Imipramine and Pregabalin Combination in Painful Polyneuropathy

Odense University Hospital75 enrolled

Overview

Polyneuropathy of different etiologies is often associated with pain and the standard treatment for this type of pain is gabapentinoids or antidepressants. The hypothesis of this study is that the combination of the gabapentinoid pregabalin and the antidepressant imipramine will provide better pain relief than the single compounds alone. This is a randomized, placebo-controlled, double-blind, 4-way, cross-over trial of pregabalin 300 mg/day, imipramine 75 mg/day and their combination versus placebo. The study will include 60 patients and the treatment outcome will be pain intensity as measured by numeric rating scales.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Polyneuropathy

Interventions

ImipramineDRUG

Tablet 25 mg, 3 tablets evening (extensive metabolizers) or 1 tablet evening (poor metabolizers), daily, 5 weeks

PregabalinDRUG

Capsule 75 mg, 2 capsules twice daily, daily, 5 weeks

Imipramine, pregabalinDRUG

Imipramine: tablet 25 mg, 3 tablets evening (extensive metabolizers) or 1 tablet evening (poor metabolizers), daily, 5 weeks Pregabalin: capsule 75 mg, 2 capsules twice daily, daily, 5 weeks

Eligibility

Sex: ALLMin age: 20 YearsMax age: 85 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age between 20 - 85 years. * Characteristic symptoms of polyneuropathy for at least 6 months. * Polyneuropathy diagnosis confirmed by typical clinical signs (distal sensory disturbance/lack of distal deep tendon reflexes) and/or electrophysiological tests and/or abnormal quantitative sensory tests. * Total pain intensity rating of at least 4 on a 0-10 points numeric rating scale. * Pain present at least 4 days a week. * For diabetics: diabetes diagnosis for at least 6 months and stable metabolic control for at least 3 months. * For other secondary polyneuropathies: stable for at least 6 months. * For fertile females: adequate anticonceptive treatment. * Written informed consent. Exclusion Criteria: * Other cause of pain. * Contraindications against imipramine. * Allergic reactions towards imipramine or pregabalin. * Known adverse reactions during imipramine or pregabalin treatment. * Pregnancy. * Severe systemic disease. * Ongoing treatment with antidepressants, antipsychotics, anticonvulsants, opioids, propranolol, kinidine, monoamine oxidase inhibitor. * Inability to follow study protocol.

Locations (3)

Department of Neurology, Aalborg Hospital

Aalborg, Denmark

Department of Neurology, Aarhus University Hospital

Aarhus, Denmark

Department of Neurology, Odense University Hospital

Odense, Denmark

Outcomes

Primary Outcomes

Total pain intensity as measured by numeric rating scale 0-10 points.

Time frame: Median of ratings from last week of each treatment period

Secondary Outcomes

Verbal pain relief scale with 6 classes

Time frame: End of each treatment period

Specific pain symptom rated by numeric rating scales 0-10 points

Time frame: Median of ratings from last week of each treatment period

Rating of evoked pains symptoms (pressure, brush, repetitive pin-prick, cold) as measured by numeric rating scales 0-10 points

Time frame: End of each treatment period

Sleep disturbance as measured by numeric rating scale 0-10 points

Time frame: Median of ratings from last week of each treatment period

Consumption of escape medication (number of tablets of paracetamol)

Time frame: Total consumption during last week of each treatment period

Health related quality of life (SF-36)

Time frame: End of each treatment period

Major Depression Inventory (MDI)

Time frame: End of each treament period

Central Contacts

Søren H. Sindrup, MD

CONTACT

+45 65412471 soeren.sindrup@ouh.regionsyddanmark.dk

Jakob V. Holbech, MD

CONTACT

Holbech@dadlnet.dk

Data from ClinicalTrials.gov

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