CREATE-1: A Study to Assess the Efficacy and Safety of AXS-02 in Patients With CRPS-1 (CREATE-1)
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ClinicalTrials.gov Identifier: NCT02504008 |
Recruitment Status : Unknown
Verified March 2018 by Axsome Therapeutics, Inc..
Recruitment status was: Active, not recruiting
First Posted : July 21, 2015
Last Update Posted : March 23, 2018
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Sponsor:
Axsome Therapeutics, Inc.
Information provided by (Responsible Party):
Axsome Therapeutics, Inc.
Tracking Information | |||
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First Submitted Date ICMJE | July 20, 2015 | ||
First Posted Date ICMJE | July 21, 2015 | ||
Last Update Posted Date | March 23, 2018 | ||
Actual Study Start Date ICMJE | July 2015 | ||
Estimated Primary Completion Date | January 2019 (Final data collection date for primary outcome measure) | ||
Current Primary Outcome Measures ICMJE |
Change in patient reported pain intensity [ Time Frame: Baseline to Week 12 ] Patient reported pain intensity is recorded as an average daily pain intensity using an 11-point scale (0 = no pain to 10 = worst pain possible).
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Original Primary Outcome Measures ICMJE | Same as current | ||
Change History | |||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||
Original Other Pre-specified Outcome Measures | Not Provided | ||
Descriptive Information | |||
Brief Title ICMJE | CREATE-1: A Study to Assess the Efficacy and Safety of AXS-02 in Patients With CRPS-1 | ||
Official Title ICMJE | CREATE-1 Study: CRPS Treatment Evaluation 1 Study. A Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of AXS-02 (Oral Zoledronate) Administered Orally to Subjects With Complex Regional Pain Syndrome Type I (CRPS-I) | ||
Brief Summary | This is a randomized, double-blind, placebo-controlled, 24-week study to evaluate the efficacy and safety of AXS-02 in patients with CRPS-I. | ||
Detailed Description | Not Provided | ||
Study Type ICMJE | Interventional | ||
Study Phase ICMJE | Phase 3 | ||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||
Recruitment Status ICMJE | Unknown status | ||
Estimated Enrollment ICMJE |
190 | ||
Original Estimated Enrollment ICMJE | Same as current | ||
Estimated Study Completion Date ICMJE | January 2019 | ||
Estimated Primary Completion Date | January 2019 (Final data collection date for primary outcome measure) | ||
Eligibility Criteria ICMJE | Key Inclusion Criteria:
Key Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||
Accepts Healthy Volunteers ICMJE | No | ||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||
Listed Location Countries ICMJE | Australia, Canada, United Kingdom, United States | ||
Removed Location Countries | |||
Administrative Information | |||
NCT Number ICMJE | NCT02504008 | ||
Other Study ID Numbers ICMJE | AXS02-301 | ||
Has Data Monitoring Committee | Yes | ||
U.S. FDA-regulated Product | Not Provided | ||
IPD Sharing Statement ICMJE | Not Provided | ||
Current Responsible Party | Axsome Therapeutics, Inc. | ||
Original Responsible Party | Same as current | ||
Current Study Sponsor ICMJE | Axsome Therapeutics, Inc. | ||
Original Study Sponsor ICMJE | Same as current | ||
Collaborators ICMJE | Not Provided | ||
Investigators ICMJE | Not Provided | ||
PRS Account | Axsome Therapeutics, Inc. | ||
Verification Date | March 2018 | ||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |