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NCT01547351 · ClinicalTrials.gov registry record
Assessing Relapse in Multiple Sclerosis (ARMS) Questionnaire
A clinical trial, sponsored by Mallinckrodt.
- Completed
- Registry status
- 103
- Enrollment target
NCT01547351 is a clinical trial that has completed, run by Mallinckrodt. The registered enrollment target is 103 participants.
The verdict
NCT01547351 has completed, sponsored by Mallinckrodt.
- COMPLETED
- Registry status
- 103 participants
- Enrollment target
Study Summary
This Phase 4 pilot cross-sectional descriptive/exploratory study is to be conducted in clinical practice settings (including MS (Multiple sclerosis) specialty clinics, general neurology practices, or other academic or private practice settings) in the United States to assess the psychometric properties of the ARMS questionnaire in approximately 100 adult patients with MS who are experiencing a confirmed relapse, as identified by the investigator or designee at each site. Neither efficacy nor safety of treatment will be evaluated in this study. The ARMS questionnaire is a 2-part, 2-page survey, with each part comprising 7 questions on 1 page. Part 1 is designed to evaluate the patient's relapse symptoms and how the symptoms affect daily activities and overall function, as well as patient's response to past treatments for previous relapses, as a means of guiding treatment selection. Part 2 is designed to evaluate treatment response in terms of symptom relief and functioning, as well as treatment tolerability. Part 1 of the survey is to be completed when the patient presents with new relapse of MS. Part 2 of the survey is to be completed 1 month (± 1 week) after initiation of treatment for relapse of MS. Treatment for relapse will be at the sole discretion of the investigator.
Interventions
- OTHER ARMS Questionnaire
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 103 participants |
| Start Date | 2011-12 |
| Est. Completion | 2012-09 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01547351
The ClinicalTrials.gov registry entry for NCT01547351 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 103 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mallinckrodt, which has 69 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which ARMS Questionnaire is the first listed.
NCT01547351 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01547351 about?
NCT01547351 is a clinical study titled "Assessing Relapse in Multiple Sclerosis (ARMS) Questionnaire". This Phase 4 pilot cross-sectional descriptive/exploratory study is to be conducted in clinical practice settings (including MS (Multiple sclerosis) specialty clinics, general neurology practices, or other academic or private practice settings) in the United States to assess the psychometric propert...
What is the current status of trial NCT01547351?
This trial is currently completed. The enrollment target is 103 participants. The study started on 2011-12. Estimated completion is 2012-09.
What interventions are being tested in trial NCT01547351?
The interventions under investigation include: ARMS Questionnaire (OTHER).
Who is sponsoring clinical trial NCT01547351?
This trial is sponsored by Mallinckrodt, which has 69 total clinical trials registered on ClinicalTrials.gov.
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