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NCT00802035 · ClinicalTrials.gov registry record · Phase 1

ALK29-002: A Study of Baclofen Formulations in Healthy Adults

A Phase 1 study, sponsored by Alkermes.

Completed
Registry status
Phase 1
Development phase
16
Enrollment target

NCT00802035: Completed Phase 1 study, sponsored by Alkermes.

NCT00802035 is a Phase 1 study that has completed, run by Alkermes. The registered enrollment target is 16 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00802035, a Phase 1 study, has completed, sponsored by Alkermes.

COMPLETED
Registry status
Phase 1
Development phase
16 participants
Enrollment target

Study Summary

The purpose of this study is to determine the pharmacokinetics, safety, and tolerability of different baclofen formulations.

Interventions

  • DRUG Baclofen IR
  • DRUG Baclofen ER

Trial Details

FieldValue
Enrollment Target 16 participants
Start Date 2008-11
Est. Completion 2009-02
Phase Phase 1
Alkermes

66 total trials

What the finished NCT00802035 record still lists

NCT00802035 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower).

The record links to 0 conditions, and to 2 interventions - of which Baclofen IR is the first listed.

NCT00802035 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00802035 about?

NCT00802035 is a clinical study titled "ALK29-002: A Study of Baclofen Formulations in Healthy Adults". The purpose of this study is to determine the pharmacokinetics, safety, and tolerability of different baclofen formulations.

What is the current status of trial NCT00802035?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2008-11. Estimated completion is 2009-02.

What interventions are being tested in trial NCT00802035?

The interventions under investigation include: Baclofen IR (DRUG), Baclofen ER (DRUG).

Who is sponsoring clinical trial NCT00802035?

This trial is sponsored by Alkermes, which has 66 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00802035's enrollment target sits among peer trials

16 1786th of 2000 higher than 203 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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Source: ClinicalTrials.gov NCT00802035, the US trial registry maintained by the National Library of Medicine. NCT00802035 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.