Trial Outcomes & Findings for Effect of Neurokinin-1 Receptor (NK1R) Antagonism on Pruritus in Patients With Sezary Syndrome (NCT NCT01625455)

Results Overview

The primary endpoint is the severity of pruritus as measured on the visual analogue scale. A score of 100 indicated the worst pruritus imaginable, while 0 indicated no pruritus.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

7 participants

Primary outcome timeframe

one week

Results posted on

2017-05-10

Participant Flow

Seven subjects were consented and enrolled. Two did not meet inclusion/exclusion criteria and were not randomized.

Participant milestones

Participant milestones
Measure	Placebo Then Aprepitant These subjects received placebo during the first week and then crossed over to aprepitant for the second week.	Aprepitant Then Placebo. These subjects received aprepitant during the first week and then crossed over to placebo for the second week.
Overall Study STARTED	2	3
Overall Study COMPLETED	2	3
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effect of Neurokinin-1 Receptor (NK1R) Antagonism on Pruritus in Patients With Sezary Syndrome

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo Then Aprepitant n=2 Participants These subjects received placebo during the first week and then crossed over to aprepitant for the second week.	Aprepitant Then Placebo. n=3 Participants These subjects received aprepitant during the first week and then crossed over to placebo for the second week.	Total n=5 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=99 Participants	2 Participants n=107 Participants	2 Participants n=206 Participants
Age, Categorical >=65 years	2 Participants n=99 Participants	1 Participants n=107 Participants	3 Participants n=206 Participants
Age, Continuous	71 years n=99 Participants	58.3 years n=107 Participants	63.4 years n=206 Participants
Sex: Female, Male Female	1 Participants n=99 Participants	2 Participants n=107 Participants	3 Participants n=206 Participants
Sex: Female, Male Male	1 Participants n=99 Participants	1 Participants n=107 Participants	2 Participants n=206 Participants
Region of Enrollment United States	2 participants n=99 Participants	3 participants n=107 Participants	5 participants n=206 Participants

PRIMARY outcome

Timeframe: one week

The primary endpoint is the severity of pruritus as measured on the visual analogue scale. A score of 100 indicated the worst pruritus imaginable, while 0 indicated no pruritus.

Outcome measures

Outcome measures
Measure	Aprepitant n=5 Participants Aprepitant will be given orally in a dose of 125mg on day 1 and 80mg daily on each subsequent day for a total of 7 days. Aprepitant: Aprepitant will be given orally in a dose of 125mg on day 1 and 80mg daily on each subsequent day for a total of 7 days.	Placebo n=5 Participants Matching placebo will be given in place of aprepitant Placebo: Placebo will be given orally for a total of 7 days.
Severity of Pruritus	58.20 units on a scale Standard Deviation 17.82	47.47 units on a scale Standard Deviation 20.22

SECONDARY outcome

Timeframe: one week

The secondary endpoint is the quality of life as measured on the Dermatology Quality of Life Index (DLQI). For a series of 10 questions the responses are scored: Very much, scored 3; A lot, scored 2; A little, scored 1; Not at all, scored 0; Not relevant, scored 0; and Question unanswered, scored 0. The scores are summed and the larger the score the greater the effect of the dermatological disease impact on quality of life. Maximum response for all ten questions 30, minimum 0.

Outcome measures

Outcome measures
Measure	Aprepitant n=5 Participants Aprepitant will be given orally in a dose of 125mg on day 1 and 80mg daily on each subsequent day for a total of 7 days. Aprepitant: Aprepitant will be given orally in a dose of 125mg on day 1 and 80mg daily on each subsequent day for a total of 7 days.	Placebo n=5 Participants Matching placebo will be given in place of aprepitant Placebo: Placebo will be given orally for a total of 7 days.
Quality of Life	14.2 scores on a scale Standard Deviation 9.7	14.8 scores on a scale Standard Deviation 10.3

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Aprepitant

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

Nancy J. Brown, M.D., Principal Investigator

VANDERBILT UNIVERSITY MEDICAL CENTER

Phone: 6153438701

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place