AP-325 in Subjects With Peripheral Post-surgical Neuropathic Pain

October 15, 2024 updated by: Algiax Pharmaceuticals GmbH

A Randomized, Double-blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of AP-325 in Subjects With Peripheral Post-surgical Neuropathic Pain

This is a Phase IIa randomized, double-blind, placebo-controlled study. The study objective is to investigate the efficacy and safety of repeat oral dosing of the investigational medicinal product (IMP) AP-325 for the treatment of peripheral post-surgical neuropathic pain (PPNP) after breast surgery (breast-conserving surgery, mastectomy, surgery to remove lymph nodes), chest surgery (e.g. thoracotomy, video assisted thoracoscopy and sternotomy), hernia repair of the abdominal wall (e.g. femoral hernia repairs, inguinal hernia repairs, umbilical hernia repair or incisional hernia repair), abdominal surgery (e.g. cholecystectomy, appendectomy but also see exclusion criterion 15), varicose vein surgery or gynecologic surgery (e.g. hysterectomy, C-section).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a Phase IIa randomized, double-blind, placebo controlled, parallel group study to evaluate the efficacy (by changes in Pain Intensity Numerical Rating Scale [PI-NRS]) and safety (by monitoring adverse events) of AP-325 in subjects with PPNP.

The clinical trial will be conducted in Germany, Spain, Czech Republic, Belgium and France.

Eligible subjects will undergo a 2-week run-in period consisting of a washout-period of prohibited medications in the 1st week and a baseline period in the 2nd week. If subjects have at least 5 self-reported pain assessments in the baseline period (documented in a diary) and meet the required pain criteria, they will be randomized to AP-325 or placebo in a 1:1 ratio.

Subjects will take the IMP (AP-325 or placebo) for 10 days (double-blind treatment period; Days 1-10) and then be followed up for a further 26 days (drug-free period; Days 11-36). An end of study visit will be performed on Day 36.

At least 96 subjects (48 for each treatment) need to be analyzed for the primary endpoint at Day 10 to reach the power estimate (120 subjects should be screened for the study).

AP-325 100 mg (4 x 25 mg capsules) or Placebo (4 capsules) will be orally taken once daily in the morning before meals for 10 consecutive days.

Pain will be assessed, and quality of life will be investigated using standardized and validated questionnaires [Pain Intensity Numerical Rating Scale (PI-NRS), patient global impression of change (PGIC), neuropathic pain symptom inventory (NPSI) questionnaire, daily sleep interference scale (DSIS) score, hospital anxiety and depression scale (HADS)].

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
99

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Belgium
      • Edegem, Belgium, 2650
        • UZ Antwerp
      • Genk, Belgium, 3600
        • Ziekenhuis Oost Limburg - campus St. Jan
      • Gent, Belgium, 9000
        • AZ Sint-Lucas, Pijnkliniek
      • Hasselt, Belgium, 3500
        • Jessa ZH Hospital
      • Pellenberg, Belgium, 3212
        • UZ Leuven, campus Pellenberg
      • Roeselare, Belgium, 8800
        • AZ Delta, Pijncentrum
  • Czechia
      • Brno, Czechia, 61500
        • Neurology and Physiotherapy Outpatient Clinic Skopalíkova
      • Choceň, Czechia, 56501
        • NEUROHK, s.r.o.
      • Plzen, Czechia, 301 00
        • Neuros, s.r.o.
      • Praha, Czechia, 150 00
        • Praglandia, s.r.o.
      • Slezská Ostrava, Czechia, 71000
        • MP-neuro s.r.o., Poliklinika Modrý pavilon
      • České Budějovice, Czechia, 370 01
        • ALGOMED s.r.o. - Centrum léčby bolesti
  • France
      • Amiens, France, 80054
        • CHU Amiens-Picardie, Centre de Recherche Clinique
      • Angers, France, 49055
        • Institut de Cancerologie de l'Ouest, Anesthésie/Douleur
      • Boulogne, France, 92100
        • Hopital Ambroise Paré, Centre d'évaluation et de traitement de la douleur
      • La Roche-sur-Yon, France, 85925
        • CHD Vendée, Département d'évaluation et du traitement de la douleur
      • Limoges, France, 87000
        • Polyclinique de Limoges - Site Chenieux, Centre d'Evaluation et de traitement de la Douleur
      • Paris, France, 75014
        • Hopîtal Cochin, Centre d'évaluation et du traitement de la douleur
  • Germany
      • Berlin, Germany, 10629
        • emovis GmbH, Dedicated Study Site
      • Bochum, Germany, 44789
        • Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil gGmbH, (Ruhr-Universität Bochum) Neurologische Klinik und Poliklinik
      • Düsseldorf, Germany, 40489
        • Florence-Nightingale-Krankenhaus der Kaiserswerther Diakonie, Klinik für Thoraxchirurgie
      • Köln, Germany, 51109
        • Kliniken der Stadt Köln gGmbH, Krankenhaus Köln-Merheim, Lungenklinik am Zentrum für Thoraxchirurgie, Pneumologie/ Onkologie, Schlaf- und Beatmungsmedizin, Klinikum der Universität Witten/Herdecke
      • Würzburg, Germany, 97078
        • Universitätsklinikum Würzburg, Klinik und Poliklinik für Anästhesiologie, Zentrum für Interdisziplinäre Schmerzmedizin
  • Spain
      • Barcelona, Spain, 08003
        • HOSPITAL DEL MAR.#Cod. CNH: 080057#
      • Cadiz, Spain, 11009
        • HOSPITAL UNIVERSITARIO PUERTA DEL MAR#Cod. CNH: 110012#
      • Hospitalet de Llobregat, Spain, 08907
        • HOSPITAL UNIVERSITARI DE BELLVITGE#Cod. CNH: 080752#
      • Madrid, Spain, 28041
        • HOSPITAL UNIVERSITARIO 12 DE OCTUBRE#Cod. CNH: 280035#
      • Madrid, Spain, 28046
        • HOSPITAL UNIVERSITARIO LA PAZ#Cod. CNH: 280014#
      • Madrid, Spain, 28050
        • HOSPITAL UNIVERSITARIO LA MORALEJA#Cod. CNH: 281179#
      • Pamplona, Spain, 31008
        • CLINICA UNIVERSIDAD DE NAVARRA#Cod. CNH: 310060#
      • Pozuelo de Alarcón, Spain, 28223
        • HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID#Cod. CNH: 281203#
      • Valencia, Spain, 46010
        • HOSPITAL CLINICO UNIVERSITARIO DE VALENCIA#Cod. CNH: 460044#

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Subjects must be at least 18 years and not older than 80 years
  2. Subjects with a diagnosis of chronic post-surgical neuropathic pain after breast surgery (e.g. breast-conserving surgery, mastectomy, surgery to remove lymph nodes), chest surgery (e.g. thoracotomy, video assisted thoracoscopy and sternotomy), hernia repair of the abdominal wall (e.g. femoral hernia repairs, inguinal hernia repairs, umbilical hernia repair or incisional hernia repair), abdominal surgery (e.g. cholecystectomy, appendectomy but also see exclusion criterion 15), varicose vein surgery or gynecologic surgery (e.g. hysterectomy, C-section)
  3. The chronic post-surgical pain developed or increased in intensity after the surgical procedure and persisted beyond the healing process, i.e. at least 3 months after the initiating event, as defined according to the international association for the study of pain (IASP) classification of chronic pain for ICD-11 (Schug et al., 2019)
  4. Subjects must have 'probable' or 'definite' neuropathic pain as assessed by the revised IASP special interest group on neuropathic pain (NeuPSIG) grading system (Finnerup et al., 2016)

  5. Subjects must be willing and able to discontinue and washout prohibited substances including

    • pain medications (e.g. antidepressants, anticonvulsants/antiepileptics, selective serotonin and dual reuptake inhibitors, opioids, long-acting benzodiazepines, muscle relaxants, and topical analgesics), except the rescue medication, and
    • substances known to be inhibitors or inducers of CYP2C9 and inhibitors of CYP3A4 for specific washout periods of at least 5 times the drug half-life Note: Subjects using prohibited substances for other indications than neuropathic pain, e.g. antiepileptics for the treatment of epilepsy, may not be included in the study, because a discontinuation of such medication is not medically justifiable.
  6. Permitted concomitant medications must have been stable for at least 4 weeks prior to Day -14 and any non-pharmacological therapies (e.g. physiotherapy, acupuncture and transcutaneous electrical neural stimulation) must have been initiated at least 3 weeks prior to Screening

