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The purpose of this study is to investigate the effect of soticlestat (TAK-935) on calculated 24-hour average pain intensity by the numeric pain scale (NPS).
The drug being tested in this study is called soticlestat (TAK-935). Soticlestat is being tested to treat people with chronic complex regional pain syndrome (CRPS). This study will look at the efficacy, safety, and tolerability of soticlestat as an adjunctive therapy in participants with CRPS.
The study will enroll approximately 24 patients. Participants will be randomly assigned (by chance, like flipping a coin) in 2:1 ratio to one of the two treatment groups-which will remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need):
Soticlestat 100 mg tablets, 100, 200 or 300 mg twice daily (BID) Placebo (dummy inactive pill) - this is a tablet that looks like the study drug but has no active ingredient
Participants will receive 100 mg soticlestat tablets or soticlestat matching placebo tablets, BID for Week 1, 2x100 mg soticlestat tablets or soticlestat matching placebo tablets, BID for Week 2 and followed by 3x100 mg soticlestat tablets or soticlestat matching placebo tablets, BID for Week 3. Dose will be uptitrated based on safety and tolerability in titration period. Participants will continue to receive the same dose in maintenance period. Dose adjustments during maintenance period may take place due to safety and tolerability.
Participants will then enter Part B (optional) or taper period. In Part B all participants will receive soticlestat 2x100 mg tablets, BID for 1 Week, followed by soticlestat 3x100 mg tablets, BID for 1 Week. Dose will be uptitrated/downtitrated based on safety and tolerability in titration period (Part B), participants will continue to receive the same dose in maintenance period (Part B) and followed by a taper period.
This multi-center trial will be conducted in United Kingdom. The overall time to participate in this study is approximately 36 weeks. Participants will make multiple visits to the clinic and will be contacted by telephone 15 days after last dose of study drug for a follow-up assessment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Double-Blind Treatment Period - Part A: Placebo | Placebo Comparator | Soticlestat matching placebo tablets, orally, twice daily (BID) for Weeks 1, 2 and 3 in Double blind Titration Period. Soticlestat matching placebo tablets, orally BID for 12 weeks in Double blind Maintenance Period. Taper period (if participant did not continue to Part B): Dose of soticlestat matching placebo tablets was reduced to next lower dose every 3 days (maximum 6 days) until discontinuation. |
|
| Double-Blind Treatment Period - Part A: Soticlestat | Experimental | Soticlestat, tablet, orally, 100 mg BID for Week 1, followed by 2×100 mg tablets, soticlestat, orally BID for Week 2, further followed by 3×100 mg tablets, soticlestat, orally BID for Week 3. Dose was uptitrated every week based on safety and tolerability. Part A (Double blind Maintenance Period): 3×100 mg tablets, soticlestat, orally BID for 12 weeks. Dose was adjusted during Maintenance Period due to safety and tolerability. Taper Period (if participant did not continue to Part B): Dose of soticlestat was reduced to next lower dose every 3 days (maximum 6 days) until soticlestat was discontinued. |
|
| Open-Label Extension Period - Part B: Soticlestat | Experimental | Soticlestat, 2×100 mg tablets, orally, BID for Week 1, followed by 3×100 mg tablets, soticlestat, orally, BID for Week 2. Dose was uptitrated every week based on safety and tolerability. Part B (Open label extension: Maintenance Period): 3×100 mg tablets, soticlestat, orally, BID for 12 weeks. Dose was adjusted during Maintenance Period due to safety and tolerability. Taper Period: Dose of soticlestat was reduced to next lower dose every 3 days (maximum 6 days) until soticlestat was discontinued. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Soticlestat | Drug | Soticlestat tablets |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Mean 24-Hour Pain Intensity as Assessed by NPS Score to the End of Part A | The 24-hour average pain intensity was calculated from current pain intensity scores collected three times a day as measured by the electronic pain diary daily using NPS. NPS is an 11-point scale, where scores range from 0-10, 0= no pain to 10 = most pain imaginable. Negative change from Baseline indicated improvement. | Baseline and Week 15 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in Mean 24-Hour Pain Intensity as Assessed by NPS Score to the End of Part A | The 24-hour average pain intensity was calculated from current pain intensity scores collected three times a day as measured by the electronic pain diary daily using NPS. NPS is an 11-point scale, where scores range from 0-10, 0= no pain to 10 = most pain imaginable. Negative percent change from Baseline indicated improvement. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St Pancras Clinical Research | London | England | WC1X 8QD | United Kingdom | ||
| Lancashire Teaching Hospitals NHS Foundation Trust |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36538782 | Derived | Ratcliffe S, Arkilo D, Asgharnejad M, Bhattacharya S, Harden RN. Randomized controlled study to evaluate the efficacy and safety of soticlestat as adjunctive therapy in adults with complex regional pain syndrome. Pain Med. 2023 Jul 5;24(7):872-880. doi: 10.1093/pm/pnac198. |
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Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
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IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Participants with a diagnosis of chronic complex regional pain syndrome (CRPS) were enrolled to receive soticlestat or placebo in Part A (Double-blind [DB] Treatment Period) and soticlestat in Part B (Open-label [OL] Treatment Period). Following completion of the Part A, participants had an option to continue into Part B.
Participants took part in the study at three investigative sites in United Kingdom (UK) from 23 July 2019 to 28 October 2020.
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| ID | Title | Description |
|---|---|---|
| FG000 | Double-Blind Treatment Period - Part A: Placebo | Soticlestat matching placebo tablets, orally, twice daily (BID) for Weeks 1, 2 and 3 in Double blind Titration Period. Soticlestat matching placebo tablets, orally BID for 12 weeks in Double blind Maintenance Period. Taper period (if participant did not continue to Part B): Dose of soticlestat matching placebo tablets was reduced to next lower dose every 3 days (maximum 6 days) until discontinuation. |
| FG001 | Double-Blind Treatment Period - Part A: Soticlestat | Soticlestat, tablet, orally, 100 mg BID for Week 1, followed by 2×100 mg tablets, soticlestat, orally BID for Week 2, further followed by 3×100 mg tablets, soticlestat, orally BID for Week 3. Dose was uptitrated every week based on safety and tolerability. Part A (Double blind Maintenance Period): 3×100 mg tablets, soticlestat, orally BID for 12 weeks. Dose was adjusted during Maintenance Period due to safety and tolerability. Taper Period (if participant did not continue to Part B): Dose of soticlestat was reduced to next lower dose every 3 days (maximum 6 days) until soticlestat was discontinued. |
| FG002 | Open-Label Extension Period - Part B: Soticlestat | Soticlestat, 2×100 mg tablets, orally, BID for Week 1, followed by 3×100 mg tablets, soticlestat, orally, BID for Week 2. Dose was uptitrated every week based on safety and tolerability. Part B (Open label extension: Maintenance Period): 3×100 mg tablets, soticlestat, orally, BID for 12 weeks. Dose was adjusted during Maintenance Period due to safety and tolerability. Taper Period: Dose of soticlestat was reduced to next lower dose every 3 days (maximum 6 days) until soticlestat was discontinued. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Part A: DB Treatment Period (15 Weeks) |
|
| |||||||||||||||||||||
| Part B: OL Extension Period (14 Weeks) |
|
Safety Analysis Set for Part A included all participants who received at least 1 dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Double-Blind Treatment Period - Part A: Placebo | Soticlestat matching placebo tablets, orally, twice daily (BID) for Weeks 1, 2 and 3 in Double blind Titration Period. Soticlestat matching placebo tablets, orally BID for 12 weeks in Double blind Maintenance Period. Taper period (if participant did not continue to Part B): Dose of soticlestat matching placebo tablets was reduced to next lower dose every 3 days (maximum 6 days) until discontinuation. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Mean 24-Hour Pain Intensity as Assessed by NPS Score to the End of Part A | The 24-hour average pain intensity was calculated from current pain intensity scores collected three times a day as measured by the electronic pain diary daily using NPS. NPS is an 11-point scale, where scores range from 0-10, 0= no pain to 10 = most pain imaginable. Negative change from Baseline indicated improvement. | Full Analysis Set for included all participants who were randomized, received at least 1 dose of study drug, and had at least one valid post-baseline value for the assessment of average 24-hour pain score. The data is reported for Part A in this outcome measure. Overall number of participants analyzed are the number of participants with data available for analyses. | Posted | Mean | Standard Deviation | scores on scale | Baseline and Week 15 |
|
From signing of the informed consent up to 15 days after last dose of the study drug (Up to approximately Week 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Double-Blind Treatment Period - Part A: Placebo | Soticlestat matching placebo tablets, orally, twice daily (BID) for Weeks 1, 2 and 3 in Double blind Titration Period. Soticlestat matching placebo tablets, orally BID for 12 weeks in Double blind Maintenance Period. Taper period (if participant did not continue to Part B): Dose of soticlestat matching placebo tablets was reduced to next lower dose every 3 days (maximum 6 days) until discontinuation. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | 23.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | 23.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Takeda | +1-877-825-3327 | TrialDisclosures@takeda.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 16, 2019 | Jun 24, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 10, 2021 | Jun 24, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D020918 | Complex Regional Pain Syndromes |
| ID | Term |
|---|---|
| D001342 | Autonomic Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
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| ID | Term |
|---|---|
| C000712808 | soticlestat |
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| Placebo | Drug | Soticlestat matching placebo tablets |
|
| Baseline and Week 15 |
| Percentage of Participants Considered Responders at the End of Part A | Response was defined as ≥ 30% improvement on the 24-hour pain intensity as assessed by the NPS score. The 24-hour average pain intensity was calculated from current pain intensity scores collected three times a day as measured by the electronic pain diary daily using NPS during Part A. NPS is an 11-point scale, where scores range from 0-10, 0= no pain to 10 = most pain imaginable. | Week 15 |
| Change From Baseline in Domain Score of PROMIS-29 Version 2.1 at the End of Part A | PROMIS-29 (v2.1) is a health-related quality of life survey assessing 7 domains with 4 questions on a 5-point Likert scale. Total raw domain scores are converted into T-scores from a reference population: Depression: 1=never to 5=always, T-scores:41.0-79.4; Physical function: 1=unable to do to 5=without any difficulty, T-scores: 22.5-57.0; Anxiety: 1=never to 5=always, T-scores: 40.3-81.6; Pain interference: 1=not at all to 5=very much, T-scores: 41.6-75.6; Fatigue: 1=not at all to 5=very much, T-scores: 33.7-75.8; Sleep disturbance: 1=very much to 5=not at all, T-scores: 32.0-73.3; Ability to participate in social roles or activities: 1=always to 5=never, T-scores: 27.5-64.2. High scores signify more of domain being measured. Thus, on symptom-oriented domains, higher scores=worse symptomatology and a negative change from Baseline indicates improvement. On function-oriented domains, higher score=better functioning and a positive change from Baseline indicates improvement. | Baseline and Week 15 |
| Percent Change From Baseline in Domain Score of PROMIS-29 Version 2.1 at the End of Part A | PROMIS-29 (v2.1) is a health-related quality of life survey assessing 7 domains with 4 questions on a 5-point Likert scale. Total raw domain scores are converted into T-scores from a reference population: Depression: 1=never to 5=always, T-scores:41.0-79.4; Physical function: 1=unable to do to 5=without any difficulty, T-scores: 22.5-57.0; Anxiety: 1=never to 5=always, T-scores: 40.3-81.6; Pain interference: 1=not at all to 5=very much, T-scores: 41.6-75.6; Fatigue: 1=not at all to 5=very much, T-scores: 33.7-75.8; Sleep disturbance: 1=very much to 5=not at all, T-scores: 32.0-73.3; Ability to participate in social roles or activities: 1=always to 5=never, T-scores: 27.5-64.2. High scores signify more of domain being measured. Thus, on symptom-oriented domains, higher scores=worse symptomatology and a negative change from Baseline indicates improvement. On function-oriented domains, higher score=better functioning and a positive change from Baseline indicates improvement. | Baseline and Week 15 |
