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NCT Number: NCT00423527

Levetiracetam in Central Pain in Multiple Sclerosis(MS)

Multiple sclerosis is often associated with pain. There is no standard treatment of this type of pain. Levetiracetam is a new anticonvulsant and it is the hypothesis that it could relieve central pain in multiple sclerosis. This is a randomised, double-blind, placebo-controlled, cross-over trial on the effect of levetiracetam 3000 mg daily on pain in multiple sclerosis.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Neurology, Odense University Hospital

Odense C, DK-5000, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ms diagnosis verified
  • age > 18 years
  • central pain symptoms for more than 3 months
  • central pain diagnosis confirmed by neurological examination
  • adequate anticonceptive treatment for women with child bearing potential
  • informed consent
  • baseline pain of more than 4 on numeric rating scale

Exclusion criteria

  • other cause of pain
  • previous allergic reaction towards levetiracetam
  • known adverse drug reaction on levetiracetam
  • pregnancy
  • severe disease
  • inability to follow study protocol
  • treatment with antidepressants, other anticonvulsants or opioids

Treatment and study plan

Levetiracetam

Drug

Levetiracetam tablets 500 mg, total daily dose 3000 mg

Primary outcomes

  1. Pain relief rated on a 0 to 10 point numeric rating scale (median value for last treatment week of each period)

    Time frame: Weekly

Secondary outcomes

  1. Pain rated on a 0 to 10 point numeric rating scale

    Time frame: Daily

  2. Pain subtypes rated on the same scale.

    Time frame: Daily

  3. Brush-evoked pain

    Time frame: Baseline and end of each treatment period

  4. Pin-prick-evoked pain

    Time frame: Daily

  5. Cold-evoked pain

    Time frame: Daily

  6. Health related quality of life (SF36)

    Time frame: Baseline and end of each treatment period

  7. Pain related sleep disturbance

    Time frame: Daily

  8. Use of escape medication

    Time frame: Daily

  9. Muscle spasms as measured on 2 different scales

    Time frame: Baseline and end of each treatment period

Sponsors and collaborators

Lead sponsor

Odense University Hospital

Other

Registry information

Official study title

Double-blind, Randomised,Placebo-controlled Trial of Levetiracetam in Central Pain in Multiple Sclerosis

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Jan 18, 2007
Registry last updated
Dec 18, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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