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Monoclonal Antibodies
Tanezumab for Schwannomatosis Pain
Phase 2
Waitlist Available
Led By Scott R Plotkin
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
The subject's weight must be ≥ 45 kg at Screening.
Age ≥ 18 years. Patients < 18 years are excluded since the safety profile of tanezumab in this population has not been determined.
Must not have
Subjects with symptoms and radiographic findings (i.e. joint space narrowing, osteophytes) consistent with osteoarthritis in the shoulder.
Radiographic (x-ray) evidence of any of the following conditions as determined by the central radiology reviewer at Screening: 1) rapidly progressive osteoarthritis, 2) atrophic or hypotrophic osteoarthritis, 3) subchondral insufficiency fracture, 4) spontaneous osteonecrosis of the knee (SPONK), 5) osteonecrosis, or 6) pathologic fracture.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 40 weeks
Summary
This trial is testing an antibody that may help relieve pain in people with schwannomatosis who are already taking other pain medications.
Who is the study for?
Adults over 18 with moderate to severe pain from schwannomatosis, who've tried and failed at least three standard treatments. They must not be pregnant or breastfeeding, agree to use two contraception methods if applicable, avoid certain medications including NSAIDs, and have normal organ/marrow function. Excluded are those with recent surgery or therapy for schwannomatosis-related tumors, history of allergic reactions to monoclonal antibodies, substance abuse within six months prior to screening.
What is being tested?
The trial is testing Tanezumab—an antibody against nerve growth factor—to see if it can relieve pain in patients with schwannomatosis better than a placebo. Participants will continue their non-NSAID background therapy during the study.
What are the potential side effects?
Tanezumab may cause side effects such as joint problems (like osteoarthritis), nerve damage that could lead to numbness or tingling sensations, potential heart issues like irregular heartbeat, and general symptoms like headache or nausea.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My weight is at least 45 kg.
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I am 18 years old or older.
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I can take care of myself but might not be able to do heavy physical work.
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I agree to use two effective birth control methods during and for 16 weeks after the study.
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I have been diagnosed with schwannomatosis.
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I have moderate to severe pain from schwannomatosis, scoring 5 or more on a pain scale.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have shoulder pain and X-rays show arthritis signs.
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My X-rays show I have a serious knee condition.
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I have NF2, shown by tumors on both sides of my brain, a genetic test, or a family history.
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I have been diagnosed with osteoarthritis in my knee or hip.
Select...
I have had severe allergic reactions to certain antibody treatments.
Select...
I have been treated with nerve growth factor or anti-nerve growth factor antibody.
Select...
I haven't had major joint surgery or serious injury in the last year.
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I am on blood thinners for a health condition.
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I have had carpal tunnel syndrome symptoms in the last year.
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I have a significant neurological condition.
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I haven't been in a drug study within the last 30 days, or 90 days for biologic treatments.
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My pain is due to reasons other than schwannomatosis, like previous cancer treatment or an infection.
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I have had bone loss or a fracture without major injury.
Select...
I have had a stroke or mini-stroke in the last 6 months that affects my ability to do certain tasks.
Select...
I do not have any serious illnesses that could interfere with the study.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 40 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~40 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Pain
Secondary study objectives
Frequency of AEs
Incidence of orthostatic hypotension
Side effects data
From 2021 Phase 3 trial • 156 Patients • NCT0260982815%
Arthralgia
15%
Oral candidiasis
14%
Anaemia
14%
Decreased appetite
13%
Oedema peripheral
13%
Prostate cancer
10%
Asthenia
10%
Breast cancer
8%
Fatigue
8%
Pain
8%
Constipation
8%
Diarrhoea
7%
Fall
7%
Headache
7%
Insomnia
6%
Vomiting
6%
Lung neoplasm malignant
6%
Nausea
6%
Influenza like illness
6%
Nasopharyngitis
6%
Pneumonia
4%
Dizziness
4%
Pain in extremity
4%
Weight decreased
4%
Pathological fracture
4%
Metastases to bone
4%
Dyspnoea
3%
Urinary retention
3%
Deep vein thrombosis
3%
Neuralgia
3%
Depressed mood
3%
Abdominal pain
3%
Pruritus
3%
Pyrexia
3%
Paraparesis
3%
Cough
3%
Pulmonary embolism
3%
Peripheral swelling
3%
Osteoarthritis
3%
Leukopenia
3%
Bacterial infection
3%
Bronchitis
3%
Dehydration
3%
Cancer pain
3%
Colon cancer
3%
Paraesthesia
3%
Somnolence
3%
Depression
3%
Haematuria
3%
Bronchitis chronic
3%
Decubitus ulcer
3%
Hypertension
3%
Pallor
1%
Muscle spasms
1%
Dyspepsia
1%
Jaundice
1%
Oral fungal infection
1%
Respiratory tract infection
1%
Ligament sprain
1%
Hypoalbuminaemia
1%
Hypokalaemia
1%
Osteonecrosis of jaw
1%
Colorectal cancer
1%
Paraneoplastic syndrome
1%
Hyposomnia
1%
Calculus urinary
1%
Hypertonic bladder
1%
Urinary tract infection
1%
Haemorrhoids
1%
Alopecia
1%
Mineral deficiency
1%
Hyperhidrosis
1%
Onycholysis
1%
Skin ulcer
1%
Plasma cell myeloma
1%
Loose tooth
1%
Upper respiratory tract infection
1%
Viral infection
1%
Contusion
1%
Cachexia
1%
Metastases to central nervous system
1%
Dysgeusia
1%
Hypoaesthesia
1%
Dermatitis allergic
1%
Malignant neoplasm progression
1%
Arrhythmia
1%
Hypoacusis
1%
Iron deficiency anaemia
1%
Coagulopathy
1%
Vertigo
1%
Keratitis
1%
Cardio-respiratory arrest
1%
Tinnitus
1%
Vision blurred
1%
Abdominal discomfort
1%
Dry mouth
1%
Gastrointestinal haemorrhage
1%
Gastrooesophageal reflux disease
1%
Stomatitis
1%
Inflammation
1%
Allergy to plants
1%
Body tinea
1%
Conjunctivitis
1%
Gingivitis
1%
Herpes zoster
1%
Infection
1%
Onychomycosis
1%
Postoperative wound infection
1%
Sepsis
1%
Nerve injury
1%
Radius fracture
1%
Rib fracture
1%
Skin abrasion
1%
Blood creatinine increased
1%
Body temperature increased
1%
Haematology test abnormal
1%
Platelet count decreased
1%
Diabetic metabolic decompensation
1%
Hypophagia
1%
Arthritis
1%
Back pain
1%
Bone pain
1%
Bursitis
1%
Chondrocalcinosis
1%
Intervertebral disc protrusion
1%
Joint stiffness
1%
Spinal pain
1%
Thoracic spinal stenosis
1%
Breast cancer metastatic
1%
Gastric cancer
1%
Metastases to liver
1%
Metastases to ovary
1%
Pancreatic carcinoma
1%
Pancreatic neoplasm
1%
Tumour pain
1%
Uterine cancer
1%
Burning sensation
1%
Cerebrovascular insufficiency
1%
Epilepsy
1%
Loss of consciousness
1%
Polyneuropathy
1%
Presyncope
1%
Sensory disturbance
1%
Syncope
1%
Tremor
1%
Adjustment disorder with depressed mood
1%
Nervousness
1%
Micturition disorder
1%
Urinary tract obstruction
1%
Oedema genital
1%
Pleurisy
1%
Rash
1%
Scab
1%
Hot flush
1%
Orthostatic hypotension
1%
Peripheral ischaemia
1%
Post thrombotic syndrome
1%
Vascular fragility
100%
80%
60%
40%
20%
0%
Study treatment Arm
Tanezumab 20 mg
Placebo
Tanezumab 10 mg
Tanezumab 10/20 mg
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm A (treatment)Experimental Treatment1 Intervention
Tanezumab 10 mg SC administered on day 1 and Day 57 (± 4 days)
Group II: Arm B (placebo then treatment)Placebo Group2 Interventions
Placebo SC (to match tanezumab SC) administered on Day 1 and tanezumab 10 mg SC on Day 57 (± 4 days)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tanezumab
Not yet FDA approved
Find a Location
Who is running the clinical trial?
Massachusetts General HospitalLead Sponsor
3,006 Previous Clinical Trials
13,307,273 Total Patients Enrolled
20 Trials studying Pain
1,875 Patients Enrolled for Pain
PfizerIndustry Sponsor
4,650 Previous Clinical Trials
17,743,654 Total Patients Enrolled
57 Trials studying Pain
14,567 Patients Enrolled for Pain
Scott R PlotkinPrincipal InvestigatorMassachusetts General Hospital
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A (treatment)
- Group 2: Arm B (placebo then treatment)
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- 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.
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