Escitalopram as a Treatment for Pain in Polyneuropathy - Full Text View

Sponsor:	Odense University Hospital
Collaborators:	Aarhus University Hospital H. Lundbeck A/S
Information provided by:	Odense University Hospital
ClinicalTrials.gov Identifier:	NCT00162968

Purpose

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.

Condition	Intervention	Phase
Pain Polyneuropathies	Drug: escitalopram	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study
Official Title:	Escitalopram as a Treatment for Pain in Polyneuropathy. A Double-Blind, Randomized, Placebo Controlled Trial.

Resource links provided by NLM:

MedlinePlus related topics: Depression

Drug Information available for: Serotonin Benzetimide Dexetimide Citalopram hydrobromide Citalopram Escitalopram Escitalopram oxalate

U.S. FDA Resources

Further study details as provided by Odense University Hospital:

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

Estimated Enrollment:	50
Study Start Date:	December 2004
Study Completion Date:	April 2007

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.

Eligibility

Ages Eligible for Study:	20 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00162968

Locations

Denmark
Dept. of Neurology, Odense University Hospital, Sdr. Boulevard 29
Odense, Denmark, 5000
Danish Pain Research Center, Aarhus University Hospital, Noerrebrogade 44
Aarhus, Denmark, 8000

Sponsors and Collaborators

Odense University Hospital

Aarhus University Hospital

H. Lundbeck A/S

Investigators

Principal Investigator:

Soeren H Sindrup, MD, PhD

Odense University Hospital, Dept. of neurology

More Information

Publications:

Burke WJ. Escitalopram. Expert Opin Investig Drugs. 2002 Oct;11(10):1477-86. Review.

Sindrup SH, Jensen TS. Pharmacologic treatment of pain in polyneuropathy. Neurology. 2000 Oct 10;55(7):915-20. Review.

Woolf CJ, Mannion RJ. Neuropathic pain: aetiology, symptoms, mechanisms, and management. Lancet. 1999 Jun 5;353(9168):1959-64. Review.

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.

Study ID Numbers:	escit01
Study First Received:	September 9, 2005
Last Updated:	April 23, 2007
ClinicalTrials.gov Identifier:	NCT00162968 History of Changes
Health Authority:	Denmark: Danish Medicines Agency

Keywords provided by Odense University Hospital:

polyneuropathies
pain
drug effects
escitalopram
serotonin uptake inhibitors

Additional relevant MeSH terms:

Parasympatholytics
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Psychotropic Drugs
Antiparkinson Agents
Cholinergic Agents
Neuromuscular Diseases
Therapeutic Uses
Dexetimide

Antidepressive Agents, Second-Generation
Antidepressive Agents
Nervous System Diseases
Polyneuropathies
Serotonin Uptake Inhibitors
Citalopram
Pharmacologic Actions
Muscarinic Antagonists
Serotonin Agents
Autonomic Agents
Peripheral Nervous System Diseases
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 27, 2009