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Research Study to Test Safety and Effectiveness of Investigational Drug in Patients With Trigeminal Neuralgia

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ClinicalTrials.gov Identifier: NCT00203229
Recruitment Status : Completed
First Posted : September 20, 2005
Results First Posted : June 3, 2014
Last Update Posted : June 3, 2014
Sponsor:
Information provided by (Responsible Party):
Thomas Jefferson University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Trigeminal Neuralgia
Interventions Drug: lamotrigine
Drug: Placebo
Enrollment 20

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo Lamotrigine
Hide Arm/Group Description 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. 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.
Period Title: Overall Study
Started 10 10
Completed 7 7
Not Completed 3 3
Arm/Group Title Placebo Lamotrigine Total
Hide Arm/Group Description 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. 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 of all reporting groups
Overall Number of Baseline Participants 7 7 14
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 7 participants 14 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
7
 100.0%
7
 100.0%
14
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 7 participants 14 participants
Female
4
  57.1%
4
  57.1%
8
  57.1%
Male
3
  42.9%
3
  42.9%
6
  42.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 7 participants 7 participants 14 participants
7 7 14
1.Primary Outcome
Title Average Number of Pain Attacks
Hide Description 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.
Time Frame Day 150 Visit #7
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Lamotrigine
Hide Arm/Group Description:
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
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
Overall Number of Participants Analyzed 7 7
Mean (Standard Deviation)
Unit of Measure: Pain attacks
3.3533  (1.1209) 3.1807  (0.7713)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Lamotrigine
Hide Arm/Group Description Subjects who received placebo Subjects who received Lamotrigine
All-Cause Mortality
Placebo Lamotrigine
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Lamotrigine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/7 (0.00%)      0/7 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo Lamotrigine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/7 (0.00%)      2/7 (28.57%)    
Nervous system disorders     
ataxia *  0/7 (0.00%)  0 2/7 (28.57%)  2
*
Indicates events were collected by non-systematic assessment
Limited enrollment due to fear of placebo and high drop out rate.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: M. Alan Stiles
Organization: Thomas Jefferson University
Phone: 215-955-6215
Responsible Party: Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT00203229     History of Changes
Other Study ID Numbers: MAS/LAM101
H92001 ( Other Grant/Funding Number: GlaxoSmithKline )
First Submitted: September 13, 2005
First Posted: September 20, 2005
Results First Submitted: February 7, 2014
Results First Posted: June 3, 2014
Last Update Posted: June 3, 2014