| Percentage of Participants in Each Category of the Patient Global Impression of Change (PGIC) Scale at the End of Part A | The PGIC is a 7-point Likert scale to address the following question: Since beginning treatment at this clinic would you describe any changes (if any) in activity, limitations, symptoms, emotions and overall quality of life related to your painful condition compared to before treatment? Participants select from scale range of 1-7: very much improved (1); much improved (2); minimally improved (3); no change (4); minimally worse (5); much worse (6); very much worse (7). Only categories with at least 1 participant were reported. | Week 15 |
| Change From Baseline in Complex Regional Pain Syndrome (CSS) at the End of Part A | Signs and symptoms reflecting the sensory, vasomotor, sudomotor/edema, and motor/trophic disturbances of CRPS had been incorporated into a clinically feasible CSS. Total CSS is a 16-point score which was calculated by the number of "yes" answers to the questions on the 8 symptoms and 8 signs when all 16 questions were answered. Negative change from Baseline indicates improvement. | Baseline and Week 15 |
| Percent Change From Baseline in CSS at the End of Part A | Signs and symptoms reflecting the sensory, vasomotor, sudomotor/edema, and motor/trophic disturbances of CRPS had been incorporated into a clinically feasible CSS. Total CSS is a 16-point score which was calculated by the number of "yes" answers to the questions on the 8 symptoms and 8 signs when all 16 questions were answered. Negative percent change from Baseline indicates improvement. | Baseline and Week 15 |
| Preston |
| England |
| PR2 9HT |
| United Kingdom |
| University Hospital Southampton NHS Foundation Trust | Southampton | England | SO16 6YD | United Kingdom |
| Withdrawal by Subject |
|
| Reason not Specified |
|
| NOT COMPLETED |
|
|
| BG001 | Double-Blind Treatment Period - Part A: Soticlestat | Soticlestat, tablet, orally, 100 mg BID for Week 1, followed by 2×100 mg tablets, soticlestat, orally BID for Week 2, further followed by 3×100 mg tablets, soticlestat, orally BID for Week 3. Dose was uptitrated every week based on safety and tolerability. Part A (Double blind Maintenance Period): 3×100 mg tablets, soticlestat, orally BID for 12 weeks. Dose was adjusted during Maintenance Period due to safety and tolerability. Taper Period (if participant did not continue to Part B): Dose of soticlestat was reduced to next lower dose every 3 days (maximum 6 days) until soticlestat was discontinued. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Numeric Pain Scale (NPS) Score | The 24-hour average pain intensity was calculated from current pain intensity scores collected three times a day as measured by the electronic pain diary daily using NPS. NPS is an 11-point scale, where scores range from 0-10, 0= no pain to 10 = most pain imaginable. | Mean | Full Range | scores on a scale |
|
| Patient-Reported Outcomes Measurement Information System (PROMIS-29) Version 2.1 Domain Score | PROMIS-29 (v2.1) assess health-related quality of life for 7 domains with T-scores of reference population: Depression:1=never-5=always;T-scores:41.0-79.4. Physical function:1=unable to do-5=without any difficulty;T-scores:22.5-57.0 3. Anxiety:1=never-5=always;T-scores:40.3-81.6. Pain interference: 1=not at all-5=very much;T-scores:41.6-75.6.Fatigue:1=not at all-5=very much;T-scores:33.7-75.8. Sleep disturbance:1=very much-5=not at all;T-scores:32.0-73.3. Ability to participate in social roles and activities:1=always-5=never;T-scores:27.5-64.2 Higher scores=more of domain being measured. | Mean | Standard Deviation | t-score |
|
| CRPS Severity Score (CSS) Total Score | Signs and symptoms reflecting the sensory, vasomotor, sudomotor/edema, and motor/trophic disturbances of CRPS had been incorporated into a clinically feasible CSS. Total CSS is a 16-point score which was calculated by the number of "yes" answers to the questions on the 8 symptoms and 8 signs when all 16 questions were answered. | Mean | Standard Deviation | scores on a scale |
|
Soticlestat matching placebo tablets, orally, twice daily (BID) for Weeks 1, 2 and 3 in Double blind Titration Period. Soticlestat matching placebo tablets, orally BID for 12 weeks in Double blind Maintenance Period. Taper period (if participant did not continue to Part B): Dose of soticlestat matching placebo tablets was reduced to next lower dose every 3 days (maximum 6 days) until discontinuation.
