Pain Relief Investigation of NeuroModulation Therapy in Adult Humans

March 2, 2006 updated by: Fralex Therapeutics

PRIMA Study: Pain Relief Investigation of NeuroModulation Therapy in an Adult Population: A Double Blind, Randomized, Multicenter, Placebo Controlled Trial.

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

Study Overview

Status

Terminated

Conditions

Chronic Musculoskeletal Pain

Intervention / Treatment

Device: PRIMA

Study Type

Interventional

Phase

Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Child
Adult
Older Adult

Accepts Healthy Volunteers

N/A

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fralex Therapeutics

Collaborators

PharmaNet

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Sepulveda-Sanchez JM, Gil-Gil M, Alonso-Garcia M, Vaz Salgado MA, Vicente E, Mesia Barroso C, Rodriguez Sanchez A, Duran G, De Las Penas R, Munoz-Langa J, Velasco G, Hernandez-Lain A, Hilario A, Navarro Martin M, Benavides M, Oleaga L, Cantero Montenegro D, Ruano Y, Sanchez-Gomez P, Martin-Soberon MC, Morales-Llombart R, Pachon V, Pineda E. Phase II Trial of Palbociclib in Recurrent Retinoblastoma-Positive Anaplastic Oligodendroglioma: A Study from the Spanish Group for Research in Neuro-Oncology (GEINO). Target Oncol. 2020 Oct;15(5):613-622. doi: 10.1007/s11523-020-00754-6.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

November 11, 2005

First Submitted That Met QC Criteria

November 11, 2005

First Posted (Estimate)

November 15, 2005

Study Record Updates

Last Update Posted (Estimate)

March 3, 2006

Last Update Submitted That Met QC Criteria

March 2, 2006

Last Verified

March 1, 2006

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

F05001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.