  7. Female subjects must not be pregnant or breastfeeding and be

    • of non-childbearing potential or
    • if of childbearing potential, use a highly effective contraceptive method from start of the IMP intake until 30 days after the last IMP intake and have a negative pregnancy test at Screening (blood test)
  8. Male subjects must agree, from start of the IMP intake until 3 months after the last IMP intake, to refrain from donating sperm and use a male condom when having sexual intercourse with a woman of childbearing potential at any time and advise her to use a highly effective contraceptive method
  9. Subjects must understand the nature of the study procedures and provide written informed consent prior to any study-related procedures
  10. Body weight ≥55 kg for men and ≥50 kg for women
  11. Body mass index (BMI) <40 kg/m²

Exclusion Criteria:

  1. Subjects with neuropathic pain not a result of a surgical procedure as defined in inclusion criterion 2
  2. Subjects with any other coexisting pain that cannot be discriminated from post-surgical neuropathic pain, in the opinion of the subject or clinician e.g., the pain is at least partially due to pain in deeper structures such as internal organs, joints, muscles or bones
  3. Inability to participate in the study, in the opinion of the investigator, because of, for example, severe brain damage, language barrier, dementia, or other clinically significant or unstable conditions
  4. Subjects using adjuvant chemotherapy or radiotherapy; adjuvant therapies must have been finished at least 4 weeks prior to the run-in period (Day -14)
  5. Creatinine clearance <60 mL/min using the Cockcroft-Gault formula
  6. White blood cell count <2500/mm³; neutrophil count <1500/mm³; platelet count <100 x 103/mm³
  7. Heart rate <50 or >100 beats per minute; systolic blood pressure <100 or >140 mmHg; diastolic blood pressure <50 or >90 mmHg after 5 minutes rest in supine position
  8. A history of multiple drug allergies
  9. History or presence of alcohol or drug abuse
  10. Subjects using strong opioids (e.g. a Morphine Equivalent Dose [MED] >80 mg/day)
  11. Positive test for drugs of abuse at Day -7
  12. Evidence of depression and/or a score of ≥11 on the HADS depression subscale
  13. Any clinically relevant psychiatric disease in the past 5 years which is likely to interfere with the conduct of the study
  14. History of any clinically relevant liver disease within the last 6 months, or episodic/chronic migraine, or kidney dysfunction or disease
  15. Clinically significant gastrointestinal conditions, likely interfering with the study medication, study procedures or the outcome of the study
  16. Positive test for human immunodeficiency virus (HIV)
  17. Positive test for hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), hepatitis C antibody and/or HIV1/HIV2 antibody at Screening
  18. Participation of subject in an interventional clinical study within 1 month or, if applicable, 5 half-lives of the IMP, whatever is longer, before Screening or during participation in this study
  19. Subjects who were previously enrolled in this clinical study and have taken study medication or terminated due to poor compliance
  20. Known hypersensitivity to the active substance or any of the excipients of the IMP or the rescue medication
  21. Subjects dependent (as an employee or relative) on the sponsor or investigator
  22. Subjects committed to an institution by virtue of an order issued either by the judicial or the administrative authorities
  23. Legal incapacity or limited legal capacity

Randomization criteria

  1. At least 5 daily pain assessments in the baseline week prior to randomization, with a mean score on the PI-NRS ≥4 and ≤9. Differences between the baseline daily pain scores on the PI-NRS must be ≤50%.
  2. For female subjects of childbearing potential: negative pregnancy test in urine on Day 1.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: AP-325
25 mg capsule for oral use, 4 capsules (100 mg) once daily in the morning before meals
Drug: AP-325
During the 10-day double-blind treatment period (Days 1 to 10), subjects will take 4 capsules of the IMP orally once daily in the morning before breakfast.
Placebo Comparator: Placebo
4 capsules once daily in the morning before meals
Drug: Placebo
During the 10-day double-blind treatment period (Days 1 to 10), subjects will take 4 capsules of the IMP orally once daily in the morning before breakfast.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change from Baseline to Day 10 in the 5-day average pain intensity score based on the Pain Intensity Numerical Rating Scale (PI-NRS; ranges from "no pain" = 0 to "the worst possible pain" = 10; the lower the score, the better the outcome)
Time Frame: Baseline to Day 10
The 5-day average pain intensity score based on the Pain Intensity Numerical Rating Scale (PI-NRS) will be assessed to investigate the efficacy of repeat oral dosing of AP-325
Baseline to Day 10

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Longitudinal analysis of the 5-day average PI-NRS score (ranges from "no pain" = 0 to "the worst possible pain" = 10; the lower the score, the better the outcome) over time from Baseline until Day 35
Time Frame: Baseline to Day 35
The 5-day average PI-NRS score will be assessed to investigate the long-lasting efficacy of repeat oral dosing of AP-325 on neuropathic pain over the entire study duration
Baseline to Day 35
Changes from Baseline in the 5-day average PI-NRS score (change can be in the range of 0 to 10; the bigger the change towards lower PI-NRS scores, the better the outcome) (from Baseline to Day 5, 15, 20, 25, 30 and 35)
Time Frame: Baseline to Day 5, 15, 20, 25, 30 and 35
The 5-day average PI-NRS score will be assessed
Baseline to Day 5, 15, 20, 25, 30 and 35
Responder rate: proportion of subjects who have a ≥30% reduction in the 5-day average PI-NRS score (in the range of 0 to 10; the bigger the change towards lower scores, the better the outcome) relative to Baseline (on Days 5, 10, 15, 25 and 35)
Time Frame: Baseline to Day 5, 10, 15, 25 and 35
The responder rate will be compared between treatments on Day 5, 10, 15, 25 and 35
Baseline to Day 5, 10, 15, 25 and 35
Responder rate: proportion of subjects who have a ≥50% reduction in the 5-day average PI-NRS score (in the range of 0 to 10; the bigger the change towards lower scores, the better the outcome) relative to Baseline (on Days 5, 10, 15, 25 and 35)
Time Frame: Baseline to Day 5, 10, 15, 25 and 35
The responder rate will be compared between treatments on Day 5, 10, 15, 25 and 35
Baseline to Day 5, 10, 15, 25 and 35
Proportion of subjects who "much improved" or "very much improved" relative to Baseline on the patient global impression of change (PGIC) on Days 3, 10, 15, and 36
Time Frame: Days 3, 10, 15, and 36
The PGIC will be dichotomized into treatment success (i.e. scoring 'much improved' or 'very much improved').
Days 3, 10, 15, and 36
Changes from Baseline in the neuropathic pain evaluation using the neuropathic pain symptom inventory (NPSI; ranges from "no pain" = 0 to "the worst possible pain" = 120; the lower the score, the better) questionnaire on Days 3, 10, 15, and 36
Time Frame: Baseline, Day 3, 10, 15 and 36
Neuropathic pain symptom inventory (NPSI) questionnaire to assess the neuropathic pain of the patients
Baseline, Day 3, 10, 15 and 36
Changes from Baseline in the 5-day average daily sleep interference scale (DSIS; ranges from "pain does not interfere with sleep" = 0 to "pain completely interferes with sleep" = 10) score (from Baseline to Day 5, 10, 15, 25 and 35)
Time Frame: Baseline to Day 5, 10, 15, 25 and 35
The 5-day average daily sleep interference scale (DSIS) score will be assessed
Baseline to Day 5, 10, 15, 25 and 35
Changes from Baseline in the anxiety and depression assessment using the hospital anxiety and depression scale (HADS; subscales range from 0 to 21, with higher values indicating higher anxiety or depression; the lower the score) on Days 10 and 36
Time Frame: Baseline, Day 10 and 36
The hospital anxiety and depression scale (HADS) to assess the anxiety and depression of the patients
Baseline, Day 10 and 36
Time to first use of rescue medication after randomization
Time Frame: A priori specification not possible, between Day 1 until Day 36
The time to first use of rescue medication after randomization will be analyzed
A priori specification not possible, between Day 1 until Day 36
Total amount of rescue medication use (in mg per day) after randomization
Time Frame: A priori specification not possible, between Day 1 until Day 36
The total amount of rescue medication (i.e. the total mg of rescue medication per day will be tabulated
A priori specification not possible, between Day 1 until Day 36
Proportion of subjects classified as treatment failure
Time Frame: A priori specification not possible, between Day1 and Day 36
Proportion of subjects classified as treatment failure at least once after randomization will be tabulated
A priori specification not possible, between Day1 and Day 36
Time to classification as treatment failure after randomization
Time Frame: A priori specification not possible, between Day1 and Day 36
Time to first classification as treatment failure after randomization will be analyzed
A priori specification not possible, between Day1 and Day 36
Incidence, severity and seriousness of treatment-emergent adverse events (TEAEs)
Time Frame: A priori specification not possible, between Day1 and Day 36
All TEAEs occurring during the clinical trial will be registered, documented and evaluated
A priori specification not possible, between Day1 and Day 36
Incidence of abnormal physical examinations
Time Frame: Baseline, Day 3, 10, 15 and 36
Abnormal physical examination results will be evaluated and reported as AEs
Baseline, Day 3, 10, 15 and 36
Changes from Baseline in vital signs: Systolic and diastolic blood pressure
Time Frame: Baseline, Day 1, 3, 10, 15 and 36
Systolic and diastolic blood pressure will be measured
Baseline, Day 1, 3, 10, 15 and 36
Changes from Baseline in vital signs: Heart rate
Time Frame: Baseline, Day 1, 3, 10, 15 and 36
Heart rate will be measured
Baseline, Day 1, 3, 10, 15 and 36
Changes from Baseline in vital signs: Respiratory rate
Time Frame: Baseline, Day 1, 3, 10, 15 and 36
Respiratory rate will be measured
Baseline, Day 1, 3, 10, 15 and 36
Changes from Baseline in vital signs: Aural body temperature
Time Frame: Baseline, Day 1, 3, 10, 15 and 36
Aural body temperature will be measured
Baseline, Day 1, 3, 10, 15 and 36
Incidence of abnormal laboratory test results
Time Frame: Baseline, Day 3, 10, 15 and 36
Abnormal laboratory test results will be evaluated
Baseline, Day 3, 10, 15 and 36
Incidence of abnormal ECG readings
Time Frame: Baseline, Day 3, 10 and 36
Abnormal 12 lead ECG readings will be evaluated
Baseline, Day 3, 10 and 36
Changes from Baseline in body weight
Time Frame: Baseline, Day 10 and 36
Body weight will be evaluated
Baseline, Day 10 and 36
Plasma concentrations of AP-325 at 1 hour post-dose on Days 1 and 10; pre-dose on Days 3 and 10; and on Day 36
Time Frame: Days 1, 3, 10 and 36
Plasma concentrations of AP-325 will be evaluated
Days 1, 3, 10 and 36
Accumulation of Ctrough from Day 3 to Day 10
Time Frame: Day 3 and 10
Plasma concentrations of AP-325 will be evaluated
Day 3 and 10
Correlation between Ctrough-ss (Day 10) and the change from Baseline to Day 10 in the 5-day average pain intensity score based on the PI-NRS
Time Frame: Baseline to Day 10
AP-325 concentration-effect relationships will be evaluated
Baseline to Day 10
Correlation between CYP2C9 genotype and the metabolism of AP-325 (optional)
Time Frame: Day 3
The effect of CYP2C9 polymorphisms (determined by CYP2C9 genotyping) on the plasma concentration of AP-325 will be evaluated
Day 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Algiax Pharmaceuticals GmbH

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
FGK Clinical Research GmbH

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Heike Rittner, Prof. Dr., Universitätsklinikum Würzburg, Interdisziplinäre Schmerzmedizin, Germany

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 22, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 4, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 4, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 29, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 10, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 12, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 16, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 15, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AP-325.04

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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