Modafinil for Treatment of Fatigue in ALS Patients
|ClinicalTrials.gov Identifier: NCT00614926|
Recruitment Status : Completed
First Posted : February 13, 2008
Results First Posted : July 25, 2011
Last Update Posted : February 20, 2012
|Condition or disease||Intervention/treatment||Phase|
|Fatigue||Drug: Modafinil Drug: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||32 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Modafinil for Treatment of Fatigue in ALS Patients: Pilot Study|
|Study Start Date :||June 2006|
|Actual Primary Completion Date :||July 2008|
|Actual Study Completion Date :||July 2008|
Eligible patients will be treated at baseline through Week 4. Those who choose to continue will have additional in-person visits at Weeks 8 and 12 visits (and Week 16 for those starting modafinil at Week 4).
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.
Other Name: Provigil
Placebo Comparator: Placebo
Sugar pill equivalent to the active comparator. Dosing schedule will be the same as the dosing schedule 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.
Other Name: Sugar pill
- Participants Considered "Responders" (Scored 1 or 2) on Clinical Global Impressions Scale [ Time Frame: 4 weeks ]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.
- Number of "Impaired" Scores on Neuropsychological (Brief) Test Battery [ Time Frame: 4 weeks ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00614926
|United States, New York|
|New York State Psychiatric Institute-Columbia University|
|New York, New York, United States, 10032|
|Principal Investigator:||Judith G Rabkin, PhD||professor|