Trial Outcomes & Findings for Capsaicin 8% Patch for Spinal Cord Injury Neuropathic Pain (NCT NCT02441660)

Results Overview

The Visual Analog Scale (VAS) was used as the primary outcome measure to quantify pain on a scale of 0-10, with 0 being no pain and 10 being the worst pain. VAS was measured at weeks 2,4,6,8,10 and12 during each 12- week block.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

11 participants

Primary outcome timeframe

Change in pain at 2,4,6,8, 10 and 12 weeks

Results posted on

2023-01-26

Participant Flow

Study participants will be randomized to either the low dose control capsacin or the higher dose 8% capsacin intervention first, and after 12 weeks, will be assigned to the opposite intervention for 12 weeks so that each person acts as their own control. Data collected will compare only the investigational drug group to the control group.

Participant milestones

Participant milestones
Measure	Qutenza Patch Followed by Low Dose Control Patch The 8% Qutenza patch will administered for 12 weeks followed by the low dose control patch for 12 weeks	Control Patch, Then Qutenza Patch The Low dose control patch will administered for 12 weeks followed by the 8% Qutenza patch for 12 weeks
Sequence 1 (12 Weeks) STARTED	5	6
Sequence 1 (12 Weeks) COMPLETED	5	6
Sequence 1 (12 Weeks) NOT COMPLETED	0	0
Sequence 2 (12 Weeks) STARTED	5	6
Sequence 2 (12 Weeks) COMPLETED	5	6
Sequence 2 (12 Weeks) NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Overall Study Demographics n=11 Participants All subjects were included in both arms of the study, so demographics are reported together for all participants.
Age, Continuous	49.72 years n=11 Participants
Sex: Female, Male Female	2 Participants n=11 Participants
Sex: Female, Male Male	9 Participants n=11 Participants
Region of Enrollment United States	11 participants n=11 Participants

PRIMARY outcome

Timeframe: Change in pain at 2,4,6,8, 10 and 12 weeks

The Visual Analog Scale (VAS) was used as the primary outcome measure to quantify pain on a scale of 0-10, with 0 being no pain and 10 being the worst pain. VAS was measured at weeks 2,4,6,8,10 and12 during each 12- week block.

Outcome measures

Outcome measures
Measure	Experimental Group n=11 Participants Qutenza, Capsaicin 8% Patch will be used Capsaicin 8% Patch: Applied topically for 1 hour	Control Group n=11 Participants Active control with low dose capsaicin Low Dose Capsaicin 0.04% gel
Change in Pain Relief With Visual Analog (VAS) Pain Scale 2 weeks	3.586 score on a scale Standard Error 0.5345	5.494 score on a scale Standard Error 0.5775
Change in Pain Relief With Visual Analog (VAS) Pain Scale 4 weeks	4.041 score on a scale Standard Error 0.5345	5.677 score on a scale Standard Error 0.5345
Change in Pain Relief With Visual Analog (VAS) Pain Scale 6 weeks	4.984 score on a scale Standard Error 0.5540	5.768 score on a scale Standard Error 0.5345
Change in Pain Relief With Visual Analog (VAS) Pain Scale 8 weeks	4.184 score on a scale Standard Error 0.5540	4.834 score on a scale Standard Error 0.5544
Change in Pain Relief With Visual Analog (VAS) Pain Scale 10 weeks	4.284 score on a scale Standard Error 0.5540	4.753 score on a scale Standard Error 0.5769
Change in Pain Relief With Visual Analog (VAS) Pain Scale 12 weeks	4.049 score on a scale Standard Error 0.5775	4.311 score on a scale Standard Error 0.6795

PRIMARY outcome

Timeframe: Every 4 weeks for 12 weeks

The World Health Organization Quality of Life (WHOQOL-BREF) questionnaire is a scale used to assess an individual's perception of their quality of life. Its domains include physical health, psychological health, social relationships, and patient environment. It is scored from 0-100, where lower scores indicate poorer perception of quality of life and higher scores indicate better perception. This scale was used to investigate if there was any pattern of change in QOL due to improved pain control. WHO-QOL-BREF was also measured every 4 weeks of each period.

Outcome measures

Outcome measures
Measure	Experimental Group n=11 Participants Qutenza, Capsaicin 8% Patch will be used Capsaicin 8% Patch: Applied topically for 1 hour	Control Group n=11 Participants Active control with low dose capsaicin Low Dose Capsaicin 0.04% gel
Change in Quality of Life as Measured by the World Health Organization Quality of Life (WHOQOL-BREF) 8 weeks	80.91 score on a scale Standard Error 4.204	85.42 score on a scale Standard Error 4.207
Change in Quality of Life as Measured by the World Health Organization Quality of Life (WHOQOL-BREF) 4 weeks	79.26 score on a scale Standard Error 4.092	80.91 score on a scale Standard Error 4.092
Change in Quality of Life as Measured by the World Health Organization Quality of Life (WHOQOL-BREF) 12 weeks	74.90 score on a scale Standard Error 4.092	87.42 score on a scale Standard Error 4.207

PRIMARY outcome

Timeframe: Every 4 weeks for12 weeks

The Spinal Cord Independence Measure (SCIM) is a reliable scale that measures proficiency of activities of daily living (ADL's) of patients with spinal cord injuries. (28) It is broken up into four subscales including self-care, respiration and sphincter control, and mobility with a total score combining all 3 outcomes. It is scored from 0-100, where lower numbers indicate more dependence on others and higher numbers indicate less dependence. This tool can be applied practically to the study to investigate everyday function before and after patch application. SCIM was administered every 4 weeks of each period.

Outcome measures

Outcome measures
Measure	Experimental Group n=11 Participants Qutenza, Capsaicin 8% Patch will be used Capsaicin 8% Patch: Applied topically for 1 hour	Control Group n=11 Participants Active control with low dose capsaicin Low Dose Capsaicin 0.04% gel
Change in Spinal Cord Independence Measure (SCIM) 4 weeks	20.32 score on a scale Standard Error 0.9886	18.86 score on a scale Standard Error 0.9886
Change in Spinal Cord Independence Measure (SCIM) 8 weeks	20.70 score on a scale Standard Error 1.0132	18.66 score on a scale Standard Error 1.0140
Change in Spinal Cord Independence Measure (SCIM) 12 weeks	19.23 score on a scale Standard Error 0.9886	18.86 score on a scale Standard Error 1.0140

Adverse Events

Experimental Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Michelle Trbovich

UT Health San Antonio

Phone: 210-617-5300

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place