Escitalopram as a Treatment for Pain in Polyneuropathy

Pain Clinical Trial

Official title:

Escitalopram as a Treatment for Pain in Polyneuropathy. A Double-Blind, Randomized, Placebo Controlled Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00162968
• Other study ID #: escit01
• Status: Completed
• Phase: Phase 4
• First received: September 9, 2005
• Last updated: April 23, 2007
• Start date: December 2004
• Est. completion date: April 2007

Study information

• Verified date: April 2007
• Source: Odense University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: April 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain
• Polyneuropathies

Intervention

Drug:
• escitalopram

Locations

Country	Name	City	State
Denmark	Danish Pain Research Center, Aarhus University Hospital, Noerrebrogade 44	Aarhus
Denmark	Dept. of Neurology, Odense University Hospital, Sdr. Boulevard 29	Odense

Sponsors (3)

Lead Sponsor	Collaborator
Odense University Hospital	Aarhus University Hospital, H. Lundbeck A/S

Country where clinical trial is conducted

Denmark, 

References & Publications (4)

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

Mørk A, Kreilgaard M, Sánchez 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. — View Citation

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

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pain relief
Secondary	effect on total pain and different subtypes of pain
Secondary	effect on quantitative sensory testing
Secondary	effect on pain related sleep disturbances
Secondary	effect on quality of life
Secondary	to determine if depression before treatment predicts an eventual pain relieving effect of escitalopram