NCT00555347

Brief Summary

To determine the effect of Armodafinil (Nuvigil) on fatigue and sleep in sarcoidosis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Oct 2007

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 7, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 8, 2007

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

May 27, 2015

Status Verified

April 1, 2013

Enrollment Period

2.8 years

First QC Date

November 7, 2007

Last Update Submit

May 26, 2015

Conditions

SarcoidosisFatigueSleepiness

Keywords

SarcoidosisFatigue

Outcome Measures

Primary Outcomes (1)

  • To determine the effect of Armodafinil (Nuvigil) on fatigue and sleep in sarcoidosis.

    Prospective

Secondary Outcomes (2)

  • To determine the effect of Armodafinil (Nuvigil) on pulmonary function in sarcoidosis.

    Prospective

  • To determine the safety and tolerability of Armodafinil (Nuvigil) in sarcoidosis.

    Prospective

Study Arms (2)

Armnodafinil

ACTIVE COMPARATOR

Armodafinil

Drug: Armodafinil

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

ArmodafinilDRUG

Dosage 150-250 mg

Also known as: Nuvigil
Armnodafinil
PlaceboDRUG

Placebo

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of sarcoidosis using standard criteria 15.
  • Disease for more than one year
  • On stable, systemic therapy
  • Complain of fatigue which has been present for more than six months.
  • Over 18 years of age
  • Provide written informed consent.

You may not qualify if:

  • Pregnancy
  • Change in therapy for sarcoidosis in prior three months
  • History of ventricular arrythmias

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Cincinnati

Cincinnati, Ohio, 45267, United States

Location

MeSH Terms

Conditions

SarcoidosisFatigueSleepiness

Interventions

Modafinil

Condition Hierarchy (Ancestors)

Lymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesHypersensitivity, DelayedHypersensitivityImmune System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzhydryl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Robert P Baughman, MD

    University of Cincinnati

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof Medicine

Study Record Dates

First Submitted

November 7, 2007

First Posted

November 8, 2007

Study Start

October 1, 2007

Primary Completion

August 1, 2010

Study Completion

August 1, 2011

Last Updated

May 27, 2015

Record last verified: 2013-04

Locations

US(1)