Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2018-004792-13 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 ā„ 4 measured with a VAS scale during the last week at screening
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm NFX88 - 1 | Active Comparator | 1.05 g/day NFX88 |
|
| Arm NFX88 - 2 | Active Comparator | 2.10 g/day NFX88 |
|
| Arm NFX88 - 3 | Active Comparator | 4.20 g/day NFX88 |
|
| Arm PLACEBO - 4 | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NFX88 - 1 | Drug | 3 times a day |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
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:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| ANTONIO OLIVIERO, MD | HOSPITAL DE PARAPLEGICOS DE TOLEDO | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Complejo Hospitalario Universitario A CoruƱa | A CoruƱa | Spain | ||||
| Hospital Vall de Hebron |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24824524 | Result | 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. | |
| 29244816 | Result | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 28, 2018 | May 29, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 8, 2019 | Jun 13, 2019 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D009437 | Neuralgia |
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| NFX88 - 2 |
| Drug |
3 times a day |
|
|
| NFX88 - 3 | Drug | 3 times a day |
|
|
| PLACEBO - 4 | Drug | 3 times a day |
|
| Barcelona |
| Spain |
| Instituto Guttmann | Barcelona | Spain |
| Hospital Virgen de las Nieves | Granada | Spain |
| Hospital los MadroƱos | Madrid | Spain |
| Hospital Virgen del Rocio | Seville | Spain |
| Hospital de paraplegicos de Toledo | Toledo | 45071 | Spain |
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |