A study to evaluate the safety and analgesic efficacy of oral CMX-020 in subjects with symptoms of sciatica resulting from lumbosacral radiculopathy.

Phase 2

Completed

• Conditions: Chronic pain; Lumbosacral radiculopathy; Musculoskeletal - Other muscular and skeletal disorders; Anaesthesiology - Pain management; Neurological - Other neurological disorders

• Registration Number: ACTRN12615000885594
• Lead Sponsor: Cytometix Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-08-24
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

adult male or female between the ages of 18-75 years,
inclusive.
- The subject has a current diagnosis of lumbar radiculopathy with a duration of greater than 6 weeks, defined by all of the following:
i. Pain radiating into one leg in a distribution consistent with lumbar radiculopathy.
ii. Positive straight leg raise (L5, S1) or positive femoral stretch test (L3, L4).
iii. Confirmation of diagnosis by CT or MRI performed no more than 6 months before Screening Visit 1. The exam should demonstrate pathology at a location consistent with the clinical symptoms of radicular pain and nerve root irritation.
iv. Mean pain score of >4 on the 11 point NRS scale for average leg pain over the last 24 hours” for at least 5 of 7 days prior to randomization. This score must be greater than mean average back pain over the last 24 hours” score for the same period.
- subject must be on a stable analgesic regimen for the treatment of sciatic pain and must be willing to continue that regimen for the duration of the study.
- if female of child bearing potential; must be surgically sterile, or practicing a medically acceptable form of contraception. Must have a negative urine pregnancy test at screening and check-in and be non-lactating.
- if male; must agree to use a condom if engaging in sexual intercourse at any time during the study.
- good health as determined by a physician.
- negative urine toxicology screen for drugs of abuse during screening and baseline treatment period 1 visit.
- negative for hepatitis B surface antigen, hepatitis C antibody and HIV at screening visit.

Exclusion Criteria

- medical history of hypertension, hypotension or postural hypotension.
- history or family history of seizure, including juvenile febrile seizure.
- history of head trauma, metabolic disorder, alcohol or drug withdrawal, or CNS infection.
- recent history of syncope.
- medical condition other than lumbar radiculopathy that is not well controlled with treatment or is deemed CS by the PI.
- diagnosis of complex regional pain syndrome, acute spinal cord compression, severe or progressive lower extremity weakness/ numbness, bowel/bladder dysfunction, back pain due to secondary infection or tumour or confirmed/suspected neoplasm.
- undergone surgical procedure for back pain will be evaluated for study eligibility on a case by case basis and may be excluded at the discretion of PI.
- received a nerve or plexus block, including epidural steroid injections or facet blocks, within 2 weeks prior to screening visit.
- radicular pain involving more than one spinal nerve.
- clinically significant abnormal ECG at screening.
- history of long QT syndrome or a QTcF interval > 450 msec at screening.
- participated in an investigational study within past 30 days or 5 half lives of the investigational drug (whichever is longer) prior to study drug administration.
- major psychiatric condition (e.g. major depression, schizophrenia) or who has clinically significant anxiety or depression as defined by a HADS score greater than 10.
- intolerant to oxycodone.
- received MAO inhibitors within 14 days prior to the screening visit.
- positive alcohol or drugs of abuse test at any visit (except for opioids if currently on prescribed or OTC opioids used as analgesic regimen).
- history or clinical significant disease or abnormal surgical or medical condition which might compromise gastrointestinal, hepatic, or renal function and alter the absorption, distribution, metabolism, or excretion of study drug.
- AST or ALT> twice ULN or creatinine > 1.9 mg/dl at screening or any lab abnormality which in opinion of Investigator would contraindicate study participation.
- Creatinine clearance of less than 60 mL/min during the Screening visit.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. To evaluate the efficacy of CMX-020 administered orally to male and female subjects with lumbosacral radiculopathy (sciatica) pain.<br><br>The primary efficacy endpoint will be the difference between the average of the placebo treatment and the average of the drug treatment for change in daily worst leg pain. Change in daily worst leg pain is the difference between baseline worst leg pain and worst leg pain on last full day of dosing.[Daily pain intensity scores will be recorded in the Patient Daily Pain Diary by the subject each day of the study beginning on Day 1, with the final entry on Day 33. The NRS scale assessments needs to be completed each evening immediately prior to the evening dose of the study medication]