Expired Study
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New York, New York 10032


Purpose:

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.


Study summary:

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.


Criteria:

Inclusion Criteria: - Clinical diagnosis of ALS - Ages 18-80 - Clinically significant fatigue (4.5+ on Fatigue Severity Scale with duration 3+ months plus impairment in 1+ categories of role function) - Speaks English - Able and willing to give informed consent - Can communicate verbally or with assistive device - Can swallow capsules - Forced vital capacity 50+% Exclusion Criteria: - Untreated hypothyroidism (TSH > 4.25 UIU/ML) - Untreated and uncontrolled hypertension - Clinically significant anemia (HCT < 33%) - Untreated or under-treated major depressive disorder - Current clinically significant suicidal ideation - Started antidepressant medication for treatment of depression during past 6 weeks - Currently taking psychostimulant medication - History or current psychosis or bipolar disorder - Fecund women not currently using barrier methods of contraception


NCT ID:

NCT00614926


Primary Contact:

Principal Investigator
Judith G Rabkin, PhD
professor


Backup Contact:

N/A


Location Contact:

New York, New York 10032
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: March 16, 2018

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