Phase 2
N=300
A Study to Evaluate the Safety and Efficacy of Topically Applied TV 45070 Ointment in Patients With Postherpetic Neuralgia (PHN)
Postherpetic Neuralgia
Bottom Line
View on ClinicalTrials.gov: NCT02365636 ↗Enrolled (actual)
300
Serious AEs
0.3%
Results posted
Oct 2018
Primary outcome: Primary: Change From Baseline to Week 4 in the Weekly Average of the Daily Average Numeric Rating Scale (NRS) Pain Scores Using a Mixed Model for Repeated Measures — 5.37; 5.60; 5.51; -1.64 units on a scale — p=0.130
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- TV-45070 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Primary completion
- May 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to Week 4 in the Weekly Average of the Daily Average Numeric Rating Scale (NRS) Pain Scores Using a Mixed Model for Repeated Measures |
5.37; 5.60; 5.51; -1.64; -1.71; -1.90 | 0.130 |
| SECONDARY Change From Baseline to Week 4 in the Weekly Average of the Average Numeric Rating Scale (NRS) Pain Scores Recorded in the Evening Using a Mixed Model for Repeated Measures |
5.45; 5.66; 5.58; -1.70; -1.73; -1.96 | 0.128 |
| SECONDARY Change From Baseline to Week 4 in the Weekly Average of the Average Numeric Rating Scale (NRS) Pain Scores Recorded in the Morning Using a Mixed Model for Repeated Measures |
5.30; 5.53; 5.44; -1.60; -1.68; -1.84 | 0.177 |
| SECONDARY Change From Baseline to Week 4 in the Weekly Average of the Worst Numeric Rating Scale (NRS) Pain Scores Recorded in the Evening Using a Mixed Model for Repeated Measures |
6.09; 6.35; 6.09; -1.73; -1.83; -1.97 | 0.202 |
| SECONDARY Percentage of Participants With >=30% and >=50% Improvement From Baseline in the Weekly Average of the Daily Average Numeric Rating Scale (NRS) Pain Scores at Week 4 Using a Mixed Model for Repeated Measures |
43.9; 43.9; 47.0; 22.4; 25.5; 28.0 | 0.815 |
| SECONDARY Change From Baseline to Weeks 2 and 4 in the Neuropathic Pain Symptom Inventory (NPSI) Total Score Using a Mixed Model for Repeated Measures (MMRM) |
41.9; 44.0; 44.0; -8.1; -9.9; -10.8 | 0.251 |
| SECONDARY Change From Baseline to Week 4 in the Neuropathic Pain Impact on Quality of Life (NePIQoL) Total Score |
127.1; 126.5; 127.6; -11.5; 11.3; -12.6 | 0.609 |
| SECONDARY Participants' Global Assess of Treatment as Measured by the Patient Global Impression of Change (PGIC) at Weeks 2 and 4 Using a Mixed Model for Repeated Measures (MMRM) |
2.9; 2.9; 2.7; 2.6; 2.5; 2.4 | 0.166 |
| SECONDARY Change From Baseline to Weeks 2 and 4 in the Daily Sleep Interference Scale (DSIS) Using a Mixed Model for Repeated Measures |
4.5; 4.4; 4.4; -1.1; -1.1; -1.3 | 0.311 |
| SECONDARY Kaplan-Meier Estimates for First Time to Reach 30% or More Sustained Improvement in Weekly Average of the Daily Average NRS Pain Scores |
NA; NA; NA | 0.245 |
| SECONDARY Change From Baseline to Weeks 2 and 4 in Maximal Intensity of Brush-Evoked Allodynia as Measured on an 11-point Numeric Rating Scale (NRS) Using a Mixed Model for Repeated Measures (MMRM) |
1.6; 1.8; 2.0; -0.7; -1.0; -0.8 | 0.556 |
| SECONDARY Change From Baseline to Weeks 2 and 4 in Maximal Intensity of Punctate-Evoked Hyperalgesia as Measured on an 11-point Numeric Rating Scale (NRS) Using a Mixed Model for Repeated Measures (MMRM) |
2.4; 3.0; 2.8; -1.0; -1.3; -1.1 | 0.563 |
| SECONDARY Participants With Treatment-Emergent Adverse Events |
15; 32; 24; 0; 1; 0 | — |
Summary
This is a study to evaluate the safety and efficacy of 4% and 8% w/w TV 45070 ointment compared with placebo ointment applied topically and twice daily to the area of PHN pain for 4 weeks in patients with PHN
Eligibility Criteria
Inclusion Criteria
- Patient has chronic Postherpetic Neuralgia (PHN), defined as pain present for more than 6 months and less than 10 years after onset of herpes zoster skin rash affecting a single dermatome. Patients with more than 1 involved dermatome may also be included, provided the affected dermatomes are contiguous.
- Patient is ≥18 years of age, with a body mass index (BMI) between 18 and 34 kg/m2, inclusive, at the screening visit.
- If the patient is a woman and is fertile, the patient is not pregnant and has negative pregnancy tests at both the screening and randomization visits, and agrees to use an acceptable method of contraception for the duration of the study, including follow-up.
- If the patient is a man and is capable of producing offspring, the patient must agree to use an acceptable method of contraception, unless the partner cannot become pregnant for the duration of the study, including follow-up.
- Patient must sign the written Informed Consent Form (ICF) for the study and be willing to comply with all study procedures and restrictions.
- Patient must be judged by the investigator to be medically healthy (except for PHN) and able to participate in the study
- Other criteria apply, please contact the investigator for more information
Exclusion Criteria
- Patient has any other severe pain that might confound assessment or self-evaluation of pain due to PHN.
- Patient has PHN affecting the face (trigeminal nerve distribution).
- Patient has a history, in the judgment of the investigator, of inadequate response to more than 3 adequate courses of treatment with other medications used to treat neuropathic pain (eg, tricyclic antidepressants, serotonin-norepinephrine reuptake inhibitors, anticonvulsants, topical lidocaine, and/or topical capsaicin).
- Patient is taking oral analgesics (either opioid or non-opioid) or is receiving topical therapy such as the 5% topical lidocaine patch for the treatment of pain and is unwilling or unable to complete a washout period during which the patient will discontinue analgesic therapy or topical pain therapy.
- Patient has been treated with topical capsaicin at any time in the past 6 months for neuropathic pain.
- Patient has a history of fibromyalgia.
- Other criteria apply, please contact the investigator for more information
Data sourced from ClinicalTrials.gov (NCT02365636). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.