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Completed

NCT Number: NCT00614926

Modafinil for Treatment of Fatigue in ALS Patients

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.

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Key information

Conditions

Fatigue Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

New York State Psychiatric Institute-Columbia University

New York, 10032, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Modafinil

Drug

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

Drug

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

New York State Psychiatric Institute

Other

Registry information

Official study title

Modafinil for Treatment of Fatigue in ALS Patients: Pilot Study

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Feb 13, 2008
Registry last updated
Feb 20, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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