None listed
Conditions
Brief summary
This is a Phase IIa, randomized, double-blind, placebo-controlled crossover study to evaluate the efficacy and safety of oral CMX-020 in subjects with lumbosacral radiculopathy (sciatica).
Interventions
The study will consist of a Screening Period (Pretreatment Day –28 to Day –1), a 10 day Treatment Period (Days 1-10), a 7 day Washout Period (Days 11-17), a second 10 day Treatment period (Days 18-27) and a 7 day Follow-up Period (Days 28-34). There will be six clinic visits during the course of the study; Visit 1 during Screening; Visit 2 will occur on the first Day of Treatment Period One (Day 1); Visit 3 on Day 10 at the end of Treatment Period One; Visit 4 at the start of Treatment Period Tw
The study will consist of a Screening Period (Pretreatment Day –28 to Day –1), a 10 day Treatment Period (Days 1-10), a 7 day Washout Period (Days 11-17), a second 10 day Treatment period (Days 18-27) and a 7 day Follow-up Period (Days 28-34). There will be six clinic visits during the course of the study; Visit 1 during Screening; Visit 2 will occur on the first Day of Treatment Period One (Day 1); Visit 3 on Day 10 at the end of Treatment Period One; Visit 4 at the start of Treatment Period Two (Day 18); Visit 5 on Day 27 at the conclusion of Treatment Period Two; and Visit 6 at the end of the Follow-up Period (Day 34) for study exit. The interventional product, CMX-020, will be administered as an oral capsule. CMX-020 and matching placebo will be provided as 25 mg capsules. Each dose will consist of 125 mg CMX-020/ placebo in the form of five 25 mg softgel capsules taken three times daily during the treatment periods one and two in cross-over randomised double-blinded manner. Subjects will orally self-administer the randomised dose at home, three times per day (TID): - in the morning (approx. 06:00 to 08:00) - midday (approx. 12:00 to 14:00) - evening (approx. 19:00 to 21:00) Subjects will be instructed to take each dose with a full glass of room temperature water. Fasting will be required for one hour before until 30 minutes after the dose. The date and time of each dose will be recorded by the patient in the Patient Daily Pain Diary. On study Day 1 (Visit 2) and Day 18 (Visit 4), the initial dose for the treatment period will be administered at the study unit under the supervision of the study staff. This will be the midday dose (12:00 to 14:00). The later evening dose (19:00-21:00) will be self-administered by the subject at home. No morning dose will be taken on these days. To confirm self-administration at home, the participants will be contacted by phone (verbally or text) daily to confirm medication dosing and completion of the pain diary. This will also be captured in the CRF. On the mornings of study Day 10 and Day 27, the last dose for each of the treatments periods will be self-administered by the subject at home, before returning to the study unit for Study Visits 3 and 5, respectively. This will be the only dose administered on these study days. During the follow-up period following the end of treatment period two; the participants will record their pain in the diary but will receive no treatment.
Sponsors
Cytometix Inc.
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Outcome results
None listed