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Evaluation of IV AMBTX-01 (Neridronate) for Treatment of CRPS Type 1 (CRPS-RISE)

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

About this trial

Phase 3 Trial of AMBTX-01 (neridronate) for Complex Regional Pain Syndrome Type 1

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male or female participant ≥ 18 years of age at time of Screening.

A diagnosis of CRPS-1 according to the clinical Budapest Criteria as recommended by the International Association for the Study of Pain (IASP), as well as no known peripheral nerve injury. Signs and symptoms of CRPS must apply to a single identified affected limb (i.e., arm, hand, wrist, leg, ankle or foot) and must demonstrate asymmetry with respect to the contralateral limb.

Edema in the affected limb

Obvious redness in the affected region relative to the same region on the contralateral limb on inspection

Disqualifiers

A current or prior diagnosis of CRPS Type 2 or CRPS not otherwise specified (CRPS NOS), or whose CRPS has no known inciting event, or CRPS-1 without criteria of the warm subtype at the time of Screening.

≥ 40 points on the Pain Catastrophizing Scale.

Prior use of neridronate or participation in a clinical study where the participant may have received neridronate.

IV bisphosphonates

Trial design

Design model

Parallel

Treatments tested in this trial

  • Neridronate

    Drug

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

  • Placebo

    Drug

    placebo comparator

Treatment groups

270 Participants
are divided into 2 treatment groups
Group A: neridronateExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in pain intensity from baseline to Week 12.

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

Time frame
Week 12

Secondary outcomes

1

At least a 50% reduction from baseline to Week 12 in pain intensity.

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

Time frame
Week 12
2

Change from baseline in CRPS Severity Score (CSS) to Week 12.

Assessed using the CRPS CSS, a 0-16 scale where higher scores denotes greater CRPS symptom severity and lower scores reflect milder symptoms.

Time frame
Week 12
3

Patient Global Impression of Change (PGI-C) in CRPS-Related Health.

Assessed using the PGI-C, a 7-point numerical rating scale where 1 indicates "very much improved" and 7 indicates "very much worse."

Time frame
Week 12
4

Change from baseline in the Short Form 36 (SF-36) Item Health Survey Physical Functioning domain.

Assessed using the SF-36, a validated 36-item self-reported questionnaire that measures health-related quality of life across eight domains: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health. Scores range from 0 to 100, with higher scores indicating better health status.

Time frame
Week 12

Other outcomes

Sponsors and contacts

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

Ambros Therapeutics, Inc.

Lead sponsor

Source ClinicalTrials.gov
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