Modafinil for Treatment of Fatigue in ALS Patients

• Status: Completed
• Trial end date: 2008-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: New York State Psychiatric Institute
• Treatments: Armodafinil; Modafinil

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