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

NCT04145310 | Completed Phase 1

• 1 other identifier: BOL-P-11
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Low Back Pain; Sciatica

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Brief Pain Index

  Baseline to Day 100

• Short Form (SF12) Mental

  Screening to Day 100

• Pittsburgh Sleep Quality Index

  Screening to Day 100

• Opiate consumption and analgesic medication consumption

  Screening to Day 100

• Patient Global Impression

  Baseline to Day 100

Study Arms (2)

Arm A

EXPERIMENTAL

Drug: BOL-DP-o-04 + SCO

Arm B

PLACEBO COMPARATOR

Drug: Placebo + SCO

Interventions

BOL-DP-o-04 + SCO DRUG

sublingual drops

Arm A

Placebo + SCO DRUG

sublingual drops

Arm B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>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

You may not qualify if:

• 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

Sponsors & Collaborators

• Breath of Life International Pharma Ltd: lead

Study Sites (1)

Beilinson Medical Center

Petah Tikva, Israel

Location

MeSH Terms

Conditions

Low Back Pain; Sciatica

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sciatic Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Neuralgia

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2019
• First Posted: October 30, 2019
• Study Start: November 27, 2018
• Primary Completion: July 7, 2022
• Study Completion: July 7, 2022
• Last Updated: December 8, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)