Trial Outcomes & Findings for Research Study to Test Safety and Effectiveness of Investigational Drug in Patients With Trigeminal Neuralgia (NCT NCT00203229)
NCT ID: NCT00203229
Last Updated: 2014-06-03
Results Overview
The average number of attacks daily experienced between Visit #1 and Visit #2 (baseline diary) was compared to the average daily number of attacks recorded between Visit #5 and Visit #7 after the patient has titrated the drug to the maximum tolerated dose.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
20 participants
Primary outcome timeframe
Day 150 Visit #7
Results posted on
2014-06-03
Participant Flow
Participant milestones
| Measure |
Placebo
The intervention type is 'drug' and this arm is a placebo pill created and supplied by the manufacturers of lamotrigine (Lamictal) to be exact replicas of the actual drug being studied. The placebo arm is titrated in the exact same manor as the active drug arm.
|
Lamotrigine
The intervention type is 'drug' and this arm is the active drug supplied by the manufacturers of lamotrigine (Lamictal) to be exact replicas of the actual drug being studied. This drug is an anti-seizure medication.
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
|
Overall Study
COMPLETED
|
7
|
7
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Research Study to Test Safety and Effectiveness of Investigational Drug in Patients With Trigeminal Neuralgia
Baseline characteristics by cohort
| Measure |
Placebo
n=7 Participants
The intervention type is 'drug' and this arm is a placebo pill created and supplied by the manufacturers of lamotrigine (Lamictal) to be exact replicas of the actual drug being studied. The placebo arm is titrated in the exact same manor as the active drug arm.
|
Lamotrigine
n=7 Participants
The intervention type is 'drug' and this arm is the active drug created and supplied by the manufacturers of lamotrigine (Lamictal). This is an anti-seizure medication.
|
Total
n=14 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=5 Participants
|
7 participants
n=7 Participants
|
14 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 150 Visit #7The average number of attacks daily experienced between Visit #1 and Visit #2 (baseline diary) was compared to the average daily number of attacks recorded between Visit #5 and Visit #7 after the patient has titrated the drug to the maximum tolerated dose.
Outcome measures
| Measure |
Placebo
n=7 Participants
Dosing Schedule Morning Evening Daily Total Week 1-2 ---- 50mg 50mg Week 3-4 50mg 50mg 100mg Week 5 100mg 100mg 200mg Week 6 150mg 150mg 300mg Week 7 200mg 200mg 400mg Week 8 (if needed for pain) 200mg 300mg 500mg Week 9 (if needed for pain) 300mg 300mg 600mg Week 10 (if needed for pain) 300mg 400mg 700mg
|
Lamotrigine
n=7 Participants
Dosing Schedule Morning Evening Daily Total Week 1-2 ---- 50mg 50mg Week 3-4 50mg 50mg 100mg Week 5 100mg 100mg 200mg Week 6 150mg 150mg 300mg Week 7 200mg 200mg 400mg Week 8 (if needed for pain) 200mg 300mg 500mg Week 9 (if needed for pain) 300mg 300mg 600mg Week 10 (if needed for pain) 300mg 400mg 700mg
|
|---|---|---|
|
Average Number of Pain Attacks
|
3.3533 Pain attacks
Standard Deviation 1.1209
|
3.1807 Pain attacks
Standard Deviation 0.7713
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Lamotrigine
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=7 participants at risk
Subjects who received placebo
|
Lamotrigine
n=7 participants at risk
Subjects who received Lamotrigine
|
|---|---|---|
|
Nervous system disorders
ataxia
|
0.00%
0/7
|
28.6%
2/7 • Number of events 2
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place