Migraine Study in Adolescent Patients

Migraine Disorders Clinical Trial

Official title:

TXA107979: A Randomized, Multicenter, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of a Combination Product Containing Sumatriptan and Naproxen Sodium for the Acute Treatment of Migraine in Adolescents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00843024
• Other study ID #: 107979
• Status: Completed
• Phase: Phase 3
• First received: February 12, 2009
• Last updated: November 21, 2012
• Start date: December 2008
• Est. completion date: June 2010

Study information

• Verified date: November 2012
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study was designed to determine how well the combination medication, sumatriptan and naproxen sodium, treats migraine headache in adolescents 12-17 years old

Description:

The purpose of this study is to determine whether the combination product, sumatriptan and naproxen sodium, is effective compared to placebo in the treatment of acute migraine in adolescent subjects 12-17 years old. Subjects will treat two migraine attacks over a ~25 week period.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 589
• Est. completion date: June 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 17 Years

Eligibility

Inclusion Criteria: Subjects eligible for enrollment in the study must meet all of the following criteria:

1. Subject is >/=12 years of age and </=17 years of age at the Screening Visit.

2. Subject has migraine with or without aura (ICHD-II criteria, 1.2.1 or 1.1). A history of at least two, but no more than eight attacks per month, for the six months prior to the Screening Visit is required. Attacks should last a minimum of three hours and be associated with moderate-to-severe headache pain.

3. Subject is able to distinguish migraine from other headaches (i.e., tension-type headaches).

4. Male or female subjects. Female subjects are eligible for participation in the study if they are:

1. Females of non-childbearing potential; or

2. Females of childbearing potential, and who have a negative urine pregnancy test at screening, and agree to use one of the GlaxoSmithKline (GSK)-specified highly effective methods for avoiding pregnancy

5. Any subject taking oral contraceptives at enrollment must be on a stable regimen for at least 2 months prior to screening.

6. Subject and subject's parent or legal guardian are able to read and write English or Spanish.

7. Subject is able to read, comprehend, and complete subject diaries.

8. Subject's parent or legal guardian is willing and able to provide Informed Consent prior to subject entry into the study.

9. Subject is willing and able to provide Informed Assent prior to entry into the study (if required).

Exclusion Criteria:

• Subjects meeting any of the following criteria must not be enrolled in the study:

1. Subject is < 74 pounds (33.3 kg).

2. Subject has =15 headache days per month in total (migraine, probable migraine, or tension-type), retinal (ICHD-II 1.4), basilar (ICHD-II 1.2.6), or hemiplegic migraine (ICHD-II 1.2.4), or secondary headaches.

3. Subject, in the investigator's opinion is likely to have unrecognized cardiovascular or cerebrovascular disease.

4. Subject has uncontrolled hypertension at screening or is taking any angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker.

5. Subject has a history of congenital heart disease, cardiac arrhythmias requiring medication, or a history of a clinically significant electrocardiogram abnormality that, in the investigator's opinion, contraindicates participation in this study.

6. Subject has evidence or history of any ischemic vascular diseases including:

ischemic heart disease, ischemic abdominal syndromes, peripheral vascular disease, or signs/symptoms consistent with any of the above.

7. Subject has evidence or history of central nervous system pathology including stroke and/or transient ischemic attacks (TIAs), epilepsy or structural brain lesions which lower the convulsive threshold, or has been treated with an antiepileptic drug for seizure control within 5 years prior to screening.

8. Subject has a history of impaired hepatic or renal function that, in the investigator's opinion, contraindicates participation in this study.

9. Subject has hypersensitivity, allergy, intolerance, or contraindication to the use of any triptan, NSAID, or aspirin (including all sumatriptan and naproxen preparations) or has nasal polyps and asthma.

10. Subject has used an ergot medication in the previous three months for migraine prophylaxis or is taking a medication that is not stabilized (i.e., change of dose within the past 2 months) for either chronic or intermittent migraine prophylaxis or for a co-morbid condition that is not stabilized.

