Trial Outcomes & Findings for Open-label Extension Study to Evaluate the Safety of USL255 in Patients With Refractory Partial-onset Seizures (NCT NCT01191086)
NCT ID: NCT01191086
Last Updated: 2015-02-23
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
210 participants
Primary outcome timeframe
Open label treatment of up to 62 weeks
Results posted on
2015-02-23
Participant Flow
Participant milestones
| Measure |
Open-label USL255
Topiramate extended-release capsules (USL255) up to a maximum of 400 mg per day
USL255
|
|---|---|
|
Overall Study
STARTED
|
210
|
|
Overall Study
COMPLETED
|
148
|
|
Overall Study
NOT COMPLETED
|
62
|
Reasons for withdrawal
| Measure |
Open-label USL255
Topiramate extended-release capsules (USL255) up to a maximum of 400 mg per day
USL255
|
|---|---|
|
Overall Study
Adverse Event
|
20
|
|
Overall Study
Lack of Efficacy
|
10
|
|
Overall Study
Lost to Follow-up
|
4
|
|
Overall Study
Physician Decision
|
2
|
|
Overall Study
Withdrawal by Subject
|
24
|
|
Overall Study
Discontinuation criterion met
|
1
|
|
Overall Study
Other
|
1
|
Baseline Characteristics
Open-label Extension Study to Evaluate the Safety of USL255 in Patients With Refractory Partial-onset Seizures
Baseline characteristics by cohort
| Measure |
Open-label USL255
n=210 Participants
Topiramate extended-release capsules (USL255) up to a maximum of 400 mg per day
USL255
|
|---|---|
|
Age, Continuous
|
37.5 years
STANDARD_DEVIATION 11.09 • n=5 Participants
|
|
Sex: Female, Male
Female
|
114 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
96 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Open label treatment of up to 62 weeksPopulation: 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.
Outcome measures
| Measure |
Open-label USL255
n=210 Participants
Topiramate extended-release capsules (USL255) up to a maximum of 400 mg per day
USL255
|
|---|---|
|
Evaluate the Safety of USL255 Through the Collection of Adverse Events and Clinical Laboratory Evaluations
No. of participants analyzed
|
210 participants
|
|
Evaluate the Safety of USL255 Through the Collection of Adverse Events and Clinical Laboratory Evaluations
No. with ≥ 1 treatment-emergent AE
|
146 participants
|
|
Evaluate the Safety of USL255 Through the Collection of Adverse Events and Clinical Laboratory Evaluations
No. with ≥ 1 treatment-related AE
|
102 participants
|
|
Evaluate the Safety of USL255 Through the Collection of Adverse Events and Clinical Laboratory Evaluations
No. with severe AEs
|
15 participants
|
|
Evaluate the Safety of USL255 Through the Collection of Adverse Events and Clinical Laboratory Evaluations
No. with serious AEs
|
14 participants
|
|
Evaluate the Safety of USL255 Through the Collection of Adverse Events and Clinical Laboratory Evaluations
No. with TEAEs leading to study discontinuation
|
20 participants
|
|
Evaluate the Safety of USL255 Through the Collection of Adverse Events and Clinical Laboratory Evaluations
No. of deaths related to study drug
|
0 participants
|
|
Evaluate the Safety of USL255 Through the Collection of Adverse Events and Clinical Laboratory Evaluations
No. of deaths unrelated to study drug
|
1 participants
|
Adverse Events
Open-label USL255
Serious events: 14 serious events
Other events: 61 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Open-label USL255
n=210 participants at risk
Topiramate extended-release capsules (USL255) up to a maximum of 400 mg per day
USL255
|
|---|---|
|
Hepatobiliary disorders
Cholelithiasis
|
0.95%
2/210 • Open-label treatment of up to 62 weeks
Safety of adjunctive USL255 was assessed through collection of adverse events (AEs) reports and clinical laboratory evaluations during the open-label treatment study
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.48%
1/210 • Open-label treatment of up to 62 weeks
Safety of adjunctive USL255 was assessed through collection of adverse events (AEs) reports and clinical laboratory evaluations during the open-label treatment study
|
|
Nervous system disorders
Status epilepticus
|
0.95%
2/210 • Open-label treatment of up to 62 weeks
Safety of adjunctive USL255 was assessed through collection of adverse events (AEs) reports and clinical laboratory evaluations during the open-label treatment study
|
|
Nervous system disorders
Convulsion
|
0.48%
1/210 • Open-label treatment of up to 62 weeks
Safety of adjunctive USL255 was assessed through collection of adverse events (AEs) reports and clinical laboratory evaluations during the open-label treatment study
|
|
Nervous system disorders
