Efficacy Study of Nabilone in the Treatment of Diabetic Peripheral Neuropathic Pain

Launched by UNIVERSITY OF CALGARY · Dec 17, 2009

Keywords

ClinConnect Summary

This is a multicenter trial amongst 3 Western Canadian sites to compare the efficacy of nabilone versus placebo in treating patients with chronic neuropathic pain (NeP) due to diabetic peripheral neuropathy (DPN).

A one-week screening period will occur, during which pain scores and sleep scores will be tabulated.

Following screening, a 4-week period of single blind treatment with nabilone 0.5 - 4 mg/day flexible dosing will take place. All subjects will begin with nabilone therapy of 1 mg daily for a minimum of 4 days, with the dose of the study medication assessed and adjusted either upw...

Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• • Male or female subjects, ages between 18-80 years;
• • Signed and dated informed consent;
• • Females of childbearing potential must have a negative serum β-HCG pregnancy test and be practicing an effective form of contraception (accepted methods are hormonal \[oral contraceptive or injectable contraceptive\], double barrier with spermicide, or intrauterine device-IUD). Complete abstinence may be considered acceptable, but must be determined on a case-by-case basis with the clinical investigator.
• • Diagnosis of DPN-associated NeP syndrome, confirmed by a qualified Neurologist or pain specialist, with persistence for a minimum of 3 months.
• • Score of ≥4 on the DN4 questionnaire, a single page survey consisting of historical questions and one examination portion using light touch and pinprick over the region of suspected neuropathic pain. This has high sensitivity and specificity for neuropathic pain.
• • Must complete ≥4 daily pain diaries during the week of the screening phase prior to randomization;
• • Must have a daily mean pain score of ≥4 over the screening period prior to randomization based on Daily Pain Rating Scale (DPRS);
• • Must have a score of \>40 mm on the visual analog scale (VAS) of the Short Form McGill Pain Questionnaire (SF-MPQ);
• • Screening laboratory values must be within normal limits, or abnormalities must be deemed clinically insignificant in the judgment of the investigator
• • Subject must be deemed capable of complying with study schedule, procedures and medications.
• • Exclusion Criteria
• • Pregnant or lactating women or women of childbearing potential not using acceptable method of contraception;
• • Subjects with neuropathic pain that is not due to DPN
• • Any skin conditions in the affected areas with NeP that (in the judgment of the investigator) could interfere with evaluation of the NeP
• • Current or past DSM-IV-TRTM (2000) diagnosis of schizophrenia, psychotic disorder, bipolar affective disorder or obsessive-compulsive disorder and Major Depressive Disorder (MDD);
• • Current or past DSM-IV-TRTM (2000) diagnosis of substance abuse or dependence within the last 6 month;
• • Use of marijuana or other cannabinoids during the study. Discontinuation of these substances 30 days prior to the screening visit is permitted. The study consent must be signed and dated prior to the discontinuation of these substances;
• • Clinically significant or unstable conditions that, in the opinion of the investigator, would compromise participation in the study. This includes, for example, medical conditions such as, but not limited to: hepatic, renal, respiratory, hematological, immunologic, or cardiovascular diseases (eg, myocardial infarction within previous month, ventricular arrhythmia recent severe heart insufficiency), inflammatory or rheumatologic disease, active infections, symptomatic peripheral vascular disease, and untreated endocrine disorders;
• • History of seizure disorder, except febrile seizures of childhood;
• • A glycated hemoglobin (HbA1C) of more than 11% at screening
• • Any other condition, which in the investigator's judgment might increase the risk to the subject or decrease the chance of obtaining satisfactory data to achieve the objectives of the study. This includes any condition precluding nabilone use;
• • Malignancy within past 2 years with exception of basal cell carcinoma;
• • Urine screen positive for illicit substances, including tetrahydrocannaboids (THC) such as marijuana at screening (Visit 1);
• • Liver function tests or liver enzymes \>3 times the upper limit of normal (ULN)
• • Other blood or urine laboratory results which are sufficiently abnormal in the view of the investigator(s) to raise concern about the enrollment of this subject in this study.
• • A previous history of intolerance or hypersensitivity to cannabinoids or other medications or substances with similar chemical structure;
• • Anticipated need for surgery during the study or within 4 weeks of completion;
• • Anticipated need for general anesthetics during the course of the study;
• • Anticipated need for hospitalization for any reason during the course of the study or within 4 weeks of completion;
• • Previous prescribed use of nabilone or other cannabinoids, including use of sample medications, within the 30 days prior to screening. Note that prior use of marijuana is not an exclusion criterion.
• • Participation in any other studies involving investigational or marketed products, concomitantly or within 30 days prior to entry in the study and/or
• • Employees or relatives of employees of the investigational site or Valeant Canada