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|NCT02266329 : Chronic Postconcussive Headache: A Placebo-Controlled Treatment Trial of Prazosin|
|Ages||Min: 18 Years Max: N/A|
- Good general health
- History of blast and/or impact head/neck trauma meeting DVBIC criteria for mild TBI,
i.e., injury as manifested by at least one of the following:
- 1) any period of loss of consciousness
- 2) any loss of memory for events immediately before or after the accident
- 3) any alteration in mental status at the time of the accident (e.g., feeling
dazed, disoriented, or confused)
- 4) focal neurological deficit(s) that may or may not be transient, with severity
of injury not exceeding loss of consciousness 30 minutes, Glasgow Coma Scale
<13-15 after 30 minutes, or posttraumatic amnesia >24 hrs,
- Frequent headaches, defined as headaches of moderate or severe intensity occurring
for at least 30 minutes on at least 8 days per 4-week period for at least 3-months
prior to the screen logkeeping period. Headaches must have started within 30 days
after head injury.
- Comorbid PTSD or other anxiety disorder is not exclusionary.
- Fluency in English is required.
- Persons of both genders and all races and ethnicities are eligible.
- Female participants must agree to abstain from sexual relations that could result in
pregnancy or use a reliable form of birth control during the study.
- Continued use of a single prophylactic migraine medication other than the study drug
is permissible if the participant has been on a stable dose for at least 4 weeks
prior to the Screening period and intends to continue the medication for the duration
of the trial.
- History of TBI more severe than that classified as mild by CVBIC criteria
- Acute or unstable chronic medical illness, including unstable angina, myocardial
infarction within 6 months, congestive heart failure, symptomatic or concerning
cardiac arrhythmias; pre-existing hypotension (systolic BP<110) or orthostatic
hypotension (systolic drop >20 mm mercury (Hg) after 2 min standing accompanied by
- Significant headaches preceding the onset of posttraumatic headaches, specifically
clinically diagnosed primary or secondary headache disorder, symptoms suggesting
migraine or probable migraine, or moderate or severe headaches occurring on average
more than 2 times per month.
- Continuous headaches of any severity, i.e., persistent daily headaches with no
headache-free period less than 8 hours between attacks
- Unable to reliably keep the headache log on a minimum of 80% of recordable days
- Severe depression
- Active psychosis or psychotic disorder
- Severe psychiatric instability or severe situational life crises, including evidence
of being actively suicidal or homicidal
- History of epilepsy, stroke, delirium within the prior 3 months, dementia, psychotic
disorder, bipolar disorder; current Substance Use Disorder except caffeine-related
disorders, tobacco-related disorders or cannabis intoxication; structural brain
abnormalities on any prior imaging with associated clinically evident manifestations;
or current participation in transcranial magnetic stimulation studies.
- Women of childbearing potential must not be pregnant, planning to become pregnant
during the study period, or nursing.
- Participation in a headache support group or other activity such as meditation or
yoga intended to mitigate headache or other chronic pain within 4 weeks of beginning
the Screening log-keeping period. Participants must not enroll in such an activity
during the titration or stable dose phase of the study.
- Current use of prazosin or other alpha-1 antagonist for any purpose
- Allergy or previous adverse reaction to prazosin or other alpha-1 antagonist
- Use of opioids for any reason on more than 14 days per 4 week period
- Subjects must be on a stable dose of the following medications/treatments for at
least 4 weeks prior to the Screening Headache Log period, and must intend to continue
the medication for the duration of the trial: psychoactive drugs, for example
anticonvulsants, benzodiazepines, antidepressants, sedative/hypnotics;
antihypertensive medications, including beta blockers, calcium channel blockers,
angiotensin converting enzyme inhibitors, and angiotensin receptor blockers;
magnesium prescribed specifically for headache.
- Potential participants who have been taking trazodone will undergo a 2-week washout
period before beginning the Screening Headache Log. Because combining prazosin and
trazodone may increase risk of priapism, trazodone is not allowed during the study.
- Sildenafil (Viagra), tadalafil (Cialis), vardenafil (Levitra), and avanafil (Stendra)
will not be permitted during the dose titration period, because of increased risk of
hypotension in combination with alpha-1 blockers, but will be allowed at half the
usual starting dose following the study drug dose titration period, per VA
- Use of triptans, ergotamines, or combination medications > 10 days/month for >3
months , i.e., regular use of these medications on 10 or more days per month.
- Use of butalbital within 4 weeks of beginning the screening period through the end of
participant's study involvement .
|Links||Permanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT02266329
| Link to official Clinicaltrials.gov listing