Postherpetic neuralgia MedDRA version: 7.1 Level: LLT Classification code 10019979
Conditions
Interventions
Product Code: TAK-583
Pharmaceutical Form: Tablet
Current Sponsor code: TAK-583
Concentration unit: mg milligram(s)
Concentration type:
Sponsors
Takeda Global Research & Development Centre (Europe) Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and female subjects with PHN whose pain has been present for >3 months following healing of the herpes zoster rash. 2. Subjects with an mean pain intensity score of 4 or more (determined from at least 4 daily recordings of pain intensity on an 11-point numerical scale over the preceding 7 days) during the baseline phase. 3. Subjects aged 50 years and above. 4. The female subject is postmenopausal. 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Malignancy within the past 2 years with the exception of basal cell carcinoma. 2. Subjects who have undergone neurolytic or neurosurgical therapy for PHN. 3. Clinically significant, actively treated or unstable hepatic, biliary, respiratory, renal, rheumatologic, or hematologic illnesses, or unstable cardiovascular disease as assessed by the investigator. 4. WBC 1.5x ULN; total bilirubin =1.2x ULN (excluding Gilbert’s Disease); predicted GFR using MDRD formula = 45 mL/min. 5. Subjects with > 5 RBCs per high-power field on urinalysis. 6. Subjects with an albumin/creatinine ratio in an untimed (“spot”) morning urine specimen >ULN. 7. Subjects who are immunocompromised or have clinically significant haematological abnormalities. 8. Subjects with a history of HIV infection. 9. Subjects with a positive hepatitis panel (including hepatitis B surface antigen, antibody to hepatitis B core antigen, antibody to hepatitis B surface antigen, or antibody to hepatitis C virus), except subjects with positive antibodies to hepatitis B surface antigen who have received hepatitis B vaccination and who have no history of serological evidence of liver disease. 10. Subjects having other severe pain which may impair the self assessment of the pain due to PHN. 11. Subjects who have participated in a clinical trial for an investigational drug and/or agent within 30 days prior to baseline. 12. Subjects who have received TAK-583 in a previous clinical study. 13. Subjects who have donated more than 400 mL of blood in the 90 days prior to the beginning of the study. 14. Subjects who have a history of alcohol or illicit drug abuse in the past 2 years 15. Clinically significant abnormal 12 lead ECG. A QTc >450 ms that is confirmed on a repeat ECG is considered cllinically significant 16. Subjects who have skin conditions in the affected dermatome that could alter sensation. 17. Subjects who have taken any excluded substances (prescription or non-prescription) in the timeframe specified in Section 7.3 (Excluded Medications). 18. Clinically significant or unstable medical or psychological conditions that, in the opinion of the investigator, would compromise participation in the study. 19. The subject is a study site employee, or is an immediate family member (ie, spouse, parent, child, sibling) of a study site employee involved in conduct of this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of TAK-583 in relieving pain in subjects with PHN.; Secondary Objective: · To evaluate the safety and tolerability of TAK-583 in PHN subjects · To evaluate the effect of TAK-583 on symptoms associated with PHN such as sleep disturbance and quality of life · To evaluate the pharmacokinetics of TAK-583 using a population pharmacokinetic model ; Primary end point(s): Efficacy: · Change from baseline to week 8 (or withdrawal) in average daily pain intensity score for the prvious 7 days. Secondary Endpoints: - Safety: · Adverse events, vital signs, clinical laboratory tests (haematology, biochemistry and urinalysis), albumin/creatinine ratio and cortisol/creatinine ratio, Urinary excretion of N-acetyl-b-D-glucosaminidase (NAG), 12-lead ECGs and physical examinations. - Efficacy: · Change from baseline to each study visit in average daily pain intensity score for the previous 7 days · Change from baseline to week 8 (or withdrawal) pain assessment as assessed by Short form McGill Pain Questionnaire · Change from baseline to week 8 (or withdrawal) in weekly sleep interference scores (assessed on an 11-point numerical scale in the patient’s sleep diary) · Clinician and patient global impression of change at week 8 (or withdrawal) using a 7-point scale · Change from baseline to week 8 (or withdrawal) in quality of life as assessed by SF-36 · Change from baseline to week 8 (or withdrawal) in Profile of Mood States (POMS) · Proportions of patients with at least 30% and 50% reduction from baseline to week 8 (or withdrawal) in average daily pain score - Pharmacokinetics: · Plasma samples will be collected for analysis of TAK-583 on two visi | — |
Countries
Czech Republic, Germany, Netherlands, United Kingdom
Outcome results
None listed