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Escitalopram as a Treatment for Pain in Polyneuropathy

Primary Purpose

Pain, Polyneuropathies

Status
Completed
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
escitalopram
Sponsored by
Odense University Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain focused on measuring polyneuropathies, pain, drug effects, escitalopram, serotonin uptake inhibitors

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: median total pain score at baseline week >=4 on a 10 point numerical rating scale characteristic symptoms of polyneuropathy within at least 6 months diagnosis confirmed by physical examination, neurophysiologic exam. and/or quantitative sensory testing pain at least 4 of 7 days fertile women are using anticonceptive Exclusion Criteria: other cause to pain than polyneuropathy former allergic reactions on escitalopram known adverse events on escitalopram pregnancy or nursing critical disease (terminal cancer, cardial incompensation or critical renal or lung disease) treatment with monoamine oxidase inhibitors between the trial or 2 weeks before or after treatment with other antidepressants, antiepileptic agents or opioids

Sites / Locations

  • Danish Pain Research Center, Aarhus University Hospital, Noerrebrogade 44
  • Dept. of Neurology, Odense University Hospital, Sdr. Boulevard 29

Outcomes

Primary Outcome Measures

pain relief

Secondary Outcome Measures

effect on total pain and different subtypes of pain
effect on quantitative sensory testing
effect on pain related sleep disturbances
effect on quality of life
to determine if depression before treatment predicts an eventual pain relieving effect of escitalopram

Full Information

First Posted
September 9, 2005
Last Updated
April 23, 2007
Sponsor
Odense University Hospital
Collaborators
Aarhus University Hospital, H. Lundbeck A/S
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1. Study Identification

Unique Protocol Identification Number
NCT00162968
Brief Title
Escitalopram as a Treatment for Pain in Polyneuropathy
Official Title
Escitalopram as a Treatment for Pain in Polyneuropathy. A Double-Blind, Randomized, Placebo Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2007
Overall Recruitment Status
Completed
Study Start Date
December 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Odense University Hospital
Collaborators
Aarhus University Hospital, H. Lundbeck A/S

4. Oversight

5. Study Description

Brief Summary
Many people with polyneuropathy suffer from pain which is difficult to treat. Escitalopram is a relatively new drug used in the treatment of depression. Escitalopram's action mechanism on the brain suggests that escitalopram also may have an effect on neuropathic pain. This study will test the efficacy of escitalopram in patients with painful polyneuropathy.
Detailed Description
Tricyclic antidepressants appear to be the most efficacious treatment of painful polyneuropathy. However, these drugs are contraindicated in some patients and a substantial number of patients decline treatment due to side-effects. Therefore, effective drugs that are better tolerated are needed. Clinical and basic research has demonstrated that drugs with serotonergic action can alleviate neuropathic pain. Escitalopram increases serotonin concentration in the central nervous system, suggesting that it might be a potential alternative to current treatments of neuropathic pain. The aim of this study is to test if escitalopram would relieve painful polyneuropathy. Comparisons: Treatment with 20 mg escitalopram daily will be compared in a cross-over design with placebo. Each treatment period will last 6 weeks. During the last week of each treatment period, the dose will be tapered.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Polyneuropathies
Keywords
polyneuropathies, pain, drug effects, escitalopram, serotonin uptake inhibitors

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
50 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
escitalopram
Primary Outcome Measure Information:
Title
pain relief
Secondary Outcome Measure Information:
Title
effect on total pain and different subtypes of pain
Title
effect on quantitative sensory testing
Title
effect on pain related sleep disturbances
Title
effect on quality of life
Title
to determine if depression before treatment predicts an eventual pain relieving effect of escitalopram

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: median total pain score at baseline week >=4 on a 10 point numerical rating scale characteristic symptoms of polyneuropathy within at least 6 months diagnosis confirmed by physical examination, neurophysiologic exam. and/or quantitative sensory testing pain at least 4 of 7 days fertile women are using anticonceptive Exclusion Criteria: other cause to pain than polyneuropathy former allergic reactions on escitalopram known adverse events on escitalopram pregnancy or nursing critical disease (terminal cancer, cardial incompensation or critical renal or lung disease) treatment with monoamine oxidase inhibitors between the trial or 2 weeks before or after treatment with other antidepressants, antiepileptic agents or opioids
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Soeren H Sindrup, MD, PhD
Organizational Affiliation
Odense University Hospital, Dept. of neurology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Danish Pain Research Center, Aarhus University Hospital, Noerrebrogade 44
City
Aarhus
ZIP/Postal Code
8000
Country
Denmark
Facility Name
Dept. of Neurology, Odense University Hospital, Sdr. Boulevard 29
City
Odense
ZIP/Postal Code
5000
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
12387707
Citation
Burke WJ. Escitalopram. Expert Opin Investig Drugs. 2002 Oct;11(10):1477-86. doi: 10.1517/13543784.11.10.1477.
Results Reference
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PubMed Identifier
11061244
Citation
Sindrup SH, Jensen TS. Pharmacologic treatment of pain in polyneuropathy. Neurology. 2000 Oct 10;55(7):915-20. doi: 10.1212/wnl.55.7.915.
Results Reference
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PubMed Identifier
10371588
Citation
Woolf CJ, Mannion RJ. Neuropathic pain: aetiology, symptoms, mechanisms, and management. Lancet. 1999 Jun 5;353(9168):1959-64. doi: 10.1016/S0140-6736(99)01307-0.
Results Reference
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PubMed Identifier
12842122
Citation
Mork A, Kreilgaard M, Sanchez C. The R-enantiomer of citalopram counteracts escitalopram-induced increase in extracellular 5-HT in the frontal cortex of freely moving rats. Neuropharmacology. 2003 Aug;45(2):167-73. doi: 10.1016/s0028-3908(03)00138-2.
Results Reference
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Escitalopram as a Treatment for Pain in Polyneuropathy

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