Modafinil for Treatment of Fatigue in ALS Patients

Fatigue Clinical Trial

Official title: Modafinil for Treatment of Fatigue in ALS Patients: Pilot Study

Status Completed

Clinical Trial Summary

The purpose of this pilot study is to evaluate whether modafinil is helpful in alleviating fatigue, low energy, drowsiness and difficulty concentrating among patients with amyotrophic lateral sclerosis (ALS), and to evaluate incidence and frequency of adverse events, if any.

Clinical Trial Description

ALS is an untreatable, progressive, fatal neurodegenerative disease whose etiology is unknown and whose course is relatively rapid (median survival 3 years after diagnosis). Palliative care, including symptom management, can contribute greatly to improved quality of life. In this context, alleviation of fatigue can help maintain function, extend the duration of time when employment is feasible for those still working, and can enable patients to more fully participate in and enjoy social and recreational activities. Given the prevalence of fatigue in this population, identification of effective treatment is a meaningful goal. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fatigue

• NCT number: NCT00614926
• Study type: Interventional
• Source: New York State Psychiatric Institute
• Status: Completed
• Phase: Phase 4
• Start date: June 2006
• Completion date: July 2008