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Migraine Study in Adolescent Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00843024
First received: February 12, 2009
Last updated: November 21, 2012
Last verified: November 2012
History of Changes
Results First Received: January 22, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Migraine Disorders
Interventions: Drug: Sumatriptan and Naproxen Sodium
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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
12 to 14 Years Age Group: Single-blind Phase Participants 12 to 14 years old treated one moderate to severe migraine attack with one tablet of single-blind placebo within a 12-week period. After completion of the run-in phase, participants were randomized to one of four double-blind treatment groups.
15 to 17 Years Age Group: Single-blind Phase Participants 15 to 17 years old treated one moderate to severe migraine attack with one tablet of single-blind placebo within a 12-week period. After completion of the run-in phase, participants were randomized to one of four double-blind treatment groups.
Placebo After completing the single-blind phase, participants received a single matching placebo tablet taken within a 12-week period
Sumatriptan 10 mg/ Naproxen 60 mg After completing the single-blind phase, participants received a single combination tablet of sumatriptan 10 milligrams (mg) and naproxen sodium 60 mg taken within a 12-week period
Sumatriptan 30 mg/ Naproxen 180 mg After completing the single-blind phase, participants received a single combination tablet of sumatriptan 30 mg and naproxen sodium 180 mg taken within a 12-week period
Sumatriptan 85 mg/ Naproxen 500 mg After completing the single-blind phase, participants received a single combination tablet of sumatriptan 85 mg and naproxen sodium 500 mg taken within a 12-week period

Participant Flow for 2 periods

 Period 1:   Single-blind Placebo Run-In Phase
    12 to 14 Years Age Group: Single-blind Phase     15 to 17 Years Age Group: Single-blind Phase     Placebo     Sumatriptan 10 mg/ Naproxen 60 mg     Sumatriptan 30 mg/ Naproxen 180 mg     Sumatriptan 85 mg/ Naproxen 500 mg  
STARTED     408     457     0     0     0     0  
COMPLETED     268     321     0     0     0     0  
NOT COMPLETED     140     136     0     0     0     0  
Did not meet continuation criteria                 79                 74                 0                 0                 0                 0  
Lost to Follow-up                 36                 31                 0                 0                 0                 0  
Withdrawal by Subject                 19                 18                 0                 0                 0                 0  
Protocol Violation                 4                 5                 0                 0                 0                 0  
Physician Decision                 2                 6                 0                 0                 0                 0  
Adverse Event                 0                 1                 0                 0                 0                 0  
Unknown                 0                 1                 0                 0                 0                 0  

Period 2:   Double-blind Treatment Phase
    12 to 14 Years Age Group: Single-blind Phase     15 to 17 Years Age Group: Single-blind Phase     Placebo     Sumatriptan 10 mg/ Naproxen 60 mg     Sumatriptan 30 mg/ Naproxen 180 mg     Sumatriptan 85 mg/ Naproxen 500 mg  
STARTED     0     0     176     119     117     177  
COMPLETED     0     0     145     96     97     152  
NOT COMPLETED     0     0     31     23     20     25  
No opportunity to treat migraine                 0                 0                 20                 10                 13                 14  
Lost to Follow-up                 0                 0                 8                 4                 4                 4  
Withdrawal by Subject                 0                 0                 0                 6                 0                 2  
Protocol Violation                 0                 0                 3                 0                 0                 3  
Physician Decision                 0                 0                 0                 3                 1                 1  
Adverse Event                 0                 0                 0                 0                 1                 1  
Lack of Efficacy                 0                 0                 0                 0                 1                 0  



  Baseline Characteristics
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Reporting Groups
  Description
Placebo A single matching placebo tablet taken within a 12-week period
Sumatriptan 10 mg/ Naproxen 60 mg A single combination tablet of sumatriptan 10 milligrams (mg) and naproxen sodium 60 mg taken within a 12-week period
Sumatriptan 30 mg/ Naproxen 180 mg A single combination tablet of sumatriptan 30 mg and naproxen sodium 180 mg taken within a 12-week period
Sumatriptan 85 mg/ Naproxen 500 mg A single combination tablet of sumatriptan 85 mg and naproxen sodium 500 mg taken within a 12-week period
Total Total of all reporting groups

Baseline Measures
    Placebo     Sumatriptan 10 mg/ Naproxen 60 mg     Sumatriptan 30 mg/ Naproxen 180 mg     Sumatriptan 85 mg/ Naproxen 500 mg     Total  
Number of Participants  
[units: participants]
 		  145     96     97     152     490  
Age [1]
[units: Years]
Mean ± Standard Deviation 		  14.7  ± 1.76     14.8  ± 1.81     14.7  ± 1.65     14.8  ± 1.69     14.7  ± 1.72  
Gender  
[units: Participants]
 		         
Female     85     52     56     94     287  
Male     60     44     41     58     203  
Race/Ethnicity, Customized  
[units: participants]
 		         
African American/African Heritage     25     17     9     12     63  
American Indian or Alaska Native     0     0     0     1     1  
Asian     1     0     0     3     4  
Native Hawaiian or other Pacific Islander     1     0     0     0     1  
White     108     75     84     130     397  
African American/African Heritage and White     2     1     1     2     6  
American Indian or Alaska Native and White     1     2     2     3     8  
Asian and Native Hawaiian/other Pacific Islander     1     0     0     0     1  
Asian and White     3     1     0     1     5  
Native Hawaiian/ other Pacific Islander and White     1     0     1     0     2  
Missing     2     0     0     0     2  
Weight  
[units: Kilograms (kg)]
Mean ± Standard Deviation 		  63.8  ± 16.67     64.2  ± 19.29     62.8  ± 14.49     66.8  ± 19.13     64.6  ± 17.63  
Body Mass Index [2]
[units: Kilograms per meters squared (kg/m^2)]
Mean ± Standard Deviation 		  23.5  ± 5.28     23.3  ± 5.62     22.9  ± 4.53     24.6  ± 5.68     23.7  ± 5.36  
[1] Baseline characteristics are provided for participants in the Intent-to-Treat (ITT) Population, comprised of all participants who provided any post-treatment efficacy assessment.
[2] Body Mass Index is calculated as: weight (kg)/height (m^2)



  Outcome Measures
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1.  Primary:   Number of Participants Who Were Pain Free at 2 Hours Post-dose   [ Time Frame: 2 hours after single dose of double-blind treatment (Randomization through Week 13) ]
  Show Outcome Measure 1

2.  Secondary:   Number of Participants Sustained Pain-free From 2-24 Hours   [ Time Frame: 2 to 24 hours after single dose of double-blind treatment (Randomization through Week 13) ]
  Show Outcome Measure 2

3.  Secondary:   Number of Participants Photophobia-free at 2 Hours Post-dose   [ Time Frame: 2 hours after single dose of double-blind treatment (Randomization through Week 13) ]
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4.  Secondary:   Number of Participants Phonophobia-free at 2 Hours Post-dose   [ Time Frame: 2 hours after single dose of double-blind treatment (Randomization through Week 13) ]
  Show Outcome Measure 4

5.  Secondary:   Number of Participants Pain-free at 1 Hour Post-dose   [ Time Frame: 1 hour after single dose of double-blind treatment (Randomization through Week 13) ]
  Show Outcome Measure 5

6.  Secondary:   Number of Participants Sustained Photophobia-free From 2-24 Hours   [ Time Frame: 2 to 24 hours after single dose of double-blind treatment (Randomization through Week 13) ]
  Show Outcome Measure 6

7.  Secondary:   Number of Participants Sustained Phonophobia-free From 2-24 Hours   [ Time Frame: 2 to 24 hours after single dose of double-blind treatment (Randomization through Week 13) ]
  Show Outcome Measure 7

8.  Secondary:   Number of Participants Sustained Nausea-free From 2-24 Hours   [ Time Frame: 2 to 24 hours after single dose of double-blind treatment (Randomization through Week 13) ]
  Show Outcome Measure 8

9.  Secondary:   Number of Participants Who Used Rescue Medication From 2 to 24 Hours Post Dose   [ Time Frame: 2 to 24 hours after single dose of double-blind treatment (Randomization through Week 13) ]
  Show Outcome Measure 9

10.  Secondary:   Number of Participants Who Used Their First Dose of Rescue Medication Through the Indicated Time Points   [ Time Frame: Dosing to 24 hours after single dose of double-blind treatment (Randomization through Week 13) ]
  Show Outcome Measure 10

11.  Secondary:   Number of Participants Nausea-free at 2 Hours Post-dose   [ Time Frame: 2 hours after single dose of double-blind treatment (Randomization through Week 13) ]
  Show Outcome Measure 11

12.  Other Pre-specified:   Mean Age of Participants at Baseline Categorized by Age Group   [ Time Frame: Baseline ]
  Show Outcome Measure 12

13.  Other Pre-specified:   Number of Participants Randomized to Double-blind Treatment in the Indicated Age Categories at Baseline   [ Time Frame: Baseline ]
  Show Outcome Measure 13

14.  Other Pre-specified:   Number of Female and Male Participants Categorized by Age Group   [ Time Frame: Baseline ]
  Show Outcome Measure 14

15.  Other Pre-specified:   Number of Participants of the Indicated Race Categorized by Age Group   [ Time Frame: Baseline ]
  Show Outcome Measure 15

16.  Other Pre-specified:   Mean Weight of Participants at Baseline Categorized by Age Group   [ Time Frame: Baseline ]
  Show Outcome Measure 16

17.  Other Pre-specified:   Mean Body Mass Index of Participants at Baseline Categorized by Age Group   [ Time Frame: Baseline ]
  Show Outcome Measure 17


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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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
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Results Point of Contact:  
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343


Publications:

Publications automatically indexed to this study:


Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00843024     History of Changes
Other Study ID Numbers: 107979
Study First Received: February 12, 2009
Results First Received: January 22, 2011
Last Updated: November 21, 2012
Health Authority: United States: Food and Drug Administration