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Escitalopram as a Treatment for Pain in Polyneuropathy

NCT ID: NCT00162968

Last Updated: 2007-04-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-12-31

Study Completion Date

2007-04-30

Brief Summary

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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

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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.

Conditions

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Pain Polyneuropathies

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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escitalopram

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aarhus University Hospital

OTHER

Sponsor Role collaborator

H. Lundbeck A/S

INDUSTRY

Sponsor Role collaborator

Odense University Hospital

OTHER

Sponsor Role lead

Principal Investigators

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Soeren H Sindrup, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Odense University Hospital, Dept. of neurology

Locations

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Danish Pain Research Center, Aarhus University Hospital, Noerrebrogade 44

Aarhus, , Denmark

Site Status

Dept. of Neurology, Odense University Hospital, Sdr. Boulevard 29

Odense, , Denmark

Site Status

Countries

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Denmark

References

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Burke WJ. Escitalopram. Expert Opin Investig Drugs. 2002 Oct;11(10):1477-86. doi: 10.1517/13543784.11.10.1477.

Reference Type BACKGROUND
PMID: 12387707 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11061244 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10371588 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12842122 (View on PubMed)

Other Identifiers

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escit01

Identifier Type: -

Identifier Source: org_study_id