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Trial record 4 of 512 for:    ESCITALOPRAM AND Serotonin Uptake

Escitalopram as a Treatment for Pain in Polyneuropathy

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ClinicalTrials.gov Identifier: NCT00162968
Recruitment Status : Completed
First Posted : September 13, 2005
Last Update Posted : April 24, 2007
Sponsor:
Collaborators:
Aarhus University Hospital
H. Lundbeck A/S
Information provided by:
Odense University Hospital

Tracking Information
First Submitted Date  ICMJE September 9, 2005
First Posted Date  ICMJE September 13, 2005
Last Update Posted Date April 24, 2007
Study Start Date  ICMJE December 2004
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: September 9, 2005)
pain relief
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00162968 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 18, 2006)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: September 9, 2005)
  • a. effect on total pain and different subtypes of pain
  • b. effect on quantitative sensory testing
  • c. effect on pain related sleep disturbances
  • d. effect on quality of life
  • e. to determine if depression before treatment predicts an eventual pain relieving effect of escitalopram
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Escitalopram as a Treatment for Pain in Polyneuropathy
Official Title  ICMJE Escitalopram as a Treatment for Pain in Polyneuropathy. A Double-Blind, Randomized, Placebo Controlled Trial.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE
  • Pain
  • Polyneuropathies
Intervention  ICMJE Drug: escitalopram
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: September 9, 2005)
50
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00162968
Other Study ID Numbers  ICMJE escit01
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Odense University Hospital
Collaborators  ICMJE
  • Aarhus University Hospital
  • H. Lundbeck A/S
Investigators  ICMJE
Principal Investigator: Soeren H Sindrup, MD, PhD Odense University Hospital, Dept. of neurology
PRS Account Odense University Hospital
Verification Date April 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP