CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 42 enrolled
Drug / intervention
Dalfampridine-ERdrug
Likely dose
Dalfampridine-ER 7.5 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/NCT01316055
NCT01316055Phase 1Completed
CompareCT.gov

A Parallel, Three Arm, Open-label, Multi-dose Pharmacokinetic Study of Dalfampridine-ER 7.5 mg Twice Daily in Both Healthy Volunteers and Those With Mild and Moderate Renal Impairment

Acorda Therapeutics·interventional·Posted Mar 16, 2011·Updated Nov 7, 2012

In Brief

A Phase 1 clinical trial evaluating Dalfampridine-ER for Renal Insufficiency. Completed, enrolled 42 participants across 2 sites.

Detailed Summary

The steady-state pharmacokinetics of Dalfampridine-ER (extended release) 7.5 mg (milligram) tablets in healthy adult volunteers and those with mild and moderate renal impairment, and examine between group comparisons.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRenal Insufficiency
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMar 16, 2011
Enrollment StartJan 1, 2011
Primary CompletionAug 1, 2011
Study CompletionSep 1, 2011
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 15.3 years ago

Interventions

Dalfampridine-ERdrug

2 days of single dose 7.5 mg, 4 days of bid dosing, and a 3 day follow-up