Clinical Trial Results:
A Phase 2, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of LX9211 in the Treatment of Postherpetic Neuralgia (RELIEF-PHN1)
Summary
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EudraCT number |
2020-004639-26 |
Trial protocol |
CZ PL |
Global end of trial date |
28 Dec 2022
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Results information
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Results version number |
v1(current) |
This version publication date |
06 Jan 2024
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First version publication date |
06 Jan 2024
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Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
LX9211.1-202-PHN
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT04662281 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Lexicon Pharmaceuticals, Inc.
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Sponsor organisation address |
2445 Technology Forest Blvd, The Woodlands, TX, United States, 77381-5261
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Public contact |
Vice President, Clinical Operations, Lexicon Pharmaceuticals, +1 281-863-3000, clinicaloperations@lexpharma.com
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Scientific contact |
Head of LX9211 Clinical Development, Lexicon Pharmaceuticals, +1 281-863-3000, clinicaloperations@lexpharma.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
28 Dec 2022
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
28 Dec 2022
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
The primary objective of this study is to evaluate the efficacy of LX9211 in reducing pain related to postherpetic neuralgia (PHN).
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Protection of trial subjects |
All study subjects were required to read and sign an Informed Consent Form.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
10 Dec 2020
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
Yes
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Poland: 7
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Country: Number of subjects enrolled |
Czechia: 4
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Country: Number of subjects enrolled |
United States: 68
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Worldwide total number of subjects |
79
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EEA total number of subjects |
11
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
35
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From 65 to 84 years |
44
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85 years and over |
0
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Recruitment
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Recruitment details |
Subjects took part in the study at multiple investigative sites in Poland, Czechia, and the United States from 10 December 2020 to 28 December 2022. | ||||||||||||||||||||||||
Pre-assignment
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Screening details |
Following a 2-week single blind Placebo Run-in period, a total of 79 subjects were randomised and treated in the study, with 41 subjects receiving a placebo and 38 subjects receiving LX9211. | ||||||||||||||||||||||||
Period 1
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Period 1 title |
Overall study (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | ||||||||||||||||||||||||
Roles blinded |
Subject, Investigator, Monitor | ||||||||||||||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Placebo | ||||||||||||||||||||||||
Arm description |
Following a 2-week Single-blind Placebo Run-in period, subjects received a single loading dose of matching-placebo to LX9211 tablet, orally, on Day 1 and maintenance doses, orally, once daily from Day 2 to Week 6. | ||||||||||||||||||||||||
Arm type |
Placebo | ||||||||||||||||||||||||
Investigational medicinal product name |
Placebo
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
LX9211-matching -placebo tablet was administered, orally as specified in the respective arm.
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Arm title
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LX9211 | ||||||||||||||||||||||||
Arm description |
Following a 2-week Single-blind Placebo Run-in period, subjects received a single loading dose of 200 milligrams (mg) tablet, orally, on Day 1 and maintenance doses of 20 mg, orally, once daily from Day 2 to Week 6. | ||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||
Investigational medicinal product name |
LX9211
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
LX9211 tablet was administered, orally as specified in the respective arm.
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Baseline characteristics reporting groups
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Reporting group title |
Placebo
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Reporting group description |
Following a 2-week Single-blind Placebo Run-in period, subjects received a single loading dose of matching-placebo to LX9211 tablet, orally, on Day 1 and maintenance doses, orally, once daily from Day 2 to Week 6. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
LX9211
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Reporting group description |
Following a 2-week Single-blind Placebo Run-in period, subjects received a single loading dose of 200 milligrams (mg) tablet, orally, on Day 1 and maintenance doses of 20 mg, orally, once daily from Day 2 to Week 6. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Placebo
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Reporting group description |
Following a 2-week Single-blind Placebo Run-in period, subjects received a single loading dose of matching-placebo to LX9211 tablet, orally, on Day 1 and maintenance doses, orally, once daily from Day 2 to Week 6. | ||
Reporting group title |
LX9211
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Reporting group description |
Following a 2-week Single-blind Placebo Run-in period, subjects received a single loading dose of 200 milligrams (mg) tablet, orally, on Day 1 and maintenance doses of 20 mg, orally, once daily from Day 2 to Week 6. |
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End point title |
Change from Baseline (Week 2 of the Run-in period) in Average Daily Pain Score (ADPS) | ||||||||||||
End point description |
ADPS is based on question 5 of Zoster Brief Pain Inventory (ZBPI) and assessed on an 11-point numerical rating scale where, 0 (no pain) to 10 (pain as
bad as you can imagine). Higher ADPS scores indicated a worse outcome. The mITT population included all randomised subjects who had taken at least 1 dose of study drug.
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End point type |
Primary
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End point timeframe |
Baseline (Week 2 of the Run-in period) to Week 6
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Notes [1] - Number of subjects analysed signifies subjects who were evaluable for this endpoint. [2] - Number of subjects analysed signifies subjects who were evaluable for this endpoint. |
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Statistical analysis title |
Placebo Vs LX9211 | ||||||||||||
Statistical analysis description |
The Mixed Model Repeated Measures (MMRM) model was used to assess the difference between LX9211 and placebo in the primary endpoint and it included fixed effects of treatment, week, treatment-by-week interaction, the randomization stratum of Baseline pain severity (moderate, severe), and the Baseline ADPS score as a covariate.
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Comparison groups |
LX9211 v Placebo
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Number of subjects included in analysis |
58
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
Method |
MMRM | ||||||||||||
Parameter type |
Difference in Least Squares Means | ||||||||||||
Point estimate |
-0.8
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Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
-1.82 | ||||||||||||
upper limit |
0.21 |
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End point title |
Change from Baseline in Pain Interfering With Sleep based on Question 9F of the ZBPI at Week 6 | ||||||||||||
End point description |
Pain interfering with sleep is based on Question 9F of the ZBPI “Indicate the one number that describes how, in the past 24-hours shingles pain has interfered with your: Sleep; 0 = does not interfere to 10 = Completely interferes. Higher the number more the worsening of sleep due to pain interference. The mITT population included all randomised subjects who had taken at least 1 dose of study drug.
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End point type |
Secondary
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End point timeframe |
Baseline to Week 6
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Notes [3] - Number of subjects analysed signifies subjects who were evaluable for this endpoint. [4] - Number of subjects analysed signifies subjects who were evaluable for this endpoint. |
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Statistical analysis title |
Placebo Vs LX9211 | ||||||||||||
Statistical analysis description |
The MMRM model included fixed effects of treatment, week, treatment-by-week interaction, the randomisation stratum of Baseline pain severity (moderate, severe), and the Baseline ADPS score as a covariate.
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Comparison groups |
Placebo v LX9211
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Number of subjects included in analysis |
57
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
= 0.181 | ||||||||||||
Method |
MMRM | ||||||||||||
Parameter type |
Difference in Least Squares Means | ||||||||||||
Point estimate |
-0.62
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Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
-1.53 | ||||||||||||
upper limit |
0.29 |
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End point title |
Percentage of Subjects with ≥30% Reduction in Pain Intensity in ADPS From Baseline at Week 6 | ||||||||||||
End point description |
ADPS is based on question 5 of Zoster Brief Pain Inventory (ZBPI) and assessed on an 11-point numerical rating scale where, 0 = No Pain to 10 = pain as bad as you can imagine. Higher ADPS scores indicated a worse outcome. The mITT population included all randomised subjects who had taken at least 1 dose of study drug.
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End point type |
Secondary
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End point timeframe |
Baseline to Week 6
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Statistical analysis title |
Placebo Vs LX9211 | ||||||||||||
Statistical analysis description |
Cochran-Mantel-Haenszel (CMH) test stratified by the different levels of the randomization stratification factors of Baseline severity score (moderate, severe) was used.
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Comparison groups |
Placebo v LX9211
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Number of subjects included in analysis |
79
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
= 0.504 | ||||||||||||
Method |
Cochran-Mantel-Haenszel | ||||||||||||
Parameter type |
Percentage Difference | ||||||||||||
Point estimate |
8
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Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
-13.42 | ||||||||||||
upper limit |
29.34 |
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End point title |
Percentage of Subjects with ≥50% Reduction in Pain Intensity in ADPS From Baseline at Week 6 | ||||||||||||
End point description |
ADPS is based on question 5 of ZBPI and assessed on an 11-point numerical rating scale where, 0 = No Pain to 10 = pain as bad as you can imagine. Higher ADPS scores indicated a worse outcome. The mITT population included all randomised subjects who had taken at least 1 dose of study drug.
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End point type |
Secondary
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End point timeframe |
Baseline to Week 6
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Statistical analysis title |
Placebo Vs LX9211 | ||||||||||||
Statistical analysis description |
CMH test stratified by the different levels of the randomisation stratification factors of Baseline severity score (moderate, severe) was used.
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Comparison groups |
Placebo v LX9211
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Number of subjects included in analysis |
79
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
= 0.671 | ||||||||||||
Method |
Cochran-Mantel-Haenszel | ||||||||||||
Parameter type |
Percentage Difference | ||||||||||||
Point estimate |
4.2
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Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
-13.99 | ||||||||||||
upper limit |
22.33 |
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End point title |
Change from Baseline in Interference in General Activity, Mood, Walking Ability, Normal Work, Relations With Other People, Sleep, and Enjoyment of Life Interference Based on the Questions 9A-G of the ZBPI | |||||||||||||||||||||||||||||||||
End point description |
The ZBPI, a 9-item questionnaire assesses the severity of pain and its impact on functioning in subjects with PHN. The categories based on questions 9A-G of the ZBPI that were analyzed are general activity, mood, walking ability, normal work (includes both outside the home and housework) relations with other people, sleep, and enjoyment of life: 0 no interference - 10 complete interference. Higher ZBPI score indicates a worse outcome. The mITT population included all randomised subjects who had taken at least 1 dose of study drug. Here, ‘n’ signifies the number of subjects analysed at a given timepoint in this endpoint
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End point type |
Secondary
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End point timeframe |
Baseline to Week 6
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Statistical analysis title |
Placebo Vs LX9211 | |||||||||||||||||||||||||||||||||
Statistical analysis description |
General Activity: The change from baseline to Week 6 in general activity was analysed using the MMRM model. The MMRM model included fixed effects of treatment, week, treatment-by-week interaction, the randomisation stratum of Baseline pain severity (moderate, severe), and the Baseline ADPS score as a covariate.
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Comparison groups |
LX9211 v Placebo
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Number of subjects included in analysis |
79
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Analysis specification |
Pre-specified
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Analysis type |
superiority | |||||||||||||||||||||||||||||||||
P-value |
= 0.024 | |||||||||||||||||||||||||||||||||
Method |
MMRM | |||||||||||||||||||||||||||||||||
Parameter type |
Difference in Least Squares Means | |||||||||||||||||||||||||||||||||
Point estimate |
-1.23
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Confidence interval |
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level |
95% | |||||||||||||||||||||||||||||||||
sides |
2-sided
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lower limit |
-2.3 | |||||||||||||||||||||||||||||||||
upper limit |
-0.17 | |||||||||||||||||||||||||||||||||
Statistical analysis title |
Placebo Vs LX9211 | |||||||||||||||||||||||||||||||||
Statistical analysis description |
Mood: The change from baseline to Week 6 in mood was analysed using the MMRM model. The MMRM model included fixed effects of treatment, week, treatment-by-week interaction, the randomisation stratum of Baseline pain severity (moderate, severe), and the Baseline ADPS score as a covariate.
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Comparison groups |
Placebo v LX9211
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Number of subjects included in analysis |
79
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Analysis specification |
Pre-specified
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Analysis type |
superiority | |||||||||||||||||||||||||||||||||
P-value |
= 0.138 | |||||||||||||||||||||||||||||||||
Method |
MMRM | |||||||||||||||||||||||||||||||||
Parameter type |
Difference in Least Squares Means | |||||||||||||||||||||||||||||||||
Point estimate |
-0.84
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Confidence interval |
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level |
95% | |||||||||||||||||||||||||||||||||
sides |
2-sided
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lower limit |
-1.95 | |||||||||||||||||||||||||||||||||
upper limit |
0.27 | |||||||||||||||||||||||||||||||||
Statistical analysis title |
Placebo Vs LX9211 | |||||||||||||||||||||||||||||||||
Statistical analysis description |
Walking Ability: The change from baseline to Week 6 in walking ability was analysed using the MMRM model. The MMRM model included fixed effects of treatment, week, treatment-by-week interaction, the randomisation stratum of Baseline pain severity (moderate, severe), and the Baseline ADPS score as a covariate.
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Comparison groups |
Placebo v LX9211
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Number of subjects included in analysis |
79
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Analysis specification |
Pre-specified
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Analysis type |
superiority | |||||||||||||||||||||||||||||||||
P-value |
= 0.397 | |||||||||||||||||||||||||||||||||
Method |
MMRM | |||||||||||||||||||||||||||||||||
Parameter type |
Difference in Least Squares Means | |||||||||||||||||||||||||||||||||
Point estimate |
-0.43
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Confidence interval |
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level |
95% | |||||||||||||||||||||||||||||||||
sides |
2-sided
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lower limit |
-1.45 | |||||||||||||||||||||||||||||||||
upper limit |
0.58 | |||||||||||||||||||||||||||||||||
Statistical analysis title |
Placebo Vs LX9211 | |||||||||||||||||||||||||||||||||
Statistical analysis description |
Normal Work: The change from baseline to Week 6 in normal work was analysed using the MMRM model. The MMRM model included fixed effects of treatment, week, treatment-by-week interaction, the randomisation stratum of Baseline pain severity (moderate, severe), and the Baseline ADPS score as a covariate.
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Comparison groups |
Placebo v LX9211
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Number of subjects included in analysis |
79
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Analysis specification |
Pre-specified
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Analysis type |
superiority | |||||||||||||||||||||||||||||||||
P-value |
= 0.192 | |||||||||||||||||||||||||||||||||
Method |
MMRM | |||||||||||||||||||||||||||||||||
Parameter type |
Difference in Least Squares Means | |||||||||||||||||||||||||||||||||
Point estimate |
-0.67
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Confidence interval |
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level |
95% | |||||||||||||||||||||||||||||||||
sides |
2-sided
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lower limit |
-1.69 | |||||||||||||||||||||||||||||||||
upper limit |
0.34 | |||||||||||||||||||||||||||||||||
Statistical analysis title |
Placebo Vs LX9211 | |||||||||||||||||||||||||||||||||
Statistical analysis description |
Relations With Other People: The change from baseline to Week 6 in relation with other people was analysed using the MMRM model. The MMRM model included fixed effects of treatment, week, treatment-by-week interaction, the randomisation stratum of Baseline pain severity (moderate, severe), and the Baseline ADPS score as a covariate.
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Comparison groups |
Placebo v LX9211
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Number of subjects included in analysis |
79
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Analysis specification |
Pre-specified
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Analysis type |
superiority | |||||||||||||||||||||||||||||||||
P-value |
= 0.463 | |||||||||||||||||||||||||||||||||
Method |
MMRM | |||||||||||||||||||||||||||||||||
Parameter type |
Difference in Least Squares Means | |||||||||||||||||||||||||||||||||
Point estimate |
-0.38
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Confidence interval |
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level |
95% | |||||||||||||||||||||||||||||||||
sides |
2-sided
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lower limit |
-1.41 | |||||||||||||||||||||||||||||||||
upper limit |
0.65 | |||||||||||||||||||||||||||||||||
Statistical analysis title |
Placebo Vs LX9211 | |||||||||||||||||||||||||||||||||
Statistical analysis description |
Sleep: The change from baseline to Week 6 in relations with sleep was analysed using the MMRM model. The MMRM model included fixed effects of treatment, week, treatment-by-week interaction, the randomisation stratum of Baseline pain severity (moderate, severe), and the Baseline ADPS score as a covariate.
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Comparison groups |
Placebo v LX9211
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Number of subjects included in analysis |
79
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Analysis specification |
Pre-specified
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Analysis type |
superiority | |||||||||||||||||||||||||||||||||
P-value |
= 0.908 | |||||||||||||||||||||||||||||||||
Method |
MMRM | |||||||||||||||||||||||||||||||||
Parameter type |
Difference in Least Squares Means | |||||||||||||||||||||||||||||||||
Point estimate |
-0.06
|
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Confidence interval |
||||||||||||||||||||||||||||||||||
level |
95% | |||||||||||||||||||||||||||||||||
sides |
2-sided
|
|||||||||||||||||||||||||||||||||
lower limit |
-1.05 | |||||||||||||||||||||||||||||||||
upper limit |
0.93 | |||||||||||||||||||||||||||||||||
Statistical analysis title |
Placebo Vs LX9211 | |||||||||||||||||||||||||||||||||
Statistical analysis description |
Enjoyment of Life: The change from baseline to Week 6 in enjoyment of life was analysed using the MMRM model. The MMRM model included fixed effects of treatment, week, treatment-by-week interaction, the randomisation stratum of Baseline pain severity (moderate, severe), and the Baseline ADPS score as a covariate.
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Comparison groups |
Placebo v LX9211
|
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Number of subjects included in analysis |
79
|
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Analysis specification |
Pre-specified
|
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Analysis type |
superiority | |||||||||||||||||||||||||||||||||
P-value |
= 0.158 | |||||||||||||||||||||||||||||||||
Method |
MMRM | |||||||||||||||||||||||||||||||||
Parameter type |
Difference in Least Squares Means | |||||||||||||||||||||||||||||||||
Point estimate |
-0.79
|
|||||||||||||||||||||||||||||||||
Confidence interval |
||||||||||||||||||||||||||||||||||
level |
95% | |||||||||||||||||||||||||||||||||
sides |
2-sided
|
|||||||||||||||||||||||||||||||||
lower limit |
-1.9 | |||||||||||||||||||||||||||||||||
upper limit |
0.31 |
|
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End point title |
Percentage of Subjects Discontinuing Treatment due to Lack of Efficacy Defined as Increase in ADPS from Baseline of ≥30% Based on Question 5 of the ZBPI | ||||||||||||
End point description |
ADPS is based on question 5 of ZBPI and assessed on an 11-point numerical rating scale where, 0 = No Pain to 10 = pain as bad as you can imagine.
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End point type |
Secondary
|
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End point timeframe |
Baseline to Week 6
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|
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Notes [5] - Data for the outcome measure was not analysed due to change in planned analyses. [6] - Data for the outcome measure was not analysed due to change in planned analyses. |
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No statistical analyses for this end point |
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End point title |
Patient Global Impression of Change (PGIC) at Week 6 | ||||||||||||
End point description |
PGIC is assessed on a 7-point rating scale where 1= very much improved to 7 = very much worse. Higher scores indicate worse outcomes. The mITT population included all randomised subjects who had taken at least 1 dose of study drug.
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End point type |
Secondary
|
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End point timeframe |
Baseline to Week 6
|
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Notes [7] - Number of subjects analysed signifies subjects who were evaluable for this endpoint. [8] - Number of subjects analysed signifies subjects who were evaluable for this endpoint. |
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Statistical analysis title |
Placebo Vs LX9211 | ||||||||||||
Statistical analysis description |
Analysis of variance (ANOVA) model was used with treatment and randomisation stratum of Baseline pain severity (moderate, severe) as independent variables.
|
||||||||||||
Comparison groups |
Placebo v LX9211
|
||||||||||||
Number of subjects included in analysis |
63
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
= 0.192 | ||||||||||||
Method |
ANOVA | ||||||||||||
Parameter type |
Difference in Least Squares Means | ||||||||||||
Point estimate |
-0.42
|
||||||||||||
Confidence interval |
|||||||||||||
level |
95% | ||||||||||||
sides |
2-sided
|
||||||||||||
lower limit |
-1.05 | ||||||||||||
upper limit |
0.22 |
|
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End point title |
Time to Loss of Efficacy From Week 6 to Week 11 Among Subjects Achieving ≥30% Reduction in Pain Intensity in ADPS Based on Question 5 of the ZBPI. | ||||||||||||
End point description |
ADPS is based on question 5 of ZBPI and assessed on an 11-point numerical rating scale where, 0 = No Pain to 10 = pain as bad as you can imagine.
|
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End point type |
Secondary
|
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End point timeframe |
Week 6 to Week 11
|
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|
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Notes [9] - Data for the outcome measure was not analysed due to change in planned analyses. [10] - Data for the outcome measure was not analysed due to change in planned analyses. |
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No statistical analyses for this end point |
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End point title |
Number of Subjects With Treatment-emergent Adverse Events (TEAEs) | ||||||||||||
End point description |
Adverse Events (AEs) are defined as any sign, symptom, or diagnosis/disease that is unfavorable or unintended, that is new, or if pre-existing, worsens in subjects administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. Treatment-emergent AEs are defined as any AEs reported after the first dose of double-blind study medication on study Day 1. The safety population included those subjects who took at least 1 dose of study drug during the Double-blind Treatment period.
