NCT00324454

Brief Summary

Levetiracetam (Keppra) is used to treat partial onset seizures. Its biological effects suggest it might also be useful in treating 3 aspects of human motor neuron diseases (MNDs) for which no effective therapy exists: cramps, spasticity, and disease progression.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started May 2006

Geographic Reach
1 country

1 active site

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

May 1, 2006

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

May 9, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 11, 2006

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
Last Updated

June 19, 2013

Status Verified

January 1, 2009

Enrollment Period

1.6 years

First QC Date

May 9, 2006

Last Update Submit

June 17, 2013

Conditions

Motor Neuron DiseaseAmyotrophic Lateral SclerosisPrimary Lateral SclerosisProgressive Muscular Atrophy

Keywords

motor neuron diseaseamyotrophic lateral sclerosis primary lateralsclerosis; progressive muscular atrophycrampsspasticity

Outcome Measures

Primary Outcomes (1)

  • Safety and tolerability at 9 months of treatment.

    9 months

Secondary Outcomes (1)

  • Cramps scores, spasticity scores, FVC, ALSFRS, MMT

    9 months

Interventions

LevetiracetamBIOLOGICAL

Levetiracetam 1500 mg BID

Also known as: Keppra 1500 mg BID

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with MNDs (ALS, PLS or PMA)who have cramps with average severity 50/100 points, are able to provide informed consent, have normal renal function and are on a stable riluzole dose.

You may not qualify if:

  • Pregnancy; unstable medical illness, dementia; drug abuse or non-compliance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University ALS Clinic - 932 Morreene Road

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Motor Neuron DiseaseAmyotrophic Lateral SclerosisMuscular Atrophy, SpinalSclerosisMuscle CrampMuscle Spasticity

Interventions

LevetiracetamBID protein, human

Condition Hierarchy (Ancestors)

Neurodegenerative DiseasesNervous System DiseasesNeuromuscular DiseasesSpinal Cord DiseasesCentral Nervous System DiseasesTDP-43 ProteinopathiesProteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsMuscular DiseasesMusculoskeletal DiseasesNeuromuscular ManifestationsNeurologic ManifestationsSigns and SymptomsMuscle Hypertonia

Intervention Hierarchy (Ancestors)

AcetamidesAmidesOrganic ChemicalsAcetatesAcids, AcyclicCarboxylic AcidsPyrrolidinonesPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Richard S Bedlack, MD, PhD

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2006

First Posted

May 11, 2006

Study Start

May 1, 2006

Primary Completion

December 1, 2007

Study Completion

June 1, 2008

Last Updated

June 19, 2013

Record last verified: 2009-01

Locations

US(1)