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NCT00200109 · ClinicalTrials.gov registry record · Phase 1

Occipital Nerve Stimulation for the Treatment of Chronic Migraine Headache.

A Phase 1 study of Chronic Migraine, Headache, sponsored by MedtronicNeuro.

Completed
Registry status
Phase 1
Development phase
110
Enrollment target
9
Study locations

NCT00200109: Completed Phase 1 study of Chronic Migraine, Headache, sponsored by MedtronicNeuro.

NCT00200109 is a Phase 1 study of Chronic Migraine, Headache that has completed, run by MedtronicNeuro. The registered enrollment target is 110 participants, below the 230-participant average among 4 other Chronic Migraine, Headache trials with a reported enrollment target (52% lower). The trial reports 9 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00200109, a Phase 1 study of Chronic Migraine, Headache, has completed, sponsored by MedtronicNeuro.

COMPLETED
Registry status
Phase 1
Development phase
110 participants
Enrollment target
9
Study locations

Study Summary

Background: Medically intractable chronic migraine (CM) is a disabling illness characterized by headache greater than 15 days per month. Method: A multicenter, randomized, blinded, controlled feasibility study was conducted to obtain preliminary safety and efficacy data on occipital nerve stimulation (ONS) in CM. Eligible subjects received an occipital nerve block, and responsers were randomized to adjustable stimulation (AS), preset stimulation (PS) or medical management (MM) groups.

Conditions Studied

Interventions

  • DEVICE Occipital Nerve Stimulation

Study Locations (9)

Michigan

  • Contact Medtronic for Exact Locations - Ann Arbor
  • Contact Medtronic for Exact Locations - Detroit

Arizona

  • Contact Medtronic for Exact Location - Scottsdale

California

  • Contact Medtronic for Exact Locations - Oceanside

Colorado

  • Contact Medtronic for Exact Locations - Denver

Oklahoma

  • Contact Medtronic for Exact Locations - Oklahoma City

Pennsylvania

  • Contact Medtronic for Exact Locations - Philadelphia

Alberta

  • Contact Medtronic for Exact Location - Calgary

Other

  • Contact Medtronic for Exact Location - London

Trial Details

FieldValue
Enrollment Target 110 participants
Start Date 2004-05
Est. Completion 2011-05
Phase Phase 1
MedtronicNeuro

51 total trials

What the finished NCT00200109 record still lists

NCT00200109 is an interventional study that assigns participants to a tested intervention. The registered 110 participants enrollment target is mid-sized for trials with a published cap, below the 230-participant average among 4 other Chronic Migraine, Headache trials with a reported enrollment target (52% lower).

The record links to 1 condition, with Chronic Migraine, Headache appearing as the primary indexed condition, and to 1 intervention - of which Occipital Nerve Stimulation is the first listed.

NCT00200109 lists 9 locations in 8 states (Michigan, Arizona, California).

Frequently Asked Questions

What is clinical trial NCT00200109 about?

NCT00200109 is a clinical study titled "Occipital Nerve Stimulation for the Treatment of Chronic Migraine Headache.". Background: Medically intractable chronic migraine (CM) is a disabling illness characterized by headache greater than 15 days per month. Method: A multicenter, randomized, blinded, controlled feasibility study was conducted to obtain preliminary safety and efficacy data on occipital nerve stimulati...

What is the current status of trial NCT00200109?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 110 participants. The study started on 2004-05. Estimated completion is 2011-05.

What conditions does trial NCT00200109 study?

This clinical trial studies the following conditions: Chronic Migraine, Headache.

What interventions are being tested in trial NCT00200109?

The interventions under investigation include: Occipital Nerve Stimulation (DEVICE).

Who is sponsoring clinical trial NCT00200109?

This trial is sponsored by MedtronicNeuro, which has 51 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00200109 being conducted?

This trial has 9 study locations across Arizona, California, Colorado, Michigan, Oklahoma. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Source: ClinicalTrials.gov NCT00200109, the US trial registry maintained by the National Library of Medicine. NCT00200109 (mid enrollment · multi site footprint · completed) retrieved and formatted by PlainTrial, see methodology.