Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Vernalis (R&D) Ltd | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to investigate whether V158866 is safe and effective for the treatment of neuropathic pain due to spinal cord injury.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo followed by V158866 | Experimental | Placebo once per day for 4 weeks followed by V158866 450mg once per day for 4 weeks |
|
| V158866 followed by Placebo | Experimental | V158866 450mg once per day for 4 Weeks followed by Placebo once per day for 4 Weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| V158866 | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Pain Intensity (NRS) | Numerical Rating Scale, measuring the intensity of pain from 0 to 10, with 0 being no pain and 10 being worst pain imaginable. The comparison of the overall pain intensity, calculated as the mean of the last 7 days on treatment, for each treatment period (V158866 compared to placebo). | 4 Weeks |
| Safety and Tolerability of V158866 Compared to Placebo | Safety and tolerability were measured by occurrence of treatment-emergent adverse events; data represents the number of subjects who experienced treatment-emergent adverse events during each treatment period. | 4 weeks |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Christine N Sang, MD, MPH | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Translational Pain Research, Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
Included a 14-day period to exclude non-compliers, extremes of pain ratings, and those with high variability
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo Followed by V158866 | Placebo once per day for 4 weeks followed by V158866 450mg once per day for 4 weeks |
| FG001 | V158866 Followed by Placebo | V158866 450mg once per day for 4 weeks followed by placebo once per day for 4 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention (4 Weeks) |
| |||||||||||||
| Second Intervention (4 Weeks) |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | V158866 and Placebo | Placebo once per day for 4 weeks followed by V158866 450mg once per day for 4 weeks or vice versa |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Mean Pain Intensity (NRS) | Numerical Rating Scale, measuring the intensity of pain from 0 to 10, with 0 being no pain and 10 being worst pain imaginable. The comparison of the overall pain intensity, calculated as the mean of the last 7 days on treatment, for each treatment period (V158866 compared to placebo). | Posted | Mean | Standard Error | units on a scale | 4 Weeks |
|
From start of study participation until all adverse events had resolved following study participation, an average of 4 months
All events that were possibly, probably, or definitely related to study medication
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Placebo once per day for 4 weeks |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Difficulty Concentrating | Nervous system disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Christine N. Sang, Director of Translational Pain Research | Brigham and Women's Hospital | 617-525-7246 | csang@partners.org |
Not provided
| ID | Term |
|---|---|
| D009437 | Neuralgia |
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
|
| NOT COMPLETED |
|
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|
| Participants |
|
|
|
| Primary | Safety and Tolerability of V158866 Compared to Placebo | Safety and tolerability were measured by occurrence of treatment-emergent adverse events; data represents the number of subjects who experienced treatment-emergent adverse events during each treatment period. | Posted | Count of Participants | Participants | No | 4 weeks |
|
|
|
| 0 |
| 25 |
| 7 |
| 25 |
| EG001 | V158866 | V158866 450mg once per day for 4 Weeks | 0 | 25 | 12 | 25 |
| Fatigue (Sleepiness) | Nervous system disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Drowsiness | Nervous system disorders | Systematic Assessment |
|
Not provided
Not provided
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |