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Gabapentin for nerve pain in the leg from the lower back
EU CTIS ID: 2023-508537-13-01
What this study is testing
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.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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).
- Symptom duration between 1 week and 6 months
- 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).
- Age between 18 and 70 years
You likely can't join if
- Known pulmonary disease with marked functional limitation.
- Current treatment with anti-convulsants or anti-depressants for other conditions
- Opioids, muscle relaxants or anxiolytics (except one sleeping pill) intake last 4 days or treatment with any of these drugs evaluated to be indicated.
- Previous back surgery during the preceding year
- Insufficient understanding of the Danish language to understand the written information and questionnaires (evaluated by the investigator).
- Cauda equina syndrome
See the full eligibility criteria
- 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).
- Symptom duration between 1 week and 6 months
- 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).
- Age between 18 and 70 years
- Known pulmonary disease with marked functional limitation.
- Current treatment with anti-convulsants or anti-depressants for other conditions
- Opioids, muscle relaxants or anxiolytics (except one sleeping pill) intake last 4 days or treatment with any of these drugs evaluated to be indicated.
- Previous back surgery during the preceding year
- Insufficient understanding of the Danish language to understand the written information and questionnaires (evaluated by the investigator).
- Cauda equina syndrome
- In fertile women: Pregnancy or lactation. Unwillingness to use effective contraceptive methods.
- Central lumbar spinal stenosis symptomatology with bilateral walk related pain
- Other known pain condition of the lower extremities (e.g., knee or hip osteoarthrosis), which is deemed to influence leg pain scoring significantly
- Unable to use necessary electronic devices for the questionnaires and communication (Digital Post).
- Psychologic condition, which is evaluated likely to influence compliance negatively
- Known allergy or intolerance to Gabapentin or the content of the tablets.
- Dementia
- Cancer (besides baso- or spinocellulary carcinoma) in the preceding year.
- Severe heart disease NYHA class 3 or more.
- Known moderate to severe kidney disease (eGFR < 50 ml/h)
- Poorly controlled diabetes (last measured HbA1c > 70 mmol/l).
- Previous treatment with anti-convulsants or anti-depressants for actual pain condition or treatment with these drugs evaluated to be indicated.
- Steroid injection or corticosteroid treatment 6 weeks before start for the current pain condition
- Planed surgery for the radicular pain or major surgery next 3 month. Indication for evaluation by back surgeon or acute MR-scan ordered.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.