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NCT00676403 · ClinicalTrials.gov registry record · Phase 2

Lyrica Dose Response Study With Restless Legs Syndrome (RLS) Patients

A Phase 2 study, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris.

Completed
Registry status
Phase 2
Development phase
137
Enrollment target

NCT00676403: Completed Phase 2 study, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris.

NCT00676403 is a Phase 2 study that has completed, run by Pfizer's Upjohn has merged with Mylan to form Viatris. The registered enrollment target is 137 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00676403, a Phase 2 study, has completed, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris.

COMPLETED
Registry status
Phase 2
Development phase
137 participants
Enrollment target

Study Summary

To test the effectiveness and tolerability of Lyrica at various dose levels in RLS patients

Primary Outcome

IRLS: Subject-rated instrument to assess RLS symptom severity and impact on daily living; 10 items yielding 2 subscale scores and 1 global (total) score. Subscale scores: symptom severity (6 items) and impact on daily living (3 items), with item 5 (daytime somnolence due to RLS) loaded equally on both subscales. Global score: calculated from all 10 items. Subscale score ranges: symptom severity 0-24, impact of daily living 0-12; global score range: 0-40. Lower scores reflect lower severity and b

Interventions

  • DRUG placebo
  • DRUG Pregabalin

Trial Details

FieldValue
Enrollment Target 137 participants
Start Date 2008-04
Est. Completion 2009-01
Phase Phase 2

What the finished NCT00676403 record still lists

NCT00676403 is an interventional study that assigns participants to a tested intervention. The registered 137 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.

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

NCT00676403 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00676403 about?

NCT00676403 is a clinical study titled "Lyrica Dose Response Study With Restless Legs Syndrome (RLS) Patients". To test the effectiveness and tolerability of Lyrica at various dose levels in RLS patients

What is the current status of trial NCT00676403?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 137 participants. The study started on 2008-04. Estimated completion is 2009-01.

What interventions are being tested in trial NCT00676403?

The interventions under investigation include: placebo (DRUG), Pregabalin (DRUG).

Who is sponsoring clinical trial NCT00676403?

This trial is sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris, which has 158 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00676403's enrollment target sits among peer trials

137 527th of 2000 higher than 1,474 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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 NCT00676403, the US trial registry maintained by the National Library of Medicine. NCT00676403 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.