THC for chronic neuropathic pain

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Centre For Human Drug Research

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nervous System Diseases [C10]

Trial duration

20 Feb 2024 → ongoing

Decision date (initial)

2022-12-15

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacogenetic, Safety, Pharmacodynamic, Efficacy, Pharmacokinetic

• To investigate the analgesic effects of THC 2% oil in patients with chronic neuropathic pain.
• To investigate the difference in analgesic effects of THC 2% oil between phenotypical subgroups of patients with chronic neuropathic pain as defined by QST.

Secondary objectives 3

1. • To evaluate the association between analgesic effects of THC 2% oil and phenotypical characteristics of patients with neuropathic pain as measured by non-QST phenotyping tools.
2. • To evaluate non-analgesic beneficial effects of THC 2% oil in patients with chronic neuropathic pain.
3. • To assess the safety and tolerability of THC 2% oil in patients with chronic neuropathic pain.

Conditions and MedDRA coding

Chronic neuropathic pain

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. 1. Signed informed consent prior to any study-mandated procedure
2. 2. Male or female subjects aged 18 years or older, inclusive at screening.
3. 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).
4. 5. Score of ≥4 on the Douleur Neuropathic 4 (DN4) questionnaire.
5. 7. Has the ability to communicate well with the Investigator in the Dutch language and willing to comply with the study restrictions.

Exclusion criteria 5

1. 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.
2. 5. History of alcohol or substance use disorder or current use of more than 21 units of alcohol per week, or regular unprescribed use of sedatives, hypnotics, tranquilizers, or other addictive agents such as cocaine and non-prescribed amphetamines. The use of controlled substances, for example pain or sleep medication, will be allowed if prescribed by a registered physician. Documentation must be provided to confirm this.
3. 6. Current or recent (<4 weeks prior to screening) recreational or medicinal use of cannabis.
4. 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.
5. 11. History of cannabis-induced psychosis, schizophrenia or other clinically relevant psychiatric disorders, as judged by the investigator.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. • Pain severity NRS (measured daily), weekly average
2. • Experience sampling method (ESM) NRS pain scores

Secondary endpoints 11

1. • Sleep quality (Pittsburgh Sleep Quality Index, or PSQI)
2. • Sleep quality (Daily VAS)
3. • Anxiety severity (HADS)
4. • Depression severity (HADS)
5. • Quality of Life questionnaire (SF36)
6. • Drug effects questionnaire (DEQ), including VAS ‘Feeling high’ ‘Drug liking’ and VAS ‘Want more of the drug’
7. • Trial At Home (T@H) geospatial and phone usage tracking
8. • Treatment-emergent (serious) adverse events ((S)AEs) throughout the study at every study visit
9. • Concomitant medication throughout the study at every study visit
10. • Vital signs (Pulse Rate (bpm), Systolic blood pressure (mmHg), Diastolic blood pressure (mmHg)) as per assessment schedule
11. • Pain severity NRS (measured daily), weekly average

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Centre For Human Drug Research

Sponsor organisation

Centre For Human Drug Research

Address

Zernikedreef 8

City

Leiden

Postcode

2333 CL

Country

Netherlands

Scientific contact point

Organisation

Centre For Human Drug Research

Contact name

G.J. Groeneveld

Public contact point

Organisation

Centre For Human Drug Research

Contact name

G.J. Groeneveld

Locations

1 EU/EEA country · 2 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 19 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

8 submissions — initial application plus substantial / non-substantial modifications