Gabapentin for Radicular leg pain

Inclusion criteria

• {"criterion_text":"-Clinical diagnosis of radicular leg pain from the spine based upon the following (at least one symptom and one sign): a.\tSymptoms i.\tDermatomal leg pain pattern . ii.\tLeg pain below the knee and neuropathic leg symptom descriptors (burning, sticking, shooting, tingling, numbness) 3. b.\tSigns. i.\tReduced dermatomal sensibility. ii.\tAllodynia in dermatomal pattern (not diffuse). iii.\tReduced reflexes (focal). iv.\tParesis (strength less 5 on standard scale) in specific muscles in accordance with pain pattern (not pain induced paresis). v.\tMR-Scan with described root compression, which explain the pain. vi.\tPositive Straight leg test with pain below the knee (less than 45 deg) or by positive hip extension test)."}
• {"criterion_text":"-Symptom duration between 1 week and 6 months"}
• {"criterion_text":"-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)."}
• {"criterion_text":"-Age between 18 and 70 years"}

Exclusion criteria

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

Primary endpoints

• {"endpoint_text":"-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.","definition_or_measurement_approach":"Measured on a numeric rating scale (NRS) from 0 to 10 over the last 24 hours; analysed using a primary repeated measures mixed linear model adjusted for baseline values to produce least squares means and standard errors, change from baseline to week 6."}

Secondary endpoints

• {"endpoint_text":"-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.","definition_or_measurement_approach":"Repeated measures assessments at weeks 1, 2, 4 and 6 using NRS for pain, Oswestry Disability Index for pain-related disability and general health measures; analysed using repeated measures mixed linear model adjusted for baseline producing least squares means and standard errors."}
• {"endpoint_text":"-Change in work status during the 6 week treatment period compared between Gabapentin and placebo.","definition_or_measurement_approach":"Comparison of work status change over the 6-week treatment period between treatment arms (method not further specified)."}
• {"endpoint_text":"-Occurence of AEs and SAEs in Gabapentin compared to placebo","definition_or_measurement_approach":"Collection and comparison of adverse events (AEs) and serious adverse events (SAEs) between Gabapentin and placebo groups."}
• {"endpoint_text":"-Intake of other analgesics compared between the Gabapentin and placebo group during a 6 weeks treatment period.","definition_or_measurement_approach":"Comparison of concomitant analgesic use between groups during the 6-week treatment period (collection of intake data)."}

Methods

• Planned recruitment via general practitioners (Denmark) — procedure referenced in assessment justification; sponsor did not sufficiently specify the procedure in SM-5 assessment.
• Planned recruitment via Elephant Health / digital messages (Denmark) — proposed digital recruitment channel; MREC did not approve the proposed recruitment via Elephant Health/digital messages.

Denmark

Earliest CTIS Part Ii Submission Date

21-03-2024

Latest Decision Or Authorization Date

10-06-2025

Processing Time Days

446

Number Of Sites

3

Number Of Participants

200

Primary sponsor

Full Name

Rigshospitalet

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Denmark

Third parties

• {"country":"Denmark","full_name":"GCP-enheden ved Københavns Universitetshospital","duties_or_roles":"Sponsor duties code 1","organisation_type":"Health care"}