Neuropathic PainPhase 2NCT04148573
Clinical Trial to Evaluate Safety, Tolerability and Efficacy of NFX88 in SCI
A Phase 2 study testing NFX88 - 1, NFX88 - 2 and NFX88 - 3 in people with Neuropathic Pain and Spinal Cord Injuries, run by Neurofix S.L. at 7 sites in Spain.
Trial summary
In summary, this small-scale study is designed to demonstrate that the NFX88 is safe and well tolerated, as well as preliminary evidence of improvement in the score of VAS, PD-Q, and PGIC scales. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Neuropathic Pain, Spinal Cord Injuries
- What is being tested?
- NFX88 - 1, NFX88 - 2 and NFX88 - 3
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 7 sitesSpain
- Study dates
- 1 Oct 2019to 20 Jul 2022
- Phase
- Phase 2
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able and willing to provide written informed consent.
- Male or Female 18 to 65 years of age.
- Traumatic complete or incomplete spinal cord injury with C4-T12 level and more than three months since injury. 4. Diagnosed of neuropathic pain with an average pain score ≥
- 4 measured using the VAS scale during the last week.
- 5. Stable treatment, for at least 1 month, with pregabalin 150-300 mg/day, that should be maintained at the same dose for 90 days until the end of the study treatment.
- 6. Normotensive patients defined as patients with blood pressure values between 90-160 for systolic pressure and 50-100 for diastolic pressure.
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- 7. Patients who have been treated with stable doses of neuroactive drugs (antidepressants, anticonvulsants, antispastic and similar medicines) at least during the last month, can also be recruited.
- 8. Availability for the entire study period, absence of intellectual problems likely to limit the validity of consent to participate in the study or the compliance with protocol requirements; willingness to adhere to the protocol requirements, ability to cooperate adequately, to understand and follow the instructions of the physician or designee.
- 9. Women who are not postmenopausal (at least 12 months) or surgically sterile must have a negative pregnancy test at screening and at the end of study and either abstain from sexual intercourse or use a highly effective method of birth control for the duration of the study and after 12 weeks after the last dose of study drug.
- 10. For men: agreement to remain abstinent or use contraceptive measures and agreement to refrain from donating sperm for the duration of the study and after 12 weeks from the last dose of study drug.
Who cannot join
- Patients treated with opiates (major and minor) and cannabinoids (synthetic, natural or analogous).
- Patients with blood pressure higher than those accepted in the inclusion criteria.
- History of alcohol, drug abuse within 6 months prior to screening.
- Psychiatric patients or those with moderate or severe cognitive impairment.
- Patient who is pregnant or lactating.
- Patient who shows evidence of significant liver or kidney disease, or any other conditions known to interfere with the absorption, distribution, metabolism or excretion of drugs or known to potentiate or predispose to undesired effects.
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- Patient who has clinically significant diseases and/or infections captured in the medical history or evidence of clinically significant findings on physical examination and/or clinically significant ordinary laboratory evaluations (haematology, biochemistry, and urinalysis) or ECG.
- Patient who is currently participating in another clinical trial of an investigational drug or medical device within 90 days prior to screening.
- Inability to comply with study protocol.
- Patient unable to swallow 12 1-gram tablets.
- History of cancer except local basal or squamous cell carcinoma of the skin that has been excised.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Spain7 sites
Complejo Hospitalario Universitario A Coruña
A Coruña
Hospital Vall de Hebron
Barcelona
Instituto Guttmann
Barcelona
Hospital Virgen de las Nieves
Granada
Hospital los Madroños
Madrid
Hospital Virgen del Rocio
Seville
Hospital de paraplegicos de Toledo
Toledo, 45071
About this study
Official title: Randomized, Double-blind, Placebo Controlled, Parallel, Multicentric, Phase IIa Clinical Trial to Evaluate Safety, Tolerability, Therapeutic Efficacy of Daily Oral Treatment NFX88 on Neuropathic Pain in Patients With Spinal Cord Injury
In summary, this small-scale study is designed to demonstrate that the NFX88 is safe and well tolerated, as well as preliminary evidence of improvement in the score of VAS, PD-Q, and PGIC scales.
Read the detailed description
This is a Phase IIa (proof of concept), randomized, double-blind, placebo controlled, parallel group, multicentric, clinical trial to evaluate the safety, tolerability and efficacy of daily oral treatment with NFX88 in SCI patients who are not receiving opiates or cannabinoids and present neuropathic pain with an average pain score ≥ 4 measured with a VAS scale during the last week at screening
- Conditions
- Neuropathic Pain, Spinal Cord Injuries
- Being tested
- NFX88 - 1, NFX88 - 2, NFX88 - 3, PLACEBO - 4
- Medical subject headings
- Neuralgia, Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NFX88 - 1Drug
Also called 2OHOA
3 times a day
NFX88 - 2Drug
Also called 2OHOA
3 times a day
NFX88 - 3Drug
Also called 2OHOA
3 times a day
PLACEBO - 4Drug
3 times a day
| Study group | Role | What they receive |
|---|---|---|
| Arm NFX88 - 1 | Active comparator | 1.05 g/day NFX88 Receives: Drug: NFX88 - 1 |
| Arm NFX88 - 2 | Active comparator | 2.10 g/day NFX88 Receives: Drug: NFX88 - 2 |
| Arm NFX88 - 3 | Active comparator | 4.20 g/day NFX88 Receives: Drug: NFX88 - 3 |
| Arm PLACEBO - 4 | Placebo comparator | Placebo Receives: Drug: PLACEBO - 4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of serious adverse events
Safety and tolerability of NFX88 administered for 90 days will be evaluated by assessing the number of AE
Measured: 90 days
Incidence of severity adverse events
Safety and tolerability of NFX88 administered for 90 days will be evaluated by assessing the severity and type of AE
Measured: 90 days
Incidence of specific laboratory abnormalities
Safety and tolerability of NFX88 administered for 90 days will be evaluated by assessing specific abnormalities of laboratory values
Measured: 90 days
Incidence of relevant changes in vital signs
Safety and tolerability of NFX88 administered for 90 days will be evaluated by assessing that there are not relevant changes in vital signs that may affect the safety of the patient
Measured: 90 days
Incidence of relevant changes in 12-lead ECGs
Safety and tolerability of NFX88 administered for 90 days will be evaluated by assessing the ECGs to prove that there are not relevant changes in this test through the trial
Measured: 90 days
No changes in MAS and AIS scales.
Safety and tolerability of NFX88 administered for 90 days will be evaluated by assessing that there are not relevant changes in the MAS (e.g. to monitor spasticity worsening) and ASIA (e.g. to monitor neurological worsening) scores.
Measured: 90 days
Secondary outcomes (1)
Improvement in neuropathic pain scales VAS, PD-Q, and PGIC
Reduction from V1 to EoT in pain intensity in the VAS scale, reduction from SV to EoT in the likelihood of neuropathic pain in PD-Q scale and global improvement at EoT in patient's condition according to the PGIC scale.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2019
- Study start1 Oct 2019
- Primary completion20 May 2022
- Study completion20 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Neuropathic 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neurofix S.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ANTONIO OLIVIERO, MD, Principal investigator, HOSPITAL DE PARAPLEGICOS DE TOLEDO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04148573
- Sponsor's protocol ID
- NFX88-2A-2018
- Other IDs
- 2018-004792-13, 2018
- Status last verified
- Dec 2022
- First submitted
- 4 Jun 2019
- Last updated
- 2 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Avila-Martin G, Galan-Arriero I, Ferrer-Donato A, Busquets X, Gomez-Soriano J, Escriba PV, Taylor J. Oral 2-hydroxyoleic acid inhibits reflex hypersensitivity and open-field-induced anxiety after spared nerve injury. Eur J Pain. 2015 Jan;19(1):111-22. doi: 10.1002/ejp.528. Epub 2014 May 13.
PubMed 24824524Avila-Martin G, Mata-Roig M, Galan-Arriero I, Taylor JS, Busquets X, Escriba PV. Treatment with albumin-hydroxyoleic acid complex restores sensorimotor function in rats with spinal cord injury: Efficacy and gene expression regulation. PLoS One. 2017 Dec 15;12(12):e0189151. doi: 10.1371/journal.pone.0189151. eCollection 2017.
PubMed 29244816
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Placebo Controlled, Parallel, Multicentric, Phase IIa Clinical Trial to Evaluate Safety, Tolerability, Therapeutic Efficacy of Daily Oral Treatment NFX88 on Neuropathic Pain in Patients With Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT04148573
- Acronym / sponsor ID
- NFX88-2A-2018
- Conditions
- Neuropathic Pain, Spinal Cord Injuries
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Neurofix S.L.Industry (pharma, biotech, devices)
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 20 May 2022 (actual)
- Study completion
- 20 Jul 2022 (actual)
- First posted
- 1 Nov 2019 (actual)
- 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.
In summary, this small-scale study is designed to demonstrate that the NFX88 is safe and well tolerated, as well as preliminary evidence of improvement in the score of VAS, PD-Q, and PGIC scales.
