Status:
COMPLETED
Modafinil for Treatment of Fatigue in ALS Patients
Lead Sponsor:
New York State Psychiatric Institute
Conditions:
Fatigue
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief 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 sclerosi...
Detailed 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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00614926
Start Date
June 1 2006
End Date
July 1 2008
Last Update
February 20 2012
Active Locations (1)
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1
New York State Psychiatric Institute-Columbia University
New York, New York, United States, 10032