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ATX01 15% for Chemotherapy-induced Peripheral Neuropathy

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Hospital General Universitario Gregorio Maranon, Madrid, SpainChemotherapy-induced Peripheral NeuropathyATX01 10% - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial tests if ATX01 can help relieve chemotherapy-induced nerve pain in cancer survivors.

Eligible Conditions
  • Chemotherapy-induced Peripheral Neuropathy

Treatment Effectiveness

Effectiveness Progress

1 of 3

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BXQ-350
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Tetrodotoxin for injection

Study Objectives

1 Primary · 11 Secondary · Reporting Duration: 4 weeks, 8 weeks, 12 weeks

12 weeks
Limb structure
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)
Pain
Pain
4 weeks, 8 weeks
Limb structure
Week 12
Limb structure
Pain
Limb structure
Limb structure
Percentage of patients with at least "improved" on the Patient Global Impression of Change (PGI-C) at each visit
Limb structure
Up to 12 weeks
Use of rescue medication including the proportion of patients using rescue medication, the frequency, and amount used

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Similar Trials

1
thrombomodulin alfa
1
BXQ-350
2
Tetrodotoxin for injection

Trial Design

3 Treatment Groups

ATX01 15%
1 of 3
ATX01 10%
1 of 3
ATX01 Placebo
1 of 3

Experimental Treatment

Non-Treatment Group

240 Total Participants · 3 Treatment Groups

Primary Treatment: ATX01 15% · Has Placebo Group · Phase 2

ATX01 15%
Drug
Experimental Group · 1 Intervention: ATX01 15% · Intervention Types: Drug
ATX01 10%
Drug
Experimental Group · 1 Intervention: ATX01 10% · Intervention Types: Drug
ATX01 Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 4 weeks, 8 weeks, 12 weeks

Who is running the clinical trial?

AlgoTherapeutixLead Sponsor

Eligibility Criteria

Age 18+ · All Participants · 13 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have had nerve pain for at least 24 weeks before the screening.
You have pain in both of your hands or feet that is similar in intensity.
References

Frequently Asked Questions

Has ATX01 achieved regulatory authorization at the level of 10%?

"ATX01 10% was awarded a safety score of 2 on our internal scale due to the lack clinical data in Phase 2 trials that supports its efficacy." - Anonymous Online Contributor

Unverified Answer

Are individuals still being accepted to participate in this research?

"Affirmative. Clinicaltrials.gov states that this medical trial is currently accepting participants, with a first post date of January 1st 2023 and most recent update happening on 23rd Jan 2023. The study aims to enrol 240 people at 2 separate locations" - Anonymous Online Contributor

Unverified Answer

What is the current enrollment capacity of this clinical research trial?

"Affirmative, the clinical trial is currently seeking participants. Initially advertised on January 1st 2023 and most recently updated on January 23rd 2023, this study requires 240 enrollees from two separate locations." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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