Detailed description
This is a Phase IIa (proof of concept), randomized, double-blind, placebo controlled, parallel group, multicentric, clinical trial to evaluate the safety, tolerability and efficacy of daily oral treatment with NFX88 in SCI patients who are not receiving opiates or cannabinoids and present neuropathic pain with an average pain score ≥ 4 measured with a VAS scale during the last week at screening
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm NFX88 - 1 | Active comparator | Drug: NFX88 - 11.05 g/day NFX88 |
| Arm NFX88 - 2 | Active comparator | Drug: NFX88 - 22.10 g/day NFX88 |
| Arm NFX88 - 3 | Active comparator | Drug: NFX88 - 34.20 g/day NFX88 |
| Arm PLACEBO - 4 | Placebo comparator | Drug: PLACEBO - 4Placebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Able and willing to provide written informed consent.
- Male or Female 18 to 65 years of age.
- Traumatic complete or incomplete spinal cord injury with C4-T12 level and more than three months since injury. 4. Diagnosed of neuropathic pain with an average pain score ≥
- 4 measured using the VAS scale during the last week.
- 5. Stable treatment, for at least 1 month, with pregabalin 150-300 mg/day, that should be maintained at the same dose for 90 days until the end of the study treatment.
Key exclusion criteria (11 listed)
- Patients treated with opiates (major and minor) and cannabinoids (synthetic, natural or analogous).
- Patients with blood pressure higher than those accepted in the inclusion criteria.
- History of alcohol, drug abuse within 6 months prior to screening.
- Psychiatric patients or those with moderate or severe cognitive impairment.
- Patient who is pregnant or lactating.
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 |
|---|---|---|
| NFX88 - 1Also: 2OHOA3 times a day | Drug | Arm NFX88 - 1 |
| NFX88 - 2Also: 2OHOA3 times a day | Drug | Arm NFX88 - 2 |
| NFX88 - 3Also: 2OHOA3 times a day | Drug | Arm NFX88 - 3 |
| PLACEBO - 43 times a day | Drug | Arm PLACEBO - 4 |
Primary outcome
Incidence of serious adverse events
Time frame: 90 days
Safety and tolerability of NFX88 administered for 90 days will be evaluated by assessing the number of AE
Incidence of severity adverse events
Time frame: 90 days
Safety and tolerability of NFX88 administered for 90 days will be evaluated by assessing the severity and type of AE
Incidence of specific laboratory abnormalities
Time frame: 90 days
Safety and tolerability of NFX88 administered for 90 days will be evaluated by assessing specific abnormalities of laboratory values
Incidence of relevant changes in vital signs
Time frame: 90 days
Safety and tolerability of NFX88 administered for 90 days will be evaluated by assessing that there are not relevant changes in vital signs that may affect the safety of the patient
Incidence of relevant changes in 12-lead ECGs
Time frame: 90 days
Safety and tolerability of NFX88 administered for 90 days will be evaluated by assessing the ECGs to prove that there are not relevant changes in this test through the trial
No changes in MAS and AIS scales.
Time frame: 90 days
Safety and tolerability of NFX88 administered for 90 days will be evaluated by assessing that there are not relevant changes in the MAS (e.g. to monitor spasticity worsening) and ASIA (e.g. to monitor neurological worsening) scores.
1 secondary outcome
Improvement in neuropathic pain scales VAS, PD-Q, and PGIC
Time frame: 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2022.
- Results publication: PubMed 24824524Avila-Martin G, Galan-Arriero I, Ferrer-Donato A, Busquets X, Gomez-Soriano J, Escriba PV, Taylor J. Oral 2-hydroxyoleic acid inhibits reflex hypersensitivity and open-field-induced anxiety after spared nerve injury. Eur J Pain. 2015 Jan;19(1):111-22. doi: 10.1002/ejp.528. Epub 2014 May 13.
- Results publication: PubMed 29244816Avila-Martin G, Mata-Roig M, Galan-Arriero I, Taylor JS, Busquets X, Escriba PV. Treatment with albumin-hydroxyoleic acid complex restores sensorimotor function in rats with spinal cord injury: Efficacy and gene expression regulation. PLoS One. 2017 Dec 15;12(12):e0189151. doi: 10.1371/journal.pone.0189151. eCollection 2017.
- Individual participant dataSharing planned: No
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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.
ANTONIO OLIVIERO, MD principal investigator
HOSPITAL DE PARAPLEGICOS DE TOLEDO
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NFX88 - 1, NFX88 - 2 and NFX88 - 3 in people with Neuropathic Pain and Spinal Cord Injuries, run by Neurofix S.L. at 7 sites in Spain.
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 10 inclusion and 11 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: finished, as of the sponsor's last update on 2 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Spain. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence of serious adverse events (time frame: 90 days). The study lists 6 primary outcomes in all. 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 NCT04148573, which also lists 2 linked publications.
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 2 Dec 2022.