Methyldopa for Reduction of DQ8 Antigen Presentation in At-Risk Subjects for Type 1 Diabetes (TN-23)
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|ClinicalTrials.gov Identifier: NCT03396484|
Recruitment Status : Not yet recruiting
First Posted : January 11, 2018
Last Update Posted : May 14, 2019
|Condition or disease||Intervention/treatment||Phase|
|Type1 Diabetes Mellitus||Drug: Methyldopa Drug: Placebo||Phase 2|
The study is a randomized, double blinded, placebo-controlled, multi-center crossover clinical trial.
Eligible subjects will be randomized in a 1:1 allocation ratio to one of two treatment schedules: first methyldopa then placebo vs. first placebo then methyldopa.
The study objective is to assess the safety, efficacy, and mode of action of methyldopa to reduce DQ8 antigen presentation in individuals at Stage 1 and 2 of type 1 diabetes (T1D).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||36 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Methyldopa for Reduction of DQ8 Antigen Presentation in At-Risk Subjects for Type 1 Diabetes Mellitus|
|Estimated Study Start Date :||December 2019|
|Estimated Primary Completion Date :||March 2022|
|Estimated Study Completion Date :||March 2022|
Adults: methyldopa 500mg twice daily for one week and then increased to 500mg three times a day
Children: methyldopa dose based on weight twice daily for one week then increased to three times a day
Tablet for oral dosing
Other Name: Aldomet
Placebo Comparator: Placebo
Inactive agent to match active drug in appearance and dose frequency.
Tablet for oral dosing
- DQ8 Antigen Presentation [ Time Frame: 6 months after initiation of treatment ]insulin peptide-specific DQ8 antigen presentation
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03396484
|Contact: Lisa Rafkinfirstname.lastname@example.org|
|Contact: Ryan O'Donnell||813-396-9551||Ryan.O'Donnell@epi.usf.edu|
|Study Chair:||Carla Greenbaum, MD||Type 1 Diabetes TrialNet|