NCT00136110

Brief Summary

The purpose of this study is to determine whether the use of sodium valproate is effective in slowing the disease progression in Amyotrophic Lateral Sclerosis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
165

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Apr 2005

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

April 1, 2005

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 24, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 26, 2005

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2007

Completed
Last Updated

May 1, 2007

Status Verified

April 1, 2007

First QC Date

August 24, 2005

Last Update Submit

April 30, 2007

Conditions

Amyotrophic Lateral Sclerosis

Keywords

ALSSodium Valproaterandomised trialAmyotrophic Lateral Sclerosis (ALS)

Outcome Measures

Primary Outcomes (1)

  • Survival

Secondary Outcomes (1)

  • The rate of decline of daily functioning

Interventions

Sodium ValproateDRUG

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Definite, probable, or probable-laboratory supported ALS according to the revised El Escorial World Federation of Neurology criteria.
  • Intake of riluzole 50 mg twice a day (bid)
  • Vital capacity (VC%) ≥ 70% of normal value (slow expiration, best of a minimum of three and a maximum of five measurements, with a respiratory function validly assessable and a spontaneous, non-assisted ventilation)
  • Ages 18 - 85 years (inclusive)
  • Capable of thoroughly understanding the trial information given; has signed the informed consent.

You may not qualify if:

  • Any medical condition or intoxication known to have an association with motor neuron dysfunction, which might confound or obscure the diagnosis of ALS.
  • Presence of any concomitant life-threatening disease or any disease or impairment likely to interfere with functional assessment.
  • Confirmed hepatic insufficiency or abnormal liver function (ASAT, ALAT greater than twice the upper limit of normal range).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UMC Utrecht

Utrecht, Utrecht, 3584 CX, Netherlands

Location

Related Publications (1)

  • Piepers S, Veldink JH, de Jong SW, van der Tweel I, van der Pol WL, Uijtendaal EV, Schelhaas HJ, Scheffer H, de Visser M, de Jong JM, Wokke JH, Groeneveld GJ, van den Berg LH. Randomized sequential trial of valproic acid in amyotrophic lateral sclerosis. Ann Neurol. 2009 Aug;66(2):227-34. doi: 10.1002/ana.21620.

    PMID: 19743466DERIVED

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Interventions

Valproic Acid

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesMotor Neuron DiseaseNeurodegenerative DiseasesTDP-43 ProteinopathiesNeuromuscular DiseasesProteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Pentanoic AcidsValeratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsFatty Acids, VolatileFatty AcidsLipids

Study Officials

  • Leonard H Van den Berg, MD, PhD

    UMC Utrecht

    STUDY CHAIR

  • Sanne Piepers, MD

    UMC Utrecht

    PRINCIPAL INVESTIGATOR

  • Sonja W De Jong, MD

    UMC Utrecht

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 24, 2005

First Posted

August 26, 2005

Study Start

April 1, 2005

Study Completion

February 1, 2007

Last Updated

May 1, 2007

Record last verified: 2007-04

Locations

NL(1)