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Tanezumab for Schwannomatosis Pain
Study Summary
This trial is testing an antibody that may help relieve pain in people with schwannomatosis who are already taking other pain medications.
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 3 trial • 156 Patients • NCT02609828Trial Design
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Who is running the clinical trial?
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- I am not fit for surgery as per the ASA classification or I am unwilling to undergo joint replacement surgery.My weight is at least 45 kg.My organ and bone marrow functions are normal.I haven't had surgery or cancer treatment in the last 4-6 weeks for a painful tumor.I've been on stable doses of certain pain or mood medications for over 30 days.I am 18 years old or older.I have shoulder pain and X-rays show arthritis signs.My X-rays show I have a serious knee condition.I only use inhaled or topical steroids for lung or skin issues.I have NF2, shown by tumors on both sides of my brain, a genetic test, or a family history.I have been diagnosed with osteoarthritis in my knee or hip.I am not pregnant or breastfeeding and agree to use two effective birth control methods for 16 weeks after the last dose.I am likely to need surgery while participating in the study.I have had severe allergic reactions to certain antibody treatments.I have been treated with nerve growth factor or anti-nerve growth factor antibody.I can take care of myself but might not be able to do heavy physical work.I haven't had major joint surgery or serious injury in the last year.I agree to use two effective birth control methods during and for 16 weeks after the study.I can stop taking NSAIDs 2 weeks before treatment, but I may continue low-dose aspirin for heart health.I have been diagnosed with schwannomatosis.I am on blood thinners for a health condition.You have a high score on the Survey of Autonomic Symptoms (SAS) at Screening.I cannot use at least three standard treatments due to side effects or other reasons.I am willing to not take certain pain medications during the study.I have had carpal tunnel syndrome symptoms in the last year.I have a significant neurological condition.I haven't been in a drug study within the last 30 days, or 90 days for biologic treatments.I have a brain tumor with swelling seen on scans.I have moderate to severe pain from schwannomatosis, scoring 5 or more on a pain scale.You have a history of heavy drinking or using a lot of painkillers or drugs in the six months before the screening.My pain is due to reasons other than schwannomatosis, like previous cancer treatment or an infection.You have consistently low blood pressure when standing up.I have had bone loss or a fracture without major injury.I have had a stroke or mini-stroke in the last 6 months that affects my ability to do certain tasks.I do not have any serious illnesses that could interfere with the study.I was diagnosed with cancer in the last 3 years, excluding Gleason 6 prostate cancer, basal cell carcinoma, or carcinoma in situ.
- Group 1: Arm A (treatment)
- Group 2: Arm B (placebo then treatment)
- 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 is the enrollment quota for this research project?
"This trial is not presently open to new applicants. It was initially listed on April 30th 2020, and the last update occured on October 15th 2022. Nevertheless, if you are looking for other studies related to pain management there are currently 569 trials that accept participants as well as a single clinical trial involving Tanezumab administration."
Is this a pioneering clinical trial?
"At present, there is only one ongoing study of Tanezumab being conducted in a single city and nation. The initial research into this drug occurred during 2020 by Pfizer's team with 9 volunteers taking part. After its Phase 2 approval stage was finalized, 18334 more studies have been finished since then."
Has the Food and Drug Administration authorized Tanezumab for medical use?
"Our team at Power has given Tanezumab a score of 2 due to the limited clinical evidence supporting its safety, despite it being in Phase 2 trials. No data currently exists that shows efficacy for this drug."
Are there any remaining vacancies for participants in this experiment?
"This clinical trial has ceased actively recruiting participants. It was first posted on April 30th, 2020 and last updated October 15th, 2022. However, there are presently 569 studies seeking volunteers with pain-related conditions and one study searching for patients to participate in Tanezumab trials."
Are there any comparable experiments that have employed Tanezumab?
"Presently, one ongoing research project is looking into Tanezumab and no trials are currently in Stage 3. Most of the investigations occur at sites located around Boston, yet there is also 1 further site running clinical trial with this drug."
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