Tanezumab for Schwannomatosis Pain

Palo Alto (17 mi)

Overseen byScott R Plotkin

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Massachusetts General Hospital

Prior Safety Data

Trial Summary

What is the purpose of this trial?The primary objective of this study is to determine whether the administration of tanezumab, an anti-nerve growth factor (NGF) antibody, improves pain relief in schwannomatosis patients receiving background non-NSAID therapy.

Eligibility Criteria

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.

Inclusion Criteria

My weight is at least 45 kg.

I am 18 years old or older.

I can take care of myself but might not be able to do heavy physical work.

I agree to use two effective birth control methods during and for 16 weeks after the study.

I have been diagnosed with schwannomatosis.

I have moderate to severe pain from schwannomatosis, scoring 5 or more on a pain scale.

Exclusion Criteria

I have shoulder pain and X-rays show arthritis signs.

My X-rays show I have a serious knee condition.

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 have had severe allergic reactions to certain antibody treatments.

I have been treated with nerve growth factor or anti-nerve growth factor antibody.

I haven't had major joint surgery or serious injury in the last year.

I am on blood thinners for a health condition.

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.

My pain is due to reasons other than schwannomatosis, like previous cancer treatment or an infection.

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.

Treatment Details

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.

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)