An Open-Label Trial Measuring Satisfaction And Convenience Of Two Formulations Of Lamotrigine In Subjects With A Mood Disorder - Study Results

Study Type:	Interventional
Study Design:	Non-Randomized, Open Label, Single Group Assignment
Condition:	Mood Disorder
Intervention:	Drug: Lamotrigine

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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	Lamotrigine
STARTED	97
COMPLETED	89
NOT COMPLETED	8
Adverse Event	4
Protocol Violation	4

	Lamotrigine
Number of Participants [units: participants]	97
Age [units: years] Mean ± Standard Deviation	41.0 ± 12.07
Gender [units: participants]
Female	83
Male	14
Race/Ethnicity, Customized [units: participants]
White	94
Black	2
Mixed race	1

Outcome Measures

1. Primary:

Mean Change From Baseline in the Convenience Subscale Score (CSS) Derived From the Treatment Satisfaction Questionnaire for Medication (TSQM v 1.4) Using Items 9 (Ease of Use), 10 (Ease of Planning to Use), and 11 (Convenience) at Week 3. [ Baseline, End of Study (Week 3) or Early Withdrawal ]

Measure Type	Primary
Measure Title	Mean Change From Baseline in the Convenience Subscale Score (CSS) Derived From the Treatment Satisfaction Questionnaire for Medication (TSQM v 1.4) Using Items 9 (Ease of Use), 10 (Ease of Planning to Use), and 11 (Convenience) at Week 3.
Measure Description	The CSS is the sum of items 9 (values: 1=Extremely difficult - 7=Extremely easy), 10 (same set of values as for 9), and 11 (1=Extremely inconvenient - 7=Extremely convenient). The sum has 3 subtracted from it, is divided by 18, and then multiplied by 100; the range is 0-100. Change from baseline=end of study CSS minus baseline score.
Time Frame	Baseline, End of Study (Week 3) or Early Withdrawal
Safety Issue	No

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.
Intent to Treat (ITT). Ninety-eight participants were enrolled in the study, but one withdrew prior to receiving lamotrigine ODT treatment. All efficacy and safety analyses are based on the Intent to Treat population, which includes the 97 patients who received at least one dose of ODT treatment.

Reporting Groups

	Description
Lamotrigine	Orally Disintegrating Tablet (ODT). ODT dosing was to match the dose and regimen of the immediate release (IR) dose the subject was taking at baseline. The mean (standard deviation [SD]) ODT dose was 261.3 (118.9) mg/day.

Measured Values

	Lamotrigine
Number of Participants Analyzed [units: participants]	97
Mean Change From Baseline in the Convenience Subscale Score (CSS) Derived From the Treatment Satisfaction Questionnaire for Medication (TSQM v 1.4) Using Items 9 (Ease of Use), 10 (Ease of Planning to Use), and 11 (Convenience) at Week 3. [units: Points on a subscale] Mean ± Standard Deviation	23.3 ± 22.5

Statistical Analysis 1 for Mean Change From Baseline in the Convenience Subscale Score (CSS) Derived From the Treatment Satisfaction Questionnaire for Medication (TSQM v 1.4) Using Items 9 (Ease of Use), 10 (Ease of Planning to Use), and 11 (Convenience) at Week 3.

Groups ^[1]	Lamotrigine
Method ^[2]	t-test, 2 sided
P Value ^[3]	<0.001

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
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[2]	Other relevant information, such as adjustments or degrees of freedom:
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[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Paired t-test

2. Secondary:

Mean Change From Baseline in the Global Satisfaction Subscale Score, From the TSQM Using Items 12 (Confidence in Medicine), 13 (Certainty That Good Things About Medication Outweigh Bad Things), and 14 (Satisfaction With Medication) at Week 3 [ Baseline, End of Study (Week 3) or Early Withdrawal ]

Measure Type	Secondary
Measure Title	Mean Change From Baseline in the Global Satisfaction Subscale Score, From the TSQM Using Items 12 (Confidence in Medicine), 13 (Certainty That Good Things About Medication Outweigh Bad Things), and 14 (Satisfaction With Medication) at Week 3
Measure Description	The Global Satisfaction Subscale Score is the sum of item 12 (values: 1=Not at all confident - 5=Extremely confident), item 13 (values: 1=Not at all certain - 5=Extremely certain), and item 14 (Extremely dissatisfied - 7=Extremely satisfied). The sum has 3 subtracted from it, is divided by 14, and then multiplied by 100; thus, the range is 0-100.
Time Frame	Baseline, End of Study (Week 3) or Early Withdrawal
Safety Issue	No

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.
ITT

Reporting Groups

	Description
Lamotrigine	Orally Disintegrating Tablet (ODT). ODT dosing was to match the dose and regimen of the immediate release (IR) dose the subject was taking at baseline. The mean (standard deviation [SD]) ODT dose was 261.3 (118.9) mg/day.

Measured Values

	Lamotrigine
Number of Participants Analyzed [units: participants]	97
Mean Change From Baseline in the Global Satisfaction Subscale Score, From the TSQM Using Items 12 (Confidence in Medicine), 13 (Certainty That Good Things About Medication Outweigh Bad Things), and 14 (Satisfaction With Medication) at Week 3 [units: Points on a subscale] Mean ± Standard Deviation	-0.3 ± 29.34

No statistical analysis provided for Mean Change From Baseline in the Global Satisfaction Subscale Score, From the TSQM Using Items 12 (Confidence in Medicine), 13 (Certainty That Good Things About Medication Outweigh Bad Things), and 14 (Satisfaction With Medication) at Week 3

3. Secondary:

Mean Change From Baseline in Clinical Global Impression of Illness-Severity at Week 3 [ Baseline, End of Study (Week 3) or at Early Withdrawal ]

Measure Type	Secondary
Measure Title	Mean Change From Baseline in Clinical Global Impression of Illness-Severity at Week 3
Measure Description	Clinician assessment evaluating how mentally ill the patient is at time of evaluation. The questionnaire is based on a 7-point scale (from1 = Normal to 7 = Among the most extremely ill patients).
Time Frame	Baseline, End of Study (Week 3) or at Early Withdrawal
Safety Issue	No

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.
ITT

Reporting Groups

	Description
Lamotrigine	Orally Disintegrating Tablet (ODT). ODT dosing was to match the dose and regimen of the immediate release (IR) dose the subject was taking at baseline. The mean (standard deviation [SD]) ODT dose was 261.3 (118.9) mg/day.

Measured Values

	Lamotrigine
Number of Participants Analyzed [units: participants]	96
Mean Change From Baseline in Clinical Global Impression of Illness-Severity at Week 3 [units: Points on a scale] Mean ± Standard Deviation	0.0 ± 0.81

No statistical analysis provided for Mean Change From Baseline in Clinical Global Impression of Illness-Severity at Week 3

4. Secondary:

Mean Change From Baseline in the Beck Depression Inventory (BDI-II) Score at Week 3 [ Baseline, End of Study (Week 3 weeks) or at Early Withdrawal ]

Measure Type	Secondary
Measure Title	Mean Change From Baseline in the Beck Depression Inventory (BDI-II) Score at Week 3
Measure Description	Participant-reported questionnaire consisting of 21 items on a 4 point scale (0 to 3, with 3 indicating most severely ill), with the score being the sum of the items. The change from baseline is the end of study score minus the baseline score; larger values indicate more depression with the ODT formulation relative to the IR formulation.
Time Frame	Baseline, End of Study (Week 3 weeks) or at Early Withdrawal
Safety Issue	No

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.
ITT

Reporting Groups

	Description
Lamotrigine	Orally Disintegrating Tablet (ODT). ODT dosing was to match the dose and regimen of the immediate release (IR) dose the subject was taking at baseline. The mean (standard deviation [SD]) ODT dose was 261.3 (118.9) mg/day.

Measured Values

	Lamotrigine
Number of Participants Analyzed [units: participants]	97
Mean Change From Baseline in the Beck Depression Inventory (BDI-II) Score at Week 3 [units: Points on a scale] Mean ± Standard Deviation	-1.7 ± 9.52

No statistical analysis provided for Mean Change From Baseline in the Beck Depression Inventory (BDI-II) Score at Week 3

5. Secondary:

Number of Participants Answering the Question "Did the Tablets Dissolve Instantly (Yes or no)?" at Week 3 [ End of Study (Week 3) or Early Withdrawal ]

Measure Type	Secondary
Measure Title	Number of Participants Answering the Question "Did the Tablets Dissolve Instantly (Yes or no)?" at Week 3
Measure Description	The Organoleptic Questionnaire (9 items) was used to assess the participants' satisfaction with the physical characteristics of the ODT formulation e.g. rate of dissolution, flavor. Question number 1 on organoleptic questionnaire: Did the tablets dissolve instantly (yes or no)?
Time Frame	End of Study (Week 3) or Early Withdrawal
Safety Issue	No

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.
ITT

Reporting Groups

	Description
Lamotrigine	Orally Disintegrating Tablet (ODT). ODT dosing was to match the dose and regimen of the immediate release (IR) dose the subject was taking at baseline. The mean (standard deviation [SD]) ODT dose was 261.3 (118.9) mg/day.

Measured Values

	Lamotrigine
Number of Participants Analyzed [units: participants]	97
Number of Participants Answering the Question "Did the Tablets Dissolve Instantly (Yes or no)?" at Week 3 [units: Number of participants]
Yes	60
No	37

No statistical analysis provided for Number of Participants Answering the Question "Did the Tablets Dissolve Instantly (Yes or no)?" at Week 3

6. Secondary:

Number of Participants Answering the Question "How Satisfied or Dissatisfied Were You With the Time it Took the Tablet to Dissolve" at Week 3 [ Baseline, End of Study (Week 3) or Early Withdrawal ]

Measure Type	Secondary
Measure Title	Number of Participants Answering the Question "How Satisfied or Dissatisfied Were You With the Time it Took the Tablet to Dissolve" at Week 3
Measure Description	Question number 2 on organoleptic questionnaire: How satisfied or dissatisfied were you with the time it took the tablet to dissolve? [from a rating of 1 (Extremely dissatisfied) to 5 (Extremely satisfied)]
Time Frame	Baseline, End of Study (Week 3) or Early Withdrawal
Safety Issue	No

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.
ITT

Reporting Groups

	Description
Lamotrigine	Orally Disintegrating Tablet (ODT). ODT dosing was to match the dose and regimen of the immediate release (IR) dose the subject was taking at baseline. The mean (standard deviation [SD]) ODT dose was 261.3 (118.9) mg/day.

Measured Values

	Lamotrigine
Number of Participants Analyzed [units: participants]	97
Number of Participants Answering the Question "How Satisfied or Dissatisfied Were You With the Time it Took the Tablet to Dissolve" at Week 3 [units: Number of participants]
Extremely dissatisfied	3
Very dissatisfied	10
Satisfied	37
Very satisfied	18
Extremely satisfied	29

No statistical analysis provided for Number of Participants Answering the Question "How Satisfied or Dissatisfied Were You With the Time it Took the Tablet to Dissolve" at Week 3

7. Secondary:

Number of Participants Answering the Question “How Did the Dissolved Tablet Feel in Your Mouth?” at Week 3 [ End of Study (Week 3) or Early Withdrawal ]

Measure Type	Secondary
Measure Title	Number of Participants Answering the Question “How Did the Dissolved Tablet Feel in Your Mouth?” at Week 3
Measure Description	Question number 3 on organoleptic questionnaire: How did the dissolved tablet feel in your mouth? [from a rating of 1 (Extremely gritty) to 5 (Extremely smooth)]
Time Frame	End of Study (Week 3) or Early Withdrawal
Safety Issue	No

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.
ITT

Reporting Groups

	Description
Lamotrigine	Orally Disintegrating Tablet (ODT). ODT dosing was to match the dose and regimen of the immediate release (IR) dose the subject was taking at baseline. The mean (standard deviation [SD]) ODT dose was 261.3 (118.9) mg/day.

Measured Values

	Lamotrigine
Number of Participants Analyzed [units: participants]	97
Number of Participants Answering the Question “How Did the Dissolved Tablet Feel in Your Mouth?” at Week 3 [units: Number of participants]
Extremely gritty	0
Very gritty	19
Smooth	45
Very smooth	19
Extremely smooth	14

No statistical analysis provided for Number of Participants Answering the Question “How Did the Dissolved Tablet Feel in Your Mouth?” at Week 3

8. Secondary:

Number of Participants Answering the Question "How Satisfied Were You With the Flavor of the Tablet?" at Week 3 [ End of Study (Week 3) or Early Withdrawal ]

Measure Type	Secondary
Measure Title	Number of Participants Answering the Question "How Satisfied Were You With the Flavor of the Tablet?" at Week 3
Measure Description	Question number 4 on organoleptic questionnaire: How satisfied were you with the flavor of the tablet? [from a rating of 1 (Extremely dissatisfied) to 5 (Extremely satisfied)]
Time Frame	End of Study (Week 3) or Early Withdrawal
Safety Issue	No

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.
ITT

Reporting Groups

	Description
Lamotrigine	Orally Disintegrating Tablet (ODT). ODT dosing was to match the dose and regimen of the immediate release (IR) dose the subject was taking at baseline. The mean (standard deviation [SD]) ODT dose was 261.3 (118.9) mg/day.

Measured Values

	Lamotrigine
Number of Participants Analyzed [units: participants]	97
Number of Participants Answering the Question "How Satisfied Were You With the Flavor of the Tablet?" at Week 3 [units: Number of participants]
Extremely dissatisfied	5
Very dissatisfied	10
Satisfied	26
Very satisfied	23
Extremely satisfied	33

No statistical analysis provided for Number of Participants Answering the Question "How Satisfied Were You With the Flavor of the Tablet?" at Week 3

9. Secondary:

Number of Participants Answering the Question "How Would You Rate the Strength of the Flavor of the Tablet"? at Week 3 [ End of Study (Week 3) or Early Withdrawal ]

Measure Type	Secondary
Measure Title	Number of Participants Answering the Question "How Would You Rate the Strength of the Flavor of the Tablet"? at Week 3
Measure Description	Organoleptic Questionnaire, question 5: How would you rate the strength of the flavor of the tablet? [from 1 a rating of (Extremely bothersome) to 5 (Extremely pleasant)]
Time Frame	End of Study (Week 3) or Early Withdrawal
Safety Issue	No

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.
ITT

Reporting Groups

	Description
Lamotrigine	Orally Disintegrating Tablet (ODT). ODT dosing was to match the dose and regimen of the immediate release (IR) dose the subject was taking at baseline. The mean (standard deviation [SD]) ODT dose was 261.3 (118.9) mg/day.

Measured Values

	Lamotrigine
Number of Participants Analyzed [units: participants]	97
Number of Participants Answering the Question "How Would You Rate the Strength of the Flavor of the Tablet"? at Week 3 [units: Number of participants]
Extremely bothersome	2
Very bothersome	14
Pleasant	36
Very pleasant	22
Extremely pleasant	23

No statistical analysis provided for Number of Participants Answering the Question "How Would You Rate the Strength of the Flavor of the Tablet"? at Week 3

10. Secondary:

Number of Participants Answering the Question "How Would You Rate the Aftertaste of the Tablet"? at Week 3. [ End of Study (Week 3) or Early Withdrawal ]

Measure Type	Secondary
Measure Title	Number of Participants Answering the Question "How Would You Rate the Aftertaste of the Tablet"? at Week 3.
Measure Description	Organoleptic Questionnaire, question 6: How would you rate the aftertaste of the tablet (the taste remaining in your mouth after swallowing the tablet)? [from a rating of 1 (Extremely bothersome) to 6 (Did NOT experience an aftertaste)]
Time Frame	End of Study (Week 3) or Early Withdrawal
Safety Issue	No

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.
ITT

Reporting Groups

	Description
Lamotrigine	Orally Disintegrating Tablet (ODT). ODT dosing was to match the dose and regimen of the immediate release (IR) dose the subject was taking at baseline. The mean (standard deviation [SD]) ODT dose was 261.3 (118.9) mg/day.

Measured Values

	Lamotrigine
Number of Participants Analyzed [units: participants]	97
Number of Participants Answering the Question "How Would You Rate the Aftertaste of the Tablet"? at Week 3. [units: Number of participants]
Extremely bothersome	4
Very bothersome	20
Pleasant	25
Very pleasant	7
Extremely pleasant	12
I did NOT experience an aftertaste	29

No statistical analysis provided for Number of Participants Answering the Question "How Would You Rate the Aftertaste of the Tablet"? at Week 3.

11. Secondary:

Number of Participants Answering the Question "How Satisfied Were You With the Aftertaste of the Tablet"? at Week 3 [ Baseline, End of Study (Week 3) or Early Withdrawal ]

Measure Type	Secondary
Measure Title	Number of Participants Answering the Question "How Satisfied Were You With the Aftertaste of the Tablet"? at Week 3
Measure Description	Organoleptic Questionnaire, question 7: How satisfied were you with the aftertaste of the tablet (the taste remaining in your mouth after swallowing the tablet)? [from a rating of 1 (Extremely dissatisfied) to 6 (I did NOT experience an aftertaste)]
Time Frame	Baseline, End of Study (Week 3) or Early Withdrawal
Safety Issue	No

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.
ITT

Reporting Groups

	Description
Lamotrigine	Orally Disintegrating Tablet (ODT). ODT dosing was to match the dose and regimen of the immediate release (IR) dose the subject was taking at baseline. The mean (standard deviation [SD]) ODT dose was 261.3 (118.9) mg/day.

Measured Values

	Lamotrigine
Number of Participants Analyzed [units: participants]	97
Number of Participants Answering the Question "How Satisfied Were You With the Aftertaste of the Tablet"? at Week 3 [units: Number of participants]
Extremely dissatisfied	3
Very dissatisfied	16
Satisfied	28
Very satisfied	11
Extremely satisfied	11
I did NOT experience an aftertaste	28

No statistical analysis provided for Number of Participants Answering the Question "How Satisfied Were You With the Aftertaste of the Tablet"? at Week 3

12. Secondary:

Number of Participants Answering the Question "Compared to Standard Tablets That Need to be Swallowed With Liquid, How Convenient or Inconvenient Did You Find This Orally Disintegrating Tablet"? at Week 3 [ End of Study (Week 3) or at Early Withdrawal ]

Measure Type	Secondary
Measure Title	Number of Participants Answering the Question "Compared to Standard Tablets That Need to be Swallowed With Liquid, How Convenient or Inconvenient Did You Find This Orally Disintegrating Tablet"? at Week 3
Measure Description	Organoleptic Questionnaire, question 8: Compared to standard tablets that need to be swallowed with liquid, how convenient or inconvenient did you find this orally disintegrating tablet? (from a rating of 1 [Extremely inconvenient] to 5 [Extremely convenient])
Time Frame	End of Study (Week 3) or at Early Withdrawal
Safety Issue	No

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.
ITT

Reporting Groups

	Description
Lamotrigine	Orally Disintegrating Tablet (ODT). ODT dosing was to match the dose and regimen of the immediate release (IR) dose the subject was taking at baseline. The mean (standard deviation [SD]) ODT dose was 261.3 (118.9) mg/day.

Measured Values

	Lamotrigine
Number of Participants Analyzed [units: participants]	97
Number of Participants Answering the Question "Compared to Standard Tablets That Need to be Swallowed With Liquid, How Convenient or Inconvenient Did You Find This Orally Disintegrating Tablet"? at Week 3 [units: Number of participants]
Extremely inconvenient	8
Very inconvenient	9
Convenient	16
Very convenient	17
Extremely convenient	47

No statistical analysis provided for Number of Participants Answering the Question "Compared to Standard Tablets That Need to be Swallowed With Liquid, How Convenient or Inconvenient Did You Find This Orally Disintegrating Tablet"? at Week 3

13. Secondary:

Number of Participants Answering the Question "Compared to Standard Tablets That Need to be Swallowed With Liquid, How Easy or Difficult is it to Use This Orally Disintegrating Tablet?" at Week 3 [ End of Study (Week 3) or at Early Withdrawal ]

Measure Type	Secondary
Measure Title	Number of Participants Answering the Question "Compared to Standard Tablets That Need to be Swallowed With Liquid, How Easy or Difficult is it to Use This Orally Disintegrating Tablet?" at Week 3
Measure Description	Organoleptic Questionnaire, question 9: Compared to standard tablets that need to be swallowed with liquid, how easy or difficult is it to use this orally disintegrating tablet? [from a rating of 1 (Extremely difficult) to 5 (Extremely easy)]
Time Frame	End of Study (Week 3) or at Early Withdrawal
Safety Issue	No

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.
ITT

Reporting Groups

	Description
Lamotrigine	Orally Disintegrating Tablet (ODT). ODT dosing was to match the dose and regimen of the immediate release (IR) dose the subject was taking at baseline. The mean (standard deviation [SD]) ODT dose was 261.3 (118.9) mg/day.

Measured Values

	Lamotrigine
Number of Participants Analyzed [units: participants]	97
Number of Participants Answering the Question "Compared to Standard Tablets That Need to be Swallowed With Liquid, How Easy or Difficult is it to Use This Orally Disintegrating Tablet?" at Week 3 [units: Number of participants]
Extremely difficult	2
Very difficult	3
Easy	17
Very easy	20
Extremely easy	55

No statistical analysis provided for Number of Participants Answering the Question "Compared to Standard Tablets That Need to be Swallowed With Liquid, How Easy or Difficult is it to Use This Orally Disintegrating Tablet?" at Week 3

14. Secondary:

Number of Participants Indicating a Preference for ODT or the Standard IR Tablet at Week 3 [ End of Study (Week 3) or at Early Withdrawal ]

Measure Type	Secondary
Measure Title	Number of Participants Indicating a Preference for ODT or the Standard IR Tablet at Week 3
Measure Description	Participant indicated whether preference was for ODT or the standard IR tablet
Time Frame	End of Study (Week 3) or at Early Withdrawal
Safety Issue	No

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.
ITT

Reporting Groups

	Description
Lamotrigine	Orally Disintegrating Tablet (ODT). ODT dosing was to match the dose and regimen of the immediate release (IR) dose the subject was taking at baseline. The mean (standard deviation [SD]) ODT dose was 261.3 (118.9) mg/day.

Measured Values

	Lamotrigine
Number of Participants Analyzed [units: participants]	97
Number of Participants Indicating a Preference for ODT or the Standard IR Tablet at Week 3 [units: Number of participants]
Prefer ODT	72
Prefer standard IR tablet	25

No statistical analysis provided for Number of Participants Indicating a Preference for ODT or the Standard IR Tablet at Week 3

15. Secondary:

Number of Companions/Caregivers Indicating Whether ODT or Standard IR Tablet is More Convenient at Week 3 [ End of Study (Week 3) or at Early Withdrawal ]

Measure Type	Secondary
Measure Title	Number of Companions/Caregivers Indicating Whether ODT or Standard IR Tablet is More Convenient at Week 3
Measure Description	Companion/Caregiver indicates whether ODT is more convenient or standard IR tablet is more convenient
Time Frame	End of Study (Week 3) or at Early Withdrawal
Safety Issue	No

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.
ITT

Reporting Groups

	Description
Lamotrigine	Orally Disintegrating Tablet (ODT). ODT dosing was to match the dose and regimen of the immediate release (IR) dose the subject was taking at baseline. The mean (standard deviation [SD]) ODT dose was 261.3 (118.9) mg/day.

Measured Values

	Lamotrigine
Number of Participants Analyzed [units: participants]	97
Number of Companions/Caregivers Indicating Whether ODT or Standard IR Tablet is More Convenient at Week 3 [units: Number of participants]
ODT more convenient	79
Standard IR tablet more convenient	18

No statistical analysis provided for Number of Companions/Caregivers Indicating Whether ODT or Standard IR Tablet is More Convenient at Week 3

16. Secondary:

Number of Participants Indicating at Week 3 (by Answering Yes/no) That They Would be More Likely to Take the ODT Formulation [ End of Study (Week 3) or at Early Withdrawal ]

Measure Type	Secondary
Measure Title	Number of Participants Indicating at Week 3 (by Answering Yes/no) That They Would be More Likely to Take the ODT Formulation
Measure Description	Tablet Routine Questionnaire (Adherence): Adherence to the treatment was evaluated by asking if the participant would be more likely to take the ODT formulation (yes/no)
Time Frame	End of Study (Week 3) or at Early Withdrawal
Safety Issue	No

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.
ITT: Only 94 of the 97 subjects in the ITT Population responded to the Tablet Routine Questionnaire.

Reporting Groups

	Description
Lamotrigine	Orally Disintegrating Tablet (ODT). ODT dosing was to match the dose and regimen of the immediate release (IR) dose the subject was taking at baseline. The mean (standard deviation [SD]) ODT dose was 261.3 (118.9) mg/day.

Measured Values

	Lamotrigine
Number of Participants Analyzed [units: participants]	94
Number of Participants Indicating at Week 3 (by Answering Yes/no) That They Would be More Likely to Take the ODT Formulation [units: Number of participants]
Yes	84
No	10

No statistical analysis provided for Number of Participants Indicating at Week 3 (by Answering Yes/no) That They Would be More Likely to Take the ODT Formulation

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	LBI108884
Study First Received:	December 20, 2007
Results First Received:	June 4, 2009
Last Updated:	September 16, 2009
ClinicalTrials.gov Identifier:	NCT00579982 History of Changes
Health Authority:	United States: Food and Drug Administration