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

Breath of Life Pharma

Status and phase: Completed; Phase 2; Phase 1

Conditions: Sciatica; Low Back Pain

Treatments: Drug: Placebo + SCO; Drug: BOL-DP-o-04 + SCO

Study type: Interventional

Funder types: Industry

Identifiers

NCT04145310

BOL-P-11

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 26 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. >18 years of age
2. Mild to Severe Low Back Pain and/or Sciatica
3. Imaging studies (CT or MRI) supporting anatomical abnormality that could be the cause of the symptoms
4. Must be physically and mentally willing and able to comply with the treatment regimen and understand the informed consent and study procedures
5. Signed and dated Informed Consent Form (ICF)
6. Non-responsive to standard therapy for at least 1 month

Exclusion criteria

1. VAS Pain Subscale score at Screening is less than 6 (with 0 being no pain and 10 being worse imaginable pain)
2. Known allergy to cannabis or its components
3. A patient who is pregnant or intends to become pregnant during the study
4. A patient who is nursing or intends to nurse during the study
5. A patient suffering from a mental disorder precluding administration of study drug
6. Prisoners
7. A Patient is unable to sign an informed consent form
8. Unstable angina pectoris
9. Cardiac insufficiency precluding cannabis administration
10. Immunosuppressed patients unless BOL-DP-o-04 administration is deemed safe by the treating physician
11. Known Aspergillus infection
12. Panic attacks or anxiety unless a psychiatrist allowed BOL-DP-o-04 following intake interview
13. Any mental/psychiatric illness in first-degree relative in a young patient < 30-year-old.
14. Patient with congestive heart failure
15. Subjects who get the following medications: opiates, Primidone, Phenobarbitol, arbamazepine, Rifampicin, Rifabutin, Troglitazone, and Hypericum perforatum

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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26 participants in 2 patient groups, including a placebo group

Arm A

Experimental group

Treatment:

Drug: BOL-DP-o-04 + SCO

Arm B

Placebo Comparator group

Treatment:

Drug: Placebo + SCO