CompletedNCT04148573Updated Dec 2, 2022

Clinical Trial to Evaluate Safety, Tolerability and Efficacy of NFX88 in SCI

A Phase 2 interventional study of NFX88 - 1 and NFX88 - 2 in Neuropathic Pain and Spinal Cord Injuries, sponsored by Neurofix S.L.. Completed at 7 sites in Spain. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-12-02.

Sponsored by Neurofix S.L. · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 44
Allocation: Randomized
Ages: 18 Years to 80 Years
Sex: All

Study 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 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 studied

Neuropathic Pain
Spinal Cord Injuries

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In context

Spinal Cord Injuries

1,948 studies on the registry are indexed under Spinal Cord Injuries; 505 are open to participants now.

This study's enrollment of 44 is above the median of 24 across 1,566 interventional studies indexed under Spinal Cord Injuries.

Browse Spinal Cord Injuries studies →

Lead sponsor

This is the only study on the registry with Neurofix S.L. as lead sponsor.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 80 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

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.

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.

Normotensive patients defined as patients with blood pressure values between 90-160 for systolic pressure and 50-100 for diastolic pressure.

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.

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.

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.

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.

Exclusion criteria

Exclusion Criteria:

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.
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.

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 44 participants (actual)

Study arms

Active comparator
Arm NFX88 - 1
1.05 g/day NFX88
Drug: NFX88 - 1
Active comparator
Arm NFX88 - 2
2.10 g/day NFX88
Drug: NFX88 - 2
Active comparator
Arm NFX88 - 3
4.20 g/day NFX88
Drug: NFX88 - 3
Placebo comparator
Arm PLACEBO - 4
Placebo
Drug: PLACEBO - 4

Interventions

DrugNFX88 - 1
3 times a day
Also known as: 2OHOA
DrugNFX88 - 2
3 times a day
Also known as: 2OHOA
DrugNFX88 - 3
3 times a day
Also known as: 2OHOA
DrugPLACEBO - 4
3 times a day

What researchers measure

Primary outcomes

Incidence of serious adverse events
Safety and tolerability of NFX88 administered for 90 days will be evaluated by assessing the number of AE
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 90 days

Secondary outcomes

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.
Time frame: 90 days

Study locations

7 sites

Hospital Vall de Hebron
Barcelona, Spain
Instituto Guttmann
Barcelona, Spain
Complejo Hospitalario Universitario A Coruña
Coruña, Spain
Hospital Virgen de las Nieves
Granada, Spain
Hospital los Madroños
Madrid, Spain
Hospital Virgen del Rocio
Sevilla, Spain
Hospital de paraplegicos de Toledo
Toledo, 45071, Spain

References and documents

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 24824524 ↗
Avila-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 documents

Study protocol · Dec 28, 2018
Statistical analysis plan · May 8, 2019

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Dec 2, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04148573
Lead sponsor: Neurofix S.L.
Responsible party: Sponsor
First posted: Nov 1, 2019
Start date: Oct 1, 2019
Primary completion: May 20, 2022
Completion: Jul 20, 2022
Last update: Dec 2, 2022

Study contacts

ANTONIO OLIVIERO, MD

principal investigator · HOSPITAL DE PARAPLEGICOS DE TOLEDO

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.

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