Modafinil for Treatment of Fatigue in ALS Patients

NCT00614926 | Completed Phase 4 Results DMC

• 1 other identifier: 5178
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Fatigue

Keywords

Fatigue; low energy; ALS; treatment

Outcome Measures

Primary Outcomes (1)

• Participants Considered "Responders" (Scored 1 or 2) on Clinical Global Impressions Scale

  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.

  4 weeks

Secondary Outcomes (1)

• Number of "Impaired" Scores on Neuropsychological (Brief) Test Battery

  4 weeks

Study Arms (2)

Modafinil

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Modafinil 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.

Also known as: Provigil

Modafinil

Placebo 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.

Also known as: Sugar pill

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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+%

You may not qualify if:

• 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

Sponsors & Collaborators

• New York State Psychiatric Institute: lead

Study Sites (1)

New York State Psychiatric Institute-Columbia University

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Fatigue

Interventions

Modafinil; Sugars

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Carbohydrates

Results Point of Contact

• Title: Judith Rabkin, PhD
• Organization: Columbia University

jgr1@columbia.edu

212 543 5762

Study Officials

• Judith G Rabkin, PhD

  professor

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 28, 2007
• First Posted: February 13, 2008
• Study Start: June 1, 2006
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: February 20, 2012
• Results First Posted: July 25, 2011

Record last verified: 2012-02

Locations

US (1)