Efficacy and Safety Study of the Extended-Release Pregabalin and the Immediate-Release Pregabalin in Peripheral Neuropathic Pai
- Conditions
- Peripheral neuropathic painMedDRA version: 20.0Level: HLGTClassification code 10034606Term: Peripheral neuropathiesSystem Organ Class: 10029205 - Nervous system disordersTherapeutic area: Body processes [G] - Bones and nerves physological processes [G11]
- Registration Number
- EUCTR2020-002609-24-HU
- Lead Sponsor
- aboratorios Lesvi, S.L. (Neuraxpharm group)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 270
1. Subjects must be willing and capable of giving signed informed consent.
2. Subject must be 18 to 80 years of age inclusive, at the time of signing the informed consent.
3. Probable or definite NP diagnosis according to the IASP grading system.
4. Diagnosis of either painful diabetic neuropathy (PDN) or PHN.
5. Presence of chronic peripheral neuropathic pain for more than 3 months and less than 10 years prior to Screening.
6. Subjects with weekly average NPRS pain assessment score of = 4 and = 9 at Baseline (Visit 1).
7. Female subjects:
a) A female subject is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies:
i) Not a woman of childbearing potential (WOCBP).
OR
ii) A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 3 months after the last dose of study treatment.
8. Disease specific criteria
a) Painful Diabetic Neuropathy: PDN subjects with diagnosis of type 1 or type 2 diabetes mellitus with painful distal symmetrical sensorimotor neuropathy of more than 3 months duration with all of the following:
i) Neuropathic symptoms (e.g., numbness, nonpainful paresthesias or tingling, nonpainful sensory distortions or misinterpretations, etc).
ii) Decreased distal sensation (e.g., decreased vibration, pinprick sensation, light touch, etc).
iii) Glycosylated hemoglobin A1c (HbA1c) of = 9.5%.
iv) Stable anti-diabetic treatment for at least 3 months prior to Screening.
v) No evidence of skin ulcers, advanced retinopathy (defined as greater than State 3 [moderate nonproliferative diabetic retinopathy]) severe nephropathy, or obstructive atherosclerotic disease resulting from their diabetes.
b) Postherpetic Neuralgia: PHN subjects with pain persisting for more than 3 months after onset of herpes zoster rash with lesions healed.
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 135
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 135
1. Subjects with evidence of a known etiology of peripheral neuropathy other than diabetes mellitus or postherpetic infection, including but not limited to hereditary (e.g., amyloidosis, Tangier disease, Fabry’s disease, hereditary sensory autonomic neuropathy), alcohol-related neuropathy, drug-induced neuropathy (chemotherapy, antibiotics, antiretrovirals, or other neurotoxic agents), or autoimmune disease.
2. Subjects with diagnosis of fibromyalgia.
3. Subjects with very severe pain likely to affect self-assessment of pain due to DPN or PHN.
4. Subjects with skin conditions likely to alter sensation.
5. History of alcohol or substance dependence or abuse within 1 year before the study initiation.
6. Previous failed PGB treatment due to lack of efficacy, experienced hypersensitivity, or intolerance to PGB or other a2-d ligands.
7. History or presence of clinically significant or unstable cardiovascular, gastrointestinal, renal, or psychiatric disease or other condition that may indicate an increased risk of study participation or interfere with interpretation of the study results.
8. History or presence of any clinically significant abnormality in vital signs, electrocardiogram (ECG), or laboratory test results or has any medical or psychiatric condition that, in the opinion of the Investigator, may interfere with the study procedures or compromise subject safety.
9. History of suicide attempt within 6 months prior to Screening, or a positive response to item 4 or 5 of the Columbia Suicide Severity Rating Scale (CSSRS).
10. Episode of major depression within 6 months prior to Screening (clinically stable minor depression is not exclusionary).
11. Pregnant or breastfeeding women.
12. Subjects who have cognitive ability that makes it difficult to understand the nature, scope, and possible outcomes of the clinical study or who are not cooperative in the clinical study, as judged by the Investigator.
13. Subjects with aspartate aminotransferase (AST) or alanine aminotransferase (ALT) = 3 × the upper limit of normal (ULN) or bilirubin = 1.5 × ULN (isolated increase of bilirubin in fasting condition, consistent with Gilbert’s syndrome, is acceptable) or clinically significant abnormalities in biochemistry and hematology at Screening.
14. Subjects with creatinine clearance (CrCl) = 60 mL/minute.
15. Subjects with a history of Human Immunodeficiency Virus (HIV) infection, history of Hepatitis B infection within the past year, or history of Hepatitis C infection that has not been adequately treated.
16. Subjects that have initiated a chronic therapy with analgesics = 14 days before the Screening phase.
Note: Subjects chronically using analgesics, for conditions other than NP, may continue but they should not change the pattern of use during the study.
17. Unable or unwilling to comply with the prohibited concomitant medication restrictions as detailed in the list of excluded medication.
18. Treatment with live attenuated vaccines (including live attenuated COVID-19 vaccines) within 2 weeks before the IMPs administration or during the study.
19. History of COVID-19 PCR positivity within 3 months before the IMPs administration, suspected COVID-19 based on clinical presentation within 3 months before the IMPs administration, COVID-19 requiring hospitalization, or presence of long-term sequelae of COVID-19 after discussion with medical monitor.
20. Use of capsaicin patch within 3 months prior to Screening.
21. Pregabalin use in the last 30 days. S
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