Study designed to investigate and confirm that pregabalin is effective in treating neuropathic pain resulting from peripheral nerve trauma.
- Conditions
- Chronic post-traumatic peripheral neuropathic painMedDRA version: 17.0Level: LLTClassification code 10054095Term: Neuropathic painSystem Organ Class: 100000004852Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2012-003304-12-HR
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 470
1. Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
2. Subject is willing and able to comply with scheduled visits, treatment plan, laboratory tests, daily pain and sleep diary (recorded via interactive voice response system [IVRS]), and other study procedures.
3. Subjects must be literate in the language used in the IVRS and in the assessments/forms. In addition, subjects must have the ability (unaided) to understand and correctly use the IVRS and complete all required assessments/forms. In addition, subjects must have the ability (unaided) to understand and correctly use the IVRS, have daily access to a telephone in order to complete the IVRS assessments each day, perform telephone visits and complete all required assessments/forms. It is the responsibility of the investigator to ensure subjects are adequately and appropriately trained with respect to proper use of the IVRS and completion all non-electronic (ie, paper) assessments.
4. Men or women of any race or ethnicity who are at least 18 years of age.
5. Male and female subjects of childbearing potential must agree to use a highly effective method of contraception throughout the study and for at least 28 days after the last dose of assigned treatment (See section 4.3). A subject is of childbearing potential if, in the opinion of the investigator, he/she is biologically capable of having children and is sexually active.
6. Subject must have chronic peripheral neuropathic pain present for more than 6 months after a traumatic or surgical event per medical history (this may include, for example, motor vehicle accident, fall, sports injury, knee or hip replacement, hernia repair, thoracotomy, mastectomy, focal/localized burns or crush injury).
7. In addition, to be eligible for inclusion in the study, all subjects must:
a. Have a score =4 on a Weekly Pain Numeric Rating Scale (NRS) at Visit 1; and
b. Have completed at least 4 daily pain diaries during Screening during the 7 days prior to Visit 2 with a mean pain score of =4 and =9 based on Daily Pain NRS to be eligible for randomization.
c. Must have their implicated peripheral nerve(s) identified.
d. Must meet criteria for neuropathic pain assessment as described in Section 7.2.3.1.
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 376
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 94
Subjects presenting with ANY of the following will NOT be included in the study:
1. Subjects with neuropathic pain due to DPN, PHN, HIV, trigeminal neuralgia (TGN), or carpal tunnel syndrome (CTS); subjects whose post-traumatic neuropathic pain is categorized as central (eg, spinal cord injury) rather than
peripheral.
2. Subjects with pain due to Complex Regional Pain Syndrome (CRPS, Type I or Type II).
3. Subjects with skin conditions in the affected dermatome that in the judgment of the investigator could interfere with evaluation of the neuropathic pain condition.
4. Subjects with other pain that may confound assessment or self-evaluation of the peripheral neuropathic pain; subjects with significant somatic pain at the site of their trauma that may confound assessment or self-evaluation of their neuropathic pain.
5. Subjects who have failed pregabalin treatment due to lack of efficacy with an adequate course of therapy at doses =150 mg/day, have hypersensitivity or intolerance to pregabalin or gabapentin, or who have participated in a pregabalin clinical trial at any time; subjects treated with pregabalin at any time during the 6 month period prior to the Screening visit (V1). Subjects previously treated with pregabalin may be eligible to participate in the study if they meet all protocol-specified criteria.
6. Any subject considered at risk of suicide or self-harm based on investigator judgment and/or the details of a risk assessment, as specified in Section 7.3.
7. Use of prohibited medications in the absence of appropriate washout periods (see Section 5.5).
8. Participation in any other clinical trial within the 30 days prior to screening and/or during participation in this study.
9. Subjects with epilepsy; pernicious anemia; hematologic illnesses; known HIV infection; any clinically unstable cardiovascular (including a myocardial infarction in the 3 months prior to Visit 1), hematological, autoimmune, endocrine, renal, hepatic (including chronic hepatitis B, hepatitis B within the past 3 months), respiratory, or gastrointestinal disease; symptomatic peripheral vascular disease including intermittent claudication; uncontrolled diabetes mellitus, untreated hypothyroidism.
10. Subjects who have had a diagnosis of malignancy other than basal cell carcinoma or carcinoma in situ of the cervix within the past 5 years.
11. Subjects with creatinine clearance (CLcr) =60 mL/min (estimated prior to Visit 2 from serum creatinine obtained at Visit 1, body weight, age, and gender using the Cockcroft and Gault equation; see Section 7.2.1; Subjects who have an estimated CLcr =60 mL/min by this screening method may have their CLcr measured, at the investigator’s discretion, with a 24-hour urine collection performed at the central laboratory. If this 24-hour urine CLcr is >60 mL/min, the subject may be included.
12. Abnormal clinically significant electrocardiogram (ECG).
13. Pregnant females; breastfeeding females; males and females of childbearing potential not using highly effective contraception or not agreeing to continue highly effective contraception for at least 28 days after the last dose of investigational product.
14. Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality, or other factors that may increase the risk associated with study participation or investigational product administration or may interfere with compliance or the interpretation of study results and, in the judgment
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