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Protocol Details

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

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

001681-CH

Sponsoring Institute

National Institute of Child Health and Human Development (NICHD)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 1 wk
Max Age: 100 Years

Referral Letter Required

No

Population Exclusion(s)

None

Keywords

MEHMO;
X-linked MEHMO Syndrome;
eIF2-Pathway Related Conditions;
EIF2S3

Recruitment Keyword(s)

None

Condition(s)

Intellectual Disability;
Epilepsy;
Hypogonadisms;
Microcephaly;
Nervous System Malformations;
Obesity

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Institute of Child Health and Human Development

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.

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Eligibility

Inclusion Criteria

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

Be greater than or equal to 1-week of age if affected, or greater than or equal to 1-month of age if unaffected.

19

For Screening:

Have a combination of signs/symptoms suggestive of MEHMO syndrome, AND no or inconclusive molecular testing.

For Main Study

1. 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

2. Be a first-degree relative of an individual with EIF2S3-related MEHMO syndrome, AND a carrier of the pathogenic or likely pathogenic variant.

OR

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

Exclusion Criteria

Any individual who, in the opinion of the Investigators, is unable to comply with the protocol

or have medical conditions that would potentially increase the risk of participation will be

excluded from participation in this study.


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

An N. Dang Do, M.D.
National Institute of Child Health and Human Development (NICHD)
NIHBC 10 - CRC BG RM 1-3342
10 CENTER DR
BETHESDA MD 20892
(301) 496-8849
an.dangdo@nih.gov

An N. Dang Do, M.D.
National Institute of Child Health and Human Development (NICHD)
NIHBC 10 - CRC BG RM 1-3342
10 CENTER DR
BETHESDA MD 20892
(301) 496-8849
an.dangdo@nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: TTY Users Dial 7-1-1
ccopr@nih.gov

Clinical Trials Number:

NCT06019182

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