Trial · NCT07210515
Evaluation of IV AMBTX-01 (Neridronate) for Treatment of CRPS Type 1 (CRPS-RISE)
NCT07210515, Phase 3, Recruiting, Ambros Therapeutics, Inc.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Evaluation of IV AMBTX-01 (Neridronate) for Treatment of CRPS Type 1 (CRPS-RISE). Trials, record NCT07210515. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07210515
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluation of IV AMBTX-01 (Neridronate) for Treatment of CRPS Type 1 (CRPS-RISE)
- NCT number
- NCT07210515
- Status
- Recruiting
- Phases
- Phase 3
- Enrollment
- 270 participants, estimated
- Lead sponsor
- Ambros Therapeutics, Inc.
- Conditions
- Complex Regional Pain Syndrome Type I
- Interventions
- Neridronate, Placebo
- First posted
- 2025-10-07
- Last updated
- 2026-10-29
Source ClinicalTrials.gov
Registered outcomes34
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in pain intensity from baseline to Week 12. | Week 12 | Assessed on an 11-point Numerical Rating Scale (NRS), with 0 representing no pain and 10 representing the worst possible pain. |
| Secondary | At least a 50% reduction from baseline to Week 12 in pain intensity. | Week 12 | Assessed using an 11-point Numerical Rating Scale (NRS), with 0 representing no pain and 10 the worst possible pain. |
| Secondary | Change from baseline in CRPS Severity Score (CSS) to Week 12. | 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. |
| Secondary | Patient Global Impression of Change (PGI-C) in CRPS-Related Health. | Week 12 | Assessed using the PGI-C, a 7-point numerical rating scale where 1 indicates "very much improved" and 7 indicates "very much worse." |
| Secondary | Change from baseline in the Short Form 36 (SF-36) Item Health Survey Physical Functioning domain. | Week 12 | 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. |
| Secondary | Change from baseline over time in pain intensity. | Day 10, Weeks 3, 6, and 9 | Assessed on an 11-point Numerical Rating Scale (NRS), with 0 representing no pain and 10 representing the worst possible pain. |
| Secondary | At least a 50% reduction from baseline in pain intensity. | Day 10, Weeks 3, 6, and 9 | Assessed using an 11-point Numerical Rating Scale (NRS), with 0 representing no pain and 10 the worst possible pain. |
| Secondary | At least a 30%, 70%, and 90% reduction from baseline in pain intensity. | Day 10, Weeks 3, 6, 9, and 12 | Assessed using an 11-point Numerical Rating Scale (NRS), with 0 representing no pain and 10 the worst possible pain. |
| Secondary | Time to onset of analgesic improvement. | daily assessment up to week 12 | Assessed as the time to onset of analgesic improvement, defined by a ≥30% reduction in pain intensity from baseline on the 11-point Numerical Rating Scale (NRS), with 0 representing no pain and 10 the worst possible pain. The improvement must be sustained for a minimum of one week. |
| Secondary | Time to at least a 50%, 70%, and 90% reduction from baseline in pain intensity. | 7-day average | Assessed using an 11-point Numerical Rating Scale (NRS), with 0 representing no pain and 10 the worst possible pain. |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07210515
GET https://conductscience.org/api/trials/v1/NCT07210515/registered?page=2