Modafinil for Treatment of Fatigue in ALS Patients

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.

Study Overview

• Status: Completed
• Conditions: Fatigue
• Intervention / Treatment: Drug: Modafinil; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10032
      • New York State Psychiatric Institute-Columbia University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Modafinil; 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).	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.; Other Names: Provigil
Placebo Comparator: Placebo; Sugar pill equivalent to the active comparator. Dosing schedule will be the same as the dosing schedule for Modafinil.	Drug: Placebo; 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 Names: Sugar pill

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: New York State Psychiatric Institute
• Investigators: Principal Investigator: Judith G Rabkin, PhD, Professor

Study record dates

Study Major Dates

• Study Start: June 1, 2006
• Primary Completion (Actual): July 1, 2008
• Study Completion (Actual): July 1, 2008

Study Registration Dates

• First Submitted: December 28, 2007
• First Submitted That Met QC Criteria: January 31, 2008
• First Posted (Estimate): February 13, 2008

Study Record Updates

• Last Update Posted (Estimate): February 20, 2012
• Last Update Submitted That Met QC Criteria: February 17, 2012
• Last Verified: February 1, 2012

More Information

Terms related to this study

• Keywords: treatment; ALS; Fatigue; low energy
• Additional Relevant MeSH Terms: Fatigue; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Cytochrome P-450 Enzyme Inducers; Cytochrome P-450 CYP3A Inducers; Central Nervous System Stimulants; Wakefulness-Promoting Agents; Modafinil
• Other Study ID Numbers: 5178