- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05834231
Efficacy of Memantine in Prevention of Oxaliplatin-induced Peripheral Neurotoxicity
April 17, 2023 updated by: Noha Mansour, Mansoura University
Memantine is a drug for the management of Alzheimer's Disease (AD) due to its promising neuroprotective properties.
We hypothesize that Memantine possesses a beneficial role against chemotherapy-induced neuronal damages.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
60
Phase
- Phase 2
- Phase 1
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
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
histologically confirmed diagnosis of stage III colorectal cancer performance status < 2 according to Eastern Cooperative Oncology Group (ECOG) score adequate renal function (glomerular filtration rate ≥ 90)
Exclusion Criteria:
preexisting neuropathic or brain disorders, a previous use of chemotherapeutic agents including oxaliplatin use of drugs reported to have neuroprotective role
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: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Control
|
oral
|
Active Comparator: Intervention
|
oral
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence of chemotherapy induced-peripheral neuropathy using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) criteria
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 (Anticipated)
August 1, 2023
Primary Completion (Anticipated)
March 1, 2024
Study Completion (Anticipated)
October 1, 2024
Study Registration Dates
First Submitted
April 17, 2023
First Submitted That Met QC Criteria
April 17, 2023
First Posted (Actual)
April 28, 2023
Study Record Updates
Last Update Posted (Actual)
April 28, 2023
Last Update Submitted That Met QC Criteria
April 17, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Chemically-Induced Disorders
- Nervous System Diseases
- Poisoning
- Neurotoxicity Syndromes
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Excitatory Amino Acid Antagonists
- Excitatory Amino Acid Agents
- Dopamine Agents
- Antiparkinson Agents
- Anti-Dyskinesia Agents
- Memantine
Other Study ID Numbers
- 2023 (GRAMMY Museum Foundation)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
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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