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A Study of the Effectiveness of Armodafinil to Treat Cancer-Related Fatigue in Patients With Multiple Myeloma

NCT01160380 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2014-11-06

Study results available
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Summary

The purpose of this study is to evaluate the efficacy of armodafinil for the treatment of cancer-related fatigue in adult patients with multiple myeloma. The study consists of a screening period, followed by a 56-day treatment phase, and a final assessment to occur 28 days after the end of the last treatment.

Conditions

Interventions

DRUG

armodafinil

Armodafinil taken at 150 mg daily. Taken as three 50 mg tablets.

DRUG

Placebo

Placebo taken at 150 mg daily. Taken orally as three 50 mg tablets.

Sponsors & Collaborators

  • Cephalon

    collaborator INDUSTRY

  • Oncotherapeutics

    lead INDUSTRY

Principal Investigators

  • James Berenson, MD · James R. Berenson MD, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-06-30
Primary Completion
2013-06-30
Completion
2014-05-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01160380 on ClinicalTrials.gov