Imipramine and Pregabalin Combination in Painful Polyneuropathy

Phase 4

• Conditions: Polyneuropathy
• Interventions: Drug: Imipramine, pregabalin; Drug: Placebo; Drug: Imipramine; Drug: Pregabalin

• Registration Number: NCT01047488
• Lead Sponsor: Odense University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2010-01
• Study First Submitted: 2010-01-12
• Study First Submitted QC: 2010-01-12
• Last Update Submitted: 2010-01-12
• Study First Posted: 2010-01-13
• Last Update Posted: 2010-01-13
• Study Start: 2010-02
• Primary Completion: 2013-03
• Study Completion: 2013-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 75

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Imipramine plus pregabalin	Imipramine, pregabalin	Imipramine tablets and pregabalin capsules
Placebo	Placebo	Placebo tablets to imipramine and placebo capsules to pregabalin
Imipramine	Imipramine	Imipramine tablets and placebo capsules to pregabalin
Pregabalin	Pregabalin	Pregabalin capsules and placebo tablets to imipramine

Primary Outcome Measures

Name	Time	Method
Total pain intensity as measured by numeric rating scale 0-10 points.	Median of ratings from last week of each treatment period

Secondary Outcome Measures

Name	Time	Method
Verbal pain relief scale with 6 classes	End of each treatment period
Specific pain symptom rated by numeric rating scales 0-10 points	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	End of each treatment period
Sleep disturbance as measured by numeric rating scale 0-10 points	Median of ratings from last week of each treatment period
Consumption of escape medication (number of tablets of paracetamol)	Total consumption during last week of each treatment period
Health related quality of life (SF-36)	End of each treatment period
Major Depression Inventory (MDI)	End of each treament period

Trial Locations

Locations (3)

Department of Neurology, Aalborg Hospital; 🇩🇰 Aalborg, Denmark

Department of Neurology, Odense University Hospital; 🇩🇰 Odense, Denmark

Department of Neurology, Aarhus University Hospital; 🇩🇰 Århus, Denmark