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NCT01931319 · ClinicalTrials.gov registry record · Phase 1
Dose Escalation Study of Intravenous Baclofen in Healthy Adult Volunteers
A Phase 1 study, sponsored by University of Minnesota.
- Completed
- Registry status
- Phase 1
- Development phase
- 39
- Enrollment target
NCT01931319: Completed Phase 1 study, sponsored by University of Minnesota.
NCT01931319 is a Phase 1 study that has completed, run by University of Minnesota. The registered enrollment target is 39 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (35% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01931319, a Phase 1 study, has completed, sponsored by University of Minnesota.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 39 participants
- Enrollment target
Study Summary
The objective of this study is to determine safety and characterize pharmacokinetics of higher doses of intravenous baclofen in healthy subjects. Thirty-six healthy adults received a single dose of PO baclofen (10mg, 15mg or 20mg) and a 10-minute infusion of IV baclofen (7.5mg, 11.5mg or 15mg respectively) with a minimum 48-hour wash out period. Twelve subjects also received a 60-minute infusion of 15mg IV baclofen following an additional 48-hour wash out period. The pharmacokinetic and tolerability information gained from this study will support the development of further studies to assess the use of IV baclofen to prevent or treat baclofen withdrawal syndrome.
Primary Outcome
Blood Pressure \& Pulse: Recorded every 5 minutes immediately prior to, and during the IV infusion, then every 15 minutes for 1 hour, then every hour for 12 hours. Assessment of sedation / sleepiness: Subjects will be assessed by using the sleepiness scale prior to drug administration then every 30 minutes for four hours after drug administration. Ataxia and nystagmus: Measured using the following rating scale and definitions of ataxia and nystagmus. 0=none, 1=mild, 2=severe Ataxia: For thos
Interventions
- DRUG Intravenous baclofen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2014-01 |
| Est. Completion | 2014-06 |
| Phase | Phase 1 |
What the finished NCT01931319 record still lists
NCT01931319 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 39 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (35% lower).
The record links to 0 conditions, and to 1 intervention - of which Intravenous baclofen is the first listed.
NCT01931319 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01931319 about?
NCT01931319 is a clinical study titled "Dose Escalation Study of Intravenous Baclofen in Healthy Adult Volunteers". The objective of this study is to determine safety and characterize pharmacokinetics of higher doses of intravenous baclofen in healthy subjects. Thirty-six healthy adults received a single dose of PO baclofen (10mg, 15mg or 20mg) and a 10-minute infusion of IV baclofen (7.5mg, 11.5mg or 15mg respe...
What is the current status of trial NCT01931319?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 39 participants. The study started on 2014-01. Estimated completion is 2014-06.
What interventions are being tested in trial NCT01931319?
The interventions under investigation include: Intravenous baclofen (DRUG).
Who is sponsoring clinical trial NCT01931319?
This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01931319's enrollment target sits among peer trials
39 1191st of 2000 higher than 804 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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