Modafinil for Treatment of Fatigue in ALS Patients

Completed · Phase 4 · Has a placebo group

Conditions studied: Fatigue

In brief

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.

Key facts

Study ID

NCT00614926

Run by

New York State Psychiatric Institute

People needed

32

Starts

2006-06-01

Expected to finish

2008-07-01

Last updated by the study team

2012-02-20

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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+%

You may not qualify if…

• 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

Where it is running

• New York State Psychiatric Institute-Columbia University — New York, New York, United States

Full record on ClinicalTrials.gov

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