TEAM: Treximet Early Intervention Adolescent Migraine

• Sponsor: Premiere Research Institute (Other)
• Overall Status: Completed
• CT.gov ID: NCT01016678
• Collaborator: GlaxoSmithKline (Industry)
• Enrollment: 104
• Locations: 4
• Arms: 5
• Duration (Months): 52
• Patients Per Site: 26
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

The study involves approximately 105 adolescent (ages 12-17) subjects to be screened at 4 sites across the US. All subjects enrolled will treat up to 4 MILD migraines over a 6 month period. They will be required to have three office visits during the six months. All subjects will be randomized to either Treximet (85mg Imitrex/500mg Naproxen Sodium) or Placebo (sugar-pill) in four of the five treatment arms with a 3 to 1 ratio. A fifth treatment arm will treat all 4 migraines with active drug, Treximet. The hypothesis is that Treximet will prove to be a safe and effective treatment for this population, that has so few treatment for migraine. And Treximet will be superior over placebo for pain free endpoints at 2 and 24 hours.

Condition or Disease	Intervention/Treatment	Phase
Migraine	Drug: Treximet; Drug: Placebo	Phase 2/Phase 3

Detailed Description

There are two primary treatment comparisons for this study: 1) the percentage of subjects' pain free at 2 hours after treatment with TREXIMET versus placebo across attacks, and 2) the percentage of subjects who are sustained pain free at 24 hours after treatment with TREXIMET versus placebo across attacks.

The following alternative hypothesis will be tested to see if there is a difference in the proportion of subjects who are pain free at 2 hours with TREXIMET versus placebo at all attacks, OR there is a difference in the proportion of subjects who are sustained pain free at 24 hours with TREXIMET versus placebo at all attacks.

Study Design

• Study Type: Interventional
• Actual Enrollment: 104 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: Early Intervention, Randomized, Mulitcenter, Placebo-Controlled, 4-Period Crossover, Multi-Attack Study to Evaluate Efficacy & Safety of ComboProduct Containing Sumatriptan and Naproxen Sodium for Acute Treatment of Migraine in Adolescents
• Study Start Date: Mar 1, 2010
• Actual Primary Completion Date: Jun 1, 2014
• Actual Study Completion Date: Jul 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Other: Active, Active, Active, Placebo One fifth of the 105 subjects will be randomized to this arm and treat their four migraines in this order. First three will be treated with Active Treximet and the last or 4th migraine will be treated with Placebo.	Drug: Treximet; 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period.; Other Names: Imitrex and Naproxen Sodium ; Drug: Placebo; Dummy pill comparator; Other Names: Sugar Pill
Other: Active, Active, Placebo, Active This is another of the five treatment arms. One fifth of the 105 subjects will be randomized to this group and will treat the first two migraines with Active drug, Treximet, and then the third migraine with placebo and the last (4th) migraine with Treximet.	Drug: Treximet; 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period.; Other Names: Imitrex and Naproxen Sodium ; Drug: Placebo; Dummy pill comparator; Other Names: Sugar Pill
Other: Active, Placebo, Active, Active Approximately one fifth of the 105 subjects will be randomized to this group and treat their first migraine with Active Treximet and the second migraines with Placebo. The final two migraines treated will be with Active study drug.	Drug: Treximet; 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period.; Other Names: Imitrex and Naproxen Sodium ; Drug: Placebo; Dummy pill comparator; Other Names: Sugar Pill
Other: Placebo, Active, Active, Active One fifth of the 105 subjects will be randomized to this treatment arm, where they will treat the first headache with placebo and the remaining three migraines will be treated with Active treximet.	Drug: Treximet; 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period.; Other Names: Imitrex and Naproxen Sodium ; Drug: Placebo; Dummy pill comparator; Other Names: Sugar Pill
Other: Active, Active, Active, Active One fifth of the subject will treat all their migraines with Active Treximet.	Drug: Treximet; 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period.; Other Names: Imitrex and Naproxen Sodium

Outcome Measures

Primary Outcome Measures

1. Number of Participants With 2-hour Pain Free Active Study Drug [3 years]

   All data was collected and measured from self-reported patient diaries

2. Percentage of Migraine Attacks With Sustained Pain Free Response From 2 to 24 Hours Post-Dose [3 years]

   All data was collected and measured from self-reported patient diaries

3. Percentage of Migraine Attacks With Pain Free Response at 2 Hours Post-Dose Following Early Intervention [3 years]

   All data was collected and measured from self-reported patient diaries

Secondary Outcome Measures

1. To Evaluate the Consistency of Response Across Four Migraine Attacks at 1, 2, 4, and 24 Hours After Treatment. Frequency of Rescue Medications Needed and the Consistency of Other Symptom Relief i.e. Nausea, Vomiting, Photophobia, and Phonophobia. [3 years]

   Collected from patient reported paper diaries

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years to 17 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Male or female subjects between the ages of 12-17.

2. Subject has migraine with or without aura (ICHD-II criteria, 1.2.1 or 1.1). A history of at least 1 but no more than 8 attacks per month on average over the past 6 months prior to screening visit. Attacks should be moderate to severe and last for at least 3 hours.

3. Subject is able to distinguish migraine from other headaches and can determine when a mild headache will become a moderate/severe migraine.

4. Female subjects are eligible for participation provided they are of non-child bearing potential or if started menses; they are on a stable regimen of approved contraception.

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

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

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

8. Subject is willing and able to provide Informed Assent prior to entry into the study.

Exclusion Criteria

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

1. Subject is < 74 pounds (33.3kg) and no greater than 260lbs (117.9kg)

2. Subject has greater than or equal to 15 headache days per month in total.

3. Subject has secondary headaches i.e. complex migraine, hemiplegic, or basilar.

4. Subject, in investigators opinion is likely to have unrecognized cardiovascular or cerebrovascular disease.

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

6. 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 the study.

7. 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 the above.

8. Subject has a 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 anti-epileptic drug for seizure control within 5 years prior to screening.

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

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

11. Subject has used an ergot medication in the previous three months for migraine prophylaxis or is taking a medication that is not stabilized for at least two months for either chronic or intermittent migraine prophylaxis or other co-morbid condition.

12. Subject has taken or plans to take a monoamine oxidase inhibitor (MAOI) including herbal preparations containing St. Johns Wort (Hypericum perforatum), anytime within the two weeks prior to screening and two weeks past exit of study.

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 has evidence of illicit drug or alcohol abuse within the last year or any concurrent psychiatric condition which, in the investigator's opinion, will likely interfere with study conduct and participation in the 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Premiere Research Institute	West Palm Beach	Florida	United States	33407
2	Andrew Hershey	Cincinnati	Ohio	United States	45229
3	Steve L. Linder	Dallas	Texas	United States	75230
4	Don W. Lewis	Norfolk	Virginia	United States	23507

Sponsors and Collaborators

• Premiere Research Institute
• GlaxoSmithKline

Investigators

• Principal Investigator: Paul K Winner, DO, Premiere Research Institute
• Principal Investigator: Andrew Hershey, MD, Cincinnati Childrens Hospital
• Principal Investigator: Steve L Linder, MD, Dallas Pediatric Neurology Associates
• Principal Investigator: Donald W Lewis, MD, Childrens Hospital of the King's Daughters

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Premiere Research Institute
• ClinicalTrials.gov Identifier: NCT01016678
• Other Study ID Numbers: TEAM2009
• First Posted: Nov 19, 2009
• Last Update Posted: May 4, 2016
• Last Verified: Mar 1, 2016

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Migraine Disorders; Naproxen

Study Results

Participant Flow

Recruitment Details	The study recruitment period started in March 2010 and the last subject was exited March 2013. The 4 sites who recruited all patients, consisted of 2 private practices and 2 children's hospital based site.
Pre-assignment Detail	104 patients were randomized and dispensed study drug but only 94 of those patients actually treated at least one migraine, so therefore 94 subjects data was used in the analysis.