| OG001 | Double-Blind Treatment Period - Part A: Soticlestat | Soticlestat, tablet, orally, 100 mg BID for Week 1, followed by 2×100 mg tablets, soticlestat, orally BID for Week 2, further followed by 3×100 mg tablets, soticlestat, orally BID for Week 3. Dose was uptitrated every week based on safety and tolerability. Part A (Double blind Maintenance Period): 3×100 mg tablets, soticlestat, orally BID for 12 weeks. Dose was adjusted during Maintenance Period due to safety and tolerability. Taper Period (if participant did not continue to Part B): Dose of soticlestat was reduced to next lower dose every 3 days (maximum 6 days) until soticlestat was discontinued. |
|
|
| Secondary | Percent Change From Baseline in Mean 24-Hour Pain Intensity as Assessed by NPS Score to the End of Part A | The 24-hour average pain intensity was calculated from current pain intensity scores collected three times a day as measured by the electronic pain diary daily using NPS. NPS is an 11-point scale, where scores range from 0-10, 0= no pain to 10 = most pain imaginable. Negative percent change from Baseline indicated improvement. | Full Analysis Set for included all participants who were randomized, received at least 1 dose of study drug, and had at least one valid post-baseline value for the assessment of average 24-hour pain score. The data is reported for Part A in this outcome measure. Overall number of participants analyzed are the number of participants with data available for analyses. | Posted | Mean | Standard Deviation | percent change | Baseline and Week 15 |
|
|
|
| Secondary | Percentage of Participants Considered Responders at the End of Part A | Response was defined as ≥ 30% improvement on the 24-hour pain intensity as assessed by the NPS score. The 24-hour average pain intensity was calculated from current pain intensity scores collected three times a day as measured by the electronic pain diary daily using NPS during Part A. NPS is an 11-point scale, where scores range from 0-10, 0= no pain to 10 = most pain imaginable. | Full Analysis Set for included all participants who were randomized, received at least 1 dose of study drug, and had at least one valid post-baseline value for the assessment of average 24-hour pain score. The data is reported for Part A in this outcome measure. | Posted | Number | percentage of participants | Week 15 |
|
|
|
| Secondary | Change From Baseline in Domain Score of PROMIS-29 Version 2.1 at the End of Part A | PROMIS-29 (v2.1) is a health-related quality of life survey assessing 7 domains with 4 questions on a 5-point Likert scale. Total raw domain scores are converted into T-scores from a reference population: Depression: 1=never to 5=always, T-scores:41.0-79.4; Physical function: 1=unable to do to 5=without any difficulty, T-scores: 22.5-57.0; Anxiety: 1=never to 5=always, T-scores: 40.3-81.6; Pain interference: 1=not at all to 5=very much, T-scores: 41.6-75.6; Fatigue: 1=not at all to 5=very much, T-scores: 33.7-75.8; Sleep disturbance: 1=very much to 5=not at all, T-scores: 32.0-73.3; Ability to participate in social roles or activities: 1=always to 5=never, T-scores: 27.5-64.2. High scores signify more of domain being measured. Thus, on symptom-oriented domains, higher scores=worse symptomatology and a negative change from Baseline indicates improvement. On function-oriented domains, higher score=better functioning and a positive change from Baseline indicates improvement. | Full Analysis Set for included all participants who were randomized, received at least 1 dose of study drug, and had at least one valid post-baseline value for the assessment of average 24-hour pain score. The data is reported for Part A in this outcome measure. Number analyzed are the number of participants with data available for analyses in the given category (domain). | Posted | Mean | Standard Deviation | t-score | Baseline and Week 15 |
|
|
|
