Fatigue Clinical Trial
Official title:
Modafinil for Treatment of Fatigue in ALS Patients: Pilot Study
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.
Status | Completed |
Enrollment | 32 |
Est. completion date | July 2008 |
Est. primary completion date | July 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | New York State Psychiatric Institute-Columbia University | New York | New York |
Lead Sponsor | Collaborator |
---|---|
New York State Psychiatric Institute |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Participants Considered "Responders" (Scored 1 or 2) on Clinical Global Impressions Scale | The CGI is a standardized assessment tool widely used in clinical psychopharmacology trials as an outcome measure. Scores range from 1= very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5-7 = worse. We use it as a dichotomous measure with scores of 1 or 2 signifying "responder" and all the rest as "non-responder" using all available data including clinician judgement, and ratings scales. | 4 weeks | No |
Secondary | Number of "Impaired" Scores on Neuropsychological (Brief) Test Battery | This was an initial plan but the large majority of patients were too impaired (either anarthric or unable to use hands) to complete the tests we had selected so this outcome measure turned out to be unfeasible. Therefore, 0 participants were analyzed. | 4 weeks | No |
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