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Chemotherapy-induced Peripheral NeuropathyPhase 2ACTNCT05593614

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

A Phase 2 study testing ATX01 10% and ATX01 15% in people with Chemotherapy-induced Peripheral Neuropathy, run by AlgoTherapeutix at 43 sites in 7 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
ATX01 10% and ATX01 15%
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
276 participants
Where
43 sitesin 7 countries
Study dates
28 Feb 2023to Sep 2024
Phase
Phase 2
Are there results?
Not yet: the study is under way

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

43 sites in 7 countries.

43 sites in 7 countries

Spain9 sites

  • Hospital de la Santa Creu I de Sant Pau

    Barcelona, 08041

  • Hospital Universitari de Bellvitge

    Barcelona, 08907

  • Hospital Universitario Reina Sofia

    Córdoba, 14004

  • Complejo Hospitalarion de Jaen

    Jaén, 23007

  • Hospital General Universitario Gregorio Maranon

    Madrid, 28007

  • Hospital Ruber Internacional

    Madrid, 28034

  • Madrid Sanchinarro Hospital

    Madrid, 28050

  • Hospital Universitari Sant Joan de Reus

    Reus, 43204

  • Unidad de Investigacion Clinica FINCIVO

    Valencia, 46009

Other trials in Spain

United States8 sites

  • HD Research

    Bellaire, Texas, 77401

  • The Center for Cancer and Blood Disorders (CCBD)

    Bethesda, Maryland, 20817

  • South Lake Pain Institute

    Clermont, Florida, 34711

  • MGM Medical Care Research & Rehab, LLC

    Miami, Florida, 33173

  • Neuroscience Research Center, LLC.

    Overland Park, Kansas, 66210

  • Medsol Clinical Research Center, Inc

    Port Charlotte, Florida, 33952

  • University of Rochester Medical Center

    Rochester, New York, 14642

  • Knight Neurology - Clinical Research

    Rockledge, Florida, 32955

Other trials in United States

France8 sites

  • Centre Hospitalier de la Côte Basque

    Bayonne, 64100

  • Institute Bergonie

    Bordeaux, 33076

  • CHU de Montpellier, Hôpital Saint Eloi

    Montpellier, 34295

  • Groupe Hospitalier Paris Saint Joseph

    Paris, 75014

  • CHU POITIERS, Hépato-Gastro Entérologie

    Poitiers, 86021

  • GODINOT Institute

    Reims, 51100

  • Strasbourg Oncologie Liberale

    Strasbourg, 67000

  • Hôpital Foch

    Suresnes, 92150

Other trials in France

Italy6 sites

  • Gemelli Molise S.p.a.

    Campobasso, 86100

  • Istituto Scientifico Romagnolo per lo Studio e La cura dei Tumori Srl (IRST)

    Meldola, 47014

  • Fondazione IRCCS Ca' Granda Ospedale -. Maggiore Policlinico

    Milan, 20122

  • ASST Monza - Ospedale S. Gerardo di Monza

    Monza, 20900

  • Fondazione IRCCS Policlinico San Matteo - Universita degli Studi di Pavia

    Pavia, 27100

  • Azienda Ospedaliera San Camillo-Forlanini

    Roma, 00152

Other trials in Italy

Belgium5 sites

  • OLV Hospital Aalst: gastro-enterologie

    Aalst, 9300

  • Universitair Ziekenhuis Antwerpen

    Edegem, 2650

  • Universitair Ziekenhuis Gent (UZ Gent)

    Ghent, 9000

  • UZ Leuven / Campus Pellenberg / Pain Center

    Pellenberg, 3212

  • CHU UCL Namur - site Godinne

    Yvoir, 5530

Other trials in Belgium

Poland4 sites

  • Przychodnia Lekarska "Komed" Roman Karaszewski Oddzial Chemioterapii Jednego Dnia

    Konin, 62500

  • Instytut "Centrum Zdrowia Matki Polki" Klinika Onkologii

    Lodz, 93338

  • Niepubliczny Zaklad Opieki Zdrowotnej Poradnia Leczenia Bolu Przewleklego

    Tychy, 43100

  • ClinHouse sp z o.o. - ClinHouse Centrum Medyczne

    Zabrze, 41807

Other trials in Poland

Czechia3 sites

  • Clinitrial s.r.o.

    Prague, 10000

  • Praglandia s.r.o.

    Prague, 15000

  • Nemocnice Teplice

    Teplice, 41529

Other trials in Czechia

About this study

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)

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.

Being tested
ATX01 10%, ATX01 15%, Placebo

What participants receive

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

  • ATX01 10%Drug

    A 100 mL bottle of hydrogel formulation containing 10% amitriptyline hydrochloride w/w

  • ATX01 15%Drug

    A 100 mL bottle of hydrogel formulation containing 15% amitriptyline hydrochloride w/w

  • PlaceboDrug

    A 100 mL bottle of hydrogel formulation containing no active substance

Study groups in NCT05593614
Study groupRoleWhat they receive
ATX01 10%ExperimentalA 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.
Receives: Drug: ATX01 10%
ATX01 15%ExperimentalA 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.
Receives: Drug: ATX01 15%
ATX01 PlaceboPlacebo comparatorA bottle of hydrogel formulation containing no active ingredient, for topical use on the hands and/or feet, morning and night for 3 months.
Receives: Drug: Placebo

What is being measured

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

  1. 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.

    Measured: 12 weeks

Secondary outcomes (12)

  1. Percentage of patients achieving ≥30% pain reduction from baseline in the weekly mean NPRS average pain intensity related to CIPN at Week 12

    Measured: 12 weeks

  2. Percentage of patients achieving ≥50% pain reduction from baseline in the weekly mean NPRS average pain intensity related to CIPN at Week 12.

    Measured: 12 weeks

  3. 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

    Measured: 4 weeks, 8 weeks, 12 weeks

  4. Proportion of patients achieving various percentages of reduction in average pain intensity in target study extremities (cumulative responder curve) throughout the study.

    Measured: 4 weeks, 8 weeks, 12 weeks

  5. Proportion of patients achieving various percentages of reduction in worst pain intensity in target study extremities (cumulative responder curve) throughout the study.

    Measured: 4 weeks, 8 weeks, 12 weeks

  6. 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

    Measured: 4 weeks, 8 weeks

  7. 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

    Measured: 4 weeks, 8 weeks, 12 weeks

  8. Percentage of patients with at least "improved" on the Patient Global Impression of Change (PGI-C) at each visit

    Measured: 4 weeks, 8 weeks, 12 weeks

  9. 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)

    Measured: 4 weeks, 8 weeks, 12 weeks

  10. Mean change from baseline to each visit in the calculated mean NPRS average pain intensity in the nontarget study extremities

    Measured: 4 weeks, 8 weeks, 12 weeks

  11. 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)

    Measured: 12 weeks

  12. Use of rescue medication including the proportion of patients using rescue medication, the frequency, and amount used

    Measured: Up to 12 weeks

Timeline

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

  1. First posted25 Oct 2022
  2. Study start28 Feb 2023
  3. Primary completionSep 2024 (estimated)
  4. Study completionSep 2024 (estimated)

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
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
276 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05593614
Sponsor's protocol ID
ATX01-22-01-CIPN
Other IDs
2022-000435-23
Acronym
ACT
Status last verified
Jan 2024
First submitted
21 Oct 2022
Last updated
16 Jul 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ATX01 10% and ATX01 15% in people with Chemotherapy-induced Peripheral Neuropathy, run by AlgoTherapeutix at 43 sites in 7 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 16 inclusion and 33 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: under way, not looking for participants, as of the sponsor's last update on 16 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 43 sites in Spain, United States, France, Italy, Belgium and 2 more countries. 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 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.

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

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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 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). 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 NCT05593614.

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 16 Jul 2024.

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