| Secondary | Percent Change From Baseline in Domain Score of PROMIS-29 Version 2.1 at the End of Part A | PROMIS-29 (v2.1) is a health-related quality of life survey assessing 7 domains with 4 questions on a 5-point Likert scale. Total raw domain scores are converted into T-scores from a reference population: Depression: 1=never to 5=always, T-scores:41.0-79.4; Physical function: 1=unable to do to 5=without any difficulty, T-scores: 22.5-57.0; Anxiety: 1=never to 5=always, T-scores: 40.3-81.6; Pain interference: 1=not at all to 5=very much, T-scores: 41.6-75.6; Fatigue: 1=not at all to 5=very much, T-scores: 33.7-75.8; Sleep disturbance: 1=very much to 5=not at all, T-scores: 32.0-73.3; Ability to participate in social roles or activities: 1=always to 5=never, T-scores: 27.5-64.2. High scores signify more of domain being measured. Thus, on symptom-oriented domains, higher scores=worse symptomatology and a negative change from Baseline indicates improvement. On function-oriented domains, higher score=better functioning and a positive change from Baseline indicates improvement. | Full Analysis Set for included all participants who were randomized, received at least 1 dose of study drug, and had at least one valid post-baseline value for the assessment of average 24-hour pain score. The data is reported for Part A in this outcome measure. Number analyzed are the number of participants with data available for analyses in the given category (domain). | Posted | Mean | Standard Deviation | percent change | Baseline and Week 15 |
|
|
|
| Secondary | Percentage of Participants in Each Category of the Patient Global Impression of Change (PGIC) Scale at the End of Part A | The PGIC is a 7-point Likert scale to address the following question: Since beginning treatment at this clinic would you describe any changes (if any) in activity, limitations, symptoms, emotions and overall quality of life related to your painful condition compared to before treatment? Participants select from scale range of 1-7: very much improved (1); much improved (2); minimally improved (3); no change (4); minimally worse (5); much worse (6); very much worse (7). Only categories with at least 1 participant were reported. | Full Analysis Set for included all participants who were randomized, received at least 1 dose of study drug, and had at least one valid post-baseline value for the assessment of average 24-hour pain score. The data is reported for Part A in this outcome measure. | Posted | Number | percentage of participants | Week 15 |
|
|
|
| Secondary | Change From Baseline in Complex Regional Pain Syndrome (CSS) at the End of Part A | Signs and symptoms reflecting the sensory, vasomotor, sudomotor/edema, and motor/trophic disturbances of CRPS had been incorporated into a clinically feasible CSS. Total CSS is a 16-point score which was calculated by the number of "yes" answers to the questions on the 8 symptoms and 8 signs when all 16 questions were answered. Negative change from Baseline indicates improvement. | Full Analysis Set for included all participants who were randomized, received at least 1 dose of study drug, and had at least one valid post-baseline value for the assessment of average 24-hour pain score. The data is reported for Part A in this outcome measure. Overall number of participants analyzed are the number of participants with data available for analyses. | Posted | Mean | Standard Deviation | scores on scale | Baseline and Week 15 |
|
|
|
|
| Secondary | Percent Change From Baseline in CSS at the End of Part A | Signs and symptoms reflecting the sensory, vasomotor, sudomotor/edema, and motor/trophic disturbances of CRPS had been incorporated into a clinically feasible CSS. Total CSS is a 16-point score which was calculated by the number of "yes" answers to the questions on the 8 symptoms and 8 signs when all 16 questions were answered. Negative percent change from Baseline indicates improvement. | Full Analysis Set for included all participants who were randomized, received at least 1 dose of study drug, and had at least one valid post-baseline value for the assessment of average 24-hour pain score. The data is reported for Part A in this outcome measure. Overall number of participants analyzed are the number of participants with data available for analyses. | Posted | Mean | Standard Deviation | percent change | Baseline and Week 15 |
|
|
|
| 0 |
| 9 |
| 0 |
| 9 |
| 9 |
| 9 |
| EG001 | Double-Blind Treatment Period - Part A: Soticlestat | Soticlestat, tablet, orally, 100 mg BID for Week 1, followed by 2×100 mg tablets, soticlestat, orally BID for Week 2, further followed by 3×100 mg tablets, soticlestat, orally BID for Week 3. Dose was uptitrated every week based on safety and tolerability. Part A (Double blind Maintenance Period): 3×100 mg tablets, soticlestat, orally BID for 12 weeks. Dose was adjusted during Maintenance Period due to safety and tolerability. Taper Period (if participant did not continue to Part B): Dose of soticlestat was reduced to next lower dose every 3 days (maximum 6 days) until soticlestat was discontinued. | 0 | 15 | 3 | 15 | 12 | 15 |
| EG002 | Open-Label Extension Period - Part B: Soticlestat | Soticlestat, 2×100 mg tablets, orally, BID for Week 1, followed by 3×100 mg tablets, soticlestat, orally, BID for Week 2. Dose was uptitrated every week based on safety and tolerability. Part B (Open label extension: Maintenance Period): 3×100 mg tablets, soticlestat, orally, BID for 12 weeks. Dose was adjusted during Maintenance Period due to safety and tolerability. Taper Period: Dose of soticlestat was reduced to next lower dose every 3 days (maximum 6 days) until soticlestat was discontinued. | 0 | 18 | 0 | 18 | 10 | 18 |
| Cholecystitis | Hepatobiliary disorders | 23.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | 23.0 | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | 23.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | 23.0 | Systematic Assessment |
|
| Fatigue | General disorders | 23.0 | Systematic Assessment |
|
| Influenza like illness | General disorders | 23.0 | Systematic Assessment |
|
| Conjunctivitis | Infections and infestations | 23.0 | Systematic Assessment |
|
| Lower respiratory tract infection | Infections and infestations | 23.0 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | 23.0 | Systematic Assessment |
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| Oral candidiasis | Infections and infestations | 23.0 | Systematic Assessment |
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| Oral herpes | Infections and infestations | 23.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | 23.0 | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | 23.0 | Systematic Assessment |
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| Procedural pain | Injury, poisoning and procedural complications | 23.0 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | 23.0 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | 23.0 | Systematic Assessment |
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| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | 23.0 | Systematic Assessment |
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| Neck pain | Musculoskeletal and connective tissue disorders | 23.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | 23.0 | Systematic Assessment |
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| Headache | Nervous system disorders | 23.0 | Systematic Assessment |
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| Lethargy | Nervous system disorders | 23.0 | Systematic Assessment |
|
| Depressed mood | Psychiatric disorders | 23.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | 23.0 | Systematic Assessment |
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| Suicidal ideation | Psychiatric disorders | 23.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | 23.0 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | 23.0 | Systematic Assessment |
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In general, Investigators may publish clinical data after the earlier of (i) publication by the Sponsor or (ii) 12 months following the abandonment, early termination or database lock; provided a copy of the publication provided to Sponsor at least 30 days ahead of publication, the Sponsor's confidential information is removed as may be requested by Sponsor and Investigator defers publication for up to 60 days in the event Sponsor provides notice that it intends to file a patent application.
| Anxiety |
|
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| Depression |
|
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| Fatigue |
|
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| Sleep Disturbance |
|
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| Ability to Participate in Social Roles |
|
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| Pain Interference |
|
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| Anxiety |
|
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| Depression |
|
|
| Fatigue |
|
|
| Sleep Disturbance |
|
|
| Ability to Participate in Social Roles |
|
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| Pain Interference |
|
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| No Change |
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| Minimally Worse |
|
| Missing |
|