Status:
COMPLETED
Trial of Sodium Valproate in Amyotrophic Lateral Sclerosis
Lead Sponsor:
UMC Utrecht
Collaborating Sponsors:
Princess Beatrix Muscle Foundation
Conditions:
Amyotrophic Lateral Sclerosis
Eligibility:
All Genders
18-85 years
Phase:
PHASE3
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.
Detailed Description
Amyotrophic lateral sclerosis (ALS) is a devastating disease characterized by progressive degeneration of motor neurons leading to muscle weakness. The pathogenesis of ALS is unknown, but there is co...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2007
Estimated Enrollment :
165 Patients enrolled
Trial Details
Trial ID
NCT00136110
Start Date
April 1 2005
End Date
February 1 2007
Last Update
May 1 2007
Active Locations (1)
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1
UMC Utrecht
Utrecht, Utrecht, Netherlands, 3584 CX