BOL-DP-o-04 in Patients With Low Back Pain and Sciatica

Study Overview
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Brief Summary
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The study is aimed to evaluate the pain-relieving effect of BOL-DP-o-04, in addition to SOC, on Low Back Pain and Sciatica.

Detailed Description
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A Prospective, Single-Center, Double-Blind, Placebo-Controlled Trial of BOL-DP-o-04 in Patients with Low Back Pain and Sciatica. The study is aimed to evaluate the pain-relieving effect of BOL-DP-o-04, in addition to SOC, on Low Back Pain and Sciatica.

Official Title
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A Prospective, Single-Center, Double-Blind, Placebo-Controlled Trial of BOL-DP-o-04 in Patients With Low Back Pain and Sciatica

Conditions
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Low Back Pain, Sciatica

Intervention / Treatment
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* Drug: BOL-DP-o-04 + SCO
* Drug: Placebo + SCO


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: >18 years of age Mild to Severe Low Back Pain and/or Sciatica Imaging studies (CT or MRI) supporting anatomical abnormality that could be the cause of the symptoms Must be physically and mentally willing and able to comply with the treatment regimen and understand the informed consent and study procedures Signed and dated Informed Consent Form (ICF) Non-responsive to standard therapy for at least 1 month Exclusion Criteria: VAS Pain Subscale score at Screening is less than 6 (with 0 being no pain and 10 being worse imaginable pain) Known allergy to cannabis or its components A patient who is pregnant or intends to become pregnant during the study A patient who is nursing or intends to nurse during the study A patient suffering from a mental disorder precluding administration of study drug Prisoners A Patient is unable to sign an informed consent form Unstable angina pectoris Cardiac insufficiency precluding cannabis administration Immunosuppressed patients unless BOL-DP-o-04 administration is deemed safe by the treating physician Known Aspergillus infection Panic attacks or anxiety unless a psychiatrist allowed BOL-DP-o-04 following intake interview Any mental/psychiatric illness in first-degree relative in a young patient < 30-year-old. Patient with congestive heart failure Subjects who get the following medications: opiates, Primidone, Phenobarbitol, arbamazepine, Rifampicin, Rifabutin, Troglitazone, and Hypericum perforatum

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A<br> | Drug: BOL-DP-o-04 + SCO<br>* sublingual drops<br>|
| Placebo Comparator: Arm B<br> | Drug: Placebo + SCO<br>* sublingual drops<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oswestry Disability Index | Change in the Oswestry Disability Index. The questionnaire is composed by 10 sections Each section can be scored 0 to 5, 5 being the worst case. The score is calculated by summing the different sections and then doubling the total. Maximum score is 100. | Baseline to Day 114 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brief Pain Index | Change in the Brief Pain Index relative to baseline. The Brief Pain Inventory rapidly assesses the severity of pain and its impact on functioning | Baseline to Day 100 | 
| Short Form (SF12) Mental | Change in Short Form (SF12) Mental Composite Score.The SF-12 consists of a subset of 12 items that measure eight health domains to assess physical and mental health | Screening to Day 100 | 
| Pittsburgh Sleep Quality Index | Change in Pittsburgh Sleep Quality Index. The Pittsburgh Sleep Quality Index is a self-report questionnaire that assesses sleep quality over a 1-month time interval. The measure consists of 19 individual items, creating 7 components that produce one global score | Screening to Day 100 | 
| Opiate consumption and analgesic medication consumption | Change in Opiate consumption and analgesic medication consumption | Screening to Day 100 | 
| Patient Global Impression | Change in Patient global impression. The Patient Global Impression is a 7 point scale depicting a patient's rating of overall improvement | Baseline to Day 100 |