Modafinil for Treatment of Fatigue in ALS Patients

NCT ID: NCT00614926

Last Updated: 2012-02-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-06-30
• Study Completion Date: 2008-07-31

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.

Conditions

Fatigue

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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).

Group Type: EXPERIMENTAL

Modafinil

Intervention Type: 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.

Placebo

Sugar pill equivalent to the active comparator. Dosing schedule will be the same as the dosing schedule for Modafinil.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Provigil; Sugar pill

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

New York State Psychiatric Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Judith G Rabkin, PhD

Role: PRINCIPAL_INVESTIGATOR

professor

Locations

New York State Psychiatric Institute-Columbia University

New York, New York, United States

Countries

United States

Other Identifiers

5178

Identifier Type: -

Identifier Source: org_study_id