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MT1621 for TK2 Deficiency (Continuation Trial)

Phase 2

Waitlist Available

Research Sponsored by Zogenix MDS, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Confirmed genetic mutation in the TK2 gene

Absence of other genetic disease or polygenic disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 3 years

Awards & highlights

Continuation Trial Summary

This trial is testing a new drug, MT1621, for safety and efficacy in people with a deficiency in the TK2 protein. The trial will compare measurements taken before treatment with dC/dT (a similar drug) to those taken after treatment with MT1621.

Who is the study for?

This trial is for patients with TK2 deficiency who have a confirmed genetic mutation in the TK2 gene, are not pregnant or breastfeeding, agree to use contraception, and can maintain their current treatment and exercise regimens. They must not have liver disease or certain other medical conditions that could affect study results.Check my eligibility

What is being tested?

The safety and effectiveness of two drugs, doxecitine and doxribtimine, are being tested in individuals with thymidine kinase 2 (TK2) deficiency. This Phase 2 trial is open-label, meaning both researchers and participants know which treatment is given.See study design

What are the potential side effects?

While specific side effects aren't listed here, common ones may include reactions at the injection site, fatigue, nausea or digestive issues. Participants will be monitored closely for any adverse effects throughout the study.

Continuation Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My condition involves a confirmed TK2 gene mutation.

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I do not have any genetic or complex inherited diseases.

Continuation Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Safety as adverse events (AEs): number of participants who experience adverse events

Safety as determined by electrocardiograms (ECGs)

Safety as determined by laboratory measurements

Secondary outcome measures

AUC - area under the plasma concentration time curve of deoxycytidine and deoxythymidine

Apparent elimination half-life (t1/2) of deoxycytidine and deoxythymidine

Biomarkers (plasma from blood)

+8 more

Continuation Trial Design

1Treatment groups

Experimental Treatment

Group I: doxecitine and doxribtimineExperimental Treatment1 Intervention

This is an open label study with all participants in a single arm. Study participants will take doxecitine and doxribtimine up to a maximum of 800 mg/kg/day (400 mg/kg/day doxecitine and 400 mg/kg/day doxiribtimine).

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Zogenix MDS, Inc.Lead Sponsor

3 Previous Clinical Trials

99 Total Patients Enrolled

Modis Therapeutics, Inc.Lead Sponsor

3 Previous Clinical Trials

99 Total Patients Enrolled

Zogenix, Inc.Industry Sponsor

24 Previous Clinical Trials

2,526 Total Patients Enrolled

Media Library

doxecitine and doxribtimine Clinical Trial Eligibility Overview. Trial Name: NCT03845712 — Phase 2

Thymidine Kinase Deficiency Research Study Groups: doxecitine and doxribtimine

Thymidine Kinase Deficiency Clinical Trial 2023: doxecitine and doxribtimine Highlights & Side Effects. Trial Name: NCT03845712 — Phase 2

doxecitine and doxribtimine 2023 Treatment Timeline for Medical Study. Trial Name: NCT03845712 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research project represent a pioneering effort?

"Presently, 9 ongoing trials for MT1621 are in progress across 5 nations and 10 urban areas. Initially launched by GenVivo, Inc., the Phase 1 trial of 122 patients was completed back in 2014; since then, 4 more studies have been executed."

Answered by AI

Are there any vacancies remaining in this clinical trial?

"Unfortunately, this trial is not presently looking for candidates. Initially posted on July 5th 2019 and latest updated October 3rd 2022, the research team are no longer accepting applications at present. For those searchng for other studies, there is one thymidine kinase clinical trials with active recruitment and 9 MT1621 trials recruiting participants."

Answered by AI

Are there any other experiments involving MT1621 that have been conducted?

"Currently, 9 clinical trials involving MT1621 are in progress with none yet reaching Phase 3. These studies primarily take place in Buffalo, New york but span 26 distinct sites."

Answered by AI

Is MT1621 a secure medication for human consumption?

"Our team at Power gauged the safety of MT1621 as a 2. This is due to its status as a Phase 2 trial, which indicates preliminary evidence of safety but not effectiveness."

Answered by AI

How many individuals are enrolled in the experiment?

"At this time, no additional participants are being sought for the trial posted 7/5/19 and last updated 10/3/2022. However, if you are seeking alternative studies involving thymidine kinase there is currently one open study recruiting patients; additionally, 9 different clinical trials utilizing MT1621 need to be filled with volunteers."

Answered by AI

Recent research and studies

BMJ Open Respiratory ResearchJournal

Deoxynucleoside Therapy for Respiratory Involvement in Adult Patients with Thymidine Kinase 2-deficient Myopathy

Hernandez-Voth, Ana, Javier Sayas Catalan, Marta Corral Blanco, Alba Castaño Mendez, Miguel Angel Martin, Carlos De Fuenmayor Fernandez de la Hoz, Victoria Villena Garrido, and Cristina Dominguez-Gonzalez. 2020. “Deoxynucleoside Therapy for Respiratory Involvement in Adult Patients with Thymidine Kinase 2-deficient Myopathy”. BMJ Open Respiratory Research. BMJ. doi:10.1136/bmjresp-2020-000774.

clinicaltrials.govStudy

An Open-Label Study of Continuation Treatment With Combination Pyrimidine Nucleosides in Patients With TK2 Deficiency

2019. "An Open-Label Study of Continuation Treatment With Combination Pyrimidine Nucleosides in Patients With TK2 Deficiency". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03845712.

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