capsule containing 10mg of 4-AP 4-Aminopyridine: Single drug test for nerve continuity	Placebo n=1 Participants Opaque capsule identical looking to the 4AP placebo pill Placebo oral tablet: Placebo arm	Total n=1 Participants Total of all reporting groups
Age, Continuous	—	53 years STANDARD_DEVIATION 0 • n=4 Participants	53 years STANDARD_DEVIATION 0 • n=27 Participants
Sex: Female, Male Female	—	0 Participants n=4 Participants	0 Participants n=27 Participants
Sex: Female, Male Male	—	1 Participants n=4 Participants	1 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	—	0 Participants n=4 Participants	0 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	—	1 Participants n=4 Participants	1 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	—	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	—	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	—	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	—	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	—	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) White	—	1 Participants n=4 Participants	1 Participants n=27 Participants
Race (NIH/OMB) More than one race	—	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	—	0 Participants n=4 Participants	0 Participants n=27 Participants
Region of Enrollment United States	—	1 participants n=4 Participants	1 participants n=27 Participants

PRIMARY outcome

Timeframe: During dosing of drug intervention (5 hours) and 2, 6, 9, 12, 15, 20 weeks post injury

Population: Subject enrolled from Orthopaedic Trauma service following traumatic peripheral nerve injury

Outcome measures

Outcome measures
Measure	Single Dose 4AP 15mm opaque capsule containing 10mg of 4-AP 4-Aminopyridine: Single drug test for nerve continuity	Placebo n=1 Participants Opaque capsule identical looking to the 4AP placebo pill Placebo oral tablet: Placebo arm
Subjective Return of Sensation Return of sensation 6 weeks post injury	—	0 participants
Subjective Return of Sensation Return of sensation 9 weeks post injury	—	0 participants
Subjective Return of Sensation Return of sensation 12 weeks post injury	—	NA participants Subject not evaluated past 9 weeks post injury due to early termination of the study
Subjective Return of Sensation Return of sensation 15 weeks post injury	—	NA participants Subject not evaluated past 9 weeks post injury due to early termination of the study
Subjective Return of Sensation Return of sensation 18 weeks post injury	—	NA participants Subject not evaluated past 9 weeks post injury due to early termination of the study
Subjective Return of Sensation Return of sensation 20 weeks post injury	—	NA participants Subject not evaluated past 9 weeks post injury due to early termination of the study
Subjective Return of Sensation Return of sensation prior to administration of study drug-baseline	—	0 participants
Subjective Return of Sensation Return of sensation 1 hour post study drug administration	—	0 participants
Subjective Return of Sensation Return of sensation 2 hours post study drug administration	—	0 participants
Subjective Return of Sensation Return of sensation 3 hours post study drug administration	—	0 participants
Subjective Return of Sensation Return of sensation 4 hours post study drug administration	—	0 participants
Subjective Return of Sensation Return of sensation 5 hours post study drug administration	—	0 participants
Subjective Return of Sensation Return of sensation 2 weeks post injury	—	0 participants

Adverse Events

Single Dose 4AP

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Kenneth Taylor, MD, Professor of Orthopaedics and Rehabilitation

Penn State Hershey Medical Center

Phone: 717-531-2948

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place