135 Participants NeededMy employer runs this trial

Neridronate for Complex Regional Pain Syndrome

MA
Overseen ByMedical Affairs Ambros Therapeutics
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Ambros Therapeutics, Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

A Phase 3 open-label extension study of AMBTX-01 (neridronate) for Complex Regional Pain Syndrome Type 1

Who Is on the Research Team?

GC

Gail Cawkwell, MD, PhD

Principal Investigator

Ambros Therapeutics, Inc.

Are You a Good Fit for This Trial?

This trial is for people with Complex Regional Pain Syndrome Type 1 who finished a previous neridronate study, are not pregnant or breastfeeding, can use effective birth control, have good vein access for IV infusions and blood tests, and are able to follow the treatment plan.

Inclusion Criteria

I completed the Week 12 visit in the neridronate AMBTX-01-301 trial.
I am able and willing to attend all treatment and safety visits.
My doctor and I agree that neridronate could help me without causing too much risk.
See 7 more

What Are the Treatments Tested in This Trial?

Interventions

  • Neridronate

Trial Overview

The study is testing ongoing treatment with neridronate (AMBTX-01) given by IV infusion to see if it helps manage pain in people with CRPS Type 1. All participants receive the drug; there is no placebo group.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: NeridronateExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Ambros Therapeutics, Inc.

Lead Sponsor