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

NCT04148573 | Completed Phase 2

• 2 other identifiers: NFX88-2A-20182018-004792-13
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 7

Brief 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.

Conditions

Neuropathic Pain; Spinal Cord Injuries

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (1)

• Improvement in neuropathic pain scales VAS, PD-Q, and PGIC

  90 days

Study Arms (4)

Arm NFX88 - 1

ACTIVE COMPARATOR

1.05 g/day NFX88

Drug: NFX88 - 1

Arm NFX88 - 2

ACTIVE COMPARATOR

2.10 g/day NFX88

Drug: NFX88 - 2

Arm NFX88 - 3

ACTIVE COMPARATOR

4.20 g/day NFX88

Drug: NFX88 - 3

Arm PLACEBO - 4

PLACEBO COMPARATOR

Placebo

Drug: PLACEBO - 4

Interventions

NFX88 - 1 DRUG

3 times a day

Also known as: 2OHOA

Arm NFX88 - 1

NFX88 - 2 DRUG

3 times a day

Also known as: 2OHOA

Arm NFX88 - 2

NFX88 - 3 DRUG

3 times a day

Also known as: 2OHOA

Arm NFX88 - 3

PLACEBO - 4 DRUG

3 times a day

Arm PLACEBO - 4

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 ≥
• 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.

You may not qualify if:

• Patients treated with opiates (major and minor) and cannabinoids (synthetic, natural or analogous).
• 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.

Sponsors & Collaborators

• Neurofix S.L.: lead

Study Sites (7)

Complejo Hospitalario Universitario A Coruña

A Coruña, Spain

Location

Hospital Vall de Hebron

Barcelona, Spain

Location

Instituto Guttmann

Barcelona, Spain

Location

Hospital Virgen de las Nieves

Granada, Spain

Location

Hospital los Madroños

Madrid, Spain

Location

Hospital Virgen del Rocio

Seville, Spain

Location

Hospital de paraplegicos de Toledo

Toledo, 45071, Spain

Location

Related Publications (2)

• 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.

  PMID: 24824524 RESULT

• 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.

  PMID: 29244816 RESULT

MeSH Terms

Conditions

Neuralgia; Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Spinal Cord Diseases; Central Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• ANTONIO OLIVIERO, MD

  HOSPITAL DE PARAPLEGICOS DE TOLEDO

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2019
• First Posted: November 1, 2019
• Study Start: October 1, 2019
• Primary Completion: May 20, 2022
• Study Completion: July 20, 2022
• Last Updated: December 2, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (7)