CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 32 enrolled
Drug / intervention
Modafinil +1 moredrug
Likely dose
Modafinil 50 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00614926
NCT00614926Phase 4Completed
CompareCT.gov

Modafinil for Treatment of Fatigue in ALS Patients: Pilot Study

New York State Psychiatric Institute·interventional·Posted Feb 13, 2008·Updated Feb 20, 2012

In Brief

A Phase 4 clinical trial evaluating Modafinil and Placebo for Fatigue. Completed, enrolled 32 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFatigue
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 13, 2008
Enrollment StartJun 1, 2006
Primary CompletionJul 1, 2008
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 18.4 years ago

Interventions

Modafinildrug

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.

Placebodrug

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.