Phase 2
N=99
RN624 For Pain Of Post-Herpetic Neuralgia
Neuralgia, Postherpetic
Bottom Line
View on ClinicalTrials.gov: NCT00568321 ↗Enrolled (actual)
99
Serious AEs
4.2%
Results posted
May 2021
Primary outcome: Primary: Change From Baseline in Average Daily Pain Numeric Rating Scale (NRS) Score at Week 6 — 6.40; 6.42; 6.39; -1.22 units on a scale — p=0.687
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- RN624 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Dec 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Average Daily Pain Numeric Rating Scale (NRS) Score at Week 6 |
6.40; 6.42; 6.39; -1.22; -0.97; -1.72 | 0.687 |
| SECONDARY Change From Baseline in Average Daily Pain Numeric Rating Scale (NRS) Score at Weeks 1, 2, 4, 8, 12 and 16 |
-0.54; -0.64; -0.91; -0.80; -0.46; -0.66 | 0.399 |
| SECONDARY Change From Baseline in Average Daily Pain Numeric Rating Scale (NRS) Score Over Weeks 1 to 4, 1 to 8, 1 to 12, 1 to 16, 5 to 8, 5 to 12 and 5 to 16 |
-0.87; -0.70; -1.08; -0.97; -0.81; -1.35 | 0.683 |
| SECONDARY Change From Baseline in Modified Brief Pain Inventory-Short Form (mBPI-sf) Scale Score for Worst Pain, Average Pain and Pain Severity at Weeks 1, 2, 4, 6, 8 ,12 and 16 |
7.13; 6.78; 6.93; 6.27; 6.06; 6.20 | 0.764 |
| SECONDARY Number of Participants With Mean Average Daily Pain Score of Less Than or Equal to (<=) 2 at Weeks 1, 2, 4, 6, 8, 12 and 16 |
0; 2; 1; 1; 2; 1 | — |
| SECONDARY Number of Participants With Percent Reduction From Baseline in Average Daily Pain Score at Week 6 |
19; 22; 19; 15; 15; 17 | — |
| SECONDARY Number of Participants With at Least 30 Percent (%) and 50% Sustained Reduction From Baseline in Daily Average Pain Score at Week 6 |
14; 14; 16; 11; 9; 13 | — |
| SECONDARY Number of Participants With at Least 30 Percent (%) and 50% Reduction From Baseline in Average Daily Pain Numeric Rating Scale (NRS) Score at Week 1, 2, 4, 6, 8, 12 and 16 |
4; 5; 5; 6; 4; 6 | — |
| SECONDARY Time to Achieve at Least 30% (Percent) and 50% Sustained Reduction From Baseline in Average Daily Pain Score |
65.00; NA; 57.00; NA; NA; NA | — |
| SECONDARY Total Duration of at Least 30 Percent (%) and 50% Reduction From Baseline in Average Daily Pain Numeric Rating Scale (NRS) Score in Participants |
8.00; 2.00; 14.50; 0.00; 0.00; 2.50 | — |
| SECONDARY Change From Baseline in Modified Brief Pain Inventory- Short Form (mBPI-sf) Score for Pain Interference With CS Score, GA Subtest and NW Subtest at Weeks 1, 2, 4, 6, 8, 12 and 16 |
3.87; 3.90; 4.67; 4.13; 4.16; 4.83 | 0.343 |
| SECONDARY Number of Participants With Change From Baseline in Patient's Global Assessment of Pain Score at Weeks 1, 2, 4, 6, 8, 12 and 16 |
0; 0; 0; 1; 0; 0 | — |
| SECONDARY Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication |
11; 13; 13; 5; 5; 8 | — |
| SECONDARY Change From Baseline in Modified Brief Pain Inventory-Short Form (mBPI-sf) Score for Pain Interference With Sleep at Weeks 1, 2, 4, 6, 8 ,12 and 16 |
4.87; 4.66; 5.48; -1.03; -1.50; -1.37 | 0.111 |
| SECONDARY Number of Participants Who Discontinued the Study Due to Lack of Efficacy |
8; 5; 6 | — |
| SECONDARY Time to Discontinuation Due to Lack of Efficacy |
71.32; 40.79; 72.13 | — |
| SECONDARY Number of Participants Who Used Rescue Medications |
18; 22; 12; 16; 17; 14 | — |
| SECONDARY Duration of Rescue Medication Use |
1.00; 1.00; 0.00; 1.00; 1.00; 0.00 | — |
| SECONDARY Amount of Rescue Medication Taken |
3677.4; 3015.2; 2125.0; 3419.4; 3515.2; 2467.7 | — |
| SECONDARY Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) |
20; 24; 21; 1; 2; 1 | — |
| SECONDARY Number of Participants With Abnormal Physical Examinations Findings at Screening |
0; 3; 1; 0; 1; 2 | — |
| SECONDARY Number of Participants With Change From Baseline in Physical Examinations Findings at Week 16 |
1; 3; 1 | — |
| SECONDARY Number of Participants With Change From Baseline in Neurological Examination Findings at Week 16 |
1; 0; 0 | — |
| SECONDARY Number of Participants With Clinically Significant Change From Baseline in Vital Signs at Week 16 |
0; 0; 0 | — |
| SECONDARY Number of Participants With Laboratory Abnormalities |
22; 25; 20 | — |
| SECONDARY Number of Participants With Electrocardiogram (ECG) Abnormalities |
0; 0; 0 | — |
| SECONDARY Number of Participants With Positive Anti-Drug Antibody (ADA) Response |
0; 0 | — |
| SECONDARY Change From Baseline in Hopkins Verbal Learning Test - Revised (HVLT-R) at Week 2, 6, 12, 16 and End of Study |
24.58; 23.15; 26.84; -0.03; 0.19; 0.70 | 0.548 |
| SECONDARY Area Under the Plasma Concentration-Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) for Tanezumab |
843814.9; 2559793.7 | — |
Summary
This study will test the efficacy and safety of two doses levels of RN624 versus placebo for the relief of pain caused by post-herpetic neuralgia (PHN).
Eligibility Criteria
Inclusion Criteria
- Male or female of any race, at least 18 years of age.
- Patients must have pain present for more than 3 months after healing of the herpes zoster skin rash.
- Has a pain score at screening that qualifies.
- Completes at least 3 average daily pain diaries during the 3 days prior to randomization and has an average pain level that qualifies.
- Body Mass Index less than or equal to 39 kg/m2.
- If female, is post-menopausal, surgically sterile, or uses adequate contraception consisting of 2 forms of birth control, one of which must be barrier method, is not lactating, and is not breastfeeding.
- Male patients must agree that female spouses/partners will use contraception as defined above or be of nonchildbearing potential (post-menopausal or surgically sterile).
- Patients must be willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
- Patients must consent in writing to participate in the study.
Exclusion Criteria
- Patients who cannot discontinue the use of other pain medications during the screening period and during the study.
- Disqualifying scores on questionnaires.
- Other moderate to severe pain from other conditions.
- History of allergic or anaphylactic reaction to antibodies.
- Use of biologics, including any live vaccines within 3 months of the week prior to the baseline visit.
- Unable to use acetaminophen.
- Disqualify laboratory values, Hepatitis B or C or HIV.
- Patients that have had a stroke or TIAs, dementia, epilepsy or seizures, or peripheral neuropathy from other conditions.
- Significant cardiac disease within 3 months of the study such as angina, heart attack, congestive heart failure, and other cardiac problems.
- Cancer other than basal cell or squamous cell carcinoma.
- Fails a urine test for illegal drugs including prescription drugs without a prescription.
- Plans for surgery during the study.
- History of alcoholism or drug abuse in the past two years.
- Surgery for post-herpetic neuralgia.
- Any condition that the investigator feels would put the safety of the patient at risk.
Data sourced from ClinicalTrials.gov (NCT00568321). 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.