Modafinil for Treatment of Fatigue in ALS Patients

This study has been completed.

Study NCT00614926 Information provided by Columbia University

First Received on December 28, 2007. Last Updated on August 15, 2011 History of Changes

Results First Received: January 12, 2011

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
Condition:	Fatigue
Interventions:	Drug: Modafinil Drug: Placebo

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
dates of recruitment were June 2006 through October 2007 at at the MDA-ALS Neurology Clinic at Columbia University.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Medical exclusion criteria were low thyroid levels which led to 3 patients excluded.

Reporting Groups

	Description
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.

Participant Flow: Overall Study

Baseline Characteristics

Reporting Groups

	Description
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.

Baseline Measures

	Modafinil	Placebo	Total
Number of Participants [units: participants]	25	7	32
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	23	6	29
>=65 years	2	1	3
Age [units: years] Mean ± Standard Deviation	59 ± 13	56 ± 5	58 ± 12
Gender [units: participants]
Female	11	3	14
Male	14	4	18
Region of Enrollment [units: participants]
United States	25	7	32
Fatigue Severity Scale score >40 ^[1] [units: participants]	25	7	32

[1]	Minimum score = 9, maximum = 63. Nine items, no subscales. Higher scores signify greater fatigue. Total summed scores over 40 (equal to mean item score of 4.5+) are considered to signify "clinically significant fatigue" and was a requirement for study eligibility.

Outcome Measures

1. Primary:

Participants Considered "Responders" (Scored 1 or 2) on Clinical Global Impressions Scale [ Time Frame: 4 weeks ]

Show Outcome Measure 1

2. Secondary:

Number of "Impaired" Scores on Neuropsychological (Brief) Test Battery [ Time Frame: 4 weeks ]

Show Outcome Measure 2

Serious Adverse Events

Other Adverse Events

More Information

Certain Agreements:

All Principal Investigators ARE employed by the organization sponsoring the study.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: Judith Rabkin, PhD
Organization: Columbia University
phone: 212 543 5762
e-mail: jgr1@columbia.edu

No publications provided

Responsible Party:	Judith Rabkin, PhD, principal investigator, Columbia University
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:	August 15, 2011
Health Authority:	United States: Institutional Review Board