Pain Relief Investigation of Neuromodulation Therapy in an Adult Fibromyalgia Population

ClinicalTrials.gov ID: NCT00450905

Public ClinicalTrials.gov record NCT00450905. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

View official ClinicalTrials.gov record → Back to search

ClinicalTrials.gov public records Last synced Nov 4, 2026, 2:55 AM EST

All trial information on this site comes from the official ClinicalTrials.gov public API (clinicaltrials.gov/api/v2), run by the U.S. National Library of Medicine. We only display that public information; we do not add opinions, endorsements, or any other intent. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Randomized Evaluation of a Low-Frequency Investigational Device Employing Neuromodulation Therapy in Patients With Fibromyalgia

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This study is being performed to determine the safety and efficacy of Fralex Neuromodulation Therapy (F-NMT), delivered by the Fralex PRIMA device, in reducing chronic musculoskeletal pain associated with Fibromyalgia.

Study identification

NCT ID: NCT00450905
Recruitment status: Terminated
Study type: Interventional
Phase: Phase 3
Lead sponsor: Fralex Therapeutics; Industry
Enrollment: 200 participants

Conditions and interventions

Conditions

Interventions

PRIMA Device Device

Device

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Mar 2007 (Type not available)
Primary completion: Not listed
Completion: Dec 2008 (Estimated)
Last update posted: Oct 6, 2008

2007 – 2008

United States locations

U.S. sites: 17
U.S. states: 8
U.S. cities: 17

Facility	City	State	ZIP	Site status
Not listed	Encinitas	California	92024	—
Not listed	Garden Grove	California	92845	—
Not listed	La Jolla	California	92037	—
Not listed	Lancaster	California	93534	—
Not listed	Murrieta	California	92563	—
Not listed	Palmdale	California	93550	—
Not listed	Gainsville	Florida	32610	—
Not listed	West Palm Beach	Florida	33409	—
Not listed	Winter Park	Florida	32789	—
Not listed	Lexington	Kentucky	40503	—
Not listed	Rochester	Minnesota	55905	—
Not listed	New York	New York	10003	—
Not listed	Rochester	New York	14642-8604	—
Not listed	Winston-Salem	North Carolina	27103	—
Not listed	Altoona	Pennsylvania	16602	—
Not listed	Seattle	Washington	98104	—
Not listed	Spokane	Washington	99216	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 4 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT00450905, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Oct 6, 2008 · Synced Nov 4, 2026

Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00450905 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →