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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: Completed study, sponsored by Mallinckrodt.
NCT01547351 is a clinical trial that has completed, run by Mallinckrodt. The registered enrollment target is 103 participants. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Total composite score is calculated from three interrelated questions on part 2 of the ARMS questionnaire (to be completed 1 month ± 1 week after relapse treatment).
Interventions
- OTHER ARMS Questionnaire
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 103 participants |
| Start Date | 2011-12 |
| Est. Completion | 2012-09 |
What the finished NCT01547351 record still lists
NCT01547351 is an observational study that tracks outcomes without assigning an intervention. The registered 103 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which ARMS Questionnaire is the first listed.
NCT01547351 does not publish any study locations in the registry export this page uses.
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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