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NCT00742209 · ClinicalTrials.gov registry record · Phase 2

Prevention Study in Adult Patients Suffering From Migraine Headaches

A Phase 2 study of Migraine and Migraine Disorders, sponsored by XenoPort.

Completed
Registry status
Phase 2
Development phase
526
Enrollment target
20
Study locations

NCT00742209: Completed Phase 2 study of Migraine and Migraine Disorders, sponsored by XenoPort.

NCT00742209 is a Phase 2 study of Migraine and Migraine Disorders that has completed, run by XenoPort. The registered enrollment target is 526 participants, above the 353-participant average among 102 other Migraine trials with a reported enrollment target (49% higher). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00742209, a Phase 2 study of Migraine and Migraine Disorders, has completed, sponsored by XenoPort.

COMPLETED
Registry status
Phase 2
Development phase
526 participants
Enrollment target
20
Study locations

Study Summary

Purpose of the study is to evaluate dose response relationship, efficacy, safety and tolerability of target doses of GSK1838262 compared to placebo in the prophylactic treatment of migraine headache. Once subjects complete the baseline and meet the randomization criteria, they will complete a 5-wk flexible titration period and then enter the 12 week maintenance period.

Primary Outcome

A migraine headache day is defined as a calendar day with any occurrence of migraine headache pain of at least 30 minutes in duration. Change from baseline was calculated as the mean number of MHD over the last 4 weeks of treatment prior to taper minus the number at baseline using the Last Observation Carried Forward (LOCF). The last 4-week treatment phase is based on the last 4 weeks prior to taper for each participant.

Interventions

  • DRUG Placebo
  • DRUG GSK1838262

Study Locations (20)

California

  • GSK Investigational Site - Anaheim
  • GSK Investigational Site - Newport Beach
  • GSK Investigational Site - Redlands
  • GSK Investigational Site - San Francisco
  • GSK Investigational Site - Santa Monica
  • GSK Investigational Site - Westlake Village

Colorado

  • GSK Investigational Site - Colorado Springs
  • GSK Investigational Site - Colorado Springs
  • GSK Investigational Site - Denver

Florida

  • GSK Investigational Site - DeLand
  • GSK Investigational Site - Sunrise
  • GSK Investigational Site - West Palm Beach

Arizona

  • GSK Investigational Site - Phoenix
  • GSK Investigational Site - Phoenix

Georgia

  • GSK Investigational Site - Atlanta
  • GSK Investigational Site - Stockbridge

Alabama

  • GSK Investigational Site - Birmingham

Illinois

  • GSK Investigational Site - Chicago

Kansas

  • GSK Investigational Site - Wichita

Trial Details

FieldValue
Enrollment Target 526 participants
Start Date 2008-08
Est. Completion 2010-06
Phase Phase 2
XenoPort

19 total trials

What the finished NCT00742209 record still lists

NCT00742209 is an interventional study that assigns participants to a tested intervention. The registered 526 participants enrollment target is mid-sized for trials with a published cap, above the 353-participant average among 102 other Migraine trials with a reported enrollment target (49% higher).

The record links to 2 conditions, with Migraine appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT00742209 names 20 study sites across 9 states, led by California, Colorado, Florida.

Frequently Asked Questions

What is clinical trial NCT00742209 about?

NCT00742209 is a clinical study titled "Prevention Study in Adult Patients Suffering From Migraine Headaches". Purpose of the study is to evaluate dose response relationship, efficacy, safety and tolerability of target doses of GSK1838262 compared to placebo in the prophylactic treatment of migraine headache. Once subjects complete the baseline and meet the randomization criteria, they will complete a 5-wk f...

What is the current status of trial NCT00742209?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 526 participants. The study started on 2008-08. Estimated completion is 2010-06.

What conditions does trial NCT00742209 study?

This clinical trial studies the following conditions: Migraine, Migraine Disorders.

What interventions are being tested in trial NCT00742209?

The interventions under investigation include: Placebo (DRUG), GSK1838262 (DRUG).

Who is sponsoring clinical trial NCT00742209?

This trial is sponsored by XenoPort, which has 19 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00742209 being conducted?

This trial has 20 study locations across Alabama, Arizona, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Migraine

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT00742209's enrollment target sits among peer trials

526 21st of 102 higher than 82 of 102 other Migraine trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Migraine 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 NCT00742209, the US trial registry maintained by the National Library of Medicine. NCT00742209 (mid enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.