CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 21 enrolled
Drug / intervention
placebo +1 moredrug
Likely dose
memantine 10 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00638027
NCT00638027Phase 4Completed

Memantine for Spasticity in MS Patients

University of Rochester·interventional·Posted Mar 18, 2008·Updated Dec 7, 2015

In Brief

A Phase 4 clinical trial evaluating placebo and memantine for Multiple Sclerosis. Completed, enrolled 21 participants across 1 site.

Detailed Summary

Participants (n=20) will be identified at routine care visits performed at the Rochester Multiple Sclerosis Center. Eligible participants will have MS by McDonald Criteria,7 and will have a modified Ashworth spasticity rating8 of two or higher in at least one lower extremity muscle group. Participants will be seen at screening, one, and three months, and will be evaluated using the modified Ashworth scale,8 pendulum test,9 toe tapping test,10 manual muscle testing,11 timed 25 foot walk,12 and Multiple Sclerosis Functional Composite.13 The type and severity of any adverse events will be recorded using standard definitions. Participants will be instructed to call between visits to inform the investigators regarding any adverse events they experience. Follow-up will continue until all adverse events resolve or stabilize.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsForest Laboratories

Timeline

Phase 4CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 18, 2008
Enrollment StartJul 1, 2006
Primary CompletionFeb 1, 2009
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 18.3 years ago

Interventions

placebodrug

matched tablets bid

memantinedrug

10 mg bid