Ambros Therapeutics, Inc.
A Phase 3 open-label extension study of AMBTX-01 (neridronate) for Complex Regional Pain Syndrome Type 1
This is a multicenter, open-label extension study to assess the safety, tolerability, and efficacy of IV neridronate 400 mg in eligible participants who have completed the Phase 3 AMBTX-01-301 Randomized Clinical Trial. The total planned trial duration for each participant will be approximately up to 24 weeks and will include: * Screening period of up to 12 weeks * Treatment period on Days 1, 4, 7, and 10 * Post-treatment follow-up through Week 12
Inclusion Criteria: 1. Participants must have completed the Week 12 visit of the neridronate AMBTX-01-301 Randomized Clinical Trial (RCT). 2. 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. 3. 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. 4. Participants must be capabl…
100 mg, given as a 2-hour infusion on Days 1, 4, 7, and 10.
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