None listed
Conditions
Brief summary
Chronic pain after a musculoskeletal injury is a chronic pain syndrome characterised by a persistent chronic pain that persists following injury to the musculoskeletal system. Currently, the commonly recommended pain medications carry risks relating to side effects (in particular opioids). This trial aims to study the oral formulation, ZTL-106, in patients with chronic pain as a result of a previous musculoskeletal injury of the knee or hip. The study is a double-blind, placebo controlled, phase 2a study to determine the effect of ZTL-106 on pain, quality of life, emotional state and function, in people with chronic pain that follows a prior knee or hip musculoskeletal injury. Eligible participants will be randomised to receive ether ZTL-106 or Placebo. The investigational treatments will be administered as an oral oil twice daily, once in the morning and once in the evening for each participant for up to 6 weeks. Throughout the study participants will complete a range of patient reported outcome measures (PROMs) that assess their pain interference and severity, as well as the effect of their pain on their quality of life, the frequency of pain flares, and their emotional wellbeing. In addition, blood samples will be taken at several time points throughout the study.
Interventions
The study is a double-blind, placebo controlled interventional trial.
Participants eligible to participate will be randomised to receive either ZTL-106 or Placebo. The investigational treatments will be administered as an oral oil twice daily, once in the morning and once in the evening for each participant for up to 6 weeks.
ZTL-106 is a 1:1 formulation of THC (10 mg/ml) : CBD (10 mg/ml) dissolved in medium-chain triglyceride (MCT) oil with a proprietary blend of terpenes (<0.1% v/v) and a natu
The study is a double-blind, placebo controlled interventional trial. Participants eligible to participate will be randomised to receive either ZTL-106 or Placebo. The investigational treatments will be administered as an oral oil twice daily, once in the morning and once in the evening for each participant for up to 6 weeks. ZTL-106 is a 1:1 formulation of THC (10 mg/ml) : CBD (10 mg/ml) dissolved in medium-chain triglyceride (MCT) oil with a proprietary blend of terpenes (<0.1% v/v) and a natural lemon flavouring added. Placebo will contain the MCT oil, terpenes and natural lemon flavouring. It does not contain any cannabinoids. Administration will begin with an initial 2 week period of up titration, starting at 0.25ml (5mg total cannabinoids) for two days and then increasing the dose in 0.25ml (5mg total cannabinoids) increments every second or third day. Titration will target a maximal daily intake of 2 mls (40mg total cannabinoids) or until a maximum tolerable dose has been disinterred. Participant will maintain their maximal dose for the remaining 4 weeks up until week 6. Participants adherence to the dosing regime will be assessed based on both a self-completed dosing diary and by weight the returned drug bottles.
Sponsors
Levin Health Ltd
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
25 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
• Adult male and female age 25-75 years, inclusive. • Confirmed incidence of average pain severity of equal to or greater than 4 on a numeric rating scale. • Chronic pain for more than 6 months prior to screening that followed a knee or hip musculoskeletal injury. • Participant agrees to abide by all study restrictions and comply with all study procedures. • Participants must be informed of the investigational nature of this study and give written informed consent and agree to provide a contact phone number. • Male participants must agree to an approved contraception method. This criterion must be followed from the time of the first dose of study medication until the last follow-up visit. • Females of childbearing potential must have a negative pregnancy test at the Screening Visit and at the baseline visit prior to randomisation. • Must not have used recreational medicinal cannabis for the last 30 days and agree to cease recreational medicinal cannabis during the study treatment and follow up period.
Exclusion criteria
• Changes to current medications, or commencement of any new medications including prescription drugs (except hormonal contraception), vitamins, or herbal supplements within 28 days prior to the Screening Visit and during the study treatment phase. Daily administration of 100 mg aspirin will be allowed as long as the dose is stable for 30 days prior to Screening. • Known history of cardiovascular disorders such as bradycardia, (<50 beats/min.) or tachycardia (>100 beats/min.), cardiac arrhythmia or a history of arrhythmias, myocardial infarction, stroke or signs or symptoms of unstable coronary artery disease within the last year. • Poorly managed hypertension (systolic >160 mm Hg and/or diastolic >95 mm Hg) or hypotension (systolic <90 mm Hg and/or diastolic <60 mm Hg). • Any medical condition that could account for the chronic pain (e.g., fibromyalgia) other than as a result of a previous musculoskeletal injury in the opinion of the clinical investigator. • Recognised inflammatory condition (including rheumatoid arthritis, seronegative arthritis) that may influence the chronic pain in the opinion of the clinical investigator. • Blood glucose, FBC, haemoglobin, platelets, creatinine, bilirubin, and AST/ALT outside the normal limits. • Evidence of any clinically significant findings on Screening or baseline evaluations which, in the opinion of the clinical investigator would pose a safety risk or interfere with appropriate interpretation of study data. • History of major psychiatric illness. • History of drug or alcohol abuse within 1 year prior to screening as per investigator judgement or a positive alcohol or urine drug screen. • Clinically significant infection (including bacterial, fungal or mycobacterial) within four weeks prior to screening. • History of disorder that may necessitate the use of antibiotics during the study period. • Positive serology for HIV, HBV or HCV. • Receipt of any live attenuated vaccines within 4 weeks prior to entry. • Any medical condition that in the judgement of the investigator will exclude the patient from participating in the study. • Surgery within 3 months prior to screening. • Known allergy to cannabinoids or related compounds. • Planned participation in an investigational drug or device study; or has received an investigational biopharmaceutical product within 6 months prior to screening, or an investigational non-biopharmaceutical product or device within 30 days prior to screening. • Required to operate heavy machinery for the duration of the study. • Unable to refrain from driving for the duration of the study. • Have a current compensable injury claim. • If, in the opinion of the clinical investigator, the participant appears unable to perform the needed responsibilities of the clinical study. • Females who are pregnant, breast feeding or planning a pregnancy; females of childbearing potential and male participants with a partner of childbearing potential, who are unwilling or unable to use an acceptable method of contraception as outlined in this protocol from at least 21 days prior to the first dose of study medication and for 28 days after the last dose of study medication. o Standard acceptable methods include abstinence or the use of a highly effective method of contraception, including hormonal contraception, diaphragm, cervical cap, vaginal sponge, condom, vasectomy, intrauterine device.
Outcome results
None listed