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

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.

Study Overview

• Status: Completed
• Conditions: Neuropathic Pain; Spinal Cord Injuries
• Intervention / Treatment: Drug: NFX88 - 1; Drug: NFX88 - 2; Drug: NFX88 - 3; Drug: PLACEBO - 4

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 Type: Interventional
• Enrollment (Actual): 44
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Able and willing to provide written informed consent.
2. Male or Female 18 to 65 years of age.
3. 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.

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.

Exclusion Criteria:

1. Patients treated with opiates (major and minor) and cannabinoids (synthetic, natural or analogous).
2. Patients with blood pressure higher than those accepted in the inclusion criteria.
3. History of alcohol, drug abuse within 6 months prior to screening.
4. Psychiatric patients or those with moderate or severe cognitive impairment.
5. Patient who is pregnant or lactating.
6. 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.
7. 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.
8. Patient who is currently participating in another clinical trial of an investigational drug or medical device within 90 days prior to screening.
9. Inability to comply with study protocol.
10. Patient unable to swallow 12 1-gram tablets.
11. History of cancer except local basal or squamous cell carcinoma of the skin that has been excised.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Arm NFX88 - 1; 1.05 g/day NFX88	Drug: NFX88 - 1; 3 times a day; Other Names: 2OHOA
Active Comparator: Arm NFX88 - 2; 2.10 g/day NFX88	Drug: NFX88 - 2; 3 times a day; Other Names: 2OHOA
Active Comparator: Arm NFX88 - 3; 4.20 g/day NFX88	Drug: NFX88 - 3; 3 times a day; Other Names: 2OHOA
Placebo Comparator: Arm PLACEBO - 4; Placebo	Drug: PLACEBO - 4; 3 times a day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of serious adverse events	Safety and tolerability of NFX88 administered for 90 days will be evaluated by assessing the number of AE	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	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	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	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	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.	90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	90 days

Collaborators and Investigators

• Sponsor: Neurofix S.L.
• Investigators: Principal Investigator: ANTONIO OLIVIERO, MD, Hospital de paraplegicos de Toledo

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2019
• Primary Completion (Actual): May 20, 2022
• Study Completion (Actual): July 20, 2022

Study Registration Dates

• First Submitted: June 4, 2019
• First Submitted That Met QC Criteria: October 30, 2019
• First Posted (Actual): November 1, 2019

Study Record Updates

• Last Update Posted (Actual): December 2, 2022
• Last Update Submitted That Met QC Criteria: December 1, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Wounds and Injuries; Neuromuscular Diseases; Peripheral Nervous System Diseases; Trauma, Nervous System; Spinal Cord Diseases; Neuralgia; Spinal Cord Injuries
• Other Study ID Numbers: NFX88-2A-2018; 2018-004792-13 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No