Trial Outcomes & Findings for A Long-term Safety and Tolerability Study of USL261 in Patients With Seizure Clusters (NCT NCT02161185)
NCT ID: NCT02161185
Last Updated: 2019-10-10
Results Overview
Number of Participants with Death, Serious Adverse Events, Treatment emergent adverse events (TEAEs) leading to subject discontinuation from study
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
7 participants
Primary outcome timeframe
Duration of individual subject participation was open-ended. Study ended early. Longest subject participation approximately 6 months.
Results posted on
2019-10-10
Participant Flow
Participant milestones
| Measure |
USL261
USL261: 5 mg, intranasal dose for seizure cluster, may repeat as indicated by protocol
|
|---|---|
|
Test Dose Phase
STARTED
|
7
|
|
Test Dose Phase
COMPLETED
|
7
|
|
Test Dose Phase
NOT COMPLETED
|
0
|
|
Treatment Phase
STARTED
|
7
|
|
Treatment Phase
COMPLETED
|
0
|
|
Treatment Phase
NOT COMPLETED
|
7
|
Reasons for withdrawal
| Measure |
USL261
USL261: 5 mg, intranasal dose for seizure cluster, may repeat as indicated by protocol
|
|---|---|
|
Treatment Phase
Administrative/Other
|
7
|
Baseline Characteristics
A Long-term Safety and Tolerability Study of USL261 in Patients With Seizure Clusters
Baseline characteristics by cohort
| Measure |
USL261
n=7 Participants
USL261: 5 mg, intranasal dose for seizure cluster, may repeat as indicated by protocol
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
27.0 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Duration of individual subject participation was open-ended. Study ended early. Longest subject participation approximately 6 months.Population: Participants who received at least one dose of study drug
Number of Participants with Death, Serious Adverse Events, Treatment emergent adverse events (TEAEs) leading to subject discontinuation from study
Outcome measures
| Measure |
USL261
n=7 Participants
USL261: 5 mg, intranasal dose for seizure cluster, may repeat as indicated by protocol
|
|---|---|
|
Number of Participants With Death, Serious Adverse Events, Treatment Emergent Adverse Events (TEAEs) Leading to Discontinuation
|
0 Participants
|
SECONDARY outcome
Timeframe: Duration of individual subject participation was open-ended. Study ended early. Longest subject participation approximately 6 months.Population: Not applicable. Only 6 subjects treated at least 1 seizure cluster; of the treated seizure clusters, the majority were in only 2 subjects. Analysis of this endpoint was not performed as the sponsor believed the results would not be interpretable.
Termination of seizure(s) within 10 minutes and no recurrence within 6 hours after study drug administration. Due to early termination of the study, this data was not analyzed.
Outcome measures
Outcome data not reported
Adverse Events
USL261
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
USL261
n=7 participants at risk
USL261: 5 mg, intranasal dose for seizure cluster, may repeat as indicated by protocol
|
|---|---|
|
Infections and infestations
Furuncle
|
14.3%
1/7 • Duration of individual subject participation was open-ended. Study ended early. Longest subject participation approximately 6 months.
Treatment emergent
|
|
General disorders
Product taste abnormal
|
14.3%
1/7 • Duration of individual subject participation was open-ended. Study ended early. Longest subject participation approximately 6 months.
Treatment emergent
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
28.6%
2/7 • Duration of individual subject participation was open-ended. Study ended early. Longest subject participation approximately 6 months.
Treatment emergent
|
|
Injury, poisoning and procedural complications
Laceration
|
14.3%
1/7 • Duration of individual subject participation was open-ended. Study ended early. Longest subject participation approximately 6 months.
Treatment emergent
|
|
Nervous system disorders
Somnolence
|
28.6%
2/7 • Duration of individual subject participation was open-ended. Study ended early. Longest subject participation approximately 6 months.
Treatment emergent
|
|
Nervous system disorders
Tremor
|
14.3%
1/7 • Duration of individual subject participation was open-ended. Study ended early. Longest subject participation approximately 6 months.
Treatment emergent
|
|
Gastrointestinal disorders
Nausea
|
14.3%
1/7 • Duration of individual subject participation was open-ended. Study ended early. Longest subject participation approximately 6 months.
Treatment emergent
|
|
Immune system disorders
Seasonal allergy
|
14.3%
1/7 • Duration of individual subject participation was open-ended. Study ended early. Longest subject participation approximately 6 months.
Treatment emergent
|
|
Investigations
Oxygen saturation decreased
|
14.3%
1/7 • Duration of individual subject participation was open-ended. Study ended early. Longest subject participation approximately 6 months.
Treatment emergent
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
14.3%
1/7 • Duration of individual subject participation was open-ended. Study ended early. Longest subject participation approximately 6 months.
Treatment emergent
|
|
Nervous system disorders
Headache
|
14.3%
1/7 • Duration of individual subject participation was open-ended. Study ended early. Longest subject participation approximately 6 months.
Treatment emergent
|
|
Eye disorders
Lacrimation increased
|
14.3%
1/7 • Duration of individual subject participation was open-ended. Study ended early. Longest subject participation approximately 6 months.
Treatment emergent
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.3%
1/7 • Duration of individual subject participation was open-ended. Study ended early. Longest subject participation approximately 6 months.
Treatment emergent
|
|
General disorders
Fatigue
|
14.3%
1/7 • Duration of individual subject participation was open-ended. Study ended early. Longest subject participation approximately 6 months.
Treatment emergent
|
|
Gastrointestinal disorders
Abdominal discomfort
|
14.3%
1/7 • Duration of individual subject participation was open-ended. Study ended early. Longest subject participation approximately 6 months.
Treatment emergent
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
14.3%
1/7 • Duration of individual subject participation was open-ended. Study ended early. Longest subject participation approximately 6 months.
Treatment emergent
|
|
General disorders
Pyrexia
|
14.3%
1/7 • Duration of individual subject participation was open-ended. Study ended early. Longest subject participation approximately 6 months.
Treatment emergent
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
14.3%
1/7 • Duration of individual subject participation was open-ended. Study ended early. Longest subject participation approximately 6 months.
Treatment emergent
|
|
Psychiatric disorders
Insomnia
|
14.3%
1/7 • Duration of individual subject participation was open-ended. Study ended early. Longest subject participation approximately 6 months.
Treatment emergent
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee A manuscript or abstract should not be submitted by investigator(s) for publication or presentation until a New Drug Application is approved by the US FDA or permission is granted in writing by the sponsor.
- Publication restrictions are in place
Restriction type: OTHER