Back to resultsModafinil for Treatment of Fatigue in ALS Patients
Primary Purpose
Fatigue
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Modafinil
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Fatigue focused on measuring Fatigue, low energy, ALS, treatment
Eligibility Criteria
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
Sites / Locations
- New York State Psychiatric Institute-Columbia University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Modafinil
Placebo
Arm Description
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).
Sugar pill equivalent to the active comparator. Dosing schedule will be the same as the dosing schedule for Modafinil.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT00614926
First Posted
December 28, 2007
Last Updated
February 17, 2012
Sponsor
New York State Psychiatric Institute
1. Study Identification
Unique Protocol Identification Number
NCT00614926
Brief Title
Modafinil for Treatment of Fatigue in ALS Patients
Official Title
Modafinil for Treatment of Fatigue in ALS Patients: Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
July 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
New York State Psychiatric Institute
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fatigue
Keywords
Fatigue, low energy, ALS, treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Modafinil
Arm Type
Experimental
Arm Description
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).
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Sugar pill equivalent to the active comparator. Dosing schedule will be the same as the dosing schedule for Modafinil.
Intervention Type
Drug
Intervention Name(s)
Modafinil
Other Intervention Name(s)
Provigil
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Sugar pill
Intervention Description
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.
Primary Outcome Measure Information:
Title
Participants Considered "Responders" (Scored 1 or 2) on Clinical Global Impressions Scale
Description
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.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Number of "Impaired" Scores on Neuropsychological (Brief) Test Battery
Description
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.
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Judith G Rabkin, PhD
Organizational Affiliation
professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York State Psychiatric Institute-Columbia University
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Modafinil for Treatment of Fatigue in ALS Patients
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