Responsiveness to Dalfampridine-ER Treatment Among Multiple Sclerosis Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

52 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-08-31

Study Completion Date

2015-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Ampyra (dalfampridine-ER) was approved by the FDA (2010) for improving walking speed in persons with multiple sclerosis. This project seeks to determine if there are other benefits to taking dalfampridine besides an increase in walking speed. This is strictly an observational study and research staff will not be involved in any decisions to stop or start taking the medication.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study of Fampridine-ER Tablets in Patients With Multiple Sclerosis

NCT01328379

Multiple Sclerosis

COMPLETED PHASE3

Ampyra for Optic Neuritis in Multiple Sclerosis

NCT01337986

Multiple Sclerosis Optic Neuritis

COMPLETED PHASE2/PHASE3

Dalfampridine Combined With Physical Therapy for Mobility Impairment in Multiple Sclerosis

NCT06136728

Multiple Sclerosis

RECRUITING PHASE4

Dalfampridine for Imbalance in Multiple Sclerosis

NCT01444300

Multiple Sclerosis Fatigue

COMPLETED PHASE2

A Placebo Controlled Trial of Dalfampridine ER for Ambulatory Activity in People With Multiple Sclerosis

NCT01356940

Multiple Sclerosis

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Subjects will be evaluated before starting medication, throughout a 14week period after starting D-ER as well as at 12 and 18months following the start date of medication regardless of if they stayed on medication or not.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Multiple Sclerosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

ECOLOGIC_OR_COMMUNITY

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

pwMS prescribed dalfampridine-ER

Anyone prescribed D-ER per usual clinical care was recruited into this observational study. All those willing to participate were consented and observed pre-drug and for a 14week period with two follow-up visits scheduled at 12 and 18months.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Confirmed clinical diagnosis of MS by McDonald criteria
* Prescribed ampyra (dalfampridine) as part of usual care, but have not yet started taking the medication before baseline visit
* Receive MS care at the Mandell MS center
* Cognitively able to understand directions and complete protocol (score of 22 or greater on the MMSE)
* 18 years of age or older

Exclusion Criteria

* Already began to take drug prior to baseline research visit
* Not planning to continue care at Mandell Center for at least 14 weeks after initiation of therapy
* Unwilling or unable to complete assessments

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No