Headache
|
0.48%
1/210 • Open-label treatment of up to 62 weeks
Safety of adjunctive USL255 was assessed through collection of adverse events (AEs) reports and clinical laboratory evaluations during the open-label treatment study
|
|
Nervous system disorders
Ischaemic stroke
|
0.48%
1/210 • Open-label treatment of up to 62 weeks
Safety of adjunctive USL255 was assessed through collection of adverse events (AEs) reports and clinical laboratory evaluations during the open-label treatment study
|
|
Psychiatric disorders
Acute psychosis
|
0.48%
1/210 • Open-label treatment of up to 62 weeks
Safety of adjunctive USL255 was assessed through collection of adverse events (AEs) reports and clinical laboratory evaluations during the open-label treatment study
|
|
Infections and infestations
Appendicitis
|
0.48%
1/210 • Open-label treatment of up to 62 weeks
Safety of adjunctive USL255 was assessed through collection of adverse events (AEs) reports and clinical laboratory evaluations during the open-label treatment study
|
|
Infections and infestations
Diarrhea infectious
|
0.48%
1/210 • Open-label treatment of up to 62 weeks
Safety of adjunctive USL255 was assessed through collection of adverse events (AEs) reports and clinical laboratory evaluations during the open-label treatment study
|
|
Infections and infestations
Lobar pneumonia
|
0.48%
1/210 • Open-label treatment of up to 62 weeks
Safety of adjunctive USL255 was assessed through collection of adverse events (AEs) reports and clinical laboratory evaluations during the open-label treatment study
|
|
General disorders
Balance disorder
|
0.48%
1/210 • Open-label treatment of up to 62 weeks
Safety of adjunctive USL255 was assessed through collection of adverse events (AEs) reports and clinical laboratory evaluations during the open-label treatment study
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.48%
1/210 • Open-label treatment of up to 62 weeks
Safety of adjunctive USL255 was assessed through collection of adverse events (AEs) reports and clinical laboratory evaluations during the open-label treatment study
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.48%
1/210 • Open-label treatment of up to 62 weeks
Safety of adjunctive USL255 was assessed through collection of adverse events (AEs) reports and clinical laboratory evaluations during the open-label treatment study
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.48%
1/210 • Open-label treatment of up to 62 weeks
Safety of adjunctive USL255 was assessed through collection of adverse events (AEs) reports and clinical laboratory evaluations during the open-label treatment study
|
|
Gastrointestinal disorders
Volvulus
|
0.48%
1/210 • Open-label treatment of up to 62 weeks
Safety of adjunctive USL255 was assessed through collection of adverse events (AEs) reports and clinical laboratory evaluations during the open-label treatment study
|
Other adverse events
| Measure |
Open-label USL255
n=210 participants at risk
Topiramate extended-release capsules (USL255) up to a maximum of 400 mg per day
USL255
|
|---|---|
|
Nervous system disorders
Somnolence
|
7.1%
15/210 • Open-label treatment of up to 62 weeks
Safety of adjunctive USL255 was assessed through collection of adverse events (AEs) reports and clinical laboratory evaluations during the open-label treatment study
|
|
Nervous system disorders
Dizziness
|
6.2%
13/210 • Open-label treatment of up to 62 weeks
Safety of adjunctive USL255 was assessed through collection of adverse events (AEs) reports and clinical laboratory evaluations during the open-label treatment study
|
|
Nervous system disorders
Aphasia
|
5.2%
11/210 • Open-label treatment of up to 62 weeks
Safety of adjunctive USL255 was assessed through collection of adverse events (AEs) reports and clinical laboratory evaluations during the open-label treatment study
|
|
Investigations
Weight decreased
|
7.6%
16/210 • Open-label treatment of up to 62 weeks
Safety of adjunctive USL255 was assessed through collection of adverse events (AEs) reports and clinical laboratory evaluations during the open-label treatment study
|
|
Nervous system disorders
Headache
|
7.6%
16/210 • Open-label treatment of up to 62 weeks
Safety of adjunctive USL255 was assessed through collection of adverse events (AEs) reports and clinical laboratory evaluations during the open-label treatment study
|
Additional Information
Bob Anders, Sr. Director of Clinical Operations
Upsher-Smith Laboratories, Inc.
Phone: 763-315-2000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place