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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
44
Complejo Hospitalario Universitario A Coruña
A Coruña, Spain
Hospital Vall de Hebron
Barcelona, Spain
Instituto Guttmann
Barcelona, Spain
Hospital Virgen de las Nieves
Granada, Spain
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
Improvement in neuropathic pain scales VAS, PD-Q, and PGIC
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3 times a day
Hospital los Madroños
Madrid, Spain
Hospital Virgen del Rocio
Seville, Spain
Hospital de paraplegicos de Toledo
Toledo, Spain
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