Tanezumab for Schwannomatosis Pain

Recruiting in 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.

My organ and bone marrow functions are normal.

I am 18 years old or older.

+6 more

Exclusion Criteria

I am not fit for surgery as per the ASA classification or I am unwilling to undergo joint replacement surgery.

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.

+26 more

Participant Groups

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)