Modafinil for Treatment of Fatigue in ALS Patients

New York State Psychiatric Institute

Status and phase: Completed; Phase 4

Conditions: Fatigue

Treatments: Drug: Placebo; Drug: Modafinil

Study type: Interventional

Funder types: Other

Identifiers

NCT00614926

5178

Details and patient eligibility

About

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.

Full 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.

Enrollment: 32 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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32 participants in 2 patient groups, including a placebo group

Modafinil

Experimental group

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).

Treatment:

Drug: Modafinil

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo