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

ConditionComplex Regional Pain Syndrome Type I
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorAmbros Therapeutics, Inc.

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participants must have completed the Week 12 visit of the neridronate AMBTX-01-301 Randomized Clinical Trial (RCT).

Both the Investigator and participant must agree that the participant is reasonably likely to benefit from neridronate therapy without undue risk based on information about benefits/risks in the IB.

The Investigator must characterize the participants CRPS-1 as a serious condition based on the presence of persistent moderate-to-severe pain or/and persistent moderate-to-severe CRPS-1 signs or/and symptoms other than pain.

Participants must be capable of understanding the study requirements and willing to provide informed consent prior to any study-related procedures.

Disqualifiers

Individuals who did not participate in AMBTX-01-301 RCT, or those participants from AMBTX-01-301 RCT who discontinued investigational product and/or were withdrawn from the trial.

Evidence of severely impaired renal function .

Prior or planned renal transplant.

Within the last 12 months - IV immunoglobulin, any IV bisphosphonates (excluding investigational product as part of AMBTX-01-301 RCT prior to open-label treatment);

Trial design

Design model

Single group

Treatments tested in this trial

  • Neridronate

    Drug

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

Treatment groups

135 Participants
are divided into 1 treatment group
Group A: NeridronateExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Endpoints will be summarized descriptively. Descriptive statistics for categorical variables will be frequencies and percentages. Descriptive statistics for continuous variables will be means, standard deviations, medians, minimums, and maximums.

Time frame
Week 12

Secondary outcomes

1

Change in "average pain" from baseline

Assessed using an 11-point Numerical Rating Scale (NRS), with 0 representing no pain and 10 the worst possible pain.

Time frame
Day 10, Weeks 3, 6, and 12
2

At least a 30%, 50%, 70%, and 90% reduction of "average pain" from baseline

Assessed using an 11-point Numerical Rating Scale (NRS), with 0 representing no pain and 10 the worst possible pain

Time frame
Day 10, Weeks 3, 6, and 12
3

Change from baseline in "pain now"

Assessed using an 11-point Numerical Rating Scale (NRS), with 0 representing no pain and 10 the worst possible pain.

Time frame
Day 10, Weeks 3, 6, and 12
4

At least a 30%, 50%, 70%, and 90% reduction from baseline in "pain now"

Assessed using an 11-point Numerical Scale (NRS) with 0 representing no pain and 10 the worst possible pain

Time frame
Day 10, Weeks 3, 6, and 12

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ambros Therapeutics, Inc.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: