Clinical Trial to Evaluate Safety, Tolerability and Efficacy of NFX88 in SCI
NCT ID: NCT04148573
Last Updated: 2022-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
44 participants
INTERVENTIONAL
2019-10-01
2022-07-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Arm NFX88 - 1
1.05 g/day NFX88
NFX88 - 1
3 times a day
Arm NFX88 - 2
2.10 g/day NFX88
NFX88 - 2
3 times a day
Arm NFX88 - 3
4.20 g/day NFX88
NFX88 - 3
3 times a day
Arm PLACEBO - 4
Placebo
PLACEBO - 4
3 times a day
Interventions
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NFX88 - 1
3 times a day
NFX88 - 2
3 times a day
NFX88 - 3
3 times a day
PLACEBO - 4
3 times a day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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.
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.
Exclusion Criteria
18 Years
80 Years
ALL
No
Sponsors
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Neurofix S.L.
INDUSTRY
Responsible Party
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Principal Investigators
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ANTONIO OLIVIERO, MD
Role: PRINCIPAL_INVESTIGATOR
HOSPITAL DE PARAPLEGICOS DE TOLEDO
Locations
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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
Hospital los Madroños
Madrid, , Spain
Hospital Virgen del Rocio
Seville, , Spain
Hospital de paraplegicos de Toledo
Toledo, , Spain
Countries
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References
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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.
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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2018-004792-13
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
NFX88-2A-2018
Identifier Type: -
Identifier Source: org_study_id
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