Investigations of Individuals With MEHMO Syndrome or eIF2-Pathway Related Conditions

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

This observational natural history study will follow individuals with MEHMO (Mental disability, Epileptic seizure, Hypopituitarism/Hypogenitalism, Microcephaly, Obesity) syndrome or an eIF2-pathway related disorder, who have symptoms such as intellectual delay, seizures, abnormal hormone and blood sugar levels, and decreased motor skills. No current treatment for these conditions is available. A major impediment to the testing of potential therapeutic interventions is the lack of well-defined outcome measures. This protocol seeks to identify biochemical and clinical markers to monitor disease progression, and better understand the natural history of these conditions. Any person diagnosed with MEHMO syndrome or related conditions, who can travel to the NIH Clinical Center can participate in this study. The study involves: * General health assessment and evaluation * Imaging studies * Laboratory tests * Collection of blood, urine, spinal fluid, skin biopsy.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 7 days
Maximum Age: 100
Healthy Volunteers: f
View:

⁃ To be eligible to participate in this study, an individual must meet the following criteria:

⁃ Be \>= 1-week of age if affected, or \>=1-month of age if unaffected.

⁃ For Screening:

• Have a combination of signs/symptoms suggestive of MEHMO syndrome,

• AND

• no or inconclusive molecular testing.

• OR

• Be a relative of an individual with MEHMO syndrome/eIF2-related condition and whose genetic may be informative for research.

⁃ For Main Study:

• Have a combination of signs/symptoms suggestive of MEHMO syndrome,

• AND

• disease-associated variant(s) or variant(s) of uncertain significance in one of the eIF2-pathway related genes

• OR

• Be a relative of an individual with MEHMO syndrome/eIF2-related condition, AND a carrier of the pathogenic or likely pathogenic variant.

• OR

• Be a non-affected, non-carrier family member of an individual with MEHMO syndrome or an eIF2-pathway related condition.

Locations
United States
Maryland
National Institutes of Health Clinical Center
RECRUITING
Bethesda
Contact Information
Primary
An N Dang Do, M.D.
an.dangdo@nih.gov
(301) 496-8849
Time Frame
Start Date: 2023-10-23
Estimated Completion Date: 2053-09-01
Participants
Target number of participants: 150
Treatments
Affected
Individuals who have MEHMO syndrome or eIF2-pathway related conditions 1-week of age or older.
Carrier
EIF2S3-variant carrier individuals 1-month of age or older.
Unaffected Non-carrier
Unaffected individuals 1 month of age or older who are 1st degree relative of an affected individual
Sponsors
Leads: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

This content was sourced from clinicaltrials.gov

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