Modafinil for Treatment of Fatigue in ALS Patients
Information source: Columbia University
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Fatigue
Intervention: modafinil (Drug); placebo for modafinil (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Columbia University Official(s) and/or principal investigator(s):
Judith G Rabkin, PhD, Principal Investigator, Affiliation: professor
Overall contact:
Judith Rabkin, PhD, Phone: 212 543 5762, Email: jgr1@columbia.edu
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.
Clinical Details
Official title: Modafinil for Treatment of Fatigue in ALS Patients: Pilot Study
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Clinical. Global Impressions Scale
Secondary outcome: Number of "impaired" scores on neuropsychological (brief) test battery
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 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.
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
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
Locations and Contacts
Judith Rabkin, PhD, Phone: 212 543 5762, Email: jgr1@columbia.edu
New York State Psychiatric Institute-Columbia University, New York, New York 10032, United States; Recruiting
Judith Rabkin, PhD, Phone: 212-543-5762, Email: jgr1@columbia.edu
Martin McElhiney, PhD, Phone: 212 543 5331, Email: mcelhin@pi.cpmc.columbia.edu
Paul Gordon, MD, Sub-Investigator
Hiroshi Mitsumoto, MD, Sub-Investigator
Martin McElhiney, PhD, Sub-Investigator
Richard Rabkin, MD, Sub-Investigator
Additional Information
Starting date: June 2006
Ending date: December 2008
Last updated: April 1, 2008
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