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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.

Participant Flow:   Overall Study
    Placebo   Lamotrigine
STARTED   10   10 
COMPLETED   7   7 
NOT COMPLETED   3   3 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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 created and supplied by the manufacturers of lamotrigine (Lamictal). This is an anti-seizure medication.
Total Total of all reporting groups

Baseline Measures
   Placebo   Lamotrigine   Total 
Overall Participants Analyzed 
[Units: Participants]
 7   7   14 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   7   7   14 
>=65 years   0   0   0 
Gender 
[Units: Participants]
     
Female   4   4   8 
Male   3   3   6 
Region of Enrollment 
[Units: Participants]
     
United States   7   7   14 


  Outcome Measures

1.  Primary:   Average Number of Pain Attacks   [ Time Frame: Day 150 Visit #7 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Limited enrollment due to fear of placebo and high drop out rate.


  More Information

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
e-mail: Alan.Stiles@Jefferson.edu



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