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NCT01316055 · ClinicalTrials.gov registry record · Phase 1
Pharmacokinetics (PK) of Dalfampridine-ER 7.5 mg BID in Healthy Volunteers and Subjects With Mild or Moderate Renal Impairment
A Phase 1 study, sponsored by Acorda Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 42
- Enrollment target
NCT01316055: Completed Phase 1 study, sponsored by Acorda Therapeutics.
NCT01316055 is a Phase 1 study that has completed, run by Acorda Therapeutics. The registered enrollment target is 42 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (30% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01316055, a Phase 1 study, has completed, sponsored by Acorda Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 42 participants
- Enrollment target
Study 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.
Primary Outcome
AUC(0-12) was based on blood samples taken at specified outcome measure time frame for dalfampridine-ER 7.5 mg tablets in healthy adult volunteers and people with mild or moderate renal impairment.
Interventions
- DRUG Dalfampridine-ER
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2011-01 |
| Est. Completion | 2011-09 |
| Phase | Phase 1 |
What the finished NCT01316055 record still lists
NCT01316055 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (30% lower).
The record links to 0 conditions, and to 1 intervention - of which Dalfampridine-ER is the first listed.
NCT01316055 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01316055 about?
NCT01316055 is a clinical study titled "Pharmacokinetics (PK) of Dalfampridine-ER 7.5 mg BID in Healthy Volunteers and Subjects With Mild or Moderate Renal Impairment". 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.
What is the current status of trial NCT01316055?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 42 participants. The study started on 2011-01. Estimated completion is 2011-09.
What interventions are being tested in trial NCT01316055?
The interventions under investigation include: Dalfampridine-ER (DRUG).
Who is sponsoring clinical trial NCT01316055?
This trial is sponsored by Acorda Therapeutics, which has 36 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01316055's enrollment target sits among peer trials
42 1105th of 2000 higher than 876 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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