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Gabapentin + Tizanidine for Insomnia in Chronic Pain
Study Summary
This trial is testing whether gabapentin or tizanidine can help improve insomnia in people with chronic pain.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2021 Phase 4 trial • 88 Patients • NCT03012815Trial Design
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Who is running the clinical trial?
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- You are allergic to tizanidine or gabapentin, or cannot tolerate them.I have been in pain for 3 months or more.I have trouble sleeping and my sleep issues score is 6 or higher.People of any race or background can participate.You have fainted before or are scared of blood or needles.You plan to travel across different time zones while the trial is happening.You have a body mass index (BMI) of 35 or lower.Your body clock is not in sync with the regular day-night cycle.I have been diagnosed with chronic kidney disease.Your previous EKG showed that your heart's electrical activity is too slow.You can't fill out daily questionnaires.People who work night shifts or rotating shifts.
- Group 1: Placebo
- Group 2: Gabapentin 300mg
- Group 3: Tizanidine 2mg
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What are some common off-label uses for Gabapentin?
"Gabapentin is a medication that's frequently used to alleviate acute low back pain. However, it can also be taken to manage other conditions such as neuralgia, drug withdrawal headache, spasticity, and muscle pain."
Has the Federal Drug Administration given its okay to market Gabapentin?
"While there is some clinical data supporting Gabapentin's safety, it remains unproven whether or not the medication is effective. Consequently, it received a score of 2."
Are there specific requirements for participants in this clinical trial?
"This study will involve 24 individuals that suffer from chronic pain and meet the body mass index, age, ethnicity, and condition requirements. Patients must also report regularly experiencing difficulty sleeping and score a 6 or higher on the AIS questionnaire."
Could you please provide a history of clinical trials that have used Gabapentin?
"At this time, there are a total of 28 different clinical trials evaluating gabapentin. Of these active studies, 11 are in Phase 3. Columbus, Ohio is home to many of these trials; however, there are 71 locations across the country where patients can participate."
Can new patients still enroll in this research program?
"Though this particular clinical trial is not actively recruiting patients at the moment, that may change in the future. The last time this study was edited on September 8th, 2020 and it was initially posted almost 2 years ago on July 29th, 2020. There are 651 other medical trials that are looking for participants right now if you're interested."
Would this trial be suitable for patients who are over 40?
"The age limit to qualify for this study is 65 years old. As long as participants are above the age of 18, they are eligible."
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