Text Size

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: October 26, 2011
Last verified: October 2011
History of Changes
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
  Hide 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
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 No text entered.
GEn 1200 mg No text entered.
GEn 1800 mg No text entered.
GEn 2400 mg No text entered.
GEn 3000 mg No text entered.

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
  Hide Baseline Characteristics

Reporting Groups
  Description
Placebo No text entered.
GEn 1200 mg No text entered.
GEn 1800 mg No text entered.
GEn 2400 mg No text entered.
GEn 3000 mg No text entered.
Total Total of all reporting groups

Baseline Measures
    Placebo     GEn 1200 mg     GEn 1800 mg     GEn 2400 mg     GEn 3000 mg     Total  
Number of Participants  
[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) ]
  Show Outcome Measure 1

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) ]
  Show Outcome Measure 2

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) ]
  Show Outcome Measure 3

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) ]
  Show Outcome Measure 4

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) ]
  Show Outcome Measure 5

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) ]
  Show Outcome Measure 6

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) ]
  Show Outcome Measure 7

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) ]
  Show Outcome Measure 8

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) ]
  Show Outcome Measure 9

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) ]
  Hide Outcome Measure 10

Measure Type Secondary
Measure Title Mean Change From Baseline to the Last 4-Week Treatment Phase in the Number of Acute Migraine Medication Doses Administered by Opioid Use
Measure Description The Number of Acute Migraine Medication Doses Administered by Opioid Use was measured via the participant-assessed Daily Migraine Diary.
Time Frame Baseline and last 4 weeks of treatment prior to taper (up to Week 17)  
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 Population

Reporting Groups
  Description
Placebo No text entered.
GEn 1200 mg No text entered.
GEn 1800 mg No text entered.
GEn 2400 mg No text entered.
GEn 3000 mg No text entered.

Measured Values
    Placebo     GEn 1200 mg     GEn 1800 mg     GEn 2400 mg     GEn 3000 mg  
Number of Participants Analyzed  
[units: participants]
 		  120     59     114     123     58  
Mean Change From Baseline to the Last 4-Week Treatment Phase in the Number of Acute Migraine Medication Doses Administered by Opioid Use  
[units: Number of days]
Mean ± Standard Error 		         
Opioid Use (n=20, 7, 14, 26, 10)     -1.7  ± 1.66     1.4  ± 2.81     -3.2  ± 1.97     -6.0  ± 1.45     -5.1  ± 2.34  
Non-Opioid Use (n=100, 52, 100, 97, 48)     -5.1  ± 0.75     -5.7  ± 0.75     -6.2  ± 0.74     -4.9  ± 0.75     -4.4  ± 1.08  

No statistical analysis provided for Mean Change From Baseline to the Last 4-Week Treatment Phase in the Number of Acute Migraine Medication Doses Administered by Opioid Use



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) ]
  Show Outcome Measure 11

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) ]
  Show Outcome Measure 12

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 ]
  Show Outcome Measure 13

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 ]
  Show Outcome Measure 14

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 ]
  Show Outcome Measure 15

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 ]
  Show Outcome Measure 16

17.  Other Pre-specified:   Mean Change From Baseline in the Headache Impact Test (HIT-6) Total Scores at Week 17   [ Time Frame: Week 17 ]
  Show Outcome Measure 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 ]
  Show Outcome Measure 18

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


  Serious Adverse Events
  Show Serious Adverse Events


  Other Adverse Events
  Show Other Adverse Events


  More Information
  Hide More Information

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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


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
No text entered.  


Results Point of Contact:  
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343


No publications provided by XenoPort, Inc.

Publications automatically indexed to this study:


Responsible Party: XenoPort, Inc.
ClinicalTrials.gov Identifier: NCT00742209     History of Changes
Other Study ID Numbers: 111381
Study First Received: August 26, 2008
Results First Received: July 25, 2011
Last Updated: October 26, 2011
Health Authority: Canada: Health Canada
United States: Food and Drug Administration