Imipramine and Pregabalin Combination in Painful Polyneuropathy

Condition(s) targeted: Polyneuropathy

Intervention: Imipramine (Drug); Pregabalin (Drug); Imipramine, pregabalin (Drug); Placebo (Drug)

Phase: Phase 4

Status: Not yet recruiting

Sponsored by: Odense University Hospital

Official(s) and/or principal investigator(s):
Søren H. Sindrup, MD, Study Chair, Affiliation: Department of Neurology, Odense University Hospital
Jakob V. Holbech, MD, Principal Investigator, Affiliation: Department of Neurology, Odense University Hospital

Overall contact:
Søren H. Sindrup, MD, Phone: +45 65412471, Email: soeren.sindrup@ouh.regionsyddanmark.dk

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.

Official title: Randomised, Double-blind, Placebo-controlled Trial of the Effect of the Combination of Imipramine and Pregabalin for the Treatment of Painful Polyneuropathy

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

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

Secondary outcome:

Verbal pain relief scale with 6 classes

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

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

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

Consumption of escape medication (number of tablets of paracetamol)

Health related quality of life (SF-36)

Major Depression Inventory (MDI)

Minimum age: 20 Years. Maximum age: 85 Years. Gender(s): Both.

Criteria:

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.

Søren H. Sindrup, MD, Phone: +45 65412471, Email: soeren.sindrup@ouh.regionsyddanmark.dk

Department of Neurology, Aalborg Hospital, Aalborg DK-9000, Denmark; Not yet recruiting
Flemming W. Bach, MD, Phone: +45 99321928, Email: fwb@rn.dk
Flemming W. Bach, MD, Principal Investigator

Department of Neurology, Odense University Hospital, Odense DK-5000, Denmark; Not yet recruiting
Søren H. Sindrup, MD, Phone: +45 65412471, Email: soeren.sindrup@ouh.regionsyddanmark.dk
Jakob V. Holbech, MD, Email: Holbech@dadlnet.dk
Søren H. Sindrup, MD, Principal Investigator
Jakob V. Holbech, MD, Principal Investigator

Department of Neurology, Aarhus University Hospital, Århus DK-8000, Denmark; Not yet recruiting
Troels S. Jensen, MD, Phone: +45 89494137, Email: tsjensen@ki.au.dk
Nanna Finnerup, MD, Email: finnerup@ki.au.dk
Troels S. Jensen, MD, Principal Investigator
Nanna Finnerup, MD, Sub-Investigator

Starting date: February 2010
Last updated: January 12, 2010