Levetiracetam in Central Pain in Multiple Sclerosis(MS)

NCT00423527 | Completed Phase 4

• 1 other identifier: keppra3
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Keywords

multiple sclerosis; central pain; levetiracetam

Outcome Measures

Primary Outcomes (1)

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

  Weekly

Secondary Outcomes (9)

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

  Daily

• 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

Interventions

levetiracetam DRUG

Levetiracetam tablets 500 mg, total daily dose 3000 mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Odense University Hospital: lead

Study Sites (1)

Department of Neurology, Odense University Hospital

Odense C, DK-5000, Denmark

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Levetiracetam

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Søren H Sindrup, MD

  Department of Neurology, Odense Unviersity Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 16, 2007
• First Posted: January 18, 2007
• Study Start: January 1, 2007
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: December 18, 2009

Record last verified: 2007-01

Locations

DK (1)