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| Sponsored by: |
Columbia University |
|---|---|
| Information provided by: | Columbia University |
| ClinicalTrials.gov Identifier: | NCT00614926 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Fatigue |
Drug: modafinil Drug: placebo for modafinil |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Modafinil for Treatment of Fatigue in ALS Patients: Pilot Study |
| Estimated Enrollment: | 35 |
| Study Start Date: | June 2006 |
| Estimated Study Completion Date: | December 2008 |
| Estimated Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Active Comparator
3 in 4 patients are randomized to modafinil
|
Drug: modafinil
Dose schedule: 50 mg/day for 1 week, increasing to 100 mg/day at Week 2. Thereafter, dose may be increased to 300 mg/day as clinically indicated, in the absence of dose-limiting side effects. Dose is daily, in A.M., for 4 weeks.
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2: Placebo Comparator
One in 4 patients is randomized to placebo medication
|
Drug: placebo for modafinil
placebo capsules are administered on the same schedule as active drug: 50 mg/day for 1 week, increasing to 100 mg/day at Week 2. Thereafter, dose may be increased to 300 mg/day in the absence of clinical improvement and dose limiting side effects. Dose is daily, in A.M.
|
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| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Judith Rabkin, PhD | 212 543 5762 | jgr1@columbia.edu |
| Contact: Martin McElhiney | 212 543 5331 | McElhin@pi.cpmc.columbia.edu |
| United States, New York | |
| New York State Psychiatric Institute-Columbia University | Recruiting |
| New York, New York, United States, 10032 | |
| Contact: Judith Rabkin, PhD 212-543-5762 jgr1@columbia.edu | |
| Contact: Martin McElhiney, PhD 212 543 5331 mcelhin@pi.cpmc.columbia.edu | |
| Sub-Investigator: Paul Gordon, MD | |
| Sub-Investigator: Hiroshi Mitsumoto, MD | |
| Sub-Investigator: Martin McElhiney, PhD | |
| Sub-Investigator: Richard Rabkin, MD | |
| Principal Investigator: | Judith G Rabkin, PhD | professor |
More Information
| Responsible Party: | Columbia University ( Judith Rabkin, PhD, principal investigator ) |
| Study ID Numbers: | IRB5178 |
| Study First Received: | December 28, 2007 |
| Last Updated: | April 1, 2008 |
| ClinicalTrials.gov Identifier: | NCT00614926 |
| Health Authority: | United States: Institutional Review Board |
|
Fatigue low energy ALS treatment |
|
Signs and Symptoms Fatigue Modafinil |
|
Therapeutic Uses Physiological Effects of Drugs Central Nervous System Stimulants Protective Agents |
Neuroprotective Agents Central Nervous System Agents Pharmacologic Actions |
