Clinical trial to evaluate the safety, tolerability and therapeutic efficacy of daily oral treatment with NFX88 in patients with neuropathic pain after spinal cord injury.
- Conditions
- europathic pain in spinal cord injury patients.Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2018-004792-13-ES
- Lead Sponsor
- eurofix S.L.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Not specified
- Target Recruitment
- 60
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method