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

Spinal Cord Injuries Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04148573
• Other study ID #: NFX88-2A-2018
• Secondary ID: 2018-004792-13
• Status: Completed
• Phase: Phase 2
• Start date: October 1, 2019
• Est. completion date: July 20, 2022

Study information

• Verified date: December 2022
• Source: Neurofix S.L.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: July 20, 2022
• Est. primary completion date: May 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Neuralgia
• Neuropathic Pain
• Spinal Cord Injuries

Intervention

Drug:
• NFX88 - 1
3 times a day
• NFX88 - 2
3 times a day
• NFX88 - 3
3 times a day
• PLACEBO - 4
3 times a day

Locations

Country	Name	City	State
Spain	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

Sponsors (1)

Lead Sponsor	Collaborator
Neurofix S.L.

Country where clinical trial is conducted

Spain, 

References & 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 — View Citation

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 1 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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