Chronic Musculoskeletal PainPhase 3NCT00253032
Pain Relief Investigation of NeuroModulation Therapy in Adult Humans
A Phase 3 study testing PRIMA in people with Chronic Musculoskeletal Pain, run by Fralex Therapeutics.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Musculoskeletal Pain
- What is being tested?
- PRIMA
- Type of treatment
- Medical device
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- 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 Any age
- Child, Adult, Older adult
About this study
Official title: 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.
- Conditions
- Chronic Musculoskeletal Pain
- Being tested
- PRIMA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRIMADevice
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2005 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Musculoskeletal PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
Sponsor and investigators
- Lead sponsor
- Fralex Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- PharmaNet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00253032
- Sponsor's protocol ID
- F05001
- Status last verified
- Mar 2006
- First submitted
- 11 Nov 2005
- Last updated
- 3 Mar 2006
- Results posted
- No
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.
PubMed 33025213
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PRIMA Study: Pain Relief Investigation of NeuroModulation Therapy in an Adult Population: A Double Blind, Randomized, Multicenter, Placebo Controlled Trial.
- ClinicalTrials.gov ID
- NCT00253032
- Acronym / sponsor ID
- F05001
- Conditions
- Chronic Musculoskeletal Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Lead sponsor
- Fralex TherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- PharmaNet
- First posted
- 15 Nov 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
Who may qualify
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PRIMA | Device | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2006.
- Derived from this study: PubMed 33025213Sepulveda-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing PRIMA in people with Chronic Musculoskeletal Pain, run by Fralex Therapeutics.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Mar 2006. Status can change between updates, so confirm with the study contact before making plans.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00253032, which also lists 1 linked publication.
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 3 Mar 2006.