Clinical trial NCT01047488: Imipramine and Pregabalin Combination in Painful Polyneuropathy
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Polyneuropathy
Keywords: polyneuropathy
neuropathic pain
treatment
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
Collaborators: name: Pfizer
name: Nycomed
First posted: 2010-01-13
Enrollment: 75
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Total pain intensity as measured by numeric rating scale 0-10 points.
timeFrame: Median of ratings from last week of each treatment period
Secondary outcomes:
measure: Verbal pain relief scale with 6 classes
timeFrame: End of each treatment period
measure: Specific pain symptom rated by numeric rating scales 0-10 points
timeFrame: Median of ratings from last week of each treatment period
measure: Rating of evoked pains symptoms (pressure, brush, repetitive pin-prick, cold) as measured by numeric rating scales 0-10 points
timeFrame: End of each treatment period
measure: Sleep disturbance as measured by numeric rating scale 0-10 points
timeFrame: Median of ratings from last week of each treatment period
measure: Consumption of escape medication (number of tablets of paracetamol)
timeFrame: Total consumption during last week of each treatment period
measure: Health related quality of life (SF-36)
timeFrame: End of each treatment period
measure: Major Depression Inventory (MDI)
timeFrame: End of each treament period
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Department of Neurology, Aalborg Hospital
city: Odense
country: Denmark
facility: Department of Neurology, Odense University Hospital
city: Århus
country: Denmark
facility: Department of Neurology, Aarhus University Hospital
Study officials:
affiliation: Department of Neurology, Odense University Hospital
name: Søren H. Sindrup, MD
role: STUDY_CHAIR
affiliation: Department of Neurology, Odense University Hospital
name: Jakob V. Holbech, MD
role: PRINCIPAL_INVESTIGATOR
References: