← Back to Search

Other

GLM101 for Congenital Disorders of Glycosylation

Phase 2

Recruiting

Research Sponsored by Glycomine, Inc.

Eligibility Criteria Checklist

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

Must have

Has been diagnosed with PMM2-CDG with genetic test confirmation

If female of non-childbearing potential, must be pre-pubertal, surgically sterile, or have ovarian dysfunction confirmed by a follicle stimulating hormone > 40 IU/L

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks and 24 weeks

Awards & highlights

Study Summary

This trial will study if GLM101 is a safe and effective treatment for PMM2-CDG, a disease that causes problems with how the body makes and uses sugars and fats.

Who is the study for?

Adults aged 18-65 with PMM2-CDG, a genetic disorder affecting glycosylation. Participants must have low antithrombin III levels and agree to use contraception. Exclusions include severe allergies to GLM101 components, poor venous access, recent major surgery or substance abuse, active infections requiring strong medications, and other significant health issues as determined by the study leads.Check my eligibility

What is being tested?

The trial is testing GLM101 at doses of 10 and 20 mg/kg for its effects on adults with PMM2-CDG over a period of six months. It aims to assess how the body processes the drug (pharmacokinetics), its safety, tolerability, and potential effectiveness (pharmacodynamics).See study design

What are the potential side effects?

While specific side effects are not listed here, participants will be monitored for any adverse reactions related to GLM101 which could include allergic reactions or issues due to excipients in the medication.

Eligibility Criteria

Inclusion Criteria

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

Select...

I have been diagnosed with PMM2-CDG through genetic testing.

Select...

I am a woman who cannot have children due to age, surgery, or ovarian dysfunction.

Select...

I am between 18 and 65 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks and 24 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks and 24 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks and 24 weeks for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Evaluate changes from baseline in ataxia

Evaluate changes in coagulation and antithrombosis factors

Secondary outcome measures

Area under the plasma concentration vs. time curve (AUC)

Maximum observed plasma concentration (Cmax)

Number of participants with treatment-emergent adverse events assessed by severity and frequency

+2 more

Trial Design

3Treatment groups

Experimental Treatment

Group I: 30 mg/kg GLM101Experimental Treatment1 Intervention

GLM101 IV infusions, given weekly

Group II: 20 mg/kg GLM101Experimental Treatment1 Intervention

GLM101 IV infusions, given weekly

Group III: 10 mg/kg GLM101Experimental Treatment1 Intervention

GLM101 IV infusions, given weekly

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Glycomine, Inc.Lead Sponsor

1 Previous Clinical Trials

120 Total Patients Enrolled

Horacio Plotkin, MDStudy DirectorGlycomine, Inc.

Frequently Asked Questions

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

Are the patients in this trial restricted to a certain age group?

"This study requires that participants are of legal age and younger than 65."

Answered by AI

Are there any safety concerns associated with GLM101?

"While there is some data supporting GLM101's safety, it is still in Phase 2 of clinical trials and has not yet been proven effective. Therefore, it received a score of 2."

Answered by AI

Is there still room for new volunteers in this experiment?

"The clinical trial, which was first posted on November 1st 2020 and last edited on October 3rd 2020, is not currently recruiting patients. Although this specific study isn't looking for volunteers, there are 6 other trials that are actively recruiting participants."

Answered by AI

Are there specific requirements for volunteers of this clinical trial?

"This clinical trial is seeking 6 individuals that have pmm2-cdg and meet the following age criteria: 18 to 65 years old. Furthermore, potential participants must satisfy the following conditions: be male or female, between 18-65 years old, have received a diagnosis of PMM2-CDG with genetic testing confirmation, if female and of childbearing potential she cannot be pregnant (this will be confirmed via negative serum pregnancy test), agree to use contraception for 30 days after last infusion of GLM101, if sexually active male then he must agree to use contraception for 30 days after last infusion of GLM101, refrain from donating"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

24-Week Study to Assess the PD, Safety, Tolerability, and PK of GLM101 in Participants With PMM2-CDG

2022. "24-Week Study to Assess the PD, Safety, Tolerability, and PK of GLM101 in Participants With PMM2-CDG". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05549219.