Trial Outcomes & Findings for First Add-on vs. Mono-therapy Study of Topiramate in Neuro-Surgical Patients (NCT NCT01627860)
NCT ID: NCT01627860
Last Updated: 2013-10-29
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
55 participants
Primary outcome timeframe
Month 4
Results posted on
2013-10-29
Participant Flow
55 participants were randomly assigned to receive either topiramate monotherapy or add-on therapy at 6 sites in Taiwan.
Participant milestones
| Measure |
Topiramate Monotherapy
Participants received a starting dose of 25 mg/day during week 1 and the dosage increased to 50 mg/day in 2 doses during week 2. Consequently, the dosage increased to 75 mg/day and 100 mg/day in 2 doses during week 3 and week 4, respectively. The dosage increased to 150 mg/day in 2 doses at week 5\~6 and 200 mg/day in 2 doses at week 7\~8.
|
Topiramate add-on Therapy
Participants received topiramate in addition to previous ant-epileptic drug. Participants received a starting dose of 25 mg/day in the morning during week 1 and the dosage was increased to 50 mg/day in 2 doses (morning and evening) during week 2. Consequently, the dosage was increased to 75 mg/day and 100 mg/day in 2 doses during week 3 and week 4, respectively. The dosage was increased to 150 mg/day in 2 doses at week 5\~6 and 200 mg/day in 2 doses at week 7\~8.
|
|---|---|---|
|
Overall Study
STARTED
|
35
|
20
|
|
Overall Study
COMPLETED
|
23
|
14
|
|
Overall Study
NOT COMPLETED
|
12
|
6
|
Reasons for withdrawal
| Measure |
Topiramate Monotherapy
Participants received a starting dose of 25 mg/day during week 1 and the dosage increased to 50 mg/day in 2 doses during week 2. Consequently, the dosage increased to 75 mg/day and 100 mg/day in 2 doses during week 3 and week 4, respectively. The dosage increased to 150 mg/day in 2 doses at week 5\~6 and 200 mg/day in 2 doses at week 7\~8.
|
Topiramate add-on Therapy
Participants received topiramate in addition to previous ant-epileptic drug. Participants received a starting dose of 25 mg/day in the morning during week 1 and the dosage was increased to 50 mg/day in 2 doses (morning and evening) during week 2. Consequently, the dosage was increased to 75 mg/day and 100 mg/day in 2 doses during week 3 and week 4, respectively. The dosage was increased to 150 mg/day in 2 doses at week 5\~6 and 200 mg/day in 2 doses at week 7\~8.
|
|---|---|---|
|
Overall Study
Adverse Event
|
9
|
4
|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
|
Overall Study
Seizure frequency doubled
|
0
|
1
|
|
Overall Study
Protocol Violation
|
1
|
0
|
Baseline Characteristics
First Add-on vs. Mono-therapy Study of Topiramate in Neuro-Surgical Patients
Baseline characteristics by cohort
| Measure |
Topiramate Monotherapy
n=35 Participants
Participants received a starting dose of 25 mg/day during week 1 and the dosage increased to 50 mg/day in 2 doses during week 2. Consequently, the dosage increased to 75 mg/day and 100 mg/day in 2 doses during week 3 and week 4, respectively. The dosage increased to 150 mg/day in 2 doses at week 5\~6 and 200 mg/day in 2 doses at week 7\~8.
|
Topiramate add-on Therapy
n=20 Participants
Participants received topiramate in addition to previous ant-epileptic drug. Participants received a starting dose of 25 mg/day in the morning during week 1 and the dosage was increased to 50 mg/day in 2 doses (morning and evening) during week 2. Consequently, the dosage was increased to 75 mg/day and 100 mg/day in 2 doses during week 3 and week 4, respectively. The dosage was increased to 150 mg/day in 2 doses at week 5\~6 and 200 mg/day in 2 doses at week 7\~8.
|
Total
n=55 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
44.1 years
STANDARD_DEVIATION 11.91 • n=93 Participants
|
42.4 years
STANDARD_DEVIATION 12.21 • n=4 Participants
|
43.17 years
STANDARD_DEVIATION 11.41 • n=27 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
20 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=93 Participants
|
13 Participants
n=4 Participants
|
35 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Month 4Population: Intent-To-Treat population: All randomized participants who received at least one dose of study medication.
Outcome measures
| Measure |
Topiramate Monotherapy
n=35 Participants
Participants received a starting dose of 25 mg/day during week 1 and the dosage increased to 50 mg/day in 2 doses during week 2. Consequently, the dosage increased to 75 mg/day and 100 mg/day in 2 doses during week 3 and week 4, respectively. The dosage increased to 150 mg/day in 2 doses at week 5\~6 and 200 mg/day in 2 doses at week 7\~8.
|
Topiramate add-on Therapy
n=20 Participants
Participants received topiramate in addition to previous ant-epileptic drug. Participants received a starting dose of 25 mg/day in the morning during week 1 and the dosage was increased to 50 mg/day in 2 doses (morning and evening) during week 2. Consequently, the dosage was increased to 75 mg/day and 100 mg/day in 2 doses during week 3 and week 4, respectively. The dosage was increased to 150 mg/day in 2 doses at week 5\~6 and 200 mg/day in 2 doses at week 7\~8.
|
|---|---|---|
|
Seizure Free Rate: Percentage of Participants Who Did Not Have Any Seizure Episode Within the Last Month of the Maintenance Period (ie, Month 4).
|
88.57 Percentage of participants
Interval 68.78 to 97.45
|
65.00 Percentage of participants
Interval 49.2 to 95.34
|
SECONDARY outcome
Timeframe: Baseline (4 weeks retrospective assessment prior to start of titration period) to Month 4Population: Intent-To-Treat population: All randomized participants who received at least one dose of study medication.
Seizure frequency (seizure count/month) was calculated based on the number of seizure within a month. The mean seizure frequency analyzed by the ANCOVA model at each period.
Outcome measures
| Measure |
Topiramate Monotherapy
n=35 Participants
Participants received a starting dose of 25 mg/day during week 1 and the dosage increased to 50 mg/day in 2 doses during week 2. Consequently, the dosage increased to 75 mg/day and 100 mg/day in 2 doses during week 3 and week 4, respectively. The dosage increased to 150 mg/day in 2 doses at week 5\~6 and 200 mg/day in 2 doses at week 7\~8.
|
Topiramate add-on Therapy
n=20 Participants
Participants received topiramate in addition to previous ant-epileptic drug. Participants received a starting dose of 25 mg/day in the morning during week 1 and the dosage was increased to 50 mg/day in 2 doses (morning and evening) during week 2. Consequently, the dosage was increased to 75 mg/day and 100 mg/day in 2 doses during week 3 and week 4, respectively. The dosage was increased to 150 mg/day in 2 doses at week 5\~6 and 200 mg/day in 2 doses at week 7\~8.
|
|---|---|---|
|
Seizure Frequency: Percent Change of Seizure Frequency by the ANCOVA Model During the Month 4
|
-55.3 Percent change
Standard Deviation 160
|
-75.8 Percent change
Standard Deviation 54.1
|
SECONDARY outcome
Timeframe: Month 4Population: Participants who have received study medication during month 4.
Outcome measures
| Measure |
Topiramate Monotherapy
n=25 Participants
Participants received a starting dose of 25 mg/day during week 1 and the dosage increased to 50 mg/day in 2 doses during week 2. Consequently, the dosage increased to 75 mg/day and 100 mg/day in 2 doses during week 3 and week 4, respectively. The dosage increased to 150 mg/day in 2 doses at week 5\~6 and 200 mg/day in 2 doses at week 7\~8.
|
Topiramate add-on Therapy
n=14 Participants
Participants received topiramate in addition to previous ant-epileptic drug. Participants received a starting dose of 25 mg/day in the morning during week 1 and the dosage was increased to 50 mg/day in 2 doses (morning and evening) during week 2. Consequently, the dosage was increased to 75 mg/day and 100 mg/day in 2 doses during week 3 and week 4, respectively. The dosage was increased to 150 mg/day in 2 doses at week 5\~6 and 200 mg/day in 2 doses at week 7\~8.
|
|---|---|---|
|
Dosage Administration of Topamax During Month 4
|
182.46 mg
Standard Deviation 35.63
|
178.57 mg
Standard Deviation 41.98
|
Adverse Events
Topiramate Monotherapy
Serious events: 1 serious events
Other events: 33 other events
Deaths: 0 deaths
Topiramate add-on Therapy
Serious events: 1 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Topiramate Monotherapy
n=35 participants at risk
Participants received a starting dose of 25 mg/day during week 1 and the dosage increased to 50 mg/day in 2 doses during week 2. Consequently, the dosage increased to 75 mg/day and 100 mg/day in 2 doses during week 3 and week 4, respectively. The dosage increased to 150 mg/day in 2 doses at week 5\~6 and 200 mg/day in 2 doses at week 7\~8.
|
Topiramate add-on Therapy
n=20 participants at risk
Participants received topiramate in addition to previous ant-epileptic drug. Participants received a starting dose of 25 mg/day in the morning during week 1 and the dosage was increased to 50 mg/day in 2 doses (morning and evening) during week 2. Consequently, the dosage was increased to 75 mg/day and 100 mg/day in 2 doses during week 3 and week 4, respectively. The dosage was increased to 150 mg/day in 2 doses at week 5\~6 and 200 mg/day in 2 doses at week 7\~8.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Herniated Intervertebral Disc
|
0.00%
0/35 • 20 weeks
|
5.0%
1/20 • 20 weeks
|
|
Infections and infestations
Osteomyelitis
|
2.9%
1/35 • 20 weeks
|
0.00%
0/20 • 20 weeks
|
Other adverse events
| Measure |
Topiramate Monotherapy
n=35 participants at risk
Participants received a starting dose of 25 mg/day during week 1 and the dosage increased to 50 mg/day in 2 doses during week 2. Consequently, the dosage increased to 75 mg/day and 100 mg/day in 2 doses during week 3 and week 4, respectively. The dosage increased to 150 mg/day in 2 doses at week 5\~6 and 200 mg/day in 2 doses at week 7\~8.
|
Topiramate add-on Therapy
n=20 participants at risk
Participants received topiramate in addition to previous ant-epileptic drug. Participants received a starting dose of 25 mg/day in the morning during week 1 and the dosage was increased to 50 mg/day in 2 doses (morning and evening) during week 2. Consequently, the dosage was increased to 75 mg/day and 100 mg/day in 2 doses during week 3 and week 4, respectively. The dosage was increased to 150 mg/day in 2 doses at week 5\~6 and 200 mg/day in 2 doses at week 7\~8.
|
|---|---|---|
|
Nervous system disorders
Dizziness
|
28.6%
10/35 • 20 weeks
|
20.0%
4/20 • 20 weeks
|
|
Nervous system disorders
Headache
|
17.1%
6/35 • 20 weeks
|
15.0%
3/20 • 20 weeks
|
|
Nervous system disorders
Hypoaesthesia
|
22.9%
8/35 • 20 weeks
|
5.0%
1/20 • 20 weeks
|
|
Gastrointestinal disorders
Decreased appetite
|
14.3%
5/35 • 20 weeks
|
5.0%
1/20 • 20 weeks
|
|
Nervous system disorders
Somnolence
|
11.4%
4/35 • 20 weeks
|
10.0%
2/20 • 20 weeks
|
|
Investigations
Weight decreased
|
11.4%
4/35 • 20 weeks
|
5.0%
1/20 • 20 weeks
|
|
Psychiatric disorders
Insomnia
|
8.6%
3/35 • 20 weeks
|
10.0%
2/20 • 20 weeks
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
8.6%
3/35 • 20 weeks
|
10.0%
2/20 • 20 weeks
|
|
General disorders
Malaise
|
8.6%
3/35 • 20 weeks
|
5.0%
1/20 • 20 weeks
|
|
Skin and subcutaneous tissue disorders
Hypoaesthesia facial
|
11.4%
4/35 • 20 weeks
|
0.00%
0/20 • 20 weeks
|
|
Gastrointestinal disorders
Nausea
|
8.6%
3/35 • 20 weeks
|
0.00%
0/20 • 20 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
5.7%
2/35 • 20 weeks
|
5.0%
1/20 • 20 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
8.6%
3/35 • 20 weeks
|
0.00%
0/20 • 20 weeks
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
2.9%
1/35 • 20 weeks
|
10.0%
2/20 • 20 weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
8.6%
3/35 • 20 weeks
|
0.00%
0/20 • 20 weeks
|
Additional Information
Medical Director
Janssen-Cilag Taiwan
Phone: 886 2 23762155
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60