Recruiting

Observational Study

Sponsor:

Ambros Therapeutics, Inc.

Code:

NCT07811362

Conditions

Complex Regional Pain Syndrome I (CRPS I)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

The goal of this observational study is to learn about how well neridronate keeps working in the months after treatment. For 12 or up to 24 months while the registry is open participants will answer online survey questions about their CRPS pain, medication use or procedures done and how CRPS affects what they are able to do.

Conditions

Complex Regional Pain Syndrome I (CRPS I)

Study ID

NCT07811362

Start date

Sep 17, 2026

Status verified date

Sep, 2026

Completion date

Apr 16, 2029

Anticipated

Primary completion date

Apr 16, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Participants from CRPS-RISE

1. Completion of four infusions of IP (neridronate 100 mg over a \~ 10-day period \[or the renally modified dosing, as applicable\] or placebo) in CRPS-RISE .
2. Completed CRPS-RISE with a final trial visit at Week 6 (Visit 8) or later.

Participants who meet both criteria will be provisionally enrolled pending post-trial unblinding and be included in the Provisionally Enrolled Study Cohort.

After CRPS-RISE last patient last visit unblinding, only participants who meet the following neridronate exposure criterion #3 will continue in registry follow-up and be included in the Enrolled Study Cohort:
3. Completion of 4-infusions of neridronate 100 mg over approximately a 10-day period in CRPS-RISE.
  • Participants from the Open Label Extension (OLE)

1. Completion of 4 infusions of neridronate 100 mg over approximately a 10-day period (or the renally modified dosing, as applicable) in the OLE.
2. Completed OLE with a final trial visit at Week 6 (Visit 8) or later.

Exclusion Criteria:

There are no exclusion criteria.

Study Design

Enrollment

270 participants

Anticipated

Interventions and Outcome Measures

Arms

Provisionally Enrolled Study Cohort

Participants provisionally enrolled in the registry. (Note: Participants provisionally enrolled who do not meet this neridronate-exposure criterion will not continue registry follow-up.)

Enrolled Study Cohort

Participants who have consented to participate and meet all inclusion criteria including confirmation of completing four infusions of neridronate.

Primary outcome measure

  • Change from baseline to each registry assessment of average pain in the past 24 hours. [ Time Frame: Every 3 months from enrollment until up to 2 years after entry. ]
  • Time to loss of benefit where benefit is 50% reduction in average pain intensity from baseline to Week 12 of the CRPS-RISE trial. [ Time Frame: Every 3 months from enrollment until up to 2 years after entry. ]
  • Change from baseline to each registry assessment in CRPS Severity Score Self-Report (CSS-SR) total score and individual items. [ Time Frame: Every 3 months from entry to up to 24 months of participation. ]
  • Change from baseline to each registry assessment in Patient Global Impression of Severity (PGI-S). [ Time Frame: Every 3 months from enrollment until up to 2 years after entry. ]
  • Change from baseline to each registry assessment in each of the Short Form 12 Health Survey (SF-12, Acute Version 2) domains, Physical Component Score (PCS), Mental Component Score (MCS), and individual items. [ Time Frame: Every 3 months from enrollment until up to 2 years after entry. ]
  • Change from baseline to each registry assessment in Daily Sleep Interference Scale (DSIS) in the past 24 hours on an 11-point numeric rating scale. [ Time Frame: Every 3 months from enrollment until up to 2 years after entry. ]
  • CRPS-1 Related Clinical Events during the 3 months preceding each registry assessment. [ Time Frame: Every 3 months from enrollment until up to 2 years after entry. ]
  • Disability Status [ Time Frame: Every 3 months from enrollment until up to 2 years after entry. ]

Central Contacts and Locations

Central contacts

CRPS-RiseRegistry

877-834-5183CRPS-RiseRegistry@iqvia.com

Locations

CRPS-RISERegistry

Recruiting

Durham, North Carolina, United States, 27703

Contacts

CRPS-RiseRegistry CRPS-RiseRegistry

877-834-5183CRPS-RiseRegistry@iqvia.com

More Information

Sponsor

Ambros Therapeutics, Inc.

Last update posted

Sep 29, 2026

Last verified

Sep, 2026

Keywords

  • CRPS 1
  • Reflex Sympathetic Dystrophy
  • RDS
  • CRPS
  • CRPS Type 1
  • Complex Regional Pain Syndrome Type 1

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-30. This information was provided to ClinicalTrials.gov by Ambros Therapeutics, Inc. on 2026-09-29. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.