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End point type |
Secondary
|
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End point timeframe |
From informed consent to the end of safety follow-up (up to 15 weeks)
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No statistical analyses for this end point |
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Adverse events information
|
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Timeframe for reporting adverse events |
From informed consent to the end of safety follow-up (up to 15 weeks)
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Adverse event reporting additional description |
The data is reported for subjects in the Double-blind Treatment Period and Single-blind Placebo Safety Follow-up Treatment Period. The safety population included those subjects who took at least 1 dose of study drug during the Double-blind Treatment period. Adverse events reported occurred at a frequency >=5% in any treatment group.
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Assessment type |
Systematic | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
23.0
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Reporting groups
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Reporting group title |
Placebo (Double-blind Treatment Period)
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Reporting group description |
Following a 2-week Single-blind Placebo Run-in period, subjects received a single loading dose of matching-placebo to LX9211 tablet, orally, on Day 1 and maintenance doses, orally, once daily from Day 2 to Week 6. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
LX9211 (Double-blind Treatment Period)
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Reporting group description |
Following a 2-week Single-blind Placebo Run-in period, subjects received a single loading dose of 200 mg tablet, orally, on Day 1 and maintenance doses of 20 mg, orally, once daily from Day 2 to Week 6. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Placebo (Single-blind Placebo Safety Follow-up Period)
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Reporting group description |
Following completion of the 6-week double-blind Treatment Period, all subjects entered the 5-week single-blind Placebo Safety Follow-up Period and received a daily dose of matching placebo to LX9211 tablet, orally. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
LX9211 (Single-blind Placebo Safety Follow-up Period)
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Reporting group description |
Following completion of the 6-week double-blind Treatment Period, all subjects entered the 5-week single-blind Placebo Safety Follow-up Period and received a daily dose of LX9211 tablet, orally. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 5% | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
|||
Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
||
23 Oct 2020 |
• EudraCT Number was provided as unique study reference for participating European Sites • Study Drug Administration: Run-in period Tables
was removed as all patients during this time point were to be administered study placebo only • Futility assessment was not needed as interim
efficacy analysis provided needed statistical data • Global protocol alignment with regard to patients being able to consume a light meal prior to study visits to ensure that patient’s weight was collected despite having had consumed food • Safety Physician contact information was updated as
new person was performing this role • Appendix A: Clarification to table footer (i) to better outline which pregnancy test types (serum/urine)
were collected during time points (Screening and Day 1 [Baseline]) • Appendix A: Clarification to table footer (k) performed to better outline the collection time points of Cp2hr, biomarker/target engagement, and cytokine and chemokine blood samples
|
||
03 Mar 2021 |
• To streamline brand and dose, only the acetaminophen provided by the Sponsor as a rescue medicine was to be used during the course of the
study. It was noted that the use of personally acquired acetaminophen was prohibited. • To avoid confusion, the text in the protocol was globally aligned regarding the permitted time frame for brief use of opioid medication for the management of non-PHN acute pain prior to the
Screening Visit. • Use of NSAIDs for the specific treatment of PHN pain was excluded. • The Sponsor was responsible for deciding if Verified Clinical Trials were established in specific countries. • The Safety Physician contact information was updated as new person performing this role. |
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15 Oct 2021 |
• Modified plans for interim analysis and their implications • The exclusion of patients with facial PHN were eligible for participation if trigeminal neuralgia was excluded as a cause • Changed the physical address of Lexicon Pharmaceuticals, Inc. |
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Interruptions (globally) |
|||
Were there any global interruptions to the trial? No | |||
Limitations and caveats |
|||
Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |