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A Long-term Safety and Tolerability Study of USL261 in Patients With Seizure Clusters

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02161185
Recruitment Status : Terminated (Study terminated due to slow enrollment. There were no safety concerns.)
First Posted : June 11, 2014
Results First Posted : January 14, 2019
Last Update Posted : October 10, 2019
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB Biopharma S.P.R.L. )

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Epilepsy
Intervention Drug: USL261
Enrollment 7
Recruitment Details  
Pre-assignment Details  
Arm/Group Title USL261
Hide Arm/Group Description USL261: 5 mg, intranasal dose for seizure cluster, may repeat as indicated by protocol
Period Title: Test Dose Phase
Started 7
Completed 7
Not Completed 0
Period Title: Treatment Phase
Started [1] 7
Completed [2] 0
Not Completed 7
Reason Not Completed
Administrative/Other             7
[1]
6 of the 7 participants who entered Treatment Phase treated at least one seizure cluster
[2]
Study discontinued due to poor enrollment
Arm/Group Title USL261
Hide Arm/Group Description USL261: 5 mg, intranasal dose for seizure cluster, may repeat as indicated by protocol
Overall Number of Baseline Participants 7
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants
<=18 years
0
   0.0%
Between 18 and 65 years
7
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 7 participants
27.0
(19 to 43)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants
Female
3
  42.9%
Male
4
  57.1%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
7
 100.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 7 participants
7
1.Primary Outcome
Title Number of Participants With Death, Serious Adverse Events, Treatment Emergent Adverse Events (TEAEs) Leading to Discontinuation
Hide Description Number of Participants with Death, Serious Adverse Events, Treatment emergent adverse events (TEAEs) leading to subject discontinuation from study
Time Frame Duration of individual subject participation was open-ended. Study ended early. Longest subject participation approximately 6 months.
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least one dose of study drug
Arm/Group Title USL261
Hide Arm/Group Description:
USL261: 5 mg, intranasal dose for seizure cluster, may repeat as indicated by protocol
Overall Number of Participants Analyzed 7
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
2.Secondary Outcome
Title Treatment Success
Hide Description 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.
Time Frame Duration of individual subject participation was open-ended. Study ended early. Longest subject participation approximately 6 months.
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title USL261
Hide Arm/Group Description:
USL261: 5 mg, intranasal dose for seizure cluster, may repeat as indicated by protocol
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Duration of individual subject participation was open-ended. Study ended early. Longest subject participation approximately 6 months.
Adverse Event Reporting Description Treatment emergent
 
Arm/Group Title USL261
Hide Arm/Group Description USL261: 5 mg, intranasal dose for seizure cluster, may repeat as indicated by protocol
All-Cause Mortality
USL261
Affected / at Risk (%)
Total   0/7 (0.00%) 
Hide Serious Adverse Events
USL261
Affected / at Risk (%)
Total   0/7 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
USL261
Affected / at Risk (%)
Total   4/7 (57.14%) 
Eye disorders   
Lacrimation increased  1  1/7 (14.29%) 
Gastrointestinal disorders   
Nausea  1  1/7 (14.29%) 
Abdominal discomfort  1  1/7 (14.29%) 
General disorders   
Product taste abnormal  1  1/7 (14.29%) 
Fatigue  1  1/7 (14.29%) 
Pyrexia  1  1/7 (14.29%) 
Immune system disorders   
Seasonal allergy  1  1/7 (14.29%) 
Infections and infestations   
Furuncle  1  1/7 (14.29%) 
Injury, poisoning and procedural complications   
Laceration  1  1/7 (14.29%) 
Investigations   
Oxygen saturation decreased  1  1/7 (14.29%) 
Nervous system disorders   
Somnolence  1  2/7 (28.57%) 
Tremor  1  1/7 (14.29%) 
Headache  1  1/7 (14.29%) 
Psychiatric disorders   
Insomnia  1  1/7 (14.29%) 
Respiratory, thoracic and mediastinal disorders   
Oropharyngeal pain  1  2/7 (28.57%) 
Epistaxis  1  1/7 (14.29%) 
Cough  1  1/7 (14.29%) 
Respiratory tract congestion  1  1/7 (14.29%) 
Nasal congestion  1  1/7 (14.29%) 
1
Term from vocabulary, MedDRA 16.1
Indicates events were collected by systematic assessment
Early termination due to poor enrollment leading to small numbers of subjects analyzed for safety. Efficacy was not analyzed.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: David Sequeira,
Organization: Proximagen, LLC
Phone: 952-658-7437
EMail: dsequeira@proximagen.com
Layout table for additonal information
Responsible Party: UCB Pharma ( UCB Biopharma S.P.R.L. )
ClinicalTrials.gov Identifier: NCT02161185    
Other Study ID Numbers: P261-408
2014-001604-22 ( EudraCT Number )
First Submitted: June 9, 2014
First Posted: June 11, 2014
Results First Submitted: September 25, 2018
Results First Posted: January 14, 2019
Last Update Posted: October 10, 2019