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Prevention Study in Adult Patients Suffering From Migraine Headaches

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
XenoPort, Inc.
ClinicalTrials.gov Identifier:
NCT00742209
First received: August 26, 2008
Last updated: July 15, 2013
Last verified: October 2011
Results First Received: July 25, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Conditions: Migraine Disorders
Migraine
Interventions: Drug: GSK1838262
Drug: Placebo

  Participant Flow
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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
There were 3 subjects who were randomized but did not take investigational product, and, therefore, were not included in the Safety, Intent to Treat (ITT), or Per Protocol (PP) population.

Reporting Groups
  Description
Placebo Oral GEn (XP13512) placebo
GEn 1200 mg Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Weeks 2-17: 1200 mg/day.
GEn 1800 mg Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Weeks 3-17: 1800 mg/day
GEn 2400 mg Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4-17: 2400 mg/day
GEn 3000 mg Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4: 2400 mg/day. Weeks 5-17: 3000 mg/day.

Participant Flow:   Overall Study
    Placebo   GEn 1200 mg   GEn 1800 mg   GEn 2400 mg   GEn 3000 mg
STARTED   129   67   134   134   62 
COMPLETED   95   49   88   97   37 
NOT COMPLETED   34   18   46   37   25 
Adverse Event                11                4                17                16                13 
Participant Withdrew Consent                8                4                14                7                4 
Protocol Violation                6                5                4                5                3 
Lost to Follow-up                3                4                5                5                3 
Lack of Efficacy                6                1                1                3                1 
Investigator Discretion                0                0                5                1                1 



  Baseline Characteristics
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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 population

Reporting Groups
  Description
Placebo Oral GEn (XP13512) placebo on Weeks 1-17
GEn 1200 mg Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Weeks 2-17: 1200 mg/day.
GEn 1800 mg Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Weeks 3-17: 1800 mg/day.
GEn 2400 mg Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4-17: 2400 mg/day.
GEn 3000 mg Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4: 2400 mg/day. Weeks 5-17: 3000 mg/day.
Total Total of all reporting groups

Baseline Measures
   Placebo   GEn 1200 mg   GEn 1800 mg   GEn 2400 mg   GEn 3000 mg   Total 
Overall Participants Analyzed 
[Units: Participants]
 128   66   134   133   62   523 
Age 
[Units: Years]
Mean (Standard Deviation)
 41.1  (11.72)   39.4  (9.74)   37.7  (11.75)   39.0  (12.04)   39.1  (11.78)   39.2  (11.61) 
Gender 
[Units: Participants]
           
Female   111   52   115   105   46   429 
Male   17   14   19   28   16   94 
Race/Ethnicity, Customized 
[Units: Participants]
           
White   108   54   107   112   53   434 
African American/African Heritage (AA)   11   8   15   11   6   51 
American Indian (AI) or Alaska Native (AN)   2   1   3   1   0   7 
Asian   4   3   6   6   3   22 
Native Hawaiian or other Pacific Islander   1   0   0   0   0   1 
AA/African Heritage and AI or AN and White   0   0   0   1   0   1 
AA/African Heritage and White   0   0   2   1   0   3 
AI or AN and White   1   0   1   0   0   2 
Asian and White   1   0   0   1   0   2 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Adjusted Mean Change From Baseline in the Number of Migraine Headache Days (MHD) During the Last 4 Weeks of Treatment Prior to Taper   [ Time Frame: Baseline and last 4 weeks of treatment prior to taper (up to Week 17) ]

2.  Secondary:   Mean Change From Baseline in the Number of MHD in All Study Phases   [ Time Frame: Baseline and last 4 weeks of treatment prior to taper (up to Week 17) ]

3.  Secondary:   Adjusted Mean Change From Baseline in the Number of Migraine Attacks   [ Time Frame: Baseline and last 4 weeks of treatment prior to taper (up to Week 17) ]

4.  Secondary:   Mean Change From Baseline in the Number of Migraine Headache Periods (MHP)   [ Time Frame: Baseline and last 4 weeks of treatment prior to taper (up to Week 17) ]

5.  Secondary:   Change From Baseline in the Mean Migraine Attack Duration   [ Time Frame: Baseline and last 4 weeks of treatment prior to taper (up to Week 17) ]

6.  Secondary:   Change From Baseline in the Mean Peak Migraine Pain Severity   [ Time Frame: Baseline and last 4 weeks of treatment prior to taper (up to Week 17) ]

7.  Secondary:   Mean Change From Baseline to the Last 4-Week Treatment Phase in the Number of Days of Acute Migraine Medication Use   [ Time Frame: Baseline and last 4 weeks of treatment prior to taper (up to Week 17) ]

8.  Secondary:   Mean Change From Baseline to the Last 4-Week Treatment Phase in the Number of Acute Migraine Medication Doses Administered   [ Time Frame: Baseline and last 4 weeks of treatment prior to taper (up to Week 17) ]

9.  Secondary:   Mean Change From Baseline to the Last 4-Week Treatment Phase in the Number of Acute Migraine Medication Doses Administered by Triptan Use   [ Time Frame: Baseline and last 4 weeks of treatment prior to taper (up to Week 17) ]

10.  Secondary:   Mean Change From Baseline to the Last 4-Week Treatment Phase in the Number of Acute Migraine Medication Doses Administered by Opioid Use   [ Time Frame: Baseline and last 4 weeks of treatment prior to taper (up to Week 17) ]

11.  Secondary:   Mean Change From Baseline to the Last 4-Week Treatment Phase in the Number of Acute Migraine Medication Doses Administered by Prescription Headache Medication Use   [ Time Frame: Baseline and last 4 weeks of treatment prior to taper (up to Week 17) ]

