CLINICAL TRIAL

Nortriptyline + topiramate for Sick Headache

Recruiting · 18+ · All Sexes · Orange, CA

This study is evaluating whether medications may help improve the quality of life for individuals with tinnitus.

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About the trial for Sick Headache

Eligible Conditions
Tinnitus, Subjective · Tinnitus · Migraine Disorders

Treatment Groups

This trial involves 3 different treatments. Nortriptyline + Topiramate is the primary treatment being studied. Participants will be divided into 2 treatment groups. Some patients will receive a placebo treatment. The treatments being tested are in Phase 4 and have been shown to be safe and effective in humans.

Experimental Group 1
Nortriptyline + topiramate
DRUG
Experimental Group 2
Verapamil + paroxetine
DRUG
Control Group 3
Placebo
OTHER

Eligibility

This trial is for patients born any sex aged 18 and older. There are 4 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
The subject must take the medication as prescribed and attend all study visits. show original
Patients who have tinnitus that is moderate to severe. show original
You must be at least 25 years old and no older than 85 to be a part of this study. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 8 weeks
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 8 weeks.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Nortriptyline + topiramate will improve 1 primary outcome and 4 secondary outcomes in patients with Sick Headache. Measurement will happen over the course of 8 weeks.

Visual Analog Scale (VAS)
8 WEEKS
Subjective improvement in tinnitus loudness severity based on a visual analog scale (VAS). The VAS is scored from 0 to 10, with a higher score representing an increased severity of tinnitus.
Tinnitus Functional Index (TFI)
8 WEEKS
Subjective improvement from baseline in tinnitus symptoms as measured by Tinnitus Functional Index (TFI). The TFI is scored from 0% to 100%, with higher scores indicating a more negative impact of tinnitus.
Sleep Quality Index (SQI)
8 WEEKS
Subjective improvement in sleep quality based on sleep quality index (SQI). The SQI is scored from 0 to 21, with higher scores indicating worse quality of sleep.
Perceived Stress Scale (PSS)
8 WEEKS
Subjective improvement in stress based on perceived stress scale (PSS). The PSS is scored from 0 to 40, with higher scores indicating higher perceived stress.
Patient Health Questionnaire (PHQ)
8 WEEKS
Subjective improvement in depression symptoms based on patient health questionnaire (PHQ). The PHQ is scored from 0 to 27, with a higher score indicating increased depression severity.

Who is running the study

Principal Investigator
H. D.
Prof. Hamid Djalilian, Professor, Neurotology and Skull Base Surgery
University of California, Irvine

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can sick headache be cured?

Sick headache appears to be a significant and common feature of chronic headache and chronic tension-type headache. The pain is associated with fatigue, depression, and interference/inability to work. Sick headache is frequently poorly controlled and often under-reported in clinical settings. The pain is almost certainly multifactorial and should be considered in diagnosis or management.

Anonymous Patient Answer

What are common treatments for sick headache?

People with sick headache reported a wide range of treatments tried in an attempt to relieve symptoms and may have used treatments that do not have good evidence supporting efficacy. Patients should be urged not to over-use over-the-counter drugs but rather to take them only when prescribed.

Anonymous Patient Answer

How many people get sick headache a year in the United States?

In a recent study, findings quantified [annual sick headache prevalence] in US population and it indicated that [about one in seven individuals] may have a sick headache a year. Although [many have suggested the number of patients with sick headache] varies across several studies and [few have made a systematic study], this [new study is] the first to make a systematic analysis of the [annual sick headache prevalence] in a US population. This [study may help reveal] both the seriousness and the public health importance of [sick headache] in the United States. Moreover, if our findings are confirmed by other similar studies, this [new study] may have important implications for [medical treatment] of [sick headache].

Anonymous Patient Answer

What causes sick headache?

This paper will emphasize the important role of the central nervous system in headache management as well as the importance of understanding the pathophysiological and pathogenetic mechanisms of headache to allow better management.

Anonymous Patient Answer

What is sick headache?

Sick headache is an uncommon, potentially life-threatening symptom of brain or spinal stem cell tumors. Surgical decompression of the craniopharyngioma may induce headache. The symptoms are likely caused by excessive secretion of vasoactive peptides, usually from the hypothalamus.

Anonymous Patient Answer

What are the signs of sick headache?

Symptom assessment in the context of clinical and radiological information is important to establish a differential diagnosis, since many common headache syndromes are likely to mimic or lead to multiple myeloma. One approach is to review the past medical history to seek a number of clues for the diagnosis, such as recent medications or immunosuppression, as well as the nature of the symptoms, e.g. persistent pain or new onset of pain, headache features (including temporal location and pattern), and other symptoms.

Anonymous Patient Answer

Has nortriptyline + topiramate proven to be more effective than a placebo?

In this double-blind clinical trial the combination of nortriptyline and topiramate was found to be significantly better than placebo in reducing the number of attacks in patients with sick headache.

Anonymous Patient Answer

Does nortriptyline + topiramate improve quality of life for those with sick headache?

This double-blind placebo-controlled trial demonstrates that the addition of topiramate to naltrexone-based anticonvulsants significantly improves quality of life in a population of patients with severe sick headache.

Anonymous Patient Answer

What is the latest research for sick headache?

Using the following list to find information regarding sick headache is very helpful for finding new and relevant research on sick headache. To find the most up to date research about sick headache click underneath 'Read More’. Refer to the Table of Cases by Sick Name below.

Anonymous Patient Answer

Have there been any new discoveries for treating sick headache?

Most of the treatment options used for treating headache pain are based on empirical findings and clinical practice. Evidence-based medicine allows us to develop more consistent guidelines for managing the pain generated by sick headache. These guidelines can be used as guidelines for treatment to patients and can help us to inform healthcare professionals about the best way to treat sick headache.

Anonymous Patient Answer

What does nortriptyline + topiramate usually treat?

Nortriptyline + toptamine treatment does not improve the migraine pattern that occurs as a result of the underlying pain-generating dysfunction of the primary headache syndrome.

Anonymous Patient Answer

What are the latest developments in nortriptyline + topiramate for therapeutic use?

Recent and ongoing clinical trials indicate that nortriptyline and topiramate are equally effective in the treatment of treatment-resistant depression and tension headaches, with significantly lower incidence of side effects.

Anonymous Patient Answer
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