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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

  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
No text entered.

Reporting Groups
  Description
Amitriptyline Immediate

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).

Amitriptyline Delayed

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).


Participant Flow:   Overall Study
    Amitriptyline Immediate   Amitriptyline Delayed
STARTED   24   26 
COMPLETED [1]   13   14 
NOT COMPLETED   11   12 
[1] Completed the 180 day assessment



  Baseline Characteristics

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.
No text entered.

Reporting Groups
  Description
Amitriptyline Immediate

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).

Amitriptyline Delayed

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 Total of all reporting groups

Baseline Measures
   Amitriptyline Immediate   Amitriptyline Delayed   Total 
Overall Participants Analyzed 
[Units: Participants]
 24   26   50 
Age 
[Units: Participants]
Count of 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 
[Units: Years]
Mean (Standard Deviation)
 36.8  (11.7)   34.6  (12.7)   35.7  (12.2) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      13  54.2%      9  34.6%      22  44.0% 
Male      11  45.8%      17  65.4%      28  56.0% 
Region of Enrollment 
[Units: Participants]
     
United States   24   26   50 


  Outcome Measures

1.  Primary:   Frequency of Headaches   [ Time Frame: 90 days ]

2.  Primary:   Severity of Headache   [ Time Frame: 90 days ]

3.  Secondary:   Number of Participants With Adverse Events Possibly Related to Study Medication   [ Time Frame: Day 1 through Day 90 ]

4.  Secondary:   Rey Auditory Verbal Learning Test (Total)   [ Time Frame: 30 days ]

5.  Secondary:   Rey Auditory Verbal Learning Test (Short)   [ Time Frame: 30 days ]

6.  Secondary:   Rey Auditory Verbal Learning Test (Long)   [ Time Frame: 30 days ]

7.  Secondary:   Trail Making Test (A)   [ Time Frame: 30 days ]

8.  Secondary:   Trail Making Test (B)   [ Time Frame: 30 days ]

9.  Secondary:   Wechsler Adult Intelligence Scale (WAIS) IV Digit Symbol   [ Time Frame: 30 days ]


  Serious Adverse Events


  Other Adverse Events


  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
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%.


  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.


Results Point of Contact:  
Name/Title: Dr. Jeanne Hoffman
Organization: University of Washington
phone: 206-221-6511
e-mail: jeanneh@uw.edu



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