Novel Soluble Epoxide Hydrolase Inhibitor for Neuropathic Pain in Patients With Spinal Cord Injury
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorEicOsis Human Health Inc.
About this trial
The goal of this clinical trial is to evaluate safety and tolerability of multiple oral doses of EC5026 in male and female patients with neuropathic pain due to traumatic or non-traumatic (degenerative) spinal cord injury. The main question it aims to answer is whether EC5026 is safe and well tolerated in SCI patients with neuropathic pain. In addition, this trial will also study the effects of EC5026 on pain.
Researchers will compare EC5026 to placebo.
Participants will be asked to:
* Take EC5026 or placebo in a masked fashion, once daily, for 14 consecutive days. * Undergo physical exams, vital signs assessments, ECGs, and blood draws * Complete assessments of pain, sleep, functional status, and perception of change
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male and female subjects must be 18 and older.
Subjects must be willing to provide written informed consent to participate in the study.
Subjects must be able to provide own transportation to study site every day for the duration of the study.
Subjects with either a traumatic or a non-traumatic SCI may be eligible to enroll in this study. For subjects with complete or incomplete traumatic spinal cord injuries (tSCI), or complete non-traumatic spinal cord injury: Subjects must have a complete or incomplete T6 or below tSCI, or complete non-traumatic SCI of at least 12 months duration, with below-level neuropathic pain identified by the International Spinal Cord Injury Pain (ISCIP) classification criteria. Importantly, subjects must not be ventilator-dependent as detailed in
Disqualifiers
For subjects with degenerative partial spinal cord injuries (pSCI): Subjects must have an incomplete, non-traumatic, SCI at any level secondary to degenerative spinal disorders such as disc degeneration, spinal stenosis, or spondylosis, with associated chronic neuropathic pain. The injury and the associated pain must be of at least 12 months duration. Neuropathic pain should meet the ISCIP classification criteria. Importantly, subjects must not be ventilator-dependent as detailed in Exclusion Criteria 1.
Subjects must have completed a minimum of 6 of the 7 daily assessments for average and worst daily pain prior to final screening, using an 11-point numerical rating scale (NRS) for average daily pain intensity, and the arithmetic average daily SCI neuropathic pain score must be ≥4 and ≤9, with a standard deviation less than or equal to 1.2. Daily pain assessment screenings will be done over the phone with the study coordinator after informed consent is obtained.
Subjects must have failed at least 2 classes of medications for their neuropathic pain due to SCI (classes may include antidepressants, antiepileptics, opioids, anti-inflammatories, topical treatments, etc.).
Subjects must be in overall stable condition, as determined by pre-study medical history, physical examination, clinical laboratory tests, and 12 lead ECG measurements
Trial design
Design model
Parallel
Treatments tested in this trial
EC5026 oral tablet
DrugThere will be two ascending dose regimens of EC5026, which will be administered over two consecutive Treatment Periods. During each Treatment Period, EC5026 will be administered orally once daily for 7 consecutive days, with a loading dose on Day 1 and a maintenance dose on Days 2-7 of each treatment period. All study subjects will be enrolled in both Treatment Periods and will receive both dose regimens consecutively, for a total duration of 14 days. Oral doses of EC5026 tested in each Treatment Period: Treatment Period 1: 6 mg loading dose on Day 1 / 2 mg Maintenance dose on Days 2-7 Treatment Period 2: 8 mg loading dose on Day 8 / 4 mg Maintenance dose on Days 9-14
Placebo oral tablet
DrugParticipants will be administered a matching oral placebo for 14 consecutive days.
Treatment groups
36 Participants
are divided into 2 treatment groupsGroup A: EC5026Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAE) [Safety and Tolerability]
All AEs reported or observed during the study will be recorded on the electronic case report forms (eCRF). Information to be collected includes drug treatment, type of event, time of onset, dosage, investigator-specified assessment of severity and relationship to study drug, time of resolution of the event, seriousness, any required treatment or evaluations, and outcome. Any AEs resulting from concurrent illnesses, reactions to concurrent illnesses, reactions to concurrent medications, or progression of disease states must also be reported. All AEs will be followed until they are resolved, stable, or judged by the investigator to be not clinically significant. The Medical Dictionary for Regulatory Activities will be used to code all AEs.
Time frame
30 daysOther outcomes
1
Effects of 2 ascending multiple dose regimens of EC5026 versus placebo on plasma levels of EC5026
Standard validated EC5026 measurement platform will be used.
Time frame
30 days2
Effects of 2 ascending multiple dose regimens of EC5026 versus placebo on oxylipin biomarkers.
Standard validated oxylipin measurement platform will be used.
Time frame
30 days3
Effects of 2 ascending multiple dose regimens of EC5026 versus placebo on target engagement biomarkers.
Target engagement biomarkers will include epoxi fatty acids(EpFA):diol ratio
Time frame
30 days4
Effects of 2 ascending multiple dose regimens of EC5026 versus placebo on inflammatory biomarkers: C-Reactive Protein
Time frame
30 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
EicOsis Human Health Inc.
Lead sponsor
Congressionally Directed Medical Research Programs
Collaborator
Source ClinicalTrials.gov