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Complex Regional Pain Syndrome, Type IPhase 2/3NCT02402530

Efficacy and Safety of Intravenous Neridronic Acid in CRPS-I

A Phase 2/3 study testing Neridronic acid 62.5 mg in people with Complex Regional Pain Syndrome, Type I, run by Grünenthal GmbH at 59 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This clinical trial is being conducted to demonstrate the efficacy of neridronic acid in the treatment of pain associated with complex regional pain syndrome type I (CRPS-I). The trial is divided into 3 periods: a 60-day enrollment period, a 12-week trial period, and an extended follow-up period with visits at Month… Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Complex Regional Pain Syndrome, Type I
What is being tested?
Neridronic acid 62.5 mg
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
459 participants
Where
59 sitesin 3 countries
Study dates
Apr 2015to Nov 2016
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Informed consent signed.
  • Male or female participant between 18 years and 80 years of age.
  • A diagnosis of complex regional pain syndrome type I according to the clinical diagnostic criteria using the International Association for the Study of Pain clinical diagnostic criteria (Budapest criteria).
  • Baseline Pain Intensity Score of 4 or greater using an 11-point Numerical Rating Scale referring to the CRPS-affected limb.
  • In stable treatment and follow-up therapy for CRPS type I for at least 1 month.
  • Participant has undergone a recent regular dental examination.
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  • Women of child-bearing potential must have a negative urine ß-HCG pregnancy test at enrollment.
  • Women of child-bearing potential must practice protocol defined acceptable methods of birth control during the trial.
  • Participants must be able to communicate meaningfully, be able to differentiate with regard to location and intensity of the pain, and be able to answer the questions in the questionnaires used in this trial.
  • Compliance with the use of electronic diary assessed prior to allocation to treatment.

Who cannot join

  • A diagnosis of complex regional pain syndrome type II.
  • Documented history or diagnosis of peripheral neuropathy, including diabetic peripheral neuropathy or other metabolic or toxic neuropathy, or any other chronic pain condition that would significantly affect a participant's ability to report CRPS-related pain.
  • Body weight less than 40 kg.
  • Evidence of renal impairment or a history of chronic kidney disease.
  • Serum calcium or magnesium outside of the central laboratory's reference range; history of hypocalcemia; any metabolic disorder anticipated to increase risk for hypocalcemia.
  • Vitamin D deficiency. Participants with vitamin D deficiency prior to enrollment may be enrolled with appropriate supplementation during the enrollment period.
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  • Corrected QT interval greater than 470 milliseconds; treatment with medications within the last 30 days prior to allocation to IMP that have potential to prolong the QT interval or anticipated need for such medications during the course of the trial.
  • Any prior use of a bisphosphonate for treatment of CRPS, any prior administration of intravenous bisphosphonate, administration of oral bisphosphonate within the previous year, anticipated requirement for treatment with oral or intravenous bisphosphonate for another condition such as osteoporosis during the trial, or administration of denosumab (Prolia) or other bone turnover suppressing drugs within the past 6 months.
  • History of any allergic or hypersensitivity reaction to neridronic acid or other bisphosphonate, or to vitamin D or calcium supplements.
  • Recent tooth extraction, unhealed or infected extraction site, or significant dental/periodontal disease that may pre-dispose to need for tooth extraction or other invasive dental procedures during the trial.
  • Evidence of denture-related gum trauma or improperly fitting dentures causing injury.
  • Prior radiation therapy of the head or neck (within 1 year of enrollment).
  • Recent treatment with high doses of systemic steroids or anticipated need for concomitant high-dose steroid treatment during the trial.
  • History of malignancy within 2 years before enrollment with the exception of basal cell carcinoma.
  • Daily intake of long- and short-acting or controlled-release opioid analgesics of more than 200 mg morphine equivalents, regimens combining high-dose opioids and benzodiazepines, or any other treatment regimen considered unstable, unsafe, or have potential to affect the interpretation of the trial.
  • Use of nerve blocks, ketamine infusions, intravenous immunoglobulin, acupuncture, electromagnetic field treatment, or initiation/implementation of radiofrequency ablation or other sympathectomy procedures, or peripheral nerve stimulation within 6 weeks prior to allocation to investigational medicinal product.
  • Evidence of current alcohol or drug abuse, or history of alcohol or drug abuse within 2 years of enrollment, based on participant history and physical examination and according to the investigator's judgment.
  • Any other severe medical condition, including severe depression, or any other severe mood disorder, that in the opinion of the investigator may affect efficacy or safety assessments or may compromise the participant's safety during trial participation.
  • Participant is engaged in litigation related to their disability from CRPS in which monetary gain or loss (or other compensation) may affect their objective participation in the trial.
  • Women who are pregnant or breastfeeding.
  • Elevated aspartate aminotransferase (AST) or alanine aminotransferase (ALT) greater than 2-fold upper limit of normal (ULN), or evidence or history of liver disease.
  • Participation in an investigational drug trial within 3 months prior to enrollment, or prior participation in this trial with receipt of any infusion of IMP, even a partial infusion.

Trial locations and contacts

59 sites in 3 countries.

59 sites in 3 countries

United States49 sites

  • Site US166 - Albany Medical College

    Albany, New York, 12208

  • Site US110 - Orange County Research Institute

    Anaheim, California, 92801

  • Site US107 - Austin Center for Clinical Research

    Austin, Texas, 78756

  • Site US134 - Lovelace Scientific Resources, Inc

    Austin, Texas, 78758

  • Site US144 - Bellevue Surgery Center

    Bellevue, Washington, 98004

  • Site US173 - Bellevue Surgery Center

    Bellevue, Washington, 98004

  • Site US123 - Northwest Clinical Research Center

    Bellevue, Washington, 98007

  • Site US169 - Massachusetts General Hospital

    Boston, Massachusetts, 01773

  • Site US172 - Core Healthcare Group

    Cerritos, California, 90703

  • Site US112 - Clinical Trials of South Carolina

    Charleston, South Carolina, 29406

  • Site US103 - Great Lakes Clinical Trials

    Chicago, Illinois, 60640

  • Site US108 - Catalina Research Institute

    Chino, California, 91710

  • Site US153 - Clinical Research of West Florida Inc - Clearwater

    Clearwater, Florida, 33765

  • Site US162 - South Lake Pain Institute

    Clermont, Florida, 34711

  • Site US175 - Inland Pain Medicine

    Colton, California, 92324

  • Site US106 - Mountain View Clinical Research

    Denver, Colorado, 80209

  • Site US119 - G & L Research

    Foley, Alabama, 36535

  • Site US113 - Pioneer Research Solutions, Inc

    Houston, Texas, 77099

  • Site US152 - UC San Diego Healthcare Systems, Center for Pain Medicine

    La Jolla, California, 92093

  • Site US105 - Advanced Biomedical Research of America

    Las Vegas, Nevada, 89123

  • Site US154 - Woodland International Research Group

    Little Rock, Arkansas, 72211

  • Site US102 - Samaritan Center for Medical Research

    Los Gatos, California, 95032

  • Site US143 - Florida Pain Institute

    Merritt Island, Florida, 32953

  • Site US111 - Sunrise Research Institute

    Miami, Florida, 33130

  • Site US122 - Precision Research Organization, LLC

    Miami Lakes, Florida, 33016

  • Site US157 - North Star Medical Research

    Middleburg Heights, Ohio, 44130

  • Site US131 - Better Health Clinical Research, Inc

    Newnan, Georgia, 30265

  • Site US104 - Discovery Clinical Trials

    Orlando, Florida, 32806

  • Site US129 - International Clinical Research Institute

    Overland Park, Kansas, 66210

  • Site US149 - Founders Research Corporation

    Philadelphia, Pennsylvania, 19152

  • Site US133 - Gold Coast Research LLC

    Plantation, Florida, 33317

  • Site US101 - Princeton Medical Institute

    Princeton, New Jersey, 08540

  • Site US145 - University of Rochester

    Rochester, New York, 14618

  • Site US126 - Northern California Research

    Sacramento, California, 95821

  • Site US118 - Omega International Pain Clinic

    Salt Lake City, Utah, 84106

  • Site US117 - Valley Pain Consultants

    Scottsdale, Arizona, 85254

  • Site US116 - Arizona Pain Specialists

    Scottsdale, Arizona, 85258

  • Site US161 - Swedish Pain and Headache Center

    Seattle, Washington, 98104

  • Site US151 - Premier Pain Centers

    Shrewsbury, New Jersey, 07702

  • Site US156 - University Clinical Research Center

    Somerset, New Jersey, 08502

  • Site US127 - Advance Clinical Research, Inc

    St Louis, Missouri, 63128

  • Site US171 - Florida Medical Pain Management

    St. Petersburg, Florida, 33709

  • Site US121 - Clinical Research of West Florida

    Tampa, Florida, 33603

  • Site US137 - Montefiore Medical Center

    The Bronx, New York, 10467

  • Site US124 - Quality of Life Medical and Research Centers LLC

    Tucson, Arizona, 85712

  • Site US164 - Advanced Clinical Research

    West Jordan, Utah, 84088

  • Site US165 - Palm Beach Research

    West Palm Beach, Florida, 33409

  • Site US114 - Abington Neurological Associates

    Willow Grove, Pennsylvania, 19090

  • Site US135 - The Center for Clinical Research

    Winston-Salem, North Carolina, 27103

Other trials in United States

Germany5 sites

  • Site DE107 - Studienzentrum A. Schwittay

    Böhlen, 04564

  • Site DE104 - Schmerzzentrum Dr. med. C. Wachter & T. Tusker

    Fellbach, 70736

  • Site DE101 - Klinische Forschung Hannover Mitte GmbH

    Hanover, 30159

  • Site DE103 - Algesiologikum Studienzentrum und Algesiologikum MVZ

    Munich, 80799

  • Site DE102 - Universitätsklinikum Würzburg Neurologische Klinik

    Würzburg, 97080

Other trials in Germany

United Kingdom5 sites

  • Site GB104 - The Royal Victoria Infirmary

    Cambridge, NE1 4LP

  • Site GB108 - Darlington Memorial Hospital, Centre for Research and clinical Intervention

    Darlington, DL3 6HX

  • Site GB109 - Royal Devon Exeter Hospital

    Exeter, EX2 5DW

  • Site GB101 - Guys and St. Thomas NHS Foundation Trust - St Thomas Hospital

    London, SE1 7EH

  • Site GB111 - Chelsea and Westminster Hospital - NHS Foundation Trust

    London, SW10 9NH

Other trials in United Kingdom

About this study

Official title: A Randomized, Double-blind Trial Investigating the Efficacy and Safety of Intravenous Neridronic Acid in Subjects With Complex Regional Pain Syndrome Type I (CRPS-I)

This clinical trial is being conducted to demonstrate the efficacy of neridronic acid in the treatment of pain associated with complex regional pain syndrome type I (CRPS-I).

The trial is divided into 3 periods: a 60-day enrollment period, a 12-week trial period, and an extended follow-up period with visits at Month 6, Month 9, and Month 12. The extended follow-up period will be terminated for all participants after the last participant enrolled completes their Month 6 visit (Visit 9). The double-blind will be maintained throughout the 12-week trial period and extended follow-up period.

Being tested
Placebo, Neridronic acid 62.5 mg
Keywords
Neridronic Acid, Neridronate, CRPS, RSD
Medical subject headings
Reflex Sympathetic Dystrophy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboDrug

    Matching placebo administered as intravenous infusion.

  • Neridronic acid 62.5 mgDrug

    Neridronic acid administered as intravenous infusion.

Study groups in NCT02402530
Study groupRoleWhat they receive
PlaceboPlacebo comparatorMatching placebo administered as intravenous infusion on Day 1, Day 4, Day 7 and Day 10
Receives: Drug: Placebo
125 mg Neridronic acidExperimentalNeridronic acid 62.5 mg administered as intravenous infusion on Day 1 and Day 4; matching placebo administered as intravenous infusion on Day 7 and Day 10
Receives: Drug: Placebo; Drug: Neridronic acid 62.5 mg
250 mg Neridronic acidExperimentalNeridronic acid 62.5 mg administered as intravenous infusion on Day 1, Day 4, Day 7 and Day 10
Receives: Drug: Neridronic acid 62.5 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in the Pain Intensity Score to Week 12.

    The Pain Intensity Score is the mean value of current pain intensity ratings, obtained twice-daily for 1 week, using an 11-point numerical rating scale where 0 = "no pain" and 10 = "pain as bad as you can imagine". All pain intensity ratings for the primary endpoint will be in reference to the CRPS-affected limb.

    Measured: Baseline; Week 12

Secondary outcomes (6)

  1. Response to treatment: Proportion of Participants With at Least 30 Percent Reduction in the Pain Intensity Score

    Participants with at least a 30 percent decrease in the Pain Intensity Score will be considered to have responded to treatment. The Pain Intensity Score is determined as for the primary endpoint.

    Measured: Baseline; Week 12

  2. Response to treatment: Proportion of Participants With at Least 50 Percent Reduction in the Pain Intensity Score

    Participants with at least a 50 percent decrease in the Pain Intensity Score will be considered to have responded to treatment. The Pain Intensity Score is determined as for the primary endpoint.

    Measured: Baseline; Week 12

  3. Change in the Brief Pain Inventory (BPI) Interference Score

    The BPI Interference Score is the mean value of 7 self-reported items in question 9 of the BPI Short Form Questionnaire. Participants will rate their interference of pain with general activity, walking, work, sleep and other activities in the past 24 hours, with possible ratings from 0 (does not interfere) to 10 (completely interferes). The BPI interference Score ranges from 0 to 10, with higher values indicating greater pain interference of daily activities.

    Measured: Baseline; Week 12

  4. Patient Global Impression of Change (PGIC)

    The PGIC is a self-reported measure of perceived change in overall condition since the start of the study. Participants will select one of seven responses ranging from very much improved to very much worse. A response of very much improved or much improved is generally regarded as a clinically important outcome.

    Measured: Baseline; Week 12

  5. Change in the EuroQol-5 Dimension 5 Level (EQ-5D-5L) Index Score

    The EQ-5D-5L Index Score describes the participant's overall health status and is derived from self-reported scores in 5 health dimensions: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Participants will rate each dimension at one of 5 levels, with level 1 indicating the best health state (no problems) and level 5 indicating worst health state (e.g., unable to walk about). The EQ-5D-5L Index Score ranges from 0 to 1, with 0 representing death and 1.0 representing perfect health.

    Measured: Baseline; Week 12

  6. Change in the EuroQol Visual Analog Scale (EQ VAS)

    The EQ VAS is a self-reported measure of the participant's overall health "today". Participants will place a mark on a 20 cm vertical scale numbered from 0 to 100, with 0 labeled as "the worst health you can imagine" and 100 labeled as "the best health you can imagine". The EQ VAS ranges from 0 to 100, with higher scores representing better overall health.

    Measured: Baseline; Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Mar 2015 (estimated)
  2. Study startApr 2015
  3. Primary completionAug 2016
  4. Study completionNov 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
459 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02402530
Sponsor's protocol ID
KF7013-01
Other IDs
U1111-1151-2181, 2014-001915-37, 2014
Status last verified
May 2018
First submitted
25 Mar 2015
Last updated
9 May 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Information available on the Grünenthal Group Web Site (see URL below for details); according to the EFPIA Data Sharing Principles.

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Neridronic acid 62.5 mg in people with Complex Regional Pain Syndrome, Type I, run by Grünenthal GmbH at 59 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 May 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 59 sites in United States, Germany, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in the Pain Intensity Score to Week 12. (time frame: Baseline; Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02402530.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2018.

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