Levetiracetam in Central Pain in Multiple Sclerosis(MS)

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00423527

Enrollment

Registered

2007-01-18

Start date

2007-01-31

Completion date

2009-01-31

Last updated

2009-12-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis

Keywords

multiple sclerosis, central pain, levetiracetam

Brief summary

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.

Interventions

DRUGlevetiracetam

Levetiracetam tablets 500 mg, total daily dose 3000 mg

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
Pain subtypes rated on the same scale.	Daily
Brush-evoked pain	Baseline and end of each treatment period
Pin-prick-evoked pain	Daily
Cold-evoked pain	Daily
Pain rated on a 0 to 10 point numeric rating scale	Daily
Pain related sleep disturbance	Daily
Use of escape medication	Daily
Muscle spasms as measured on 2 different scales	Baseline and end of each treatment period
Health related quality of life (SF36)	Baseline and end of each treatment period

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026