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Modafinil for Treatment of Fatigue in ALS Patients

Information source: New York State Psychiatric Institute
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Fatigue

Intervention: Modafinil (Drug); Placebo (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: New York State Psychiatric Institute

Official(s) and/or principal investigator(s):
Judith G Rabkin, PhD, Principal Investigator, Affiliation: professor

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.

Clinical Details

Official title: Modafinil for Treatment of Fatigue in ALS Patients: Pilot Study

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

Primary outcome: Participants Considered "Responders" (Scored 1 or 2) on Clinical Global Impressions Scale

Secondary outcome: Number of "Impaired" Scores on Neuropsychological (Brief) Test Battery

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.

Eligibility

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

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

Locations and Contacts

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

Starting date: June 2006
Last updated: February 17, 2012

Page last updated: August 23, 2015

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