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Efficacy and Safety of ATX01 in Adult Patients With CIPN (Chemotherapy-induced Peripheral Neuropathy) (ACT)

Primary Purpose

Chemotherapy-induced Peripheral Neuropathy

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
ATX01 10%
ATX01 15%
Placebo
Sponsored by
AlgoTherapeutix
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chemotherapy-induced Peripheral Neuropathy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria

  1. Male or female patients of 18 years and older.
  2. Patients having signed a written informed consent prior to any study-related procedure.
  3. Body mass index of 18 to 32 kg/m2 (inclusive).
  4. With an estimated life expectancy ≥6 months at study entry.
  5. Patients with painful sensory CIPN resulting from prior treatment of cancer with taxanes or platins. A diagnosis of CIPN should be supported by i) onset of pain in hands or feet after exposure to taxanes or platins, ii) presence of painful symptoms in a symmetrical stocking and/or glove distribution, AND iii) painful symptoms may be accompanied by nonpainful symptoms (eg, tingling/pins and needles intensity and numbness intensity).
  6. Patients who have stopped their chemotherapy treatment with taxanes or platins or any other neurotoxic chemotherapy for ≥24 weeks at the time of the screening visit.
  7. Patients with CIPN pain for ≥24 weeks at the time of the screening visit.
  8. Patients with a mean value of pain intensity ≥4 and ≤9 in target study extremities (left and right feet or left and right hands) on the 11 point NPRS at baseline.
  9. Patients with symmetrical stocking or glove distribution pain, NPRS (≤1 point difference) in the target study extremities at screening.
  10. Neuropathic Pain (DN4) score ≥4 in the target study extremities (hands or feet) at the screening visit
  11. Treatment naïve patients or patients in whom any prior CIPN treatment (except oral amitriptyline [AMT]) has not been modified during the 4 weeks preceding the screening visit and is planned to be maintained at the same regimen during the course of the study (prior treatment includes pharmacological and nonpharmacological treatments).
  12. Male patients should agree to use a condom along with another medically acceptable contraceptive method, where applicable according to local guidelines, if he is engaged in sexual activity with a woman of childbearing potential (WOCBP) from the day of the signature of the informed consent and up to 90 days after the End-of-Study (EoS) Visit. Male patients should agree not to donate sperm until 30 calendar days after the last dose of study drug.
  13. Females must comply with the following in order to be enrolled:

    1. WOCBP with negative serum pregnancy test results can be enrolled only if willing to use an acceptable contraceptive method, ie, oral contraceptives, patch contraceptives, injection contraceptives, implantable hormonal contraceptives, male condom with intravaginal spermicide, diaphragm or cervical cap with spermicide, vaginal contraceptive ring, intrauterine device or system, surgical sterilization (hysterectomy, bilateral oophorectomy, and/or bilateral salpingectomy), tubal ligation/occlusion, vasectomized partner, or sexual abstinence, if this is the patient's current practice, from at least 14 days prior to the screening visit and throughout the study and for at least 30 days after the completion of the study.
    2. Or surgically sterilized for at least 6 months.
    3. Or menopausal for at least 1 year.

Exclusion criteria

  1. Patients who are not compliant in completion of pain ratings during the screening period. Patients having <5 of 7 records of average pain intensity in the target study extremities from Day -7 to Day -1 will be excluded. If a patient misses records of 2 days out of 7 days, the patient will be included in the study; however, patients missing 3 or more days of records will be excluded from the study.
  2. Clinical evidence of a preexisting painful peripheral neuropathy resulting from another cause than chemotherapy, eg, diabetic neuropathy, posttraumatic neuropathy, carpal/tarsal tunnel syndrome, radiculopathy, spinal stenosis, brachial plexopathy, or other preexisting symptomatic neuropathy due to alcoholism, vitamin B deficiency, hypothyroidism, human immunodeficiency virus.
  3. Skin abnormality, irritation, or lesions of any type on the hands or feet (or only on the hands if the study drug is not applied on the feet and vice versa [only on the feet if the study drug is not applied on the hands]).
  4. Presence of glaucoma.
  5. Presence of urinary retention (or significant prostatic hypertrophy at risk of urinary retention).
  6. History of coronary artery disease.
  7. History and/or presence of major depressive episode. Patients with a medical history of bipolar disorder, alcohol abuse, or psychotic disorder are also excluded.
  8. Patients who are at significant risk of suicide, or are a danger to self or others, in the opinion of the investigator, based upon clinical interview and the Columbia-Suicide Severity Rating Scale (C SSRS) at screening and baseline. Affirmative answer to suicidal ideation questions 4 or 5, or suicidal behavior (actual attempt, interrupted attempt, aborted attempt, and/or preparatory acts/behavior) within the last 6 months is exclusionary.
  9. Pregnant or lactating women.
  10. Abnormality in the 12-lead electrocardiogram (ECG) at screening that in the opinion of the investigator increases the risk of participating in the study, such as a corrected QT Fridericia (QTcF) interval >430 msec for males or >450 msec for females.
  11. A history of additional risk factors for Torsade de Pointe (eg, heart failure, hypokalemia, family history of long QT syndrome).
  12. The use of concomitant medications within 24 weeks prior to Day 1 and/or during the study or the equivalent of 5 half-lives that prolong the QT/QTc interval, eg, Class 1 antiarrhythmics (eg, quinidine, disopyramide, procainamide) and Class 3 antiarrhythmics (eg, amiodarone, sotalol), antihistamines, antipsychotics known to prolong QT interval, and antimalarials (eg, mefloquine, quinine), tricyclic antidepressants (eg, AMT), tetracyclic antidepressants (eg, maprotiline), cisapride.
  13. The use of monoamine oxidase inhibitors within 24 weeks (or the equivalent of 5 half-lives) prior to Day 1 and/or during the study.
  14. The use of opioids within 4 weeks (or the equivalent of 5 half lives) prior to Day 1 and/or during the study.
  15. History of illicit drug use or confirmed drugs of abuse at screening. Positive urine drug screen for prescribed medication is allowed at the discretion of the investigator.
  16. Patients likely to require neurotoxic chemotherapy treatment or any other treatment during the study, which may interfere with compliance to the protocol, ability to complete the study and study assessments except treatments authorized in inclusion criterion #11.
  17. Failure to respond to more than 2 analgesics (regardless of the route of administration) from different drug classes (including antidepressants and anticonvulsants) due to lack of efficacy or intolerability to treat CIPN at any time in the past.
  18. Treatment with oral or topical AMT or nortriptyline in the past 4 weeks.
  19. Any known hypersensitivity to AMT (regardless of the route of administration) in any salt form or to any constituent of the topical formulation.
  20. Any contraindication to the use of acetaminophen/paracetamol.
  21. Use of glutathione, vitamin E, minocycline, or calcium magnesium supplements within 12 weeks of screening.
  22. Any topical treatment on treated extremities for any indication, other than cosmetic use of creams and lotions, within the previous 12 weeks.
  23. Any topical treatment for pain including use of:

    1. over-the-counter capsaicin on extremities within 12 weeks of screening,
    2. and/or Qutenza within 24 weeks of screening,
    3. and/or nonsteroidal anti-inflammatory drugs, menthol, methyl salicylate, local anesthetics within 1 week of screening.
  24. Poor metabolizer for cytochrome P450 CYP2D6.
  25. Intake in the 4 weeks preceding the screening visit of any strong inhibitor of cytochrome P450 CYP2D6.
  26. Treatment with an investigational drug in the previous 4 weeks or greater, according to local requirements.
  27. Any condition that the investigator feels would place the patient at increased risk if the investigational therapy is initiated, such as, but not limited to, hyperthyroidism, convulsive disorder, advanced hepatic disease, pylorus, stenosis, or paralytic ileus.
  28. The investigator considers the patient unfit for the study as a result of the medical interview, physical examination, or screening investigations, in particular any status or disease making the patient unable to follow instructions.
  29. The patient is unable to apply the study drug on hands or feet.
  30. The patient is an employee of the investigator, study site, sponsor, or CRO with direct involvement in the proposed study or other studies under the direction of the investigator, study site, or sponsor, or a family member of the site employee or the investigator.

Sites / Locations

  • South Lake Pain InstituteRecruiting
  • MGM Medical Care Research & Rehab, LLCRecruiting
  • Medsol Clinical Research Center, IncRecruiting
  • Accel Research Sites - Neurostudies
  • Neuroscience Research Center, LLC.Recruiting
  • The Center for Cancer and Blood Disorders (CCBD)Recruiting
  • University of Rochester Medical CenterRecruiting
  • OLV Hospital Aalst: gastro-enterologieRecruiting
  • Universitair Ziekenhuis AntwerpenRecruiting
  • Universitair Ziekenhuis Gent (UZ Gent)Recruiting
  • AZ Sint-Maarten MechelenRecruiting
  • UZ Leuven / Campus Pellenberg / Pain CenterRecruiting
  • CHU UCL Namur - site GodinneRecruiting
  • Clinitrial s.r.o.Recruiting
  • Univerzita Karlova v Praze - Vseobecna Fakultni Nemocnice v Praze (VFN)Recruiting
  • Praglandia s.r.o.Recruiting
  • Nemocnice TepliceRecruiting
  • Centre Hospitalier de la Côte BasqueRecruiting
  • Institute BergonieRecruiting
  • Groupe Hospitalier Paris Saint JosephRecruiting
  • Hopital Cochin
  • CHU POITIERS, Hépato-Gastro EntérologieRecruiting
  • GODINOT InstituteRecruiting
  • Strasbourg Oncologie LiberaleRecruiting
  • Hôpital Foch
  • Istituto Scientifico Romagnolo per lo Studio e La cura dei Tumori Srl (IRST)Recruiting
  • Fondazione IRCCS Ca' Granda Ospedale -. Maggiore PoliclinicoRecruiting
  • ASST Monza - Ospedale S. Gerardo di MonzaRecruiting
  • Fondazione IRCCS Policlinico San Matteo - Universita degli Studi di PaviaRecruiting
  • Azienda Ospedaliera San Camillo-ForlaniniRecruiting
  • Przychodnia Lekarska "Komed" Roman Karaszewski Oddzial Chemioterapii Jednego DniaRecruiting
  • Niepubliczny Zaklad Opieki Zdrowotnej Poradnia Leczenia Bolu PrzewleklegoRecruiting
  • Instytut "Centrum Zdrowia Matki Polki" Klinika Onkologii
  • Hospital de la Santa Creu I de Sant PauRecruiting
  • Hospital Universitari de BellvitgeRecruiting
  • Hospital Universitario Reina SofiaRecruiting
  • Complejo Hospitalarion de JaenRecruiting
  • Hospital General Universitario Gregorio MaranonRecruiting
  • Hospital Ruber InternacionalRecruiting
  • Hospital Universitario La Paz (HULP), Servicio de Oncologia Medica
  • Madrid Sanchinarro HospitalRecruiting
  • Hospital Universitari Sant Joan de ReusRecruiting
  • Hospital Universitario Mutua de Terrassa
  • Unidad de Investigacion Clinica FINCIVORecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

ATX01 10%

ATX01 15%

ATX01 Placebo

Arm Description

A bottle of hydrogel formulation containing 10% amitriptyline hydrochloride w/w for topical use on the hands and/or feet, morning and night for 3 months.

A bottle of hydrogel formulation containing 15% amitriptyline hydrochloride w/w for topical use on the hands and/or feet, morning and night for 3 months.

A bottle of hydrogel formulation containing no active ingredient, for topical use on the hands and/or feet, morning and night for 3 months.

Outcomes

Primary Outcome Measures

Change from baseline to Week 12 in the weekly mean of the daily NPRS score assessing average pain intensity in target study extremities related to CIPN in the past 24 hours.

Secondary Outcome Measures

Percentage of patients achieving ≥30% pain reduction from baseline in the weekly mean NPRS average pain intensity related to CIPN at Week 12
Percentage of patients achieving ≥50% pain reduction from baseline in the weekly mean NPRS average pain intensity related to CIPN at Week 12.
Mean change from baseline to each visit in tingling/pins and needles intensity and numbness intensity in target study extremities as measured by the numerical rating scale (NRS) assessing each symptom
Proportion of patients achieving various percentages of reduction in average pain intensity in target study extremities (cumulative responder curve) throughout the study.
Proportion of patients achieving various percentages of reduction in worst pain intensity in target study extremities (cumulative responder curve) throughout the study.
Change from baseline to Week 4 and 8 in the weekly mean of the daily NPRS score assessing average pain intensity in target study extremities related to CIPN in the past 24 hours
Change from baseline to each visit in the weekly mean of the daily NPRS assessing worst pain intensity in target study extremities related to CIPN in the past 24 hours
Percentage of patients with at least "improved" on the Patient Global Impression of Change (PGI-C) at each visit
Mean change from baseline to each visit in pain interference with daily life using the Brief Pain Inventory Short Form questionnaire (BPI-SF item 9 only)
Mean change from baseline to each visit in the calculated mean NPRS average pain intensity in the nontarget study extremities
Mean change from baseline to Week 12 in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-CIPN 20-item scale (EORTC QLQ CIPN20)
Use of rescue medication including the proportion of patients using rescue medication, the frequency, and amount used

Full Information

First Posted
October 21, 2022
Last Updated
October 18, 2023
Sponsor
AlgoTherapeutix
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1. Study Identification

Unique Protocol Identification Number
NCT05593614
Brief Title
Efficacy and Safety of ATX01 in Adult Patients With CIPN (Chemotherapy-induced Peripheral Neuropathy)
Acronym
ACT
Official Title
A Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, Phase 2 Study to Assess the Efficacy and Safety of ATX01 (Topical Amitriptyline Hydrochloride 10% and 15% w/w) in Comparison to Placebo, in Cancer Survivor Adult Patients With Chemotherapy-induced Peripheral Neuropathy (CIPN)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 28, 2023 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AlgoTherapeutix

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this clinical trial is to compare the efficacy of twice daily applications of ATX01 (10% & 15%) versus placebo during a 12-week treatment period in treating chemotherapy-induced peripheral neuropathy (CIPN) in adult cancer survivor patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chemotherapy-induced Peripheral Neuropathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ATX01 10%
Arm Type
Experimental
Arm Description
A bottle of hydrogel formulation containing 10% amitriptyline hydrochloride w/w for topical use on the hands and/or feet, morning and night for 3 months.
Arm Title
ATX01 15%
Arm Type
Experimental
Arm Description
A bottle of hydrogel formulation containing 15% amitriptyline hydrochloride w/w for topical use on the hands and/or feet, morning and night for 3 months.
Arm Title
ATX01 Placebo
Arm Type
Placebo Comparator
Arm Description
A bottle of hydrogel formulation containing no active ingredient, for topical use on the hands and/or feet, morning and night for 3 months.
Intervention Type
Drug
Intervention Name(s)
ATX01 10%
Intervention Description
A 100 mL bottle of hydrogel formulation containing 10% amitriptyline hydrochloride w/w
Intervention Type
Drug
Intervention Name(s)
ATX01 15%
Intervention Description
A 100 mL bottle of hydrogel formulation containing 15% amitriptyline hydrochloride w/w
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
A 100 mL bottle of hydrogel formulation containing no active substance
Primary Outcome Measure Information:
Title
Change from baseline to Week 12 in the weekly mean of the daily NPRS score assessing average pain intensity in target study extremities related to CIPN in the past 24 hours.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Percentage of patients achieving ≥30% pain reduction from baseline in the weekly mean NPRS average pain intensity related to CIPN at Week 12
Time Frame
12 weeks
Title
Percentage of patients achieving ≥50% pain reduction from baseline in the weekly mean NPRS average pain intensity related to CIPN at Week 12.
Time Frame
12 weeks
Title
Mean change from baseline to each visit in tingling/pins and needles intensity and numbness intensity in target study extremities as measured by the numerical rating scale (NRS) assessing each symptom
Time Frame
4 weeks, 8 weeks, 12 weeks
Title
Proportion of patients achieving various percentages of reduction in average pain intensity in target study extremities (cumulative responder curve) throughout the study.
Time Frame
4 weeks, 8 weeks, 12 weeks
Title
Proportion of patients achieving various percentages of reduction in worst pain intensity in target study extremities (cumulative responder curve) throughout the study.
Time Frame
4 weeks, 8 weeks, 12 weeks
Title
Change from baseline to Week 4 and 8 in the weekly mean of the daily NPRS score assessing average pain intensity in target study extremities related to CIPN in the past 24 hours
Time Frame
4 weeks, 8 weeks
Title
Change from baseline to each visit in the weekly mean of the daily NPRS assessing worst pain intensity in target study extremities related to CIPN in the past 24 hours
Time Frame
4 weeks, 8 weeks, 12 weeks
Title
Percentage of patients with at least "improved" on the Patient Global Impression of Change (PGI-C) at each visit
Time Frame
4 weeks, 8 weeks, 12 weeks
Title
Mean change from baseline to each visit in pain interference with daily life using the Brief Pain Inventory Short Form questionnaire (BPI-SF item 9 only)
Time Frame
4 weeks, 8 weeks, 12 weeks
Title
Mean change from baseline to each visit in the calculated mean NPRS average pain intensity in the nontarget study extremities
Time Frame
4 weeks, 8 weeks, 12 weeks
Title
Mean change from baseline to Week 12 in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-CIPN 20-item scale (EORTC QLQ CIPN20)
Time Frame
12 weeks
Title
Use of rescue medication including the proportion of patients using rescue medication, the frequency, and amount used
Time Frame
Up to 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria Male or female patients of 18 years and older. Patients having signed a written informed consent prior to any study-related procedure. Body mass index of 18 to 35 kg/m2 (inclusive). With an estimated life expectancy ≥6 months at study entry. Patients with painful sensory CIPN resulting from prior treatment of cancer with taxanes or platins. A diagnosis of CIPN should be supported by i) onset of pain in hands or feet after exposure to taxanes or platins, ii) presence of painful symptoms in a symmetrical stocking and/or glove distribution, AND iii) painful symptoms may be accompanied by nonpainful symptoms (eg, tingling/pins and needles intensity and numbness intensity). Patients who have stopped their chemotherapy treatment with taxanes or platins or any other neurotoxic chemotherapy for ≥24 weeks at the time of the screening visit. Patients with CIPN pain for ≥24 weeks at the time of the screening visit. Patients with a mean value of pain intensity ≥4 and ≤9 in target study extremities (left and right feet or left and right hands) on the 11 point NPRS at baseline. Non target extremities can be treated regardless of the pain intensity. Patients with symmetrical stocking or glove distribution pain, NPRS (≤1 point difference) in the target study extremities at screening. Neuropathic Pain (DN4) score ≥4 in the target study extremities (hands or feet) at the screening visit Treatment naïve patients or patients in whom any prior CIPN treatment (except oral amitriptyline [AMT]) has not been modified during the 4 weeks preceding the screening visit and is planned to be maintained at the same regimen during the course of the study (prior treatment includes pharmacological and nonpharmacological treatments). Male patients should agree to use a condom along with another medically acceptable contraceptive method, where applicable according to local guidelines, if he is engaged in sexual activity with a woman of childbearing potential (WOCBP) from the day of the signature of the informed consent and up to 90 days after the End-of-Study (EoS) Visit. Male patients should agree not to donate sperm until 30 calendar days after the last dose of study drug. Females must comply with the following in order to be enrolled: WOCBP with negative serum pregnancy test results can be enrolled only if willing to use an acceptable contraceptive method, ie, oral contraceptives, patch contraceptives, injection contraceptives, implantable hormonal contraceptives, male condom with intravaginal spermicide, diaphragm or cervical cap with spermicide, vaginal contraceptive ring, intrauterine device or system, surgical sterilization (hysterectomy, bilateral oophorectomy, and/or bilateral salpingectomy), tubal ligation/occlusion, vasectomized partner, or sexual abstinence, if this is the patient's current practice, from at least 14 days prior to the screening visit and throughout the study and for at least 30 days after the completion of the study. Or surgically sterilized for at least 6 months. Or menopausal for at least 1 year. Exclusion criteria Patients who are not compliant in completion of pain ratings during the screening period. Patients having <5 of 7 records of average pain intensity in the target study extremities from Day -7 to Day -1 will be excluded. If a patient misses records of 2 days out of 7 days, the patient will be included in the study; however, patients missing 3 or more days of records will be excluded from the study. Clinical evidence of a preexisting painful peripheral neuropathy resulting from another cause than chemotherapy, eg, diabetic neuropathy, posttraumatic neuropathy, carpal/tarsal tunnel syndrome, radiculopathy, spinal stenosis, brachial plexopathy, or other preexisting symptomatic neuropathy due to alcoholism, vitamin B deficiency, hypothyroidism, human immunodeficiency virus. Patients may be included in the study, providing that pain appeared after chemotherapy, while other non-painful symptoms could have been present before start of chemotherapy. Skin irritation, or lesions (eg open skin wounds, infections, inflammations, or exfoliative dermatitis) of any type on the hands or feet (or only on the hands if the study drug is not applied on the feet and vice versa [only on the feet if the study drug is not applied on the hands]). Presence of glaucoma. Presence of urinary retention (or significant prostatic hypertrophy at risk of urinary retention). Angina or myocardial infarction in the year preceding screening visit. History and/or presence of major depressive episode. Patients with a medical history of bipolar disorder, alcohol abuse, or psychotic disorder are also excluded. Patients who are at significant risk of suicide, or are a danger to self or others, in the opinion of the investigator, based upon clinical interview and the C-SSRS at screening and baseline. Affirmative answer to suicidal ideation questions 4 or 5 within the last 6 months and / or suicidal behavior (actual attempt, interrupted attempt, aborted attempt, and/or preparatory acts/behavior) within the last 2 years are exclusionary. Pregnant or lactating women. Abnormality in the 12-lead electrocardiogram (ECG) at screening that in the opinion of the investigator increases the risk of participating in the study, such as a corrected QT Fridericia (QTcF) interval >430 msec for males or >450 msec for females. A history of additional risk factors for Torsade de Pointe (eg, heart failure, hypokalemia, family history of long QT syndrome). The use of concomitant medications within 24 weeks prior to Day 1 and/or during the study or the equivalent of 5 half-lives that prolong the QT/QTc interval, eg, Class 1 antiarrhythmics (eg, quinidine, disopyramide, procainamide) and Class 3 antiarrhythmics (eg, amiodarone, sotalol), first generation antihistamines (such as diphenhydramine, hydroxyzine, astemizole, terfenadine, and ebastine), antipsychotics known to prolong QT interval, and antimalarials (eg, mefloquine, quinine), tricyclic antidepressants (eg, AMT), tetracyclic antidepressants (eg, maprotiline), cisapride. The use of monoamine oxidase inhibitors within 24 weeks (or the equivalent of 5 half-lives) prior to Day 1 and/or during the study. The use of opioids within 4 weeks (or the equivalent of 5 half lives) prior to Day 1 and/or during the study. History of illicit drug use or confirmed drugs of abuse at screening. Positive urine drug screen for prescribed medication is allowed at the discretion of the investigator. Patients likely to require neurotoxic chemotherapy treatment or any other treatment during the study, which may interfere with compliance to the protocol, ability to complete the study and study assessments except treatments authorized in inclusion criterion #11. Failure to respond to more than 2 analgesics (regardless of the route of administration) from different drug classes (including antidepressants and anticonvulsants) due to lack of efficacy to treat CIPN at any time in the past. The definition of failure to respond is left to the investigator's judgement and should be understood as exclusion of patients who are non-responding to more than 2 analgesics thought to be effective for neuropathic pain that were used at therapeutic doses in the 6 months prior to screening visit. Treatment with oral or topical AMT or nortriptyline in the past 4 weeks prior to baseline visit. Any known hypersensitivity to AMT (regardless of the route of administration) in any salt form or to any constituent of the topical formulation. Any contraindication to the use of acetaminophen/paracetamol. Use of glutathione, vitamin E, or minocycline within 12 weeks of screening. Any topical treatment on treated extremities for any indication, other than cosmetic use of creams and lotions, within the previous 12 weeks prior to Baseline visit. Any topical treatment for pain on extremities including use of: over-the-counter capsaicin on extremities within 2 weeks of Baseline visit, and/or Qutenza within 12 weeks of Baseline visit, and/or nonsteroidal anti-inflammatory drugs, menthol, methyl salicylate, local anesthetics within 1 week of screening. Poor metabolizer for cytochrome P450 CYP2D6. Intake in the 4 weeks preceding the screening visit of any strong inhibitor of cytochrome P450 CYP2D6. Treatment with an investigational drug in the previous 4 weeks or greater prior to Baseline visit, according to local requirements. Any condition that the investigator feels would place the patient at increased risk if the investigational therapy is initiated, such as, but not limited to, hyperthyroidism, convulsive disorder, advanced hepatic disease, pylorus, stenosis, or paralytic ileus. The investigator considers the patient unfit for the study as a result of the medical interview, physical examination, or screening investigations, in particular any status or disease making the patient unable to follow instructions. The patient is unable to apply the study drug on hands or feet. The patient is an employee of the investigator, study site, sponsor, or CRO with direct involvement in the proposed study or other studies under the direction of the investigator, study site, or sponsor, or a family member of the site employee or the investigator.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
AlgoTherapeutix
Phone
+33145388600
Email
CIPN@algotx.com
Facility Information:
Facility Name
South Lake Pain Institute
City
Clermont
State/Province
Florida
ZIP/Postal Code
34711
Country
United States
Individual Site Status
Recruiting
Facility Name
MGM Medical Care Research & Rehab, LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Individual Site Status
Recruiting
Facility Name
Medsol Clinical Research Center, Inc
City
Port Charlotte
State/Province
Florida
ZIP/Postal Code
33952
Country
United States
Individual Site Status
Recruiting
Facility Name
Accel Research Sites - Neurostudies
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30030
Country
United States
Individual Site Status
Withdrawn
Facility Name
Neuroscience Research Center, LLC.
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66210
Country
United States
Individual Site Status
Recruiting
Facility Name
The Center for Cancer and Blood Disorders (CCBD)
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20817
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Individual Site Status
Recruiting
Facility Name
OLV Hospital Aalst: gastro-enterologie
City
Aalst
ZIP/Postal Code
9300
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Universitair Ziekenhuis Antwerpen
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Universitair Ziekenhuis Gent (UZ Gent)
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
AZ Sint-Maarten Mechelen
City
Mechelen
ZIP/Postal Code
2800
Country
Belgium
Individual Site Status
Recruiting
Facility Name
UZ Leuven / Campus Pellenberg / Pain Center
City
Pellenberg
ZIP/Postal Code
3212
Country
Belgium
Individual Site Status
Recruiting
Facility Name
CHU UCL Namur - site Godinne
City
Yvoir
ZIP/Postal Code
5530
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Clinitrial s.r.o.
City
Prague
ZIP/Postal Code
10000
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Univerzita Karlova v Praze - Vseobecna Fakultni Nemocnice v Praze (VFN)
City
Prague
ZIP/Postal Code
12800
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Praglandia s.r.o.
City
Prague
ZIP/Postal Code
15000
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Nemocnice Teplice
City
Teplice
ZIP/Postal Code
41529
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Centre Hospitalier de la Côte Basque
City
Bayonne
ZIP/Postal Code
64100
Country
France
Individual Site Status
Recruiting
Facility Name
Institute Bergonie
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Individual Site Status
Recruiting
Facility Name
Groupe Hospitalier Paris Saint Joseph
City
Paris
ZIP/Postal Code
75014
Country
France
Individual Site Status
Recruiting
Facility Name
Hopital Cochin
City
Paris
ZIP/Postal Code
75014
Country
France
Individual Site Status
Active, not recruiting
Facility Name
CHU POITIERS, Hépato-Gastro Entérologie
City
Poitiers
ZIP/Postal Code
86021
Country
France
Individual Site Status
Recruiting
Facility Name
GODINOT Institute
City
Reims
ZIP/Postal Code
51100
Country
France
Individual Site Status
Recruiting
Facility Name
Strasbourg Oncologie Liberale
City
Strasbourg
ZIP/Postal Code
67000
Country
France
Individual Site Status
Recruiting
Facility Name
Hôpital Foch
City
Suresnes
ZIP/Postal Code
92150
Country
France
Individual Site Status
Active, not recruiting
Facility Name
Istituto Scientifico Romagnolo per lo Studio e La cura dei Tumori Srl (IRST)
City
Meldola
ZIP/Postal Code
47014
Country
Italy
Individual Site Status
Recruiting
Facility Name
Fondazione IRCCS Ca' Granda Ospedale -. Maggiore Policlinico
City
Milan
ZIP/Postal Code
20122
Country
Italy
Individual Site Status
Recruiting
Facility Name
ASST Monza - Ospedale S. Gerardo di Monza
City
Monza
ZIP/Postal Code
20900
Country
Italy
Individual Site Status
Recruiting
Facility Name
Fondazione IRCCS Policlinico San Matteo - Universita degli Studi di Pavia
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Ospedaliera San Camillo-Forlanini
City
Roma
ZIP/Postal Code
00152
Country
Italy
Individual Site Status
Recruiting
Facility Name
Przychodnia Lekarska "Komed" Roman Karaszewski Oddzial Chemioterapii Jednego Dnia
City
Konin
ZIP/Postal Code
62500
Country
Poland
Individual Site Status
Recruiting
Facility Name
Niepubliczny Zaklad Opieki Zdrowotnej Poradnia Leczenia Bolu Przewleklego
City
Tychy
ZIP/Postal Code
43100
Country
Poland
Individual Site Status
Recruiting
Facility Name
Instytut "Centrum Zdrowia Matki Polki" Klinika Onkologii
City
Łódź
ZIP/Postal Code
93338
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
Hospital de la Santa Creu I de Sant Pau
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitari de Bellvitge
City
Barcelona
ZIP/Postal Code
08907
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Reina Sofia
City
Córdoba
ZIP/Postal Code
14004
Country
Spain
Individual Site Status
Recruiting
Facility Name
Complejo Hospitalarion de Jaen
City
Jaén
ZIP/Postal Code
23007
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital General Universitario Gregorio Maranon
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Ruber Internacional
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario La Paz (HULP), Servicio de Oncologia Medica
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Individual Site Status
Withdrawn
Facility Name
Madrid Sanchinarro Hospital
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitari Sant Joan de Reus
City
Reus
ZIP/Postal Code
43204
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Mutua de Terrassa
City
Terrassa
ZIP/Postal Code
08221
Country
Spain
Individual Site Status
Withdrawn
Facility Name
Unidad de Investigacion Clinica FINCIVO
City
Valencia
ZIP/Postal Code
46009
Country
Spain
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

Efficacy and Safety of ATX01 in Adult Patients With CIPN (Chemotherapy-induced Peripheral Neuropathy)

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