Arm/Group Title	Active, Active, Active, Placebo	Active, Active, Placebo, Active	Active, Placebo, Active, Active	Placebo, Active, Active, Active	Active, Active, Active, Active
Arm/Group Description	Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period. First three migraines will be treated with Active Treximet and the last 4th migraine will be treated with Placebo	Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period. First two migraines will be treated with Active Treximet and then the 3rd migraine will be treated with Placebo and the last 4th migraine will be treated with Treximet	Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period. The first migraine will be treated with Active Treximent and the second migraine with Placebo. The final two migraines will be treated with Active Treximet	Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period. First migraine will be treated with Placebo and the last three migraines will be treated with Active Treximet	Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period. All migraines (up to four) will be treated with active treximet
Period Title: Overall Study
STARTED	20	17	19	19	19
COMPLETED	18	14	15	19	13
NOT COMPLETED	2	3	4	0	6

Baseline Characteristics

Arm/Group Title	Adolescents Age 12-17
Arm/Group Description	All subjects were adolescent males and females with diagnosis of Migraine and a frequency of 1-8 migraines per month on average
Overall Participants	104
Age (Count of Participants)
<=18 years	104 100%
Between 18 and 65 years	0 0%
>=65 years	0 0%
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	14.8
Sex: Female, Male (Count of Participants)
Female	65 62.5%
Male	39 37.5%
Region of Enrollment (participants) [Number]
United States	104 100%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With 2-hour Pain Free Active Study Drug
Description	All data was collected and measured from self-reported patient diaries
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

The number of subjects randomized to treatment was 104, which included 94 subjects who treated at least one migraine with study drug and were included in the safety and efficacy data analysis

Arm/Group Title	Migraine Attack 1	Migraine Attack 2	Migraine Attack 3	Migraine Attack 4
Arm/Group Description	The participants were instructed to treat 4 migraine attacks in the trial and according to the randomization schedule could potentially treat 3 attacks with active study drug (sumatriptan/naproxen sodium) and 1 attack with placebo, with different placement of the placebo for every 10 subjects. There are also a group of subjects in which all attacks were treated with active study drug. Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period.	The participants were instructed to treat 4 migraine attacks in the trial and according to the randomization schedule could potentially treat 3 attacks with active study drug (sumatriptan/naproxen sodium) and 1 attack with placebo, with different placement of the placebo for every 10 subjects. There are also a group of subjects in which all attacks were treated with active study drug. Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period.	The participants were instructed to treat 4 migraine attacks in the trial and according to the randomization schedule could potentially treat 3 attacks with active study drug (sumatriptan/naproxen sodium) and 1 attack with placebo, with different placement of the placebo for every 10 subjects. There are also a group of subjects in which all attacks were treated with active study drug. Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period.	The participants were instructed to treat 4 migraine attacks in the trial and according to the randomization schedule could potentially treat 3 attacks with active study drug (sumatriptan/naproxen sodium) and 1 attack with placebo, with different placement of the placebo for every 10 subjects. There are also a group of subjects in which all attacks were treated with active study drug. Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period.
Measure Participants	94	90	82	81
Pain Free at 2 hours post dose for Active Treatmen	35 33.7%	23 NaN	21 NaN	24 NaN
Pain Free at 2 Hours Post Dose for Placebo	2 1.9%	2 NaN	3 NaN	6 NaN

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Migraine Attack 1, Migraine Attack 2, Migraine Attack 3, Migraine Attack 4
	Comments	Comparison of percentage of participants pain free at 2 hours post-dose (active) to percentage of participants pain free at 2 hours post-dose (placebo)
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0038
	Comments
	Method	Chi-squared
	Comments
Method of Estimation	Estimation Parameter	Difference in percentages
	Estimated Value	18
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Primary Outcome

Title	Percentage of Migraine Attacks With Sustained Pain Free Response From 2 to 24 Hours Post-Dose
Description	All data was collected and measured from self-reported patient diaries
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

Patients who treated with study drug and were pain free at 2 hours and then continued to be pain free through 24 hours

Arm/Group Title	Active Drug	Placebo
Arm/Group Description	Treximet 85mg Imitrex with 500mg Naproxen Sodium combination tablet for the treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hour period.	Equivalent looking pill just like Treximet but only containing sugar, "sugar pill".
Measure Participants	54	13
Measure Migraines	103	13
Number [percentage of attacks]	86	78

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Migraine Attack 1, Migraine Attack 2
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.1294
	Comments
	Method	Chi-squared
	Comments
Method of Estimation	Estimation Parameter	difference in percentages
	Estimated Value	8
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Primary Outcome

Title	Percentage of Migraine Attacks With Pain Free Response at 2 Hours Post-Dose Following Early Intervention
Description	All data was collected and measured from self-reported patient diaries
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

94 subjects treated at least one migraine attack with active drug or placebo were analyzed while only 74 subjects had the potential to take placebo during one of their 4 migraine attacks

Arm/Group Title	Active Drug	Placebo
Arm/Group Description	Treximet 85mg Imitrex with 500mg Naproxen Sodium combination tablet for the treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hour period.	Equivalent looking pill just like Treximet but only containing sugar, "sugar pill".
Measure Participants	94	74
Measure number of migraine attacks	277	70
Number [percentage of attacks]	32	18

4. Secondary Outcome

Title	To Evaluate the Consistency of Response Across Four Migraine Attacks at 1, 2, 4, and 24 Hours After Treatment. Frequency of Rescue Medications Needed and the Consistency of Other Symptom Relief i.e. Nausea, Vomiting, Photophobia, and Phonophobia.
Description	Collected from patient reported paper diaries
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

This analysis data was not collected.

Arm/Group Title	Active, Active, Active, Placebo	Active, Active, Placebo, Active	Active, Placebo, Active, Active	Placebo, Active, Active, Active	Active, Active, Active, Active
Arm/Group Description	Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period. First three migraines will be treated with Active Treximet and the last 4th migraine will be treated with Placebo	Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period. First two migraines will be treated with Active Treximet and then the 3rd migraine will be treated with Placebo and the last 4th migraine will be treated with Treximet	Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period. The first migraine will be treated with Active Treximent and the second migraine with Placebo. The final two migraines will be treated with Active Treximet	Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period. First migraine will be treated with Placebo and the last three migraines will be treated with Active Treximet	Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period. All migraines (up to four) will be treated with active treximet
Measure Participants	0	0	0	0	0

Adverse Events

Time Frame	Entire Study 3 years
Adverse Event Reporting Description	All adverse events are reported here whether patient had taken active drug or placebo and it is not separated per intervention
Arm/Group Title	Active, Active, Active, Placebo		Active, Active, Placebo, Active		Active, Placebo, Active, Active		Placebo, Active, Active, Active		Active, Active, Active, Active
Arm/Group Description	Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period.		Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period.		Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period.		Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period.		Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period.
All Cause Mortality
	Active, Active, Active, Placebo		Active, Active, Placebo, Active		Active, Placebo, Active, Active		Placebo, Active, Active, Active		Active, Active, Active, Active
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Active, Active, Active, Placebo		Active, Active, Placebo, Active		Active, Placebo, Active, Active		Placebo, Active, Active, Active		Active, Active, Active, Active
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/20 (5%)		0/17 (0%)		0/19 (0%)		0/19 (0%)		0/19 (0%)
Nervous system disorders
Prolonged Migraine	1/20 (5%)	1	0/17 (0%)	0	0/19 (0%)	0	0/19 (0%)	0	0/19 (0%)	0
Other (Not Including Serious) Adverse Events
	Active, Active, Active, Placebo		Active, Active, Placebo, Active		Active, Placebo, Active, Active		Placebo, Active, Active, Active		Active, Active, Active, Active
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/20 (10%)		8/17 (47.1%)		5/19 (26.3%)		8/19 (42.1%)		7/19 (36.8%)
Eye disorders
Herpes Simplex Right Eye	0/20 (0%)	0	0/17 (0%)	0	0/19 (0%)	0	1/19 (5.3%)	1	0/19 (0%)	0
Gastrointestinal disorders
Nausea	1/20 (5%)	1	1/17 (5.9%)	1	2/19 (10.5%)	4	0/19 (0%)	0	1/19 (5.3%)	1
General disorders
Tongue Swelling	0/20 (0%)	0	1/17 (5.9%)	2	0/19 (0%)	0	0/19 (0%)	0	1/19 (5.3%)	1
Burning Sensation Face	0/20 (0%)	0	1/17 (5.9%)	1	0/19 (0%)	0	1/19 (5.3%)	2	0/19 (0%)	0
Bad Taste	0/20 (0%)	0	0/17 (0%)	0	1/19 (5.3%)	1	0/19 (0%)	0	0/19 (0%)	0
Weird Feeling, Out of Body Sensation	0/20 (0%)	0	1/17 (5.9%)	2	0/19 (0%)	0	0/19 (0%)	0	0/19 (0%)	0
Infections and infestations
Abcess Right Leg	0/20 (0%)	0	0/17 (0%)	0	0/19 (0%)	0	1/19 (5.3%)	1	0/19 (0%)	0
Cough	1/20 (5%)	1	0/17 (0%)	0	0/19 (0%)	0	1/19 (5.3%)	1	0/19 (0%)	0
Sinus Infection	0/20 (0%)	0	0/17 (0%)	0	0/19 (0%)	0	1/19 (5.3%)	1	0/19 (0%)	0
Musculoskeletal and connective tissue disorders
Neck Spasm/Tension	0/20 (0%)	0	1/17 (5.9%)	2	3/19 (15.8%)	3	0/19 (0%)	0	2/19 (10.5%)	4
Throat tightness	0/20 (0%)	0	1/17 (5.9%)	1	0/19 (0%)	0	1/19 (5.3%)	1	3/19 (15.8%)	6
Stiff Jaw	0/20 (0%)	0	2/17 (11.8%)	3	0/19 (0%)	0	0/19 (0%)	0	1/19 (5.3%)	2
Shoulder Pain	0/20 (0%)	0	0/17 (0%)	0	0/19 (0%)	0	0/19 (0%)	0	1/19 (5.3%)	3
Bruised Coccyx	0/20 (0%)	0	1/17 (5.9%)	1	0/19 (0%)	0	0/19 (0%)	0	0/19 (0%)	0
Broken Right Arm	0/20 (0%)	0	1/17 (5.9%)	1	0/19 (0%)	0	0/19 (0%)	0	0/19 (0%)	0
Nervous system disorders
Drowsiness	1/20 (5%)	1	2/17 (11.8%)	3	0/19 (0%)	0	0/19 (0%)	0	1/19 (5.3%)	3
Dizziness	0/20 (0%)	0	1/17 (5.9%)	1	0/19 (0%)	0	0/19 (0%)	0	1/19 (5.3%)	3
Numbness	0/20 (0%)	0	0/17 (0%)	0	2/19 (10.5%)	3	0/19 (0%)	0	1/19 (5.3%)	1
Psychiatric disorders
Anxiety	0/20 (0%)	0	0/17 (0%)	0	0/19 (0%)	0	1/19 (5.3%)	1	1/19 (5.3%)	1
Skin and subcutaneous tissue disorders
Poison Ivy Rash	0/20 (0%)	0	0/17 (0%)	0	0/19 (0%)	0	1/19 (5.3%)	1	0/19 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT 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.