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Escitalopram as a Treatment for Pain in Polyneuropathy

This study has been completed.
Sponsor:
Collaborators:
Aarhus University Hospital
H. Lundbeck A/S
Information provided by:
Odense University Hospital
ClinicalTrials.gov Identifier:
NCT00162968
First received: September 9, 2005
Last updated: April 23, 2007
Last verified: April 2007
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Escitalopram as a Treatment for Pain in Polyneuropathy. A Double-Blind, Randomized, Placebo Controlled Trial.

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Denmark
Danish Pain Research Center, Aarhus University Hospital, Noerrebrogade 44
Aarhus, Denmark, 8000
Dept. of Neurology, Odense University Hospital, Sdr. Boulevard 29
Odense, Denmark, 5000
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:
ClinicalTrials.gov Identifier: NCT00162968     History of Changes
Other Study ID Numbers: escit01
Study First Received: September 9, 2005
Last Updated: April 23, 2007
Health Authority: Denmark: Danish Medicines Agency

Keywords provided by Odense University Hospital:
polyneuropathies
pain
drug effects
escitalopram
serotonin uptake inhibitors

Additional relevant MeSH terms:
Polyneuropathies
Nervous System Diseases
Neuromuscular Diseases
Peripheral Nervous System Diseases
Citalopram
Dexetimide
Anti-Dyskinesia Agents
Antidepressive Agents
Antidepressive Agents, Second-Generation
Antiparkinson Agents
Autonomic Agents
Central Nervous System Agents
Cholinergic Agents
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Muscarinic Antagonists
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Parasympatholytics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Uptake Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014