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FibromyalgiaPhase 3NCT00450905

Pain Relief Investigation of Neuromodulation Therapy in an Adult Fibromyalgia Population

A Phase 3 study testing PRIMA Device in people with Fibromyalgia and Pain, run by Fralex Therapeutics at 21 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Fibromyalgia, Pain
What is being tested?
PRIMA Device
Type of treatment
Medical device
How many people
200 participants
Where
21 sitesin 2 countries
Study dates
Mar 2007to Dec 2008
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis of chronic musculoskeletal pain of at least six months duration secondary to FMS using American College of Rheumatology (ACR) criteria and with the minimum of 11 of 18 defined tender points, measured by dolorimeter at a threshold of up to 4 kg of pressure
  • Males and females, 18 years and older
  • Able to complete assessment index forms unaided by caregiver/interpreter
  • Pain score of 4 or greater on the Numerical Rating Scale (NRS), averaged from the Baseline Period scores recorded on the 7 days immediately prior to randomization
  • Demonstration of stabilized pain scores as measured on the NRS during the Baseline Period (Days -7 to -1)
  • Able to tolerate prohibition of all medications for pain, depression and sleep disorders except for acetaminophen (up to 4 g/day) and cardiac aspirin (up to 325 mg/day) demonstrated for the Stabilization and Baseline Periods prior to randomization
  • Able and willing to provide a written informed consent

Who cannot join

  • Unwilling or unable to sign an informed consent, or to comply with the protocol
  • Evidence of inflammatory rheumatic disease, secondary fibromyalgia, or other severe painful disorders that might confound assessment of FMS pain
  • Currently under treatment (pharmacological or cognitive therapy) for a Major Depressive Episode (MDE) or has demonstrated suicidal ideation in the past
  • History or current treatment of migraine, tension or cluster headache requiring regular medication
  • History or current treatment of seizure disorder
  • History or current treatment of cancer with the exception of basal cell carcinoma and cervical dysplasia
Show all 17Show fewer
  • Cognitive dysfunction or personality disorder which would preclude self-directed treatment, self assessment and / or diary completion
  • Clinically significant or unstable medical or psychological conditions that, in the opinion of the investigator, would compromise participation
  • Hearing aids, metal implants (excludes dental work) above mid torso or in the cranium (e.g. plates, implants or clips). (Metal implants in parts of the body below mid-torso, such as knee or hips replacements, clips, screws or plates to stabilize fractures are acceptable)
  • Pacemakers, defibrillators, implanted neurostimulators, implanted drug pumps or other electrical implanted devices
  • Insufficient knowledge of English to complete the self-assessment forms
  • History of or current drug or alcohol abuse
  • History of abuse of a previous physician relationship or the medical system
  • Receiving disability insurance, applying for disability insurance, or engaged in litigation related to FMS
  • Use of an investigational drug or device in a controlled study within 30 days
  • Pregnancy (U.S. sites only)
  • Breastfeeding or intending to breastfeed (U.S. sites only)

Trial locations and contacts

21 sites in 2 countries.

21 sites in 2 countries

United States17 sites

  • Study site

    Altoona, Pennsylvania, 16602

  • Study site

    Encinitas, California, 92024

  • Study site

    Gainsville, Florida, 32610

  • Study site

    Garden Grove, California, 92845

  • Study site

    La Jolla, California, 92037

  • Study site

    Lancaster, California, 93534

  • Study site

    Lexington, Kentucky, 40503

  • Study site

    Murrieta, California, 92563

  • Study site

    New York, New York, 10003

  • Study site

    Palmdale, California, 93550

  • Study site

    Rochester, Minnesota, 55905

  • Study site

    Rochester, New York, 14642-8604

  • Study site

    Seattle, Washington, 98104

  • Study site

    Spokane, Washington, 99216

  • Study site

    West Palm Beach, Florida, 33409

  • Study site

    Winston-Salem, North Carolina, 27103

  • Study site

    Winter Park, Florida, 32789

Other trials in United States

Canada4 sites

  • Study site

    Hamilton, Ontario, L8N 3Z5

  • Study site

    Ottawa, Ontario, K1H 1A2

  • Study site

    Toronto, Ontario, M2N 6K7

  • Study site

    Toronto, Ontario, M9W 4L6

Other trials in Canada

About this study

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

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.

Conditions
Fibromyalgia, Pain
Being tested
PRIMA Device
Keywords
Chronic musculoskeletal pain secondary to Fibromyalgia
Medical subject headings
Fibromyalgia, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PRIMA DeviceDevice

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Clinically significant pain reduction, evidenced by a statistically significant difference between active and placebo groups in percentage of subjects who achieve a pain reduction of at least 30% at week 12 as compared to the Baseline.

Secondary outcomes (1)

  1. Additional outcome measures will include mood alteration, sleep quality, improvement of physical functioning and relief medication usage by subjects in both groups.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Mar 2007 (estimated)
  2. Study startMar 2007
  3. Study completionDec 2008 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00450905
Sponsor's protocol ID
F06001
Status last verified
Feb 2008
First submitted
21 Mar 2007
Last updated
6 Oct 2008
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing PRIMA Device in people with Fibromyalgia and Pain, run by Fralex Therapeutics at 21 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 6 Oct 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early. Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinically significant pain reduction, evidenced by a statistically significant difference between active and placebo groups in percentage of subjects who achieve a pain reduction of at least 30% at week 12 as compared to the Baseline.. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00450905.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2008.

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