Trial Outcomes & Findings for Long-term Safety of SPD489 When Added to Stable Doses of Antipsychotic Medications in Clinically Stable Adults With Negative Symptoms of Schizophrenia (NCT NCT01760993)
NCT ID: NCT01760993
Last Updated: 2021-06-22
Results Overview
TERMINATED
PHASE3
2 participants
Basline and 52 weeks
2021-06-22
Participant Flow
Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized
Participant milestones
| Measure |
SPD489
SPD489: Once-daily oral optimized doses of SPD489 (either 40 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg) for 52 weeks
|
|---|---|
|
Overall Study
STARTED
|
0
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Long-term Safety of SPD489 When Added to Stable Doses of Antipsychotic Medications in Clinically Stable Adults With Negative Symptoms of Schizophrenia
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: Basline and 52 weeksPopulation: Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Baseline and 52 weeksPopulation: Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Up to 52 weeksPopulation: Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Baseline and 52 weeksPopulation: Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Baseline and 52 weeksPopulation: Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Baseline and 52 weeksPopulation: Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Baseline and 52 weeksPopulation: Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Baseline and 52 weeksPopulation: Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Baseline and 52 weeksPopulation: 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 52 weeksPopulation: 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 52 weeksPopulation: 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 52Population: 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 52 weeksPopulation: 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 52 weeksPopulation: Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized
Outcome measures
Outcome data not reported
Adverse Events
SPD489
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
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