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NCT01071044 · ClinicalTrials.gov registry record · Phase 4
Efficacy and Safety of Lisdexamfetamine Dimesylate in Adults With Chronic Fatigue Syndrome
A Phase 4 study, sponsored by Rochester Center for Behavioral Medicine.
- Completed
- Registry status
- Phase 4
- Development phase
- 26
- Enrollment target
NCT01071044 is a Phase 4 study that has completed, run by Rochester Center for Behavioral Medicine. The registered enrollment target is 26 participants.
The verdict
NCT01071044, a Phase 4 study, has completed, sponsored by Rochester Center for Behavioral Medicine.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 26 participants
- Enrollment target
Study Summary
Over the past decade, the Rochester Center for Behavioral Medicine (RCBM) has evaluated many patients with attention deficit hyperactivity disorder (ADHD). A recurrent finding in these patients is a history of unexplained fatigue and musculoskeletal pain. Treatment of these patients in our clinic has revealed that when their underlying ADHD is treated with psychostimulant medication, many patients report significant improvements with regard to their fatigue and musculoskeletal pain. Patients report less subjective fatigue and pain and note overall functional improvement, although the initial and primary objective was the treatment of their attention or hyperactivity problems. We speculate that stimulants are efficacious by offering two distinct clinical properties. 1) anti-fatigue properties and 2) properties that allow patients to filter out extraneous stimuli (i.e. chronic muscle pain).
Interventions
- DRUG Lisdexamfetamine Dimesylate
- DRUG Placebo "30, 50 or 70 mg"
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2009-11 |
| Est. Completion | 2011-03 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01071044
The ClinicalTrials.gov registry entry for NCT01071044 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 26 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Rochester Center for Behavioral Medicine, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Lisdexamfetamine Dimesylate is the first listed.
NCT01071044 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01071044 about?
NCT01071044 is a clinical study titled "Efficacy and Safety of Lisdexamfetamine Dimesylate in Adults With Chronic Fatigue Syndrome". Over the past decade, the Rochester Center for Behavioral Medicine (RCBM) has evaluated many patients with attention deficit hyperactivity disorder (ADHD). A recurrent finding in these patients is a history of unexplained fatigue and musculoskeletal pain. Treatment of these patients in our clinic h...
What is the current status of trial NCT01071044?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 26 participants. The study started on 2009-11. Estimated completion is 2011-03.
What interventions are being tested in trial NCT01071044?
The interventions under investigation include: Lisdexamfetamine Dimesylate (DRUG), Placebo "30, 50 or 70 mg" (DRUG).
Who is sponsoring clinical trial NCT01071044?
This trial is sponsored by Rochester Center for Behavioral Medicine, which has 4 total clinical trials registered on ClinicalTrials.gov.
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