Modafinil for Treatment of Fatigue in ALS Patients

Fatigue Clinical Trial

Official title:

Modafinil for Treatment of Fatigue in ALS Patients: Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00614926
• Other study ID #: 5178
• Status: Completed
• Phase: Phase 4
• First received: December 28, 2007
• Last updated: February 17, 2012
• Start date: June 2006
• Est. completion date: July 2008

Study information

• Verified date: February 2012
• Source: New York State Psychiatric Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fatigue

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	New York State Psychiatric Institute-Columbia University	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York State Psychiatric Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No