Bupropion for the treatment of nerve pain. A randomized, double-blind study.

The effect of bupropion in peripheral neuropathic pain. A randomized, double-blind, placebo-controlled study. - Bupropion for the treatment of peripheral neuropathic pain.

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-000243-27-DK

Enrollment

Registered

2019-01-28

Start date

2019-03-18

Completion date

Unknown

Last updated

2021-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peripheral neuropathic , i.e. painful polyneuropathy, postherpetic neuralgia and pain after nerve injury (traumatic or surgical). MedDRA version: 20.0 Level: LLT Classification code 10077974 Term: Peripheral neuropathic pain System Organ Class: 100000004852

Interventions

Trade Name: Bupropion HCL Sandoz retard 150 mg Product Name: Bupropion HCL Pharmaceutical Form: Capsule Pharmaceutical form of the placebo: Capsule Route of administration of the placebo: Oral use

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - age over 18 years - peripheral neuropathic pain for more than 3 months - pain score at least 4 and not higher than 9 on a numeric rating scale 0-10 points Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 55 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 35

Exclusion criteria

Exclusion criteria: - other significant pain that cannot be distinguised from the peripheral neuropathic pain - significantly reduced liver and kidney function - epilepsy or recurrent seizures - known lowered seizure threshold or significant risk factors for seizures - major depressive episode within 6 months or other significant psychiatric diseases including alcohol or drug abuse - Important drug interactions (e.g. treatment with levo-dopa, amantadin, MAO-inhibitors, flecainide, risperidine, thioridazine) - pregnancy or lactation - known allergy to bupropion or exipients - concomittant pain treatment with TCAs, SNRIs, opioids, topical analgesics (lidocaine, capsaicin) and cannabinoids

Design outcomes

Primary

Measure	Time frame
Main Objective: The objective is to determine if bupropion relieves peripheral neuropathic pain;Secondary Objective: To determine if the potential effect of bupropion in peripheral neuropathic pain depends on function of conditioned pain modulation or sensory phenotype.;Primary end point(s): Week average of pain scored daily with numeric rating scale (NRS) 0 (no pain) to 10 (worst imaginable pain) points. ;Timepoint(s) of evaluation of this end point: Week average of NRS pain scores from the baseline periods and treatment periods week 1 to 6 are used in the general linear statistical model.	—

Measure

Time frame

Main Objective: The objective is to determine if bupropion relieves peripheral neuropathic pain;Secondary Objective: To determine if the potential effect of bupropion in peripheral neuropathic pain depends on function of conditioned pain modulation or sensory phenotype.;Primary end point(s): Week average of pain scored daily with numeric rating scale (NRS) 0 (no pain) to 10 (worst imaginable pain) points. ;Timepoint(s) of evaluation of this end point: Week average of NRS pain scores from the baseline periods and treatment periods week 1 to 6 are used in the general linear statistical model.

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Secondary

Measure	Time frame
Secondary end point(s): - Patient Global Impression of Change (PGIC, -3 to +3 points) - Rating of pain relief as: complete, good, moderate, mild, none, worse - Neuropathic pain symptom inventory (NPSI) - Patient-Reported Outcome Measurement Information System (PROMIS) - Columbia Suicide Severity Rating Scale (C-SSRS) ;Timepoint(s) of evaluation of this end point: PGIC and pain relief is evaluated at the end of the treatment periods (week 6). NPSI, PROMIS and C-SSRS is evaluated in the baseline periods and at the end of the treatment periods (week 6).	—

Measure

Time frame

Secondary end point(s): - Patient Global Impression of Change (PGIC, -3 to +3 points) - Rating of pain relief as: complete, good, moderate, mild, none, worse - Neuropathic pain symptom inventory (NPSI) - Patient-Reported Outcome Measurement Information System (PROMIS) - Columbia Suicide Severity Rating Scale (C-SSRS) ;Timepoint(s) of evaluation of this end point: PGIC and pain relief is evaluated at the end of the treatment periods (week 6). NPSI, PROMIS and C-SSRS is evaluated in the baseline periods and at the end of the treatment periods (week 6).

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Countries

Denmark

Contacts

Public ContactNeuromuscular Clinic

Odense University Hospital

soeren.sindrup@rsyd.dk004565412471

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026