Trial of Sodium Valproate in Amyotrophic Lateral Sclerosis

• Status: Completed
• Trial end date: 2007-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: UMC Utrecht
• Collaborator: Princess Beatrix Muscle Foundation
• Treatments: Valproic Acid

Criteria

Inclusion Criteria:

• 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)

• A disease duration at inclusion of more than 6 months and less than 36 months [inclusive] (disease onset is defined as the date of first symptoms excluding muscle cramps and fasciculations)

• 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.

Exclusion Criteria:

• Tracheostomy, tracheostomal ventilation of any type, non-invasive ventilation more than 16 hours/ day, or supplemental oxygen during the last three months prior to inclusion.

• 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).