11. Subject has a recent history of regular use of opioids or barbiturates for treatment of their migraine headache and/or other non-migraine pain. Regular use is defined as an average of 4 days per month over the last 6 months.

12. Subject has taken, or plans to take, a monoamine oxidase inhibitor (MAOI), including herbal preparations containing St. John's Wort (Hypericum perforatum), anytime within the two weeks prior to screening through two weeks post treatment.

13. Subject has a history of any bleeding disorder or is currently taking any anti-coagulant or any antiplatelet agent.

14. Subject has evidence or history of any gastrointestinal surgery, GI ulceration, or perforation in the past six months, gastrointestinal bleeding in the past year, or evidence or history of inflammatory bowel disease.

15. Subject is pregnant, actively trying to become pregnant, or breast feeding or subject is not willing to have pregnancy test(s).

16. Subject tests positive for illicit substances on toxicology screen, or has evidence of alcohol or substance abuse within the last year, or any concurrent medical or psychiatric condition which, in the investigator's judgment, will likely interfere with the study conduct, subject cooperation, or evaluation and interpretation of the study results, or which otherwise contraindicates participation in this clinical trial.

17. Subject has participated in any investigational drug trial within the previous 4 weeks or plans to participate in another study at any time during this study.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Migraine Disorders

Intervention

Drug:
• Sumatriptan and Naproxen Sodium
Sumatriptan succinate and naproxen sodium
• Placebo
Placebo to match

Locations

Country	Name	City	State
United States	GSK Investigational Site	Albuquerque	New Mexico
United States	GSK Investigational Site	Amherst	New York
United States	GSK Investigational Site	Anderson	Indiana
United States	GSK Investigational Site	Ann Arbor	Michigan
United States	GSK Investigational Site	Atlanta	Georgia
United States	GSK Investigational Site	Bardstown	Kentucky
United States	GSK Investigational Site	Bristol	Tennessee
United States	GSK Investigational Site	Charlottesville	Virginia
United States	GSK Investigational Site	Chicago	Illinois
United States	GSK Investigational Site	Chico	California
United States	GSK Investigational Site	Cincinnati	Ohio
United States	GSK Investigational Site	Cincinnati	Ohio
United States	GSK Investigational Site	Clarksville	Tennessee
United States	GSK Investigational Site	Cleveland	Ohio
United States	GSK Investigational Site	Colorado Springs	Colorado
United States	GSK Investigational Site	Conway	Arkansas
United States	GSK Investigational Site	Dallas	Texas
United States	GSK Investigational Site	Eugene	Oregon
United States	GSK Investigational Site	Fairfield	Connecticut
United States	GSK Investigational Site	Fresno	California
United States	GSK Investigational Site	Fullteron	California
United States	GSK Investigational Site	Gainesville	Florida
United States	GSK Investigational Site	Gilbert	Arizona
United States	GSK Investigational Site	Greer	South Carolina
United States	GSK Investigational Site	Hialeah	Florida
United States	GSK Investigational Site	Houston	Texas
United States	GSK Investigational Site	Huntington Beach	California
United States	GSK Investigational Site	Kansas City	Kansas
United States	GSK Investigational Site	Lexington	Kentucky
United States	GSK Investigational Site	Litchfield Park	Arizona
United States	GSK Investigational Site	Little Rock	Arkansas
United States	GSK Investigational Site	Little Rock	Arkansas
United States	GSK Investigational Site	Madison	Wisconsin
United States	GSK Investigational Site	Miami	Florida
United States	GSK Investigational Site	Middleton	Wisconsin
United States	GSK Investigational Site	Mineola	New York
United States	GSK Investigational Site	Mount Vernon	New York
United States	GSK Investigational Site	Newport Beach	California
United States	GSK Investigational Site	Norfolk	Virginia
United States	GSK Investigational Site	Oak Lawn	Illinois
United States	GSK Investigational Site	Oklahoma City	Oklahoma
United States	GSK Investigational Site	Omaha	Nebraska
United States	GSK Investigational Site	Park Ridge	Illinois
United States	GSK Investigational Site	Philadelphia	Pennsylvania
United States	GSK Investigational Site	Phoenix	Arizona
United States	GSK Investigational Site	Phoenix	Arizona
United States	GSK Investigational Site	Phoenix	Arizona
United States	GSK Investigational Site	Pikesville	Maryland
United States	GSK Investigational Site	Pittsburgh	Pennsylvania
United States	GSK Investigational Site	Plymouth	Minnesota
United States	GSK Investigational Site	Portland	Oregon
United States	GSK Investigational Site	Raleigh	North Carolina
United States	GSK Investigational Site	Roseville	California
United States	GSK Investigational Site	Sacramento	California
United States	GSK Investigational Site	Salem	Oregon
United States	GSK Investigational Site	Salt Lake City	Utah
United States	GSK Investigational Site	San Antonio	Texas
United States	GSK Investigational Site	San Francisco	California
United States	GSK Investigational Site	Santa Monica	California
United States	GSK Investigational Site	Savannah	Georgia
United States	GSK Investigational Site	Schenectady	New York
United States	GSK Investigational Site	Seattle	Washington
United States	GSK Investigational Site	Simpsonville	South Carolina
United States	GSK Investigational Site	Springfield	Missouri
United States	GSK Investigational Site	St. Louis	Missouri
United States	GSK Investigational Site	Stockbridge	Georgia
United States	GSK Investigational Site	Terre Haute	Indiana
United States	GSK Investigational Site	Vancouver	Washington
United States	GSK Investigational Site	Vorhees	New Jersey
United States	GSK Investigational Site	Wenatchee	Washington
United States	GSK Investigational Site	West Chester	Ohio
United States	GSK Investigational Site	West Palm Beach	Florida
United States	GSK Investigational Site	Westerville	Ohio
United States	GSK Investigational Site	Wichita	Kansas
United States	GSK Investigational Site	Willingboro	New Jersey
United States	GSK Investigational Site	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

References & Publications (1)

Brandes JL, Kudrow D, Stark SR, O'Carroll CP, Adelman JU, O'Donnell FJ, Alexander WJ, Spruill SE, Barrett PS, Lener SE. Sumatriptan-naproxen for acute treatment of migraine: a randomized trial. JAMA. 2007 Apr 4;297(13):1443-54. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Mean Age of Participants at Baseline Categorized by Age Group	The mean age of participants at baseline was calculated for all participants in the 12 to 14 year and 15 to 17 year age groups.	Baseline	No
Other	Number of Participants Randomized to Double-blind Treatment in the Indicated Age Categories at Baseline	The number of participants receiving double-blind treatment were reported according to age.	Baseline	No
Other	Number of Female and Male Participants Categorized by Age Group	The gender of participants at baseline was reported for all participants in the 12 to 14 year and 15 to 17 year age groups.	Baseline	No
Other	Number of Participants of the Indicated Race Categorized by Age Group	The race of participants at baseline was reported for all participants in the 12 to 14 year and 15 to 17 year age groups.	Baseline	No
Other	Mean Weight of Participants at Baseline Categorized by Age Group	The mean weight of participants at baseline was calculated for all participants in the 12 to 14 year and 15 to 17 year age groups.	Baseline	No
Other	Mean Body Mass Index of Participants at Baseline Categorized by Age Group	The mean body mass index of participants at baseline was calculated for all participants in the 12 to 14 year and 15 to 17 year age groups. Body mass index is calculated as: weight (kilograms [kg]) divided by height (meters [m]^2).	Baseline	No
Primary	Number of Participants Who Were Pain Free at 2 Hours Post-dose	Participants were evaluated (self-assessment) for pain intensity by using a 4-point rating scale: 0=none, 1=mild, 2=moderate, and 3=severe. Participants with pain-free response were considered as those who had a reduction in migraine headache pain from moderate (score=2) or severe (score=3) at baseline to none (score=0) post-treatment, without the use of rescue medication (additional medication taken by participants for the treatment of migraine pain or associated symptoms) prior to or at 2 hours post-dose.	2 hours after single dose of double-blind treatment (Randomization through Week 13)	No
Secondary	Number of Participants Sustained Pain-free From 2-24 Hours	Participants with sustained pain-freedom were defined as those with pain-freedom at 2 hours post-dose that was maintained up to 24 hours post-treatment without the use of rescue medication.	2 to 24 hours after single dose of double-blind treatment (Randomization through Week 13)	No
Secondary	Number of Participants Photophobia-free at 2 Hours Post-dose	The number of participants who did not have photophobia (sensitivity to light) at 2 hours post dose was analyzed.	2 hours after single dose of double-blind treatment (Randomization through Week 13)	No
Secondary	Number of Participants Phonophobia-free at 2 Hours Post-dose	The number of participants who did not have phonophobia (sensitivity to sound) at 2 hours post dose was analzyed.	2 hours after single dose of double-blind treatment (Randomization through Week 13)	No
Secondary	Number of Participants Pain-free at 1 Hour Post-dose	Participants with a pain-free response at 1 hour post-dose were considered as those who had a reduction in migraine headache pain from moderate (a score of 2) or severe (a score of 3) at baseline to none (a score of 0) post-treatment, without the use of rescue medication prior to or at 1 hour post dose.	1 hour after single dose of double-blind treatment (Randomization through Week 13)	No
Secondary	Number of Participants Sustained Photophobia-free From 2-24 Hours	Participants with sustained freedom from photophobia were those with an absence of photophobia (sensitivity to light) from 2 to 24 hours post-dose without the use of rescue medication.	2 to 24 hours after single dose of double-blind treatment (Randomization through Week 13)	No
Secondary	Number of Participants Sustained Phonophobia-free From 2-24 Hours	Participants with sustained freedom from phonophobia were those with an absence of phonophobia (sensitivity to sound) from 2 to 24 hours post-dose without the use of rescue medication.	2 to 24 hours after single dose of double-blind treatment (Randomization through Week 13)	No
Secondary	Number of Participants Sustained Nausea-free From 2-24 Hours	Participants with sustained freedom from nausea were those with an absence of nausea from 2 to 24 hours post-dose without the use of rescue medication.	2 to 24 hours after single dose of double-blind treatment (Randomization through Week 13)	No
Secondary	Number of Participants Who Used Rescue Medication From 2 to 24 Hours Post Dose	Rescue medication was defined as an additional medication taken by participants for the treatment of migraine pain or associated symptoms within 24 hours of dosing with investigational product. Permitted rescue medications included oral naproxen sodium (maximum 15 mg/kg), oral over-the-counter pain reliever, and anti-emetics. This outcome measure included only participants who rescued from 2 to 24 hours post-dose, inclusive.	2 to 24 hours after single dose of double-blind treatment (Randomization through Week 13)	No
Secondary	Number of Participants Who Used Their First Dose of Rescue Medication Through the Indicated Time Points	Rescue medication was defined as an additional medication taken by participants for the treatment of migraine pain or associated symptoms within 24 hours of dosing with double-blind treatment. In addition to participants who rescued from 2 to 24 hours post-dose, inclusive, this outcome measure also included nine protocol violators who rescued < 2 hours post-treatment.	Dosing to 24 hours after single dose of double-blind treatment (Randomization through Week 13)	No
Secondary	Number of Participants Nausea-free at 2 Hours Post-dose	The number of participants who did not have nausea at 2 hours post dose was analzyed.	2 hours after single dose of double-blind treatment (Randomization through Week 13)	No