NCT07210515招募中3 期
A Randomized, Triple-blind, Placebo-controlled, Phase 3 Trial to Evaluate the Efficacy, Safety, and Tolerability of Intravenous AMBTX-01 (Neridronate) for Treatment of Complex Regional Pain Syndrome Type 1 (CRPS-RISE)
Ambros Therapeutics, Inc.28 个研究点 分布在 1 个国家目标入组 270 人开始时间: 2026年4月14日最近更新:
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 270
- 试验地点
- 28
- 主要终点
- Change in pain intensity from baseline to Week 12.
研究概览
简要总结
Phase 3 Trial of AMBTX-01 (neridronate) for Complex Regional Pain Syndrome Type 1
详细描述
This is a multicenter, randomized, triple-blind, controlled trial, to assess the efficacy, safety, and tolerability of neridronate 400 mg IV in adult participants with the warm subtype of Complex Regional Pain Syndrome Type 1 (CRPS-1) and a positive triple phase bone scan (TPBS).
The total planned trial duration for each participant will be approximately up to 18 weeks and will include:
- Screening period of 2 up to 6 weeks
- Treatment period on Days 1, 4, 7, and 10
- Post-treatment follow-up through week 12
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
- •Single affected limb at the Screening and Randomization Visits meeting the following warm subtype criteria:
- •Edema in the affected limb
- •AND ≥ 2 of the following:
- •Obvious redness in the affected region relative to the same region on the contralateral limb on inspection
- •≥ 1°C increase in temperature on the affected limb relative to the contralateral limb
- •Moderate-to-severe edema
- •≤ 6 months since the onset of CRPS symptoms relative to the Randomization visit
- •Increased uptake in the involved limb compared to the contralateral limb on TPBS (phase 2 and/or phase 3) during Screening. A historic scan not older than 3 months prior to Randomization Visit is acceptable, if available and of sufficient quality for a central read.
- •Women of childbearing potential must:
- •Be nonpregnant.
- •Be nonlactating.
- •Agree to use a highly effective method of contraception and for at least 6 months following last investigational product administration.
- •Exception: Women exclusively engaging in same sex sexual activities are not required to meet this criterion.
- •Adequate compliance with the eDiary during the screening period.
排除标准
- •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.
- •The use of any of the following treatments within the timeframe specified from Randomization Visit:
- •Within the last 12 months:
- •IV bisphosphonates
- •IV immunoglobulin
- •Within the last 6 months:
- •Any oral bisphosphonate, denosumab (Prolia®) or receptor activator of nuclear factor kappa B ligand (RANKL) inhibitors (e.g., denosumab biosimilar compounds)
- •Calcitonin
- •Radiation therapy to the head or neck
- •Participants currently taking or planning to be treated with prohibited concomitant medications/therapies, or not likely able to follow the protocol restrictions for use of concomitant treatment.
- •Severely impaired renal function.
- •Hypocalcemia.
- •Vitamin D deficiency.
- •Significant dental findings such as an unhealed tooth extraction site.
- •Eye inflammation.
- •Significantly elevated liver-related lab tests or evidence of significant liver disease.
- •Clinically unstable cardiac disease.
- •Any known conditions, from 3 months prior to Screening Visit or to the Randomization Visit, that may interfere with the assessment of CRPS-1, CRPS-related pain, safety, or other trial assessments.
研究组 & 干预措施
neridronate
Experimental
400 mg AMBTX-01 infusion
干预措施: Neridronate (Drug)
Placebo
Placebo Comparator
Placebo comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change in pain intensity from baseline to Week 12.
时间窗: Week 12
Assessed on an 11-point Numerical Rating Scale (NRS), with 0 representing no pain and 10 representing the worst possible pain.
次要结局
- At least a 50% reduction from baseline in pain intensity.(Day 10, Weeks 3, 6, and 9)
- Change from baseline in the 7-day mean of daily "pain now".(Day 10, Weeks 3, 6, 9, and 12)
- Change from baseline in 7-day average mean of daily "worst pain" assessment.(Day 10, Weeks, 3, 6, 9, 12)
- At least a 30%, 50%, 70%, and 90% reduction from baseline in pain intensity(Day 10, Weeks, 3, 6, 9, 12)
- Change from baseline in pain evoked by active motion.(Day 10, Weeks 3, 6, and 12)
- At least a 50% reduction from baseline in pain evoked by active motion.(Day 10, Weeks 3, 6, 12)
- Change from baseline in active range of motion (AROM) of affected limb vs. contralateral limb.(Day 10, Weeks 3, 6, 12)
- Change from baseline in the CRPS Severity Score (CSS) and in the individual elements of the CRPS Severity Score.(Days 4, 7, 10, Weeks 3, and 6)
- Change from baseline in the CSS self-report (CSS-SR)(Week 12)
- Change from base line in edema of affected limb(Days 4, 7, 10, Weeks 3, 6, and 12)
- Change from baseline in temperature of affected limb vs contralateral limb.(Days 4, 7, 10, Weeks 3, 6, and 12)
- Patient Global Impression of Change (PGI-C) in CRPS-related health.(Days 4, 7, 10, Weeks 3, and 6)
- Clinician Global Impression of Change (CGI-C) in CRPS-related health.(Days 4, 7, 10, Weeks 3, 6, and 12)
- Change from baseline in Patient Global Impression of Severity (PGI-S) in CRPS Severity.(Days 4, 7, 10, Weeks 3, 6, and 12)
- Change from baseline in Short Form McGill Pain Questionnaire (SF-MPQ) (a) Total Pain Score, (b) each of 4 domain scores, (c) single items.(Days 4, 7, 10, and Weeks 3, 6, and 12)
- Moderate (at least 30%) and substantial (at least 50%) improvement in Short Form McGill Pain Questionnaire (SF-MPQ) (a) Total Pain Score, and (b) each of 4 domain scores.(Days 4, 7, 10, Weeks 3, 6, and 12)
- Change from baseline in the Short Form 36 (SF-36) Item Health Survey (a) 8 domain scores and (b) 2 component summary scores.(Day 10, Weeks 3, 6)
- Moderate (≥ 30%) and substantial (≥ 50%) improvement in the Short Form 36 (SF-36) Item Health Survey (a) 8 domain scores and (b) 2 component summary scores.(Days 4, 7, 10, Weeks 3, 6, and 12)
- At least a 50% reduction from baseline to Week 12 in pain intensity.(Week 12)
- Change from baseline in CRPS Severity Score (CSS) to Week 12.(Week 12)
- Patient Global Impression of Change (PGI-C) in CRPS-Related Health.(Week 12)
- Change from baseline in the Short Form 36 (SF-36) Item Health Survey Physical Functioning domain.(Week 12)
- Change from baseline over time in pain intensity.(Day 10, Weeks 3, 6, and 9)
- At least a 50% reduction from baseline in pain intensity.(Days 10, Weeks 3, 6, and 9)
- At least a 30%, 70%, and 90% reduction from baseline in pain intensity.(Day 10, Weeks 3, 6, 9, and 12)
- Time to onset of analgesic improvement.(daily assessment up to week 12)
- Time to at least a 50%, 70%, and 90% reduction from baseline in pain intensity.(7-day average)
- Change from baseline in the 7-day average of the twice-daily "worst possible pain" assessments.(7-day average)
- At least a 30%, 50%, 70%, and 90% reduction from baseline in pain intensity.(Day 10, Weeks 3, 6, 9, and 12)
- Change from baseline in pain evoked by active motion.(Days 4, 7, 10, Weeks 3, 6, 9, and 12)
- At least a 50% reduction from baseline in pain evoked by active motion.(Days 4, 7, 10, Weeks 3, 6, 9, and 12)
- Change from baseline in active range of motion (AROM) of affected limb vs. contralateral limb.(Days 4, 7, 10, Weeks 3, 6, 9, and 12)
- Change from baseline in the CRPS Severity Score (CSS) and in the individual elements of the CRPS Severity Score.(Days 4, 7, 10, Weeks 3, 6, and 9)
- Change from baseline in edema of affected limb.(Days 4, 7, 10, Weeks 3, 6, 9, and 12)
- Change from baseline in temperature of affected limb vs contralateral limb.(Days 4, 7, 10, Weeks 3, 6, 9, and 12)
- Change from baseline in use of rescue analgesic medications.(Day 10, Weeks 3, 6, 9, and 12)
- Change from baseline in heavy use of rescue analgesic medications.(Day 10, Weeks 3, 6, 9, and 12)
- Change from baseline in mean daily dose of rescue analgesic medicines.(Day 10, Weeks 3, 6, 9, and 12)
- Patient Global Impression of Change (PGI-C) in CRPS-related health.(Days 4, 7, 10, Weeks 3, 6, 9, and 12)
- Clinician Global Impression of Change (CGI-C) in CRPS-related health.(Days 4, 7, 10, Weeks 3, 6, 9, and 12)
- Change from baseline in Patient Global Impression of Severity (PGI-S) in CRPS Severity.(Days 4, 7, 10, Weeks 3, 6, 9, and 12)
- Change from baseline in Short Form McGill Pain Questionnaire (SF-MPQ) (a) Total Pain Score, (b) each of 4 domain scores, (c) single items.(Days 4, 7, 10, and Weeks 3, 6, 9, and 12)
- Moderate (at least 30%) and substantial (at least 50%) improvement in Short Form McGill Pain Questionnaire (SF-MPQ) (a) Total Pain Score, and (b) each of 4 domain scores.(Days 4, 7, 10, Weeks 3, 6, 9, and 12)
- Change from baseline in the Short Form 36 (SF-36) Item Health Survey (a) 8 domain scores and (b) 2 component summary scores.(Days 4, 7, 10, Weeks 3, 6, 9, and 12)
- Moderate (≥ 30%) and substantial (≥ 50%) improvement in the Short Form 36 (SF-36) Item Health Survey (a) 8 domain scores and (b) 2 component summary scores.(Days 4, 7, 10, Weeks 3, 6, 9, and 12)
- Change from baseline in the daily sleep interference scale (DSIS).(Day 10, Weeks 3, 6, 9, and 12)
- Moderate (≥ 30%) and substantial (≥ 50%) improvement in the daily sleep interference scale (DSIS).(Day 10, Weeks 3, 6, 9, and 12)
- Time to moderate (≥ 30%) and substantial (≥ 50%) reduction from baseline in the daily sleep interference scale (DSIS).(7-day average)
研究者
研究点 (28)
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