Efficacy, Safety and Tolerability Study of TAK-583 in Subjects With Postherpetic Neuralgia

• ClinicalTrials.gov Identifier: NCT00377598
• Recruitment Status: Completed
• First Posted: September 18, 2006
• Last Update Posted: February 2, 2012
• Sponsor: Takeda
• Information provided by (Responsible Party): Takeda

Tracking Information

• First Submitted Date: September 14, 2006
• First Posted Date: September 18, 2006
• Last Update Posted Date: February 2, 2012
• Study Start Date: October 2006
• Actual Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: December 18, 2008): Change from Baseline in average daily pain intensity score for the previous 7 days [ Time Frame: Week 8 or Final Visit ]
• Original Primary Outcome Measures (submitted: September 14, 2006): Change from baseline in average daily pain intensity score.

Current Secondary Outcome Measures (submitted: December 18, 2008)

• Change from baseline to each study visit in average daily pain intensity score for the last 7 days [ Time Frame: At All Visits ]
• Change from baseline in pain assessment as assessed by Short form McGill Pain Questionnaire [ Time Frame: Week 8 or Final Visit ]
• Change from baseline in weekly mean sleep interference scores (assessed on an 11-point numerical scale in the subject's sleep diary) [ Time Frame: Week 8 or Final Visit ]
• Clinician and subject global impression of change using a 7-point scale [ Time Frame: Week 8 or Final Visit ]
• Change from baseline in quality of life as assessed by Short Form-36 [ Time Frame: Week 8 or Final Visit ]
• Change from baseline in Profile of Mood States [ Time Frame: Week 8 or Final Visit ]
• Proportions of subjects with at least 30% and 50% reduction from baseline in average daily pain intensity score [ Time Frame: Week 8 or Final Visit ]

• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Efficacy, Safety and Tolerability Study of TAK-583 in Subjects With Postherpetic Neuralgia
• Official Title: A Phase 2, Double Blind, Placebo Controlled, Dose-Ranging Study in Subjects With Postherpetic Neuralgia (PHN) to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Four Doses of TAK-583, Compared With Placebo
• Brief Summary: The purpose of this study is to evaluate the efficacy of TAK-583, once daily (QD), in relieving pain in subjects with postherpetic neuralgia.

Detailed Description

Postherpetic neuralgia is defined as neuropathic pain still present 3 months following healing of the herpes zoster rash. Symptoms of postherpetic neuralgia may include a complex combination of symptoms, including a deep aching, shooting or burning pain, sensory deficits, hyperalgesia, allodynia, paresthesia, and dysesthesia. Postherpetic neuralgia is more common in the elderly, and it can have a debilitating effect on a patient. The most commonly prescribed treatments are tricyclic antidepressants and anticonvulsants, however these treatments are effective in approximately half of subjects and may also have undesirable side effects (eg, dizziness and somnolence).

TAK-583 is a synthetic compound under development by Takeda Global Research & Development Center, Inc. as a treatment for neuropathic pain and for delaying the progression of diabetic neuropathy.

Individuals who want to participate in this study will be required to provide written informed consent. Study participation is anticipated to be about 11 Weeks. Multiple procedures will occur at each visit which may include fasting, blood collection, urine collection, vital signs, body height and weight, physical examinations and electrocardiograms.

• Study Type: Interventional
• Study Phase: Phase 2; Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Neuralgia, Postherpetic

Intervention

• Drug: TAK-583
  TAK-583 5 mg, tablets, orally, once daily for up to 8 weeks
• Drug: TAK-583
  TAK-583 25 mg, tablets, orally, once daily for up to 8 weeks
• Drug: TAK-583
  TAK-583 50 mg, tablets, orally, once daily for up to 8 weeks
• Drug: TAK-583
  TAK-583 100 mg, tablets, orally, once daily for up to 8 weeks
• Drug: Placebo
  TAK-583 placebo-matching tablets, orally, once daily for up to 8 weeks

Study Arms

• Experimental: TAK-583 5 mg QD
  Intervention: Drug: TAK-583
• Experimental: TAK-583 25 mg QD
  Intervention: Drug: TAK-583
• Experimental: TAK-583 50 mg QD
  Intervention: Drug: TAK-583
• Experimental: TAK-583 100 mg QD
  Intervention: Drug: TAK-583
• Placebo Comparator: Placebo QD
  Intervention: Drug: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: December 18, 2008): 399
• Original Enrollment (submitted: September 14, 2006): 400
• Actual Study Completion Date: February 2008
• Actual Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Male and female subjects with postherpetic neuralgia whose pain has been present for >3 months following healing of the herpes zoster rash.
• 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.
• Subjects aged 50 years and above.
• The female subject is not of child-bearing potential (eg, sterilized, postmenopausal).

Exclusion Criteria:

• Malignancy within the past 2 years with the exception of basal cell carcinoma.
• Subjects who have undergone neurolytic or neurosurgical therapy for postherpetic neuralgia.
• Clinically significant, actively treated or unstable hepatic, biliary, respiratory, renal, rheumatologic, or hematologic illnesses, or unstable cardiovascular disease as assessed by the investigator.
• WBC less than 2500, ANC less than 1500, platelets less than 100,000; ALT, AST or alkaline phosphatase greater than 1.5x ULN; total bilirubin greater than or equal to 1.2 times the upper limit of normal (excluding Gilbert's Disease); predicted GFR using Cockcroft and Gault formula less than or equal to 40 mL/min.
• Subjects with greater than 5 red blood cells per high-power field on urinalysis.
• Subjects with an albumin/creatinine ratio in an untimed ("spot") morning urine specimen greater than the upper limit of normal.
• Subjects who are immunocompromised or have clinically significant haematological abnormalities.
• Subjects with a history of HIV infection.
• 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.
• Subjects having other severe pain which may impair the self assessment of the pain due to postherpetic neuralgia.
• Subjects who have participated in a clinical trial for an investigational drug and/or agent within 30 days prior to baseline.
• Subjects who have received TAK-583 in a previous clinical study.
• Subjects who have donated more than 400 mL of blood in the 90 days prior to the beginning of the study.
• Subjects who have a history of alcohol or illicit drug abuse in the past 2 years
• Clinically significant abnormal 12 lead electrocardiogram, including QT interval corrected for heart rate greater than 450 ms that is confirmed on a repeat electrocardiogram.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 50 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Australia, Bulgaria, Czech Republic, Germany, Netherlands, Poland, Russian Federation, South Africa, United Kingdom

Administrative Information

• NCT Number: NCT00377598
• Other Study ID Numbers: TAK-583-EC201; 2005-005863-26 ( EudraCT Number ); U1111-1127-6187 ( Registry Identifier: WHO )
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Takeda
• Study Sponsor: Takeda
• Collaborators: Not Provided

Investigators

• Study Director: VP Clinical Science; Takeda Global Research & Development Center

• PRS Account: Takeda
• Verification Date: January 2012