THC for chronic neuropathic pai

Phase 1

Recruiting

• Conditions: Chronic neuropathic pain; MedDRA version: 21.0Level: LLTClassification code: 10054095Term: Neuropathic pain Class: 10029205; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: CTIS2022-502343-35-00
• Lead Sponsor: Centre For Human Drug Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-31
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1.Signed informed consent prior to any study-mandated procedure, 2. Male or female subjects aged 18 years or older, inclusive at screening., 4.Presence of any chronic (at least 3 months) neuropathic pain with a numeric rating scale (NRS) > 4, disregarding etiology. Possible etiologies include, but are not restricted to: a.Peripheral neuropathic pain syndromes (e.g., painful (diabetic) polyneuropathy, , peripheral nerve injury pain, postamputation pain and persisting post-radiculopathy pain without evidence of current root compression); b.Central neuropathic pain syndromes (e.g., neuropathic pain associated with spinal injury, central poststroke pain, central neuropathic pain associated with multiple sclerosis); c.Complex regional pain syndrome type 2 (with evidence of nerve damage)., 5.Score of =4 on the Douleur Neuropathic 4 (DN4) questionnaire., 7.Has the ability to communicate well with the Investigator in the Dutch language and willing to comply with the study restrictions.

Exclusion Criteria

1.Evidence of any active or chronic disease or condition that is likely to interfere with, or for which the treatment is likely to interfere with, the conduct of the study, or that would pose an unacceptable risk to the subject in the opinion of the investigator (following a detailed medical history, physical examination, vital signs (systolic and diastolic blood pressure, pulse rate, body temperature) and 12-lead electrocardiogram (ECG)). Deviations from the normal range may be accepted, if judged by the Investigator to have no clinical relevance., 5.History of abuse of addictive substances (alcohol, illegal substances) or current use of more than 21 units alcohol per week, drug abuse, or regular user of sedatives, hypnotics, tranquillisers, or any other addictive agents, with the exception of opioids used for the treatment of pain., 6.Current or recent (<4 weeks prior to screening) recreational or medicinal use of cannabis., 10.Any known factor, condition, or disease that might interfere with treatment compliance, study conduct or interpretation of the results such as drug or alcohol dependence or current psychiatric disease., 11.History of cannabis-induced psychosis, schizophrenia or other clinically relevant psychiatric disorders, as judged by the investigator.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified