Phase 3, Open-Label Extension Study of AMBTX-01 (Neridronate) for Complex Regional Pain Syndrome Type 1

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Ambros Therapeutics, Inc.
Study ID
NCT07857733
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

  • Complex Regional Pain Syndrome Type I

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Neridronate — DRUG
    100 mg, given as a 2-hour infusion on Days 1, 4, 7, and 10.

Study Details

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

Key Dates

First listed
Oct 5, 2026
Start date
Oct 15, 2026
Status verified
Sep 2026
Primary completion
Dec 31, 2028
Completion
Feb 15, 2029

Study Design

Enrollment
135 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Neridronate
    400 mg AMBTX-01 infusion

Primary Outcome Measure

Number of Participants with Treatment Emergent Adverse Events (TEAEs), Acute Phase Reaction (APRs) and Treatment Emergent Serious Adverse Events (TESAEs) and Suspected Unexpected Serious Adverse Events (SUSARs) during the Open Label Extension Study. [ Time Frame: Week 12 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Ambros Clinical Study SitePhoenixArizona85032
[email protected]
+1 602-288-4673

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By research site
Ambros Clinical Study Site· Phoenix, AZ

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