Trial Outcomes & Findings for Adjunctive SPD489 to Antipsychotic Medication in Clinically Stable Adults With Persistent Predominant Negative Symptoms of Schizophrenia (NCT NCT01738698)

NCT ID: NCT01738698

Last Updated: 2021-06-22

Results Overview

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

4 participants

Primary outcome timeframe

Baseline and 12 weeks

Results posted on

2021-06-22

Participant Flow

Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized

Participant milestones

Participant milestones
Measure	SPD489 40mg SPD489 40mg: Oral administration of 40 mg once-daily for up to 12 weeks	SPD489 100mg SPD489 100mg: Oral administration of 100 mg once-daily for up to 12 weeks	SPD489 160mg SPD489 160mg: Oral administration of 160 mg once-daily for up to 12 weeks	Placebo Placebo: Oral administration once-daily for 12 weeks
Overall Study STARTED	0	0	0	0
Overall Study COMPLETED	0	0	0	0
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Adjunctive SPD489 to Antipsychotic Medication in Clinically Stable Adults With Persistent Predominant Negative Symptoms of Schizophrenia

Baseline characteristics by cohort

Baseline data not reported

PRIMARY outcome

Timeframe: Baseline and 12 weeks

Population: Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and 12 weeks

Population: Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and 12 weeks

Population: Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and 12 weeks

Population: Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and 12 weeks

Population: Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and 12 weeks

Population: Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and 12 weeks

Population: Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and 12 weeks

Population: Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and 12 weeks

Population: Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and 12 weeks

Population: Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and week 12

Population: Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 12 weeks

Population: Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 12 weeks

Population: Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and 12 weeks

Population: Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and Weeks 4 and 10

Population: Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized

Outcome measures

Outcome data not reported

Adverse Events

SPD489 40mg

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

SPD489 100mg

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

SPD489 160mg

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

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

Study Director

Shire

Phone: +1 866 842 5335

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.
Publication restrictions are in place

Restriction type: OTHER