Gabapentin for nerve pain in the leg from the lower back

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Rigshospitalet

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Musculoskeletal Diseases [C05]

Trial duration

20 Jan 2025 → ongoing

Decision date (initial)

2024-03-27

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Funding sources

Danish Rheumatism Association (455.000 kr.) · Region Hovedstadens forskningsfond 2023 · Oak foundation · The 3 clinical departments involved

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Safety, Efficacy, Dose response

The primary efficacy objectives will be to compare the effect of gabapentin (dosages up to 2700 mg/d), relative to placebo, on change in average leg pain last 24 hours from baseline to week 6.

Secondary objectives 8

1. To compare the effect of gabapentin, relative to placebo, on changes in pain related disability (ODI)
2. To examine if Gabapentin can improve return to work compared to placebo
3. To examine if can Gabapentin reduce intake of other analgesics compard to placebo
4. To examine if Gabapentin have effect on anxiety and depression compared to placebo
5. To compare adverse events between Gabapentin and placebo treated patients with sub-acute radicular leg pain
6. To examine relation between dosage and response and adverse events
7. To examine predictors of improvement on short and long term
8. To compare the effect of gabapentin, relative to placebo, on avarage and maximal leg pain and back pain during the initial 6 weeks period from baseline to week 1, 2, 4 and 6

Conditions and MedDRA coding

radicular leg pain

Regulatory references

Plan to share IPD

Yes

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Clinical diagnosis of radicular leg pain from the spine based upon the following (at least one symptom and one sign): a. Symptoms i. Dermatomal leg pain pattern . ii. Leg pain below the knee and neuropathic leg symptom descriptors (burning, sticking, shooting, tingling, numbness) 3. b. Signs. i. Reduced dermatomal sensibility. ii. Allodynia in dermatomal pattern (not diffuse). iii. Reduced reflexes (focal). iv. Paresis (strength less 5 on standard scale) in specific muscles in accordance with pain pattern (not pain induced paresis). v. MR-Scan with described root compression, which explain the pain. vi. Positive Straight leg test with pain below the knee (less than 45 deg) or by positive hip extension test).
2. Symptom duration between 1 week and 6 months
3. Average leg pain during last 24 h. Classified as at least moderate on a scale on severity (slight, moderate, severe and 4 on numeric rang score (NRS), with zero representing ‘no pain’ 10 worst imaginable pain).
4. Age between 18 and 70 years

Exclusion criteria 20

1. Known pulmonary disease with marked functional limitation.
2. Known allergy or intolerance to Gabapentin or the content of the tablets.
3. Cancer (besides baso- or spinocellulary carcinoma) in the preceding year.
4. Severe heart disease NYHA class 3 or more.
5. Known moderate to severe kidney disease (eGFR < 50 ml/h)
6. Poorly controlled diabetes (last measured HbA1c > 70 mmol/l).
7. Previous treatment with anti-convulsants or anti-depressants for actual pain condition or treatment with these drugs evaluated to be indicated.
8. Steroid injection or corticosteroid treatment 6 weeks before start for the current pain condition
9. Planed surgery for the radicular pain or major surgery next 3 month. Indication for evaluation by back surgeon or acute MR-scan ordered.
10. Current treatment with anti-convulsants or anti-depressants for other conditions
11. Opioids, muscle relaxants or anxiolytics (except one sleeping pill) intake last 4 days or treatment with any of these drugs evaluated to be indicated.
12. Previous back surgery during the preceding year
13. Insufficient understanding of the Danish language to understand the written information and questionnaires (evaluated by the investigator).
14. Cauda equina syndrome
15. In fertile women: Pregnancy or lactation. Unwillingness to use effective contraceptive methods.
16. Central lumbar spinal stenosis symptomatology with bilateral walk related pain
17. Other known pain condition of the lower extremities (e.g., knee or hip osteoarthrosis), which is deemed to influence leg pain scoring significantly
18. Unable to use necessary electronic devices for the questionnaires and communication (Digital Post).
19. Psychologic condition, which is evaluated likely to influence compliance negatively
20. Dementia

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Change in average leg pain intensity (measured on a numeric rating scale (NRS) from 0 to 10 over the last 24 hours) from baseline to week 6, based on least squares means and standard errors derived from the primary repeated measures mixed linear model, adjusted for baseline values.

Secondary endpoints 4

1. Change from baseline to the 6 weeks assessment in aA (NRS - at 1, 2, 4 weeks)maximal leg pain, average back NRS pain and changes in NRS pain last 24 hours, pain related disability (ODIswestry), general health, (all 1, 2, 4, 6 weeks) with least squares means and standard errors derived estimates derived from the main repeated measures mixed linear model, adjusted for baseline values.
2. Change in work status during the 6 week treatment period compared between Gabapentin and placebo.
3. Occurence of AEs and SAEs in Gabapentin compared to placebo
4. Intake of other analgesics compared between the Gabapentin and placebo group during a 6 weeks treatment period.

Investigational products

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

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Rigshospitalet

Sponsor organisation

Rigshospitalet

Address

Valdemar Hansens Vej 1-23

City

Glostrup

Postcode

2600

Country

Denmark

Scientific contact point

Organisation

Rigshospitalet

Contact name

Jesper Nørregaard

Public contact point

Organisation

Rigshospitalet

Contact name

Jesper Nørregaard

Third parties 1

Locations

1 EU/EEA country · 3 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 8 files

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

Application history

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