Modafinil for Treatment of Fatigue in ALS Patients - Full Text View

Sponsor:	New York State Psychiatric Institute
Information provided by (Responsible Party):	New York State Psychiatric Institute
ClinicalTrials.gov Identifier:	NCT00614926

Purpose

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.

Condition	Intervention	Phase
Fatigue	Drug: Modafinil Drug: Placebo	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Modafinil for Treatment of Fatigue in ALS Patients: Pilot Study

Resource links provided by NLM:

MedlinePlus related topics: Fatigue

Drug Information available for: Modafinil

U.S. FDA Resources

Further study details as provided by New York State Psychiatric Institute:

Primary Outcome Measures:

Participants Considered "Responders" (Scored 1 or 2) on Clinical Global Impressions Scale [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
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 [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
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.

Enrollment:	32
Study Start Date:	June 2006
Study Completion Date:	July 2008
Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 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).	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. Other Name: Provigil
Placebo Comparator: Placebo Sugar pill equivalent to the active comparator. Dosing schedule will be the same as the dosing schedule for Modafinil.	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. Other Name: Sugar pill

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

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00614926

Locations

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

Sponsors and Collaborators

New York State Psychiatric Institute

Investigators

Principal Investigator:

Judith G Rabkin, PhD

professor

More Information

No publications provided

Responsible Party:	New York State Psychiatric Institute
ClinicalTrials.gov Identifier:	NCT00614926 History of Changes
Other Study ID Numbers:	5178
Study First Received:	December 28, 2007
Results First Received:	January 12, 2011
Last Updated:	February 17, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by New York State Psychiatric Institute:

Fatigue
low energy
ALS
treatment

Additional relevant MeSH terms:

Fatigue
Signs and Symptoms
Modafinil
Central Nervous System Stimulants
Physiological Effects of Drugs

Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Neuroprotective Agents
Protective Agents

ClinicalTrials.gov processed this record on May 24, 2012