Degenerative Disc Disease, Neuropathic Pain, Spinal Cord Injuries, Spinal Stenosis, Spondylosis
Conditions
Brief summary
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
Detailed description
EC5026 has been shown to be effective in preclinical pain models of pain, including inflammatory and neuropathic pain subtypes. Three Phase 1 studies of EC5026 have been conducted in healthy volunteers; a Phase 1a Single Ascending Dose (SAD) study, a Phase 1a Fed-Fasted study, and a Phase 1b Multiple Ascending Dose (MAD) study. The Phase 1b MAD study evaluated the safety, tolerability, and PK of 2 sequential ascending dose regimens of oral EC5026, administered once daily for 7 consecutive days, in healthy volunteers. The present study will evaluate the safety and tolerability, as well as target engagement and pharmacodynamics, of EC5026 administered as multiple doses in subjects with neuropathic pain due to traumatic or non-traumatic (degenerative) spinal cord injury.
Interventions
There 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
DRUGPlacebo oral tablet
Participants will be administered a matching oral placebo for 14 consecutive days.
Sponsors
EicOsis Human Health Inc.
Congressionally Directed Medical Research Programs
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Each subject must meet all of the following criteria to be enrolled in this study: 1. Male and female subjects must be 18 and older. 2. Subjects must be willing to provide written informed consent to participate in the study. 3. Subjects must be able to provide own transportation to study site every day for the duration of the study. 4. 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
Exclusion criteria
1. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Adverse Events (AEs) and Serious Adverse Events (SAE) [Safety and Tolerability] | 30 days | 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. |
Countries
United States
Contacts
CONTACTWilliam K Schmidt, PhD
STUDY_DIRECTORWilliam K Schmidt, PhD
EicOsis Human Health Inc.
Outcome results
None listed