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Trial record 83 of 156 for:    (Dementia pugilistica OR chronic traumatic encephalopathy) AND Brain Injuries, Traumatic

Amitriptyline to Prevent Headache After Traumatic Brain Injury

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ClinicalTrials.gov Identifier: NCT01856270
Recruitment Status : Completed
First Posted : May 17, 2013
Results First Posted : December 22, 2017
Last Update Posted : January 23, 2018
Sponsor:
Information provided by (Responsible Party):
Jeanne Hoffman, University of Washington

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Brain Injuries
Post-Traumatic Headache
Intervention Drug: Amitriptyline
Enrollment 50
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Amitriptyline Immediate Amitriptyline Delayed
Hide Arm/Group Description

The Immediate group will begin study drug immediately after enrollment. Immediate Drug participants will be started on one 10 mg capsule each evening. The dosage will be adjusted upwards to 25 mg daily for Week 2 to a maximum of 50 mg daily by Week 3.

Amitriptyline: Participants with headache will be enrolled within the first 12 weeks after injury and will be randomly assigned to 2 groups. Group 1 will be assessed within 3 months of injury (baseline, Day 0) (when receiving initial ramp-up dosage containers), Day 30 and 60 (to monitor compliance and distribute study drug), and for final outcome on Day 90. Group 2 will be assessed within 3 months of injury (baseline, Day 0) but will not receive medication until Day 30 visit. Those in group 2 who report headache at Day 30 will receive their initial dosage container and will then be reassessed at Day 60 (to monitor compliance/distribute study drug) and Day 90 (final outcome).

The Delayed group will start the study drug at the Day 30 visit on one 10 mg capsule each evening. The dosage will be adjusted upwards to 25 mg daily for Week 2 to a maximum of 50 mg daily by Week 3.

Amitriptyline: Participants with headache will be enrolled within the first 12 weeks after injury and will be randomly assigned to 2 groups. Group 1 will be assessed within 3 months of injury (baseline, Day 0) (when they will receive their initial ramp-up dosage containers), Day 30 and Day 60 (to monitor compliance and distribute study drug), and for final outcome on Day 90. Group 2 will be assessed within 3 months of injury (baseline, Day 0) but will not receive medication until their Day 30 visit. Those in group 2 who report headache at Day 30 will receive their initial dosage container and will then be reassessed at Day 60 (to monitor compliance and distribute study drug) and Day 90 (final outcome).

Period Title: Overall Study
Started 24 26
Completed [1] 13 14
Not Completed 11 12
[1]
Completed the 180 day assessment
Arm/Group Title Amitriptyline Immediate Amitriptyline Delayed Total
Hide Arm/Group Description

The Immediate group will begin study drug immediately after enrollment. Immediate Drug participants will be started on one 10 mg capsule each evening. The dosage will be adjusted upwards to 25 mg daily for Week 2 to a maximum of 50 mg daily by Week 3.

Amitriptyline: Participants with headache will be enrolled within the first 12 weeks post injury and will be randomly assigned to 2 groups. Group 1 will be assessed within 3 months of injury (baseline, Day 0) (when they will receive their initial ramp-up dosage containers), Day 30 and 60 (to monitor compliance/distribute study drug), and for final outcome on Day 90. Group 2 will be assessed within 3 months of injury (baseline, Day 0) but will not receive medication until Day 30 visit. Those in group 2 who report headache at Day 30 will receive initial dosage container and reassessed at Day 60 (to monitor compliance and distribute study drug) and Day 90 (final outcome).

The Delayed group will start the study drug at the Day 30 visit on one 10 mg capsule each evening. The dosage will be adjusted upwards to 25 mg daily for Week 2 to a maximum of 50 mg daily by Week 3.

Amitriptyline: Participants with headache will be enrolled within the first 12 weeks post injury and will be randomly assigned to 2 groups. Group 1 will be assessed within 3 months of injury (baseline, Day 0) (when they will receive their initial ramp-up dosage containers), Day 30 and 60 (to monitor compliance/distribute study drug), and for final outcome on Day 90. Group 2 will be assessed within 3 months of injury (baseline, Day 0) but will not receive medication until their Day 30 visit. Those in group 2 who report headache at Day 30 will receive initial dosage container and then reassessed at Day 60 (to monitor compliance and distribute study drug) and Day 90 (final outcome).

Total of all reporting groups
Overall Number of Baseline Participants 24 26 50
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 26 participants 50 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
24
 100.0%
26
 100.0%
50
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 24 participants 26 participants 50 participants
36.8  (11.7) 34.6  (12.7) 35.7  (12.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 26 participants 50 participants
Female
13
  54.2%
9
  34.6%
22
  44.0%
Male
11
  45.8%
17
  65.4%
28
  56.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 24 participants 26 participants 50 participants
24 26 50
1.Primary Outcome
Title Frequency of Headaches
Hide Description Number of subjects reporting an average of at least one headache per week
Time Frame 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
The two arms are combined for this analysis to answer the question of frequency of headache at the 3 month outcome data point and only difference between arms was related to onset time of medication which was not expected to result in significant change in headache frequency, but only potentially in cognitive status.
Arm/Group Title Amitriptyline Sample
Hide Arm/Group Description:
Individuals enrolled into the study and who have completed headache diaries through 3 months post injury.
Overall Number of Participants Analyzed 43
Measure Type: Count of Participants
Unit of Measure: Participants
10
  23.3%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Amitriptyline Sample
Comments A positive difference of proportions would indicate an improvement in the Amitriptyline sample, while a negative difference would indicate a worsening.
Type of Statistical Test Superiority
Comments The data from this study was compared with the data from the Natural History of Headache after Mild TBI which was previously published (Lucas, Hoffman, Bell, Dikmen. (2014), A prospective study of prevalence and characterization of headache following mild traumatic brain injury. Cephalalgia (34) 93-102).
Statistical Test of Hypothesis P-Value .101
Comments A priori significance threshold α=.05
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference of proportions
Estimated Value 0.114
Confidence Interval (1-Sided) 95%
-0.017
Estimation Comments Confidence interval estimation method from Wallenstein (1997). 71 of 205 participants (at 3 Mo post) in the Natural History study endorsed having a headache more than once per week.
2.Primary Outcome
Title Severity of Headache
Hide Description Number of subjects with headache reporting an average pain of at least 6 on a 0-10 scale with 0=no pain and 10=worst pain.
Time Frame 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
The two arms are combined for this analysis to answer the question of severity of headache at the 3 month outcome data point and only difference between arms was related to onset time of medication which was not expected to result in significant change in headache frequency, but only potentially in cognitive status.
Arm/Group Title Amitriptyline Study
Hide Arm/Group Description:
Individuals enrolled into the current study.
Overall Number of Participants Analyzed 38
Measure Type: Count of Participants
Unit of Measure: Participants
7
  18.4%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Amitriptyline Study
Comments A positive difference of proportions would indicate an improvement in the Amitriptyline sample, while a negative difference would indicate a worsening
Type of Statistical Test Superiority
Comments The data from this study was compared with the data from the Natural History of Headache after Mild TBI which was previously published (Lucas, Hoffman, Bell, Dikmen. (2014), A prospective study of prevalence and characterization of headache following mild traumatic brain injury. Cephalalgia (34) 93-102).
Statistical Test of Hypothesis P-Value .017
Comments A priori significance threshold α=.05
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference of proportions
Estimated Value .194
Confidence Interval (1-Sided) 95%
.057
Estimation Comments Confidence interval estimation method from Wallenstein (1997). 56 of 148 participants (at 3 mo post) in the Natural History study reported pain >=6.
3.Secondary Outcome
Title Number of Participants With Adverse Events Possibly Related to Study Medication
Hide Description The number and types of treatment related adverse events will be monitored on a weekly basis and will be divided by severity if differing.
Time Frame Day 1 through Day 90
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Amitriptyline Immediate Amitriptyline Delayed
Hide Arm/Group Description:
The Amitriptyline Immediate group will begin study drug immediately after enrollment. Immediate Drug participants will be started on one 10 mg capsule each evening. The dosage will be adjusted upwards to 25 mg daily for Week 2 to a maximum of 50 mg daily by Week 3.
The Amitriptyline Delayed group will start the study drug at the Day 30 visit on one 10 mg capsule each evening. The dosage will be adjusted upwards to 25 mg daily for Week 2 to a maximum of 50 mg daily by Week 3.
Overall Number of Participants Analyzed 24 26
Measure Type: Count of Participants
Unit of Measure: Participants
Number wth any events
5
  20.8%
3
  11.5%
# with Possible, probable or definite rel to tx
4
  16.7%
1
   3.8%
# with tx related moderate/severe events
0
   0.0%
0
   0.0%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Amitriptyline Immediate, Amitriptyline Delayed
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .456
Comments A priori significance threshold α=.05
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference of proportions
Estimated Value .093
Confidence Interval (2-Sided) 95%
-.106 to .286
Estimation Comments Estimate is the effect observed in the Immediate group (i.e. Immediate - Delayed). Confidence interval estimation method from Wallenstein (1997).
4.Secondary Outcome
Title Rey Auditory Verbal Learning Test (Total)
Hide Description The Rey Auditory Verbal Learning Test will be administered at 30 days to detect potential changes in cognitive function due to study drug. Scoring is based on the total number of words recalled from a list of 15 across 5 trials (max score of 75) with higher score indicating better learning.
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Amitriptyline Immediate Amitriptyline Delayed
Hide Arm/Group Description:
The Amitriptyline Immediate group will begin study drug immediately after enrollment. Immediate Drug participants will be started on one 10 mg capsule each evening. The dosage will be adjusted upwards to 25 mg daily for Week 2 to a maximum of 50 mg daily by Week 3.
The Amitriptyline Delayed group will start the study drug at the Day 30 visit on one 10 mg capsule each evening. The dosage will be adjusted upwards to 25 mg daily for Week 2 to a maximum of 50 mg daily by Week 3.
Overall Number of Participants Analyzed 12 11
Mean (Standard Deviation)
Unit of Measure: words recalled
26.3  (4.7) 27.1  (5.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Amitriptyline Immediate, Amitriptyline Delayed
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .684
Comments A priori significance threshold α=.05
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.8
Confidence Interval (2-Sided) 95%
-5.1 to 3.4
Estimation Comments Estimate is the effect observed in the Immediate group (i.e. Immediate - Delayed)
5.Secondary Outcome
Title Rey Auditory Verbal Learning Test (Short)
Hide Description The Rey Auditory Verbal Learning Test will be administered at 30 days to detect potential changes in cognitive function due to study drug. Scoring is based on the total number of words recalled from the original list of 15 after a new list of 15 is given (used as distraction). Higher scores indicate better short-term memory.
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Amitriptyline Immediate Amitriptyline Delayed
Hide Arm/Group Description:
The Amitriptyline Immediate group will begin study drug immediately after enrollment. Immediate Drug participants will be started on one 10 mg capsule each evening. The dosage will be adjusted upwards to 25 mg daily for Week 2 to a maximum of 50 mg daily by Week 3.
The Amitriptyline Delayed group will start the study drug at the Day 30 visit on one 10 mg capsule each evening. The dosage will be adjusted upwards to 25 mg daily for Week 2 to a maximum of 50 mg daily by Week 3.
Overall Number of Participants Analyzed 12 11
Mean (Standard Deviation)
Unit of Measure: words recalled
10.3  (1.8) 9.4  (2.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Amitriptyline Immediate, Amitriptyline Delayed
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .306
Comments A priori significance threshold α=.05
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.0
Confidence Interval (2-Sided) 95%
-1.0 to 2.9
Estimation Comments Estimate is the effect observed in the Immediate group (i.e. Immediate - Delayed)
6.Secondary Outcome
Title Rey Auditory Verbal Learning Test (Long)
Hide Description The Rey Auditory Verbal Learning Test will be administered at 30 days to detect potential changes in cognitive function due to study drug. Scoring is based on the total number of words recalled from the original list of 15 after a 30 minute time delay. Higher scores indicate better long-term memory.
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Amitriptyline Immediate Amitriptyline Delayed
Hide Arm/Group Description:
The Amitriptyline Immediate group will begin study drug immediately after enrollment. Immediate Drug participants will be started on one 10 mg capsule each evening. The dosage will be adjusted upwards to 25 mg daily for Week 2 to a maximum of 50 mg daily by Week 3.
The Amitriptyline Delayed group will start the study drug at the Day 30 visit on one 10 mg capsule each evening. The dosage will be adjusted upwards to 25 mg daily for Week 2 to a maximum of 50 mg daily by Week 3.
Overall Number of Participants Analyzed 10 11
Mean (Standard Deviation)
Unit of Measure: words recalled
13.6  (1.3) 13.3  (1.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Amitriptyline Immediate, Amitriptyline Delayed
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .583
Comments A priori significance threshold α=.05
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.3
Confidence Interval (2-Sided) 95%
-0.9 to 1.6
Estimation Comments Estimate is the effect observed in the Immediate group (i.e. Immediate - Delayed)
7.Secondary Outcome
Title Trail Making Test (A)
Hide Description Trail Making Test will be given at 30 days to detect any impact of study drug on cognition. This is a test of visual attention and is scored by the number of seconds it takes to complete the task of making a trail through letters.
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Amitriptyline Immediate Amitriptyline Delayed
Hide Arm/Group Description:
The Amitriptyline Immediate group will begin study drug immediately after enrollment. Immediate Drug participants will be started on one 10 mg capsule each evening. The dosage will be adjusted upwards to 25 mg daily for Week 2 to a maximum of 50 mg daily by Week 3.
The Amitriptyline Delayed group will start the study drug at the Day 30 visit on one 10 mg capsule each evening. The dosage will be adjusted upwards to 25 mg daily for Week 2 to a maximum of 50 mg daily by Week 3.
Overall Number of Participants Analyzed 12 11
Mean (Standard Deviation)
Unit of Measure: seconds
28.7  (9.0) 26.3  (5.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Amitriptyline Immediate, Amitriptyline Delayed
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .444
Comments A priori significance threshold α=.05
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 2.4
Confidence Interval (2-Sided) 95%
-4.0 to 8.8
Estimation Comments Estimate is the effect observed in the Immediate group (i.e. Immediate - Delayed)
8.Secondary Outcome
Title Trail Making Test (B)
Hide Description Trail Making Test will be given at 30 days to detect any impact of study drug on cognition. This is a test of visual attention and task switching and is scored by number of seconds it takes to complete the task (switching from letters to numbers in order).
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Amitriptyline Immediate Amitriptyline Delayed
Hide Arm/Group Description:
The Amitriptyline Immediate group will begin study drug immediately after enrollment. Immediate Drug participants will be started on one 10 mg capsule each evening. The dosage will be adjusted upwards to 25 mg daily for Week 2 to a maximum of 50 mg daily by Week 3.
The Amitriptyline Delayed group will start the study drug at the Day 30 visit on one 10 mg capsule each evening. The dosage will be adjusted upwards to 25 mg daily for Week 2 to a maximum of 50 mg daily by Week 3.
Overall Number of Participants Analyzed 11 11
Mean (Standard Deviation)
Unit of Measure: seconds
87.5  (34.9) 60.3  (21.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Amitriptyline Immediate, Amitriptyline Delayed
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .041
Comments A priori significance threshold α=.05
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 27.3
Confidence Interval (2-Sided) 95%
1.2 to 53.3
Estimation Comments Estimate is the effect observed in the Immediate group (i.e. Immediate - Delayed)
9.Secondary Outcome
Title Wechsler Adult Intelligence Scale (WAIS) IV Digit Symbol
Hide Description The WAIS IV Digit Symbol test will be given to detect any effect of study drug on cognition. This test assesses processing speed and new learning and requires an individual to substitute the relevant digit for a symbol and are given a time limit. The total number of correct digits are summed and converted to a scaled score (range 1-20 with 10 being at the 50th percentile) with higher scores indicating better performance.
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Amitriptyline Immediate Amitriptyline Delayed
Hide Arm/Group Description:
The Amitriptyline Immediate group will begin study drug immediately after enrollment. Immediate Drug participants will be started on one 10 mg capsule each evening. The dosage will be adjusted upwards to 25 mg daily for Week 2 to a maximum of 50 mg daily by Week 3.
The Amitriptyline Delayed group will start the study drug at the Day 30 visit on one 10 mg capsule each evening. The dosage will be adjusted upwards to 25 mg daily for Week 2 to a maximum of 50 mg daily by Week 3.
Overall Number of Participants Analyzed 12 12
Mean (Standard Deviation)
Unit of Measure: standard score
7.5  (2.5) 9.3  (2.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Amitriptyline Immediate, Amitriptyline Delayed
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .089
Comments A priori significance threshold α=.05
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.8
Confidence Interval (2-Sided) 95%
-3.8 to 0.3
Estimation Comments Estimate is the effect observed in the Immediate group (i.e. Immediate - Delayed)
Time Frame Adverse events were collected throughout the duration of medication usage at baseline, then at day 30, day 60, and at day 90 when medication was discontinued.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Amitriptyline Immediate Amitriptyline Delayed
Hide Arm/Group Description The Immediate group will begin study drug immediately after enrollment. Immediate Drug participants will be started on one 10 mg capsule each evening. The dosage will be adjusted upwards to 25 mg daily for Week 2 to a maximum of 50 mg daily by Week 3. The Delayed group will start the study drug at the Day 30 visit on one 10 mg capsule each evening to assess whether there is any cognitive impact of the medication (comparing to those who started immediately after enrollment. The dosage will be adjusted upwards to 25 mg daily for Week 2 to a maximum of 50 mg daily by Week 3.
All-Cause Mortality
Amitriptyline Immediate Amitriptyline Delayed
Affected / at Risk (%) Affected / at Risk (%)
Total   0/24 (0.00%)      0/26 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Amitriptyline Immediate Amitriptyline Delayed
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/24 (0.00%)      0/26 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Amitriptyline Immediate Amitriptyline Delayed
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/24 (20.83%)      3/26 (11.54%)    
Cardiac disorders     
Increased QTc   1/24 (4.17%)  1 0/26 (0.00%)  0
Gastrointestinal disorders     
Dry Mouth   3/24 (12.50%)  4 0/26 (0.00%)  0
Infections and infestations     
respiratory infection   1/24 (4.17%)  1 0/26 (0.00%)  0
Nervous system disorders     
Groggy   0/24 (0.00%)  0 1/26 (3.85%)  1
headache   1/24 (4.17%)  2 1/26 (3.85%)  1
possible metabolic encephalopathy   0/24 (0.00%)  0 1/26 (3.85%)  1
sleep difficulties   1/24 (4.17%)  1 0/26 (0.00%)  0
Renal and urinary disorders     
decreased libido   1/24 (4.17%)  1 0/26 (0.00%)  0
Skin and subcutaneous tissue disorders     
rash   1/24 (4.17%)  1 0/26 (0.00%)  0
Indicates events were collected by systematic assessment
This was a prevention study recruiting from hospital inpatients or from the ED with a diagnosis of mild TBI. We were unable to recruit an adequate number of subjects and had difficult follow up. Of those recruited, we followed only 54%.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Jeanne Hoffman
Organization: University of Washington
Phone: 206-221-6511
EMail: jeanneh@uw.edu
Layout table for additonal information
Responsible Party: Jeanne Hoffman, University of Washington
ClinicalTrials.gov Identifier: NCT01856270     History of Changes
Other Study ID Numbers: STUDY00001333
First Submitted: May 10, 2013
First Posted: May 17, 2013
Results First Submitted: March 27, 2017
Results First Posted: December 22, 2017
Last Update Posted: January 23, 2018