12.  Secondary:   Mean Change From Baseline in Percentage of Migraine Attacks With Each of the Following Migraine Symptoms: Aura, Nausea, Vomiting, Photophobia, Phonophobia   [ Time Frame: Baseline and last 4 weeks of treatment prior to taper (up to Week 17) ]

13.  Secondary:   Percentage of Participants Classified as Responders for Each of the Following Measures: Migraine Headache Days, Migraine Attacks, and Migraine Headache Periods   [ Time Frame: Baseline to the Last 4 weeks of treatment ]

14.  Secondary:   Number of Participants Who Were “Much Improved” or “Very Much Improved” on the 7-point Likert Patient Global Impression of Change (PGIC) Scale Using LOCF at Week 17   [ Time Frame: Week 17 ]

15.  Secondary:   Number of Participants Who Were “Much Improved” or “Very Much Improved” (Responders) on the 7-point Likert Clinical Global Impression of Change (CGIC) Scale Using LOCF at Week 17   [ Time Frame: Week 17 ]

16.  Other Pre-specified:   Mean Change From Baseline in Migraine Specific Quality of Life Questionnaire (MSQ v2.1) Composite Score and Subscales (Role Function Restrictive, Role Function, Preventive, & Emotional Function) at Week 17   [ Time Frame: Baseline and Week 17 ]

17.  Other Pre-specified:   Mean Change From Baseline in the Headache Impact Test (HIT-6) Total Scores at Week 17   [ Time Frame: Week 17 ]

18.  Other Pre-specified:   Mean Change From Baseline in Productivity as Measured by Lost Time Equivalents (LTE) - (Work Activities, Non-work Activities, and Combination of Work and Non-work Activities)   [ Time Frame: Week 17 ]

19.  Other Pre-specified:   Assessment of Treatment Satisfaction Using the Patient Perception of Migraine Questionnaire (PPMQ-R) at Week 17   [ Time Frame: Week 17 ]


  Serious Adverse Events
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Time Frame No text entered.
Additional Description Serious adverse events (AEs) and non-serious AEs were collected in the Safety Population, comprised of all randomized participants who took at least one tablet of investigational product. There were no participants who took drug and did not have at least one post-baseline efficacy assessment; thus, the Safety and ITT Populations are the same.

Reporting Groups
  Description
Placebo Oral GEn (XP13512) placebo
GEn 1200 mg Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Weeks 2-17: 1200 mg/day
GEn 1800 mg Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Weeks 3-17: 1800 mg/day
GEn 2400 mg Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4-17: 2400 mg/day
GEn 3000 mg Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4: 2400 mg/day. Weeks 5-17: 3000 mg/day

Serious Adverse Events
    Placebo   GEn 1200 mg   GEn 1800 mg   GEn 2400 mg   GEn 3000 mg
Total, serious adverse events           
# participants affected / at risk   2/128 (1.56%)   0/66 (0.00%)   2/134 (1.49%)   1/133 (0.75%)   4/62 (6.45%) 
Hepatobiliary disorders           
Cholecystitis † 1           
# participants affected / at risk   0/128 (0.00%)   0/66 (0.00%)   1/134 (0.75%)   0/133 (0.00%)   0/62 (0.00%) 
# events   0   0   1   0   0 
Choleslithiasis † 1           
# participants affected / at risk   0/128 (0.00%)   0/66 (0.00%)   1/134 (0.75%)   0/133 (0.00%)   0/62 (0.00%) 
# events   0   0   1   0   0 
Infections and infestations           
Appendicitis † 1           
# participants affected / at risk   0/128 (0.00%)   0/66 (0.00%)   1/134 (0.75%)   0/133 (0.00%)   0/62 (0.00%) 
# events   0   0   1   0   0 
Pharyngitis † 1           
# participants affected / at risk   1/128 (0.78%)   0/66 (0.00%)   0/134 (0.00%)   0/133 (0.00%)   0/62 (0.00%) 
# events   1   0   0   0   0 
Pneumonia † 1           
# participants affected / at risk   0/128 (0.00%)   0/66 (0.00%)   0/134 (0.00%)   0/133 (0.00%)   1/62 (1.61%) 
# events   0   0   0   0   1 
Bronchopneumonia † 1           
# participants affected / at risk   0/128 (0.00%)   0/66 (0.00%)   1/134 (0.75%)   0/133 (0.00%)   0/62 (0.00%) 
# events   0   0   1   0   0 
Injury, poisoning and procedural complications           
Accidental Overdose † 1           
# participants affected / at risk   0/128 (0.00%)   0/66 (0.00%)   0/134 (0.00%)   1/133 (0.75%)   0/62 (0.00%) 
# events   0   0   0   1   0 
Musculoskeletal and connective tissue disorders           
Muscle Spasms † 1           
# participants affected / at risk   1/128 (0.78%)   0/66 (0.00%)   0/134 (0.00%)   0/133 (0.00%)   0/62 (0.00%) 
# events   1   0   0   0   0 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)           
Metastatic malignant melanoma † 1           
# participants affected / at risk   0/128 (0.00%)   0/66 (0.00%)   0/134 (0.00%)   0/133 (0.00%)   1/62 (1.61%) 
# events   0   0   0   0   1 
Nervous system disorders           
Convulsion † 1           
# participants affected / at risk   0/128 (0.00%)   0/66 (0.00%)   0/134 (0.00%)   0/133 (0.00%)   1/62 (1.61%) 
# events   0   0   0   0   1 
Psychiatric disorders           
Conversion disorder † 1           
# participants affected / at risk   0/128 (0.00%)   0/66 (0.00%)   0/134 (0.00%)   0/133 (0.00%)   1/62 (1.61%) 
# events   0   0   0   0   1 
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA (13.0)




  Other Adverse Events


  Limitations and Caveats
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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
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  More Information