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

CompletedPhase 4MS (type not specified)NCT00423527

What it found

No results found

We found no results in the registry or in papers.

This trial finished 17 years ago. We found no results in the registry or in any paper that cites it.

What was tested

Treatment tested

  • Levetiracetam

    Synaptic vesicle glycoprotein 2A modulator|Voltage-gated N-type calcium channel alpha-1B subunit blocker

What it measured

Main measures

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

    Weekly

    Pain

Other measures (9)

  • Pain rated on a 0 to 10 point numeric rating scale

    Daily

    Pain
  • Pain subtypes rated on the same scale.

    Daily

    Pain
  • Brush-evoked pain

    Baseline and end of each treatment period

    Pain
  • Pin-prick-evoked pain

    Daily

    Pain
  • Cold-evoked pain

    Daily

    Pain
  • Health related quality of life (SF36)

    Baseline and end of each treatment period

    Quality of life (reported by participants)
  • Pain related sleep disturbance

    Daily

    PainMood and sleep
  • Use of escape medication

    Daily

  • Muscle spasms as measured on 2 different scales

    Baseline and end of each treatment period

    Spasticity

Who could take part

MS (type not specified) · 18 and over

Show the full criteria

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

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

Papers

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    Related trials

    History

      1. Started

        Jan 2007

      2. Main results due

        Jan 2009

      3. Finished

        Jan 2009

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