Neuropathic pain in spinal cord injury patients.
Conditions
Interventions
Product Name: 2-OHOA
Product Code: NFX88
Pharmaceutical Form: Coated tablet
INN or Proposed INN: NFX88
Current Sponsor code: NFX88
Sponsors
Neurofix S.L.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients eligible for enrolment in the study must meet all the following 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 60 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients meeting any of the following criteria must NOT be enrolled in the study: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to assess the safety and tolerability of NFX88 in spinal cord injury patients with neuropathic pain over ninety-day treatment period.;Secondary Objective: The secondary objective is to explore the preliminary therapeutic efficacy associated with NFX88 through the analysis of validated measurement scales: VAS, PD-Q and PGIC.; Primary end point(s): Safety and tolerability of NFX88 administered for ninety days will be evaluated by assessing the number, severity, and type of Adverse Event, including changes in vital signs, safety laboratory values (haematology, clinical chemistry and urinalysis), ECGs, and MAS (Modified Ashworth Scale) (e.g. to monitor spasticity worsening) and ASIA (e.g. to monitor neurological worsening) scores. Non-worsening of spasticity and motor score will be obtaining as the non-increase of the scales values MAS and ASIA, respectively, from the beginning to the end of the treatment. ; Timepoint(s) of evaluation of this end point: Safety and tolerability of NFX88 administered for 3 months will be assessed by the number, severity, and type of Adverse Events, including changes in: - Vital signs at Screening Visit (SV), Visit 1 (V1), Visit 2 (V2), Visit 3 (V3), End of Treatment Visit (EoT) or Withdrawal Visit (WV) and Follow-up/End of Study Visit (FU/EoS). - ECG at SV, V2, V3, EoT or WV and FU/EoS. - Clinical laboratory parameters (haematology, clinical chemistry and urinalysis) at SV, V2, V3, EoT or WV and FU/EoS. - Effect of NFX88 on spasticity score as determined by MAS at SV, V1, V2, V3, EoT or WV and FU/EoS. - Effect of NFX88 on sensory and motor function by ASIA scale at SV, V1, V2, V3, EoT or WV and FU/EoS. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Efficacy of NFX88 treatment compared to placebo in pain improvement will be measured as: - Reduction from Visit 1 (V1) to End of Treatment Visit (EoT) in pain intensity in the VAS (Visual analogue scale) scale. - Reduction from Screening Visit (SV) to EoT in the likelihood of neuropathic pain in PD-Q (Pain-DETECT Questionnaire) scale. - Global improvement at EoT in patient’s condition according to the PGIC (Patient Global Impression of Change) scale. ; Timepoint(s) of evaluation of this end point: The effect of NFX88 in changes of neuropathic pain reduction scales will be obtained from: - VAS at Screening Visit (SV), Visit 1 (V1), Visit 2 (V2), Visit 3 (V3), End of Treatment Visit (EoT) or Withdrawal Visit (WV) and Follow-up/End of Study Visit (FU/EoS). - PD-Q at SV, V1, V2, V3, EoT or WV and FU/EoS. - PGIC at V3, EoT or WV. | — |
Countries
Spain
Contacts
Public ContactÓscar Mesa del Castillo
QualitecFarma S.L.
Outcome results
None listed