---
title: Use of Armodafinil for Fatigue in Sarcoidosis
nct_id: NCT00555347
overall_status: COMPLETED
phase: PHASE2, PHASE3
sponsor: University of Cincinnati
study_type: INTERVENTIONAL
primary_condition: Sarcoidosis
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00555347.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00555347"
ct_last_update_post_date: 2015-05-27
last_seen_at: "2026-05-12T07:30:23.685Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Use of Armodafinil for Fatigue in Sarcoidosis

**Official Title:** Use of Armodafinil (R-modafinil) for Fatigue in Sarcoidosis

**NCT ID:** [NCT00555347](https://clinicaltrials.gov/study/NCT00555347)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE2, PHASE3
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 20
- **Lead Sponsor:** University of Cincinnati
- **Collaborators:** Cephalon
- **Conditions:** Sarcoidosis, Fatigue, Sleepiness
- **Start Date:** 2007-10
- **Completion Date:** 2011-08
- **CT.gov Last Update:** 2015-05-27

## Brief Summary

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

## Detailed Description

The study will be divided into two halves. Patients will receive either drug or placebo in the first half. Patients receiving active drug will be started at one dose and it can be increased at the second visit. Those patients randomized to placebo will also have their dose adjusted by the investigating physician. The physicians will be blinded as to whether the patient is receiving drug or placebo. In the second half of the study, patients will receive the opposite treatment.

Patients will have complete detailed questionnaires regarding their fatigue, sleepiness, and overall quality of life.

They will have sleep studies done at the start and after each half of the study to determine the effect of therapy on sleepiness.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* 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.

Exclusion Criteria:

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

## Arms

- **Armnodafinil** (ACTIVE_COMPARATOR) — Armodafinil
- **Placebo** (PLACEBO_COMPARATOR)

## Interventions

- **Armodafinil** (DRUG) — Dosage 150-250 mg
- **Placebo** (DRUG) — Placebo

## Primary Outcomes

- **To determine the effect of Armodafinil (Nuvigil) on fatigue and sleep in sarcoidosis.** _(time frame: Prospective)_

## Secondary Outcomes

- **To determine the effect of Armodafinil (Nuvigil) on pulmonary function in sarcoidosis.** _(time frame: Prospective)_
- **To determine the safety and tolerability of Armodafinil (Nuvigil) in sarcoidosis.** _(time frame: Prospective)_

## Locations (1)

- University of Cincinnati, Cincinnati, Ohio, United States

## Recent Field Changes (last 30 days)

- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.university of cincinnati|cincinnati|ohio|united states` — added _(2026-05-12)_

---

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*Source data (authoritative): https://clinicaltrials.gov/study/NCT00555347*  
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