Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01160380 · ClinicalTrials.gov registry record · Phase 3
A Study of the Effectiveness of Armodafinil to Treat Cancer-Related Fatigue in Patients With Multiple Myeloma
A Phase 3 study, sponsored by Oncotherapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 50
- Enrollment target
NCT01160380: Completed Phase 3 study, sponsored by Oncotherapeutics.
NCT01160380 is a Phase 3 study that has completed, run by Oncotherapeutics. The registered enrollment target is 50 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01160380, a Phase 3 study, has completed, sponsored by Oncotherapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 50 participants
- Enrollment target
Study 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.
Primary Outcome
Survey measuring fatigue. The scale contains 9 items; range=0-90 (0-10 per item). Mild = 1-3 Moderate = 4-7 Severe = 8-10
Interventions
- DRUG Placebo
- DRUG armodafinil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2010-06 |
| Est. Completion | 2014-05 |
| Phase | Phase 3 |
What the finished NCT01160380 record still lists
NCT01160380 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01160380 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01160380 about?
NCT01160380 is a clinical study titled "A Study of the Effectiveness of Armodafinil to Treat Cancer-Related Fatigue in Patients With Multiple Myeloma". 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 ...
What is the current status of trial NCT01160380?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 50 participants. The study started on 2010-06. Estimated completion is 2014-05.
What interventions are being tested in trial NCT01160380?
The interventions under investigation include: Placebo (DRUG), armodafinil (DRUG).
Who is sponsoring clinical trial NCT01160380?
This trial is sponsored by Oncotherapeutics, which has 17 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01160380's enrollment target sits among peer trials
50 1844th of 2000 higher than 141 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00200889 · 50 participants · Early Phase 1
Mapping Auricular Vagus Nerve Circuitry
- NCT00409435 · 50 participants · Phase 2
A Study of Pyridostigmine in Postural Tachycardia Syndrome
- NCT01202305 · 50 participants
The Use of Lymph Node Biopsies to Support HIV Pathogenesis Studies
- NCT01225913 · 50 participants · Phase 4
Mechanism(s) of Airflow Limitation During Exacerbation of Asthma
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia