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Trial record 1 of 1 for:    01191086
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Open-label Extension Study to Evaluate the Safety of USL255 in Patients With Refractory Partial-onset Seizures

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ClinicalTrials.gov Identifier: NCT01191086
Recruitment Status : Completed
First Posted : August 30, 2010
Results First Posted : February 23, 2015
Last Update Posted : February 23, 2015
Sponsor:
Information provided by (Responsible Party):
Upsher-Smith Laboratories

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Epilepsy
Intervention Drug: USL255
Enrollment 210
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Open-label USL255
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Topiramate extended-release capsules (USL255) up to a maximum of 400 mg per day

USL255

Period Title: Overall Study
Started 210
Completed 148
Not Completed 62
Reason Not Completed
Adverse Event             20
Lack of Efficacy             10
Lost to Follow-up             4
Physician Decision             2
Withdrawal by Subject             24
Discontinuation criterion met             1
Other             1
Arm/Group Title Open-label USL255
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Topiramate extended-release capsules (USL255) up to a maximum of 400 mg per day

USL255

Overall Number of Baseline Participants 210
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 210 participants
37.5  (11.09)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 210 participants
Female
114
  54.3%
Male
96
  45.7%
1.Primary Outcome
Title Evaluate the Safety of USL255 Through the Collection of Adverse Events and Clinical Laboratory Evaluations
Hide Description [Not Specified]
Time Frame Open label treatment of up to 62 weeks
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Hide Analysis Population Description
The intent-to-treat (ITT) population was used for all analyses. The ITT population included all subjects who received at least 1 dose of study drug in this extension study.
Arm/Group Title Open-label USL255
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Topiramate extended-release capsules (USL255) up to a maximum of 400 mg per day

USL255

Overall Number of Participants Analyzed 210
Measure Type: Number
Unit of Measure: participants
No. of participants analyzed 210
No. with ≥ 1 treatment-emergent AE 146
No. with ≥ 1 treatment-related AE 102
No. with severe AEs 15
No. with serious AEs 14
No. with TEAEs leading to study discontinuation 20
No. of deaths related to study drug 0
No. of deaths unrelated to study drug 1
Time Frame Open-label treatment of up to 62 weeks
Adverse Event Reporting Description Safety of adjunctive USL255 was assessed through collection of adverse events (AEs) reports and clinical laboratory evaluations during the open-label treatment study
 
Arm/Group Title Open-label USL255
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Topiramate extended-release capsules (USL255) up to a maximum of 400 mg per day

USL255

All-Cause Mortality
Open-label USL255
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Open-label USL255
Affected / at Risk (%)
Total   14/210 (6.67%) 
Gastrointestinal disorders   
Volvulus  1  1/210 (0.48%) 
General disorders   
Balance disorder  1  1/210 (0.48%) 
Hepatobiliary disorders   
Cholelithiasis  1  2/210 (0.95%) 
Cholecystitis acute  1  1/210 (0.48%) 
Infections and infestations   
Appendicitis  1  1/210 (0.48%) 
Diarrhea infectious  1  1/210 (0.48%) 
Lobar pneumonia  1  1/210 (0.48%) 
Injury, poisoning and procedural complications   
Fibula fracture  1  1/210 (0.48%) 
Tibia fracture  1  1/210 (0.48%) 
Musculoskeletal and connective tissue disorders   
Intervertebral disc protrusion  1  1/210 (0.48%) 
Nervous system disorders   
Status epilepticus  1  2/210 (0.95%) 
Convulsion  1  1/210 (0.48%) 
Headache  1  1/210 (0.48%) 
Ischaemic stroke  1  1/210 (0.48%) 
Psychiatric disorders   
Acute psychosis  1  1/210 (0.48%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (11.0)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Open-label USL255
Affected / at Risk (%)
Total   61/210 (29.05%) 
Investigations   
Weight decreased  1  16/210 (7.62%) 
Nervous system disorders   
Somnolence  1  15/210 (7.14%) 
Dizziness  1  13/210 (6.19%) 
Aphasia  1  11/210 (5.24%) 
Headache  1  16/210 (7.62%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (11.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Bob Anders, Sr. Director of Clinical Operations
Organization: Upsher-Smith Laboratories, Inc.
Phone: 763-315-2000
EMail: bob.anders@upsher-smith.com
Layout table for additonal information
Responsible Party: Upsher-Smith Laboratories
ClinicalTrials.gov Identifier: NCT01191086    
Other Study ID Numbers: P09-005
First Submitted: August 26, 2010
First Posted: August 30, 2010
Results First Submitted: February 9, 2015
Results First Posted: February 23, 2015
Last Update Posted: February 23, 2015