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Modafinil for Treatment of Fatigue in ALS Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00614926
Recruitment Status : Completed
First Posted : February 13, 2008
Results First Posted : July 25, 2011
Last Update Posted : February 20, 2012
Information provided by (Responsible Party):
New York State Psychiatric Institute

Brief 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.

Condition or disease Intervention/treatment Phase
Fatigue Drug: Modafinil Drug: Placebo Phase 4

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  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Modafinil for Treatment of Fatigue in ALS Patients: Pilot Study
Study Start Date : June 2006
Primary Completion Date : July 2008
Study Completion Date : July 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fatigue
U.S. FDA Resources

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 Name: 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 Name: Sugar pill

Primary Outcome Measures :
  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 Outcome Measures :
  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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

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
Sponsors and Collaborators
New York State Psychiatric Institute
Principal Investigator: Judith G Rabkin, PhD professor

Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT00614926     History of Changes
Other Study ID Numbers: 5178
First Posted: February 13, 2008    Key Record Dates
Results First Posted: July 25, 2011
Last Update Posted: February 20, 2012
Last Verified: February 2012

Keywords provided by New York State Psychiatric Institute:
low energy

Additional relevant MeSH terms:
Signs and Symptoms
Wakefulness-Promoting Agents
Central Nervous System Stimulants
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs