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Trial record 54 of 216 for:    Lamotrigine

Valproate Dose Reduction and Its Clinical Evaluation by Introducing Lamotrigine in Japanese Women With Epilepsy - Single Arm, Multicenter, and Open-label Study

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ClinicalTrials.gov Identifier: NCT02100644
Recruitment Status : Completed
First Posted : April 1, 2014
Results First Posted : February 1, 2016
Last Update Posted : November 17, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Epilepsy
Intervention Drug: Lamotrigine tablets 25/100 mg
Enrollment 33
Recruitment Details Participants (par.) receiving monotherapy treatment with sodium valproate (VPA) maintenance dose of 400-1200 milligrams/day [mg/d]) due to a history of partial seizures (including secondary generalized seizures) or tonic-clonic seizures, and whose seizures had been controlled for 12 weeks (wk) prior to start of treatment were enrolled in the study.
Pre-assignment Details A total of 33 participants were enrolled into the study and 20 participants completed the study.
Arm/Group Title Escalation Phase: LTG Plus VPA Reduction Phase: LTG Plus VPA Maintenance Phase: LTG Plus VPA
Hide Arm/Group Description Participants received a fixed maintenance dose of VPA (400-1200 mg/d) along with lamotrigine (LTG) which was gradually escalated to 200 mg/d in accordance with the information of package insert: i.e. 25 mg of LTG was orally administered once every other day for the first 2 weeks and then once daily for the following 2 weeks. Thereafter, LTG was gradually escalated by 25 to 50 mg every 1 to 2 weeks for once or twice daily administration. If there were safety concerns, the LTG dose was decreased to 100 mg/d at the discretion of the investigator or sub-investigator. If there were still safety concerns despite the dose reduction to 100 mg/d, LTG was discontinued. The total duration of this phase was 8 to18 weeks. Participants received a range of VPA dose reduction as follows: When VPA was reduced to 300 mg/d, the range of reduction was determined at the discretion of the investigator or sub-investigator: e.g., 1000 mg/d (2 weeks), 800 mg/d (2 weeks), 600 mg/d (2 weeks), 400 mg/d (2 weeks), 300 mg/d OR 1000 mg/d (4 weeks), 600 mg/d (4 weeks), 300 mg/d and when VPA was reduced to less than 300 mg/d, the dose was reduced to 300, 200, 100, and 0 mg/d in 100 mg decrements in steps of at least one week duration. When VPA was concomitantly used, LTG was administered twice daily with 200 mg/d as a maintenance dose. If there were safety concerns during the LTG Escalation Phase, a fixed maintenance dose of 100 to 200 mg/d of LTG was administered twice daily. When VPA was withdrawn (that is, VPA was reduced to 0 mg/d), LTG was required to be increased by 50-100 mg/d. If there were any safety concern, 25 mg increment was also available. The total duration of this phase was 4 to16 weeks. Participants received two different treatments. In one group, participants received a fixed maintenance dose of LTG 200 mg/d (or 100 to 200 mg/d if there were safety concerns during the LTG Escalation Phase) and VPA 100 mg/d (or higher if seizures occurred during the VPA Reduction Phase) were administered twice and 1-3 times daily, respectively, for 12 weeks. The frequency of administration was not changed. If seizures occurred, VPA dose could be increased/re-introduced. On the other group, after VPA was withdrawn, LTG dose was escalated up to 300 mg/d with 50-100 mg increment per 1-2 weeks. If there was safety concern or if remaining dose to 300 mg/d was below 50 mg, 25 mg increment was also available. If seizures occurred, LTG dose was increased up to 400 mg/d. If there was safety concern, LTG dose was decreased to 100 mg/d. If there was still safety concern at 100 mg/d, the participants were discontinued from the study. The total duration of this phase was 12 weeks.
Period Title: LTG Escalation Phase
Started 33 0 0
Completed 20 0 0
Not Completed 13 0 0
Reason Not Completed
Adverse Event             9             0             0
Protocol-defined Stopping Criteria             1             0             0
Withdrawal by Subject             3             0             0
Period Title: VPA Reduction Phase
Started 0 20 0
Completed 0 20 0
Not Completed 0 0 0
Period Title: LTG and VPA Maintenance Phase
Started 0 0 20
Completed 0 0 20
Not Completed 0 0 0
Arm/Group Title LTG Plus VPA (Phase 1, 2 and 3)
Hide Arm/Group Description Par. received a fixed maintenance (maint) dose of VPA (400-1200 mg/d) along with LTG gradually escalated to 200 mg/d in accordance with the package insert information: i.e. 25 mg of LTG was orally administered once every other day for the first 2 wk and then once daily for the following 2 wk. Thereafter, LTG was gradually escalated by 25 to 50 mg every 1 to 2 wk for once or twice daily administration. Par. received a range of VPA dose reduction as follows: When VPA was reduced to 300 mg/d, the range of reduction was as follows: 1000 mg/d (2 wk), 800 mg/d (2 wk), 600 mg/d (2 wk), 400 mg/d (2 wk), 300 mg/d OR 1000 mg/d (4 wk), 600 mg/d (4 wk), 300 mg/d and when VPA was reduced to < 300 mg/d, the dose was reduced to 300, 200, 100 and 0 mg/d in 100 mg decrements in steps of at least one wk duration. Par. received a fixed maint dose of LTG 200 mg/d and VPA 100 mg/d or a maint dose of LTG 200-400 mg/d were administered twice and 1-3 times daily for LTG and VPA, respectively, for 12 wk
Overall Number of Baseline Participants 33
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 33 participants
25.6  (7.73)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants
Female
33
 100.0%
Male
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Asian- Japanese Heritage Number Analyzed 33 participants
33
1.Primary Outcome
Title Percentage of Participants Who Achieved Reduction in Daily VPA Dose
Hide Description The VPA dose reduction from Baseline is defined as post VPA dose minus the Baseline VPA dose < 0. Baseline VPA dose is the dose at the Baseline visit (Week 0) and the post VPA dose is the last VPA dose during the LTG and VPA Maintenance Phase. Percentage of participants with dose reduction during the LTG and VPA Maintenance Phase is presented.
Time Frame Baseline and at the end of the LTG and VPA Maintenance Phase, 24-46 weeks that can be varied by durations of the LTG Escalation Phase and VPA Reduction Phase
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS): comprised of all participants in the Safety Population who provided at least one efficacy data after the first dose of the investigational product during the LTG Escalation Phase.
Arm/Group Title LTG Plus VPA (Phase 1, 2 and 3)
Hide Arm/Group Description:
Par. received a fixed maintenance (maint) dose of VPA (400-1200 mg/d) along with LTG gradually escalated to 200 mg/d in accordance with the package insert information: i.e. 25 mg of LTG was orally administered once every other day for the first 2 wk and then once daily for the following 2 wk. Thereafter, LTG was gradually escalated by 25 to 50 mg every 1 to 2 wk for once or twice daily administration. Par. received a range of VPA dose reduction as follows: When VPA was reduced to 300 mg/d, the range of reduction was as follows: 1000 mg/d (2 wk), 800 mg/d (2 wk), 600 mg/d (2 wk), 400 mg/d (2 wk), 300 mg/d OR 1000 mg/d (4 wk), 600 mg/d (4 wk), 300 mg/d and when VPA was reduced to < 300 mg/d, the dose was reduced to 300, 200, 100 and 0 mg/d in 100 mg decrements in steps of at least one wk duration. Par. received a fixed maint dose of LTG 200 mg/d and VPA 100 mg/d or a maint dose of LTG 200-400 mg/d were administered twice and 1-3 times daily for LTG and VPA, respectively, for 12 wk.
Overall Number of Participants Analyzed 33
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
60.6
(42.14 to 77.09)
2.Primary Outcome
Title Percent Change in the VPA Dose
Hide Description Percent change in VPA dose is calculated as (pre-dose - post-dose) / pre-dose x 100. Pre-dose is the VPA dose at the Baseline visit and post-dose is the last VPA dose during the LTG and VPA Maintenance Phase.
Time Frame Baseline and at the end of the LTG and VPA Maintenance Phase, 24-46 weeks that can be varied by durations of the LTG Escalation Phase and VPA Reduction Phase
Hide Outcome Measure Data
Hide Analysis Population Description
FAS Population
Arm/Group Title LTG Plus VPA (Phase 1, 2 and 3)
Hide Arm/Group Description:
Par. received a fixed maintenance (maint) dose of VPA (400-1200 mg/d) along with LTG gradually escalated to 200 mg/d in accordance with the package insert information: i.e. 25 mg of LTG was orally administered once every other day for the first 2 wk and then once daily for the following 2 wk. Thereafter, LTG was gradually escalated by 25 to 50 mg every 1 to 2 wk for once or twice daily administration. Par. received a range of VPA dose reduction as follows: When VPA was reduced to 300 mg/d, the range of reduction was as follows: 1000 mg/d (2 wk), 800 mg/d (2 wk), 600 mg/d (2 wk), 400 mg/d (2 wk), 300 mg/d OR 1000 mg/d (4 wk), 600 mg/d (4 wk), 300 mg/d and when VPA was reduced to < 300 mg/d, the dose was reduced to 300, 200, 100 and 0 mg/d in 100 mg decrements in steps of at least one wk duration. Par. received a fixed maint dose of LTG 200 mg/d and VPA 100 mg/d or a maint dose of LTG 200-400 mg/d were administered twice and 1-3 times daily for LTG and VPA, respectively, for 12 wk.
Overall Number of Participants Analyzed 33
Mean (Standard Deviation)
Unit of Measure: Percentage of reduction
-60.10  (49.290)
3.Secondary Outcome
Title Number of Days in Total That Epileptic Seizures Occurred up to the LTG and VPA Maintenance Phase
Hide Description The participants with no seizure, had no record in seizure dairy. Only those participants with more than one seizure were assessed for this Outcome Measure.
Time Frame Baseline and up to 46 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS Population
Arm/Group Title LTG Plus VPA (Phase 1, 2 and 3)
Hide Arm/Group Description:
Par. received a fixed maintenance (maint) dose of VPA (400-1200 mg/d) along with LTG gradually escalated to 200 mg/d in accordance with the package insert information: i.e. 25 mg of LTG was orally administered once every other day for the first 2 wk and then once daily for the following 2 wk. Thereafter, LTG was gradually escalated by 25 to 50 mg every 1 to 2 wk for once or twice daily administration. Par. received a range of VPA dose reduction as follows: When VPA was reduced to 300 mg/d, the range of reduction was as follows: 1000 mg/d (2 wk), 800 mg/d (2 wk), 600 mg/d (2 wk), 400 mg/d (2 wk), 300 mg/d OR 1000 mg/d (4 wk), 600 mg/d (4 wk), 300 mg/d and when VPA was reduced to < 300 mg/d, the dose was reduced to 300, 200, 100 and 0 mg/d in 100 mg decrements in steps of at least one wk duration. Par. received a fixed maint dose of LTG 200 mg/d and VPA 100 mg/d or a maint dose of LTG 200-400 mg/d were administered twice and 1-3 times daily for LTG and VPA, respectively, for 12 wk.
Overall Number of Participants Analyzed 33
Measure Type: Number
Unit of Measure: Days
2
4.Secondary Outcome
Title Change From Baseline in Quality of Life in Epilepsy-31-P (QOLIE-31-P) in Participants Aged 18 Years and Older
Hide Description QOLIE-31-P is a questionnaire analyzed according to the scoring manual at Baseline, at the end of LTG/VPA Maintenance Phase and withdrawals for the participants aged 18 years and older (n=26, excluding 1 participant withdrawn due to protocol violation). Overall score was calculated as an average of sub scores that were normalized to 0 to 100. QOLIE-31-P has 7 subscale items (energy, mood, daily activities, cognition, medication effect, seizure worry and overall QOL). Higher score presents higher quality of life. Epileptic symptoms generally affect the QOL of participants, and so QOLIE-31-P is world widely used for the QOL assessment of adult participants. Baseline is defined as Day 1 (pre-dose) value. Change from Baseline is calculated as post-dose visit value minus Baseline value.
Time Frame Baseline and up to 46 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS Population. Only those participants available at the indicated phase were analyzed (represented by n=X in the category titles).
Arm/Group Title LTG Plus VPA (Phase 1, 2 and 3)
Hide Arm/Group Description:
Par. received a fixed maintenance (maint) dose of VPA (400-1200 mg/d) along with LTG gradually escalated to 200 mg/d in accordance with the package insert information: i.e. 25 mg of LTG was orally administered once every other day for the first 2 wk and then once daily for the following 2 wk. Thereafter, LTG was gradually escalated by 25 to 50 mg every 1 to 2 wk for once or twice daily administration. Par. received a range of VPA dose reduction as follows: When VPA was reduced to 300 mg/d, the range of reduction was as follows: 1000 mg/d (2 wk), 800 mg/d (2 wk), 600 mg/d (2 wk), 400 mg/d (2 wk), 300 mg/d OR 1000 mg/d (4 wk), 600 mg/d (4 wk), 300 mg/d and when VPA was reduced to < 300 mg/d, the dose was reduced to 300, 200, 100 and 0 mg/d in 100 mg decrements in steps of at least one wk duration. Par. received a fixed maint dose of LTG 200 mg/d and VPA 100 mg/d or a maint dose of LTG 200-400 mg/d were administered twice and 1-3 times daily for LTG and VPA, respectively, for 12 wk.
Overall Number of Participants Analyzed 33
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
LTG Escalation-Withdrawal, n=10 -7.19  (7.531)
LTG and VPA Maintenance-Visit 5, n=16 0.19  (9.082)
5.Secondary Outcome
Title Change From Baseline in Quality of Life in Epilepsy for Adolescents (QOLIE-AD-48) in Participants Aged 15-17 Years
Hide Description QOLIE-AD-48 is a questionnaire analyzed according to the scoring manual at Baseline, at the end of the LTG/VPA Maintenance Phase and withdrawals for participants aged 15-17 years (n=6). Particpants who has started by QOLIE-AD-48 were using the same questionnaire even after 18 years old. Overall score was calculated as an average of sub scores that were normalized to 0 to 100. QOLIE-AD-48 has 8 subscale items (epilepsy impact, memory/concentration, physical fuctioning, stigma, social support, school behavior, attitudes towards epilepsy and health perceptions). Higher score presents higher quality of life. Epileptic symptoms generally affect the QOL of participants, and so QOLIE-AD-48 is world widely used for the QOL assessment of non-adult participants. Baseline is defined as Day 1 (pre-dose) value. Change from Baseline is calculated as post-dose visit value minus Baseline value.
Time Frame Baseline and up to 46 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS Population. Only those participants available at the indicated phase were analyzed (represented by n=X in the category titles).
Arm/Group Title LTG Plus VPA (Phase 1, 2 and 3)
Hide Arm/Group Description:
Par. received a fixed maintenance (maint) dose of VPA (400-1200 mg/d) along with LTG gradually escalated to 200 mg/d in accordance with the package insert information: i.e. 25 mg of LTG was orally administered once every other day for the first 2 wk and then once daily for the following 2 wk. Thereafter, LTG was gradually escalated by 25 to 50 mg every 1 to 2 wk for once or twice daily administration. Par. received a range of VPA dose reduction as follows: When VPA was reduced to 300 mg/d, the range of reduction was as follows: 1000 mg/d (2 wk), 800 mg/d (2 wk), 600 mg/d (2 wk), 400 mg/d (2 wk), 300 mg/d OR 1000 mg/d (4 wk), 600 mg/d (4 wk), 300 mg/d and when VPA was reduced to < 300 mg/d, the dose was reduced to 300, 200, 100 and 0 mg/d in 100 mg decrements in steps of at least one wk duration. Par. received a fixed maint dose of LTG 200 mg/d and VPA 100 mg/d or a maint dose of LTG 200-400 mg/d were administered twice and 1-3 times daily for LTG and VPA, respectively, for 12 wk.
Overall Number of Participants Analyzed 33
Mean (Standard Deviation)
Unit of Measure: Units on a scale
LTG Escalation-Withdrawal, n=2 -10.83  (11.862)
LTG and VPA Maintenance-Visit 5, n=4 -2.67  (6.356)
6.Secondary Outcome
Title Percentage of Participants Who Completed or Discontinued From the Study
Hide Description Following cases were considered for participants to have completed a part of or whole of the study. For whole period completion: participants who completed the last LTG and VPA Maintenance Phase visit (M5) in the LTG and VPA Maintenance Phase and follow-up examination. For LTG Escalation Phase completion: participants who reached 200 mg/d of LTG (or 100-200 mg/d of LTG if there were safety concerns) within 8-18 weeks of the phase. For VPA Reduction Phase completion: participants who completed the last fixed dose of VPA Reduction Phase visit (0 mg/d) (FR4) of the phase. For LTG and VPA Maintenance Phase completion: participants who completed M5 of the phase. Participants who met any of the withdrawal criteria after the start of investigational product were considered to have discontinued the study. Percentage of participants who completed or discontinued/withdrawn from the study is presented.
Time Frame Up to 50 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Enrolled Population: comprised of all participants who had a Baseline (Week 0) visit.
Arm/Group Title LTG Plus VPA (Phase 1, 2 and 3)
Hide Arm/Group Description:
Par. received a fixed maintenance (maint) dose of VPA (400-1200 mg/d) along with LTG gradually escalated to 200 mg/d in accordance with the package insert information: i.e. 25 mg of LTG was orally administered once every other day for the first 2 wk and then once daily for the following 2 wk. Thereafter, LTG was gradually escalated by 25 to 50 mg every 1 to 2 wk for once or twice daily administration. Par. received a range of VPA dose reduction as follows: When VPA was reduced to 300 mg/d, the range of reduction was as follows: 1000 mg/d (2 wk), 800 mg/d (2 wk), 600 mg/d (2 wk), 400 mg/d (2 wk), 300 mg/d OR 1000 mg/d (4 wk), 600 mg/d (4 wk), 300 mg/d and when VPA was reduced to < 300 mg/d, the dose was reduced to 300, 200, 100 and 0 mg/d in 100 mg decrements in steps of at least one wk duration. Par. received a fixed maint dose of LTG 200 mg/d and VPA 100 mg/d or a maint dose of LTG 200-400 mg/d were administered twice and 1-3 times daily for LTG and VPA, respectively, for 12 wk.
Overall Number of Participants Analyzed 33
Measure Type: Number
Unit of Measure: Percentage of participants
Completed 61
Withdrawn 39
7.Secondary Outcome
Title Number of Participants With Adverse Events (AEs), AEs Leading to Discontinuation of the Investigational Product and/or Withdrawal From the Study, Drug-related AEs, Deaths and Serious Adverse Events (SAEs) Throughout the Study
Hide Description An AE is defined as untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalisation or prolongation of existing hospitalisation, results in disability/incapacity, is a congenital anomaly/birth defect, based on medical or scientific judgement and all events of possible drug-induced liver injury.
Time Frame From the start of study treatment until follow-up (up to 50 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population: comprised of participants who received at least one dose of the investigational product during the LTG Escalation Phase.
Arm/Group Title LTG Plus VPA (Phase 1, 2 and 3)
Hide Arm/Group Description:
Par. received a fixed maintenance (maint) dose of VPA (400-1200 mg/d) along with LTG gradually escalated to 200 mg/d in accordance with the package insert information: i.e. 25 mg of LTG was orally administered once every other day for the first 2 wk and then once daily for the following 2 wk. Thereafter, LTG was gradually escalated by 25 to 50 mg every 1 to 2 wk for once or twice daily administration. Par. received a range of VPA dose reduction as follows: When VPA was reduced to 300 mg/d, the range of reduction was as follows: 1000 mg/d (2 wk), 800 mg/d (2 wk), 600 mg/d (2 wk), 400 mg/d (2 wk), 300 mg/d OR 1000 mg/d (4 wk), 600 mg/d (4 wk), 300 mg/d and when VPA was reduced to < 300 mg/d, the dose was reduced to 300, 200, 100 and 0 mg/d in 100 mg decrements in steps of at least one wk duration. Par. received a fixed maint dose of LTG 200 mg/d and VPA 100 mg/d or a maint dose of LTG 200-400 mg/d were administered twice and 1-3 times daily for LTG and VPA, respectively, for 12 wk.
Overall Number of Participants Analyzed 33
Measure Type: Number
Unit of Measure: Participants
Any AEs 30
Drug-related AEs 17
Any SAEs 4
AEs leading to discontinuation/withdrawal 9
AEs leading to death 0
Time Frame Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment and until the follow-up contact (up to 50 weeks).
Adverse Event Reporting Description AEs and SAEs were collected from participants of the safety population, comprised of all participants who received atleast one dose of the investigational product during the LTG Escalation Phase.
 
Arm/Group Title LTG Plus VPA (Phase 1, 2 and 3)
Hide Arm/Group Description Par. received a fixed maintenance (maint) dose of VPA (400-1200 mg/d) along with LTG gradually escalated to 200 mg/d in accordance with the package insert information: i.e. 25 mg of LTG was orally administered once every other day for the first 2 wk and then once daily for the following 2 wk. Thereafter, LTG was gradually escalated by 25 to 50 mg every 1 to 2 wk for once or twice daily administration. Par. received a range of VPA dose reduction as follows: When VPA was reduced to 300 mg/d, the range of reduction was as follows: 1000 mg/d (2 wk), 800 mg/d (2 wk), 600 mg/d (2 wk), 400 mg/d (2 wk), 300 mg/d OR 1000 mg/d (4 wk), 600 mg/d (4 wk), 300 mg/d and when VPA was reduced to &lt; 300 mg/d, the dose was reduced to 300, 200, 100 and 0 mg/d in 100 mg decrements in steps of at least one wk duration. Par. received a fixed maint dose of LTG 200 mg/d and VPA 100 mg/d or a maint dose of LTG 200-400 mg/d were administered twice and 1-3 times daily for LTG and VPA, respectively, for 12 wk.
All-Cause Mortality
LTG Plus VPA (Phase 1, 2 and 3)
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
LTG Plus VPA (Phase 1, 2 and 3)
Affected / at Risk (%)
Total   4/33 (12.12%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Histiocytic necrotising lymphadenitis  1  1/33 (3.03%) 
Skin and subcutaneous tissue disorders   
Drug eruption  1  3/33 (9.09%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
LTG Plus VPA (Phase 1, 2 and 3)
Affected / at Risk (%)
Total   23/33 (69.70%) 
General disorders   
Pyrexia  1  3/33 (9.09%) 
Immune system disorders   
Seasonal allergy  1  2/33 (6.06%) 
Infections and infestations   
Nasopharyngitis  1  9/33 (27.27%) 
Gastroenteritis  1  4/33 (12.12%) 
Influenza  1  3/33 (9.09%) 
Injury, poisoning and procedural complications   
Arthropod bite  1  2/33 (6.06%) 
Nervous system disorders   
Somnolence  1  5/33 (15.15%) 
Dizziness  1  3/33 (9.09%) 
Headache  1  3/33 (9.09%) 
Tremor  1  2/33 (6.06%) 
Psychiatric disorders   
Insomnia  1  2/33 (6.06%) 
Skin and subcutaneous tissue disorders   
Rash  1  5/33 (15.15%) 
Drug eruption  1  2/33 (6.06%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Layout table for additonal information
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT02100644     History of Changes
Other Study ID Numbers: 200776
First Submitted: March 27, 2014
First Posted: April 1, 2014
Results First Submitted: November 5, 2015
Results First Posted: February 1, 2016
Last Update Posted: November 17, 2017