Trial · NCT01856270
Amitriptyline to Prevent Headache After Traumatic Brain Injury
NCT01856270, Phase 2, Completed, University of Washington; results first posted 2017-12-22
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Amitriptyline to Prevent Headache After Traumatic Brain Injury. Trials, record NCT01856270. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01856270
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Amitriptyline to Prevent Headache After Traumatic Brain Injury
- NCT number
- NCT01856270
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 50 participants, actual
- Lead sponsor
- University of Washington
- Conditions
- Brain Injuries, Post-Traumatic Headache
- Interventions
- Amitriptyline
- First posted
- 2013-05-17
- Last updated
- 2024-09-19
- Results first posted
- 2017-12-22
- Limitations and caveats
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%.
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Frequency of Headaches | 90 days | Number of subjects reporting an average of at least one headache per week |
| Primary | Severity of Headache | 90 days | 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. |
| Secondary | Number of Participants With Adverse Events Possibly Related to Study Medication | Day 1 through Day 90 | The number and types of treatment related adverse events will be monitored on a weekly basis and will be divided by severity if differing. |
| Secondary | Rey Auditory Verbal Learning Test (Total) | 30 days | 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. |
| Secondary | Rey Auditory Verbal Learning Test (Short) | 30 days | 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. |
| Secondary | Rey Auditory Verbal Learning Test (Long) | 30 days | 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. |
| Secondary | Trail Making Test (A) | 30 days | 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. |
| Secondary | Trail Making Test (B) | 30 days | 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). |
| Secondary | Wechsler Adult Intelligence Scale (WAIS) IV Digit Symbol | 30 days | 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. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Frequency of Headaches | 90 days | 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. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Severity of Headache | 90 days | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Adverse Events Possibly Related to Study Medication | Day 1 through Day 90 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Rey Auditory Verbal Learning Test (Total) | 30 days | words recalled | MEAN | |
| SECONDARY | Rey Auditory Verbal Learning Test (Short) | 30 days | words recalled | MEAN | |
| SECONDARY | Rey Auditory Verbal Learning Test (Long) | 30 days | words recalled | MEAN | |
| SECONDARY | Trail Making Test (A) | 30 days | seconds | MEAN | |
| SECONDARY | Trail Making Test (B) | 30 days | seconds | MEAN | |
| SECONDARY | Wechsler Adult Intelligence Scale (WAIS) IV Digit Symbol | 30 days | standard score | MEAN |
Source ClinicalTrials.gov
Results by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Frequency of Headaches | Amitriptyline Sample | 10 | Participants | ||
| Severity of Headache | Amitriptyline Study | 7 | Participants | ||
| Number of Participants With Adverse Events Possibly Related to Study Medication | Amitriptyline Immediate | Number wth any events | 5 | Participants | |
| Number of Participants With Adverse Events Possibly Related to Study Medication | Amitriptyline Delayed | Number wth any events | 3 | Participants | |
| Number of Participants With Adverse Events Possibly Related to Study Medication | Amitriptyline Immediate | # with Possible, probable or definite rel to tx | 4 | Participants | |
| Number of Participants With Adverse Events Possibly Related to Study Medication | Amitriptyline Delayed | # with Possible, probable or definite rel to tx | 1 | Participants | |
| Number of Participants With Adverse Events Possibly Related to Study Medication | Amitriptyline Immediate | # with tx related moderate/severe events | 0 | Participants | |
| Number of Participants With Adverse Events Possibly Related to Study Medication | Amitriptyline Delayed | # with tx related moderate/severe events | 0 | Participants | |
| Rey Auditory Verbal Learning Test (Total) | Amitriptyline Immediate | 26.3 | Standard Deviation 4.7 | words recalled | |
| Rey Auditory Verbal Learning Test (Total) | Amitriptyline Delayed | 27.1 | Standard Deviation 5.0 | words recalled |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Amitriptyline Immediate | 24 | |
| Overall Study | STARTED | Amitriptyline Delayed | 26 | |
| Overall Study | COMPLETED | Amitriptyline Immediate | 13 | |
| Overall Study | COMPLETED | Amitriptyline Delayed | 14 | |
| Overall Study | NOT COMPLETED | Amitriptyline Immediate | 11 | |
| Overall Study | NOT COMPLETED | Amitriptyline Delayed | 12 |
Source ClinicalTrials.gov
Adverse events18
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Dry Mouth | Gastrointestinal disorders | Amitriptyline Immediate | 3 | 24 | 4 |
| other | Dry Mouth | Gastrointestinal disorders | Amitriptyline Delayed | 0 | 26 | 0 |
| other | Groggy | Nervous system disorders | Amitriptyline Immediate | 0 | 24 | 0 |
| other | Groggy | Nervous system disorders | Amitriptyline Delayed | 1 | 26 | 1 |
| other | Increased QTc | Cardiac disorders | Amitriptyline Immediate | 1 | 24 | 1 |
| other | Increased QTc | Cardiac disorders | Amitriptyline Delayed | 0 | 26 | 0 |
| other | headache | Nervous system disorders | Amitriptyline Immediate | 1 | 24 | 2 |
| other | headache | Nervous system disorders | Amitriptyline Delayed | 1 | 26 | 1 |
| other | decreased libido | Renal and urinary disorders | Amitriptyline Immediate | 1 | 24 | 1 |
| other | decreased libido | Renal and urinary disorders | Amitriptyline Delayed | 0 | 26 | 0 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Amitriptyline Immediate | 0 | 24 |
| Total, all-cause mortality | Amitriptyline Delayed | 0 | 26 |
| Total, other adverse events | Amitriptyline Immediate | 5 | 24 |
| Total, other adverse events | Amitriptyline Delayed | 3 | 26 |
| Total, serious adverse events | Amitriptyline Immediate | 0 | 24 |
| Total, serious adverse events | Amitriptyline Delayed | 0 | 26 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Amitriptyline Immediate vs Amitriptyline Delayed: deaths from any cause | Trial comparisons |
| Amitriptyline Immediate vs Amitriptyline Delayed: serious adverse events | Trial comparisons |
Tests5
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Symbol Coding | Secondary outcome | ConductCognition |
| Task Switching Test | Secondary outcome | ConductCognition |
| Trail Making Test A | Secondary outcome | ConductCognition |
| Trail Making Test B | Secondary outcome | ConductCognition |
| Verbal Learning | Secondary outcome | ConductCognition |
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01856270
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