NCT00162968

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_4 pain

Timeline
Completed

Started Dec 2004

Typical duration for phase_4 pain

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2004

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 13, 2005

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
Last Updated

April 24, 2007

Status Verified

April 1, 2007

First QC Date

September 9, 2005

Last Update Submit

April 23, 2007

Conditions

PainPolyneuropathies

Keywords

polyneuropathiespaindrug effectsescitalopramserotonin uptake inhibitors

Outcome Measures

Primary Outcomes (1)

  • pain relief

Secondary Outcomes (5)

  • 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

Interventions

escitalopramDRUG

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Danish Pain Research Center, Aarhus University Hospital, Noerrebrogade 44

Aarhus, 8000, Denmark

Location

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

Odense, 5000, Denmark

Location

Related Publications (4)

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

    PMID: 12387707BACKGROUND

  • 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.

    PMID: 11061244BACKGROUND

  • 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.

    PMID: 10371588BACKGROUND

  • 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.

    PMID: 12842122BACKGROUND

MeSH Terms

Conditions

PainPolyneuropathies

Interventions

Escitalopram

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

PropylaminesAminesOrganic ChemicalsNitrilesBenzofuransHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Soeren H Sindrup, MD, PhD

    Odense University Hospital, Dept. of neurology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 13, 2005

Study Start

December 1, 2004

Study Completion

April 1, 2007

Last Updated

April 24, 2007

Record last verified: 2007-04

Locations

DK(2)