Trial Outcomes & Findings for A Placebo-controlled Study to Investigate Safety and Efficacy of BIA 2-093 (NCT NCT02170077)
NCT ID: NCT02170077
Last Updated: 2017-08-18
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
144 participants
Primary outcome timeframe
baseline, week 12
Results posted on
2017-08-18
Participant Flow
Participant milestones
| Measure |
ODG - Once-daily Group
BIA 2-093 once-daily; Daily doses of BIA 2-093 were increased at four-weekly periods (400 mg, 800 mg and 1200 mg).
BIA 2-093: BIA 2-093 (tablets) administered at increasing daily doses of 400 mg, 800 mg and 1200 mg once-daily or twice-daily, oral route
|
TDG - Twice-daily Group
BIA 2-093 twice-daily; Daily doses of BIA 2-093 were increased at four-weekly periods (400 mg, 800 mg and 1200 mg).
BIA 2-093: BIA 2-093 (tablets) administered at increasing daily doses of 400 mg, 800 mg and 1200 mg once-daily or twice-daily, oral route
|
PLG - Placebo Group
placebo
Placebo: Placebo tablets administered orally
|
|---|---|---|---|
|
Overall Study
STARTED
|
50
|
47
|
47
|
|
Overall Study
Intent to Treat (ITT) Population
|
50
|
46
|
47
|
|
Overall Study
COMPLETED
|
41
|
34
|
35
|
|
Overall Study
NOT COMPLETED
|
9
|
13
|
12
|
Reasons for withdrawal
| Measure |
ODG - Once-daily Group
BIA 2-093 once-daily; Daily doses of BIA 2-093 were increased at four-weekly periods (400 mg, 800 mg and 1200 mg).
BIA 2-093: BIA 2-093 (tablets) administered at increasing daily doses of 400 mg, 800 mg and 1200 mg once-daily or twice-daily, oral route
|
TDG - Twice-daily Group
BIA 2-093 twice-daily; Daily doses of BIA 2-093 were increased at four-weekly periods (400 mg, 800 mg and 1200 mg).
BIA 2-093: BIA 2-093 (tablets) administered at increasing daily doses of 400 mg, 800 mg and 1200 mg once-daily or twice-daily, oral route
|
PLG - Placebo Group
placebo
Placebo: Placebo tablets administered orally
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
4
|
2
|
|
Overall Study
Adverse Event
|
4
|
4
|
4
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
|
Overall Study
Exclusion criteria
|
2
|
2
|
5
|
|
Overall Study
Exacerbation of seizures
|
0
|
2
|
1
|
Baseline Characteristics
A Placebo-controlled Study to Investigate Safety and Efficacy of BIA 2-093
Baseline characteristics by cohort
| Measure |
ODG - Once-daily Group
n=50 Participants
BIA 2-093 once-daily; Daily doses of BIA 2-093 were increased at four-weekly periods (400 mg, 800 mg and 1200 mg).
BIA 2-093: BIA 2-093 (tablets) administered at increasing daily doses of 400 mg, 800 mg and 1200 mg once-daily or twice-daily, oral route
|
TDG - Twice-daily Group
n=47 Participants
BIA 2-093 twice-daily; Daily doses of BIA 2-093 were increased at four-weekly periods (400 mg, 800 mg and 1200 mg).
BIA 2-093: BIA 2-093 (tablets) administered at increasing daily doses of 400 mg, 800 mg and 1200 mg once-daily or twice-daily, oral route
|
PLG - Placebo Group
n=47 Participants
placebo
Placebo: Placebo tablets administered orally
|
Total
n=144 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
39.3 years
STANDARD_DEVIATION 11.4 • n=99 Participants
|
39.8 years
STANDARD_DEVIATION 11.9 • n=107 Participants
|
40.4 years
STANDARD_DEVIATION 10.8 • n=206 Participants
|
39.8 years
STANDARD_DEVIATION 11.3 • n=7 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=99 Participants
|
31 Participants
n=107 Participants
|
27 Participants
n=206 Participants
|
87 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
57 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: baseline, week 12Outcome measures
| Measure |
ODG - Once Daily Group
n=50 Participants
Intent to treat (TT) Population
|
TDG - Twice Daily Group
n=46 Participants
Intent to treat (TT) Population
|
PLG - Placebo Group
n=47 Participants
Intent to treat (TT) Population
|
|---|---|---|---|
|
The Percentage of Participants With a 50% or Greater Reduction in Seizure Frequency (Further Referred to as "Responders") in a Treatment Period Compared to the Baseline Period
|
54 percentage of responders
|
41 percentage of responders
|
28 percentage of responders
|
Adverse Events
ODG - Once Daily Group
Serious events: 2 serious events
Other events: 18 other events
Deaths: 0 deaths
TDG - Twice Daily Group
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
PLG - Placebo Group
Serious events: 1 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ODG - Once Daily Group
n=50 participants at risk
Intent to treat (TT) Population
|
TDG - Twice Daily Group
n=46 participants at risk
Intent to treat (TT) Population
|
PLG - Placebo Group
n=47 participants at risk
Intent to treat (TT) Population
|
|---|---|---|---|
|
Infections and infestations
BACTERIAL INFECTION OF INTESTINES
|
2.0%
1/50
|
0.00%
0/46
|
0.00%
0/47
|
|
Nervous system disorders
ISCHAEMIC STROKE
|
2.0%
1/50
|
0.00%
0/46
|
0.00%
0/47
|
|
Infections and infestations
VIRAL GASTROENTERITIS
|
0.00%
0/50
|
0.00%
0/46
|
2.1%
1/47
|
Other adverse events
| Measure |
ODG - Once Daily Group
n=50 participants at risk
Intent to treat (TT) Population
|
TDG - Twice Daily Group
n=46 participants at risk
Intent to treat (TT) Population
|
PLG - Placebo Group
n=47 participants at risk
Intent to treat (TT) Population
|
|---|---|---|---|
|
Ear and labyrinth disorders
Ear buzzing
|
0.00%
0/50
|
4.3%
2/46
|
0.00%
0/47
|
|
Ear and labyrinth disorders
Vertigo
|
4.0%
2/50
|
0.00%
0/46
|
0.00%
0/47
|
|
Eye disorders
Diplopia
|
2.0%
1/50
|
2.2%
1/46
|
0.00%
0/47
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/50
|
4.3%
2/46
|
0.00%
0/47
|
|
Gastrointestinal disorders
Gastric pain
|
0.00%
0/50
|
0.00%
0/46
|
4.3%
2/47
|
|
Gastrointestinal disorders
Nausea
|
4.0%
2/50
|
6.5%
3/46
|
4.3%
2/47
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/50
|
10.9%
5/46
|
2.1%
1/47
|
|
General disorders
Chest pain
|
0.00%
0/50
|
2.2%
1/46
|
2.1%
1/47
|
|
Infections and infestations
Bacteriuria
|
0.00%
0/50
|
0.00%
0/46
|
4.3%
2/47
|
|
Infections and infestations
Influenza
|
2.0%
1/50
|
0.00%
0/46
|
2.1%
1/47
|
|
Investigations
Body temperature increased
|
2.0%
1/50
|
0.00%
0/46
|
2.1%
1/47
|
|
Investigations
Creatine kinase increased
|
0.00%
0/50
|
0.00%
0/46
|
6.4%
3/47
|
|
Nervous system disorders
Concentration impaired
|
2.0%
1/50
|
4.3%
2/46
|
2.1%
1/47
|
|
Nervous system disorders
Dizziness
|
2.0%
1/50
|
10.9%
5/46
|
2.1%
1/47
|
|
Nervous system disorders
Drowsiness
|
2.0%
1/50
|
0.00%
0/46
|
2.1%
1/47
|
|
Nervous system disorders
Headache
|
4.0%
2/50
|
17.4%
8/46
|
6.4%
3/47
|
|
Nervous system disorders
Incoordination
|
2.0%
1/50
|
2.2%
1/46
|
0.00%
0/47
|
|
Nervous system disorders
Somnolence
|
6.0%
3/50
|
2.2%
1/46
|
0.00%
0/47
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/50
|
0.00%
0/46
|
4.3%
2/47
|
|
Skin and subcutaneous tissue disorders
Hair loss
|
4.0%
2/50
|
4.3%
2/46
|
2.1%
1/47
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER