Trial Outcomes & Findings for Evaluation of TAK-058 and Ondansetron on P50 Auditory Gating in Participants With Stable Schizophrenia (NCT NCT02614586)

Last Updated: 2017-05-01

Results Overview

Participants were planned to check for P50 gating ratio. Stimulus signal of 90 decibel pulses of 0.1 millisecond (msec) was to be generated and recorded the event-related potential waveforms. 32 pairs of auditory clicks were to be presented every 10 seconds, with a 500 msec interclick interval. S1 is defined as the conditioning P50 wave with the most positive peak between 30 and 90 msec after the conditioning stimulus. S2 is defined as the test P50 wave with the positive peak after the test stimulus that was closest in latency to the conditioning P50. Amplitude is the difference between the positive peak and the preceding negative trough for both waves. The data from the vertex (Cz site) was to be collected and the P50 gating ratio (S2/S1) was to be calculated as the ratio of the test P50 amplitude to the conditioning P50 amplitude.

Recruitment status

TERMINATED

Study phase

PHASE1

Target enrollment

11 participants

Primary outcome timeframe

Part 2: Day 1 pre-dose and at multiple time points (up to 2 hours) post-dose in each period.

Results posted on

2017-05-01

Participant Flow

Participants took part in the study at 1 investigative site in the United States from 09 December 2015 to 29 April 2016.

Participants with a diagnosis of schizophrenia were enrolled in this 2-part study comprised of Part-1, screening and Part-2, treatment phase. Part-2 was not initiated because in Part-1 (sequential step 2), the P50 auditory gating (stimulus\[S\]2/S1) ratio for alpha and beta frequency bands demonstrated high variability and the study was terminated.

Participant milestones

Participant milestones
Measure	Part-1: Screening Phase Participants received 2 P50 electroencephalography (EEG) sessions, first session was conducted in the morning, and second session was conducted in the afternoon. Participants did not receive any study medication in Screening Phase (Part-1) of the study.
Overall Study STARTED	11
Overall Study COMPLETED	11
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of TAK-058 and Ondansetron on P50 Auditory Gating in Participants With Stable Schizophrenia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Part-1: Screening Phase n=11 Participants Participants received 2 P50 electroencephalography (EEG) sessions, first session was conducted in the morning, and second session was conducted in the afternoon. Participants did not receive any study medication in Screening Phase (Part-1) of the study.
Age, Continuous	46.5 years STANDARD_DEVIATION 4.63 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	11 participants n=5 Participants
Race/Ethnicity, Customized Black or African American	11 participants n=5 Participants
Region of Enrollment United States	11 participants n=5 Participants
Height	170.7 centimeter (cm) STANDARD_DEVIATION 12.39 • n=5 Participants
Weight	87.75 kilogram (kg) STANDARD_DEVIATION 19.351 • n=5 Participants
Body Mass Index (BMI)	29.93 kilogram per square meter (kg/m^2) STANDARD_DEVIATION 4.929 • n=5 Participants
Smoking Classification Never Smoked	6 participants n=5 Participants
Smoking Classification Current Smoker	5 participants n=5 Participants
Caffeine Consumption Consumed Caffeine	9 participants n=5 Participants
Caffeine Consumption Did not Consume Caffeine	2 participants n=5 Participants
Female Reproductive Status Postmenopausal	1 participants n=5 Participants
Female Reproductive Status Surgically Sterile	1 participants n=5 Participants
Female Reproductive Status Have Childbearing Potential	3 participants n=5 Participants
Female Reproductive Status Not Applicable	6 participants n=5 Participants

PRIMARY outcome

Timeframe: Part 2: Day 1 pre-dose and at multiple time points (up to 2 hours) post-dose in each period.

Population: Part 2 was not initiated because it was not possible to calculate an ICC due to the magnitude of the intrasubject variability in relation to the intersubject variability.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Part 2: Day 1 of Intervention Period 1 up to Day 21

Population: Part 2 was not initiated because it was not possible to calculate an ICC due to the magnitude of the intrasubject variability in relation to the intersubject variability.

Outcome measures

Outcome data not reported

Adverse Events

Part 2: TAK-058 and Ondansetron

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

Medical Director

Takeda

Phone: +1-877-825-3327

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Research Organization shall not publish any articles or papers nor make any presentations, nor assist any other person in publishing any articles or papers or in making any presentations relating or referring to the Study or any results, data or insights from or any data, information or materials obtained or generated in the performance of its obligations without the prior written consent of Takeda, which consent may be granted or withheld in Takeda's sole discretion.
Publication restrictions are in place

Restriction type: OTHER