CLINICAL TRIALS PROFILE FOR COPPER HISTIDINATE

All Clinical Trials for COPPER HISTIDINATE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00811785 ↗	Molecular Bases of Response to Copper Treatment in Menkes Disease, Related Phenotypes, and Unexplained Copper Deficiency	Completed	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Phase 3	2009-02-27	Menkes disease and occipital horn syndrome are two forms of copper deficiency that must be diagnosed and treated very early in life to prevent serious developmental problems. However, these and other forms of copper deficiency are not very well understood, and further research is needed to determine whether certain treatments are useful in treating copper deficiency. One such treatment is copper histidine, a copper replacement that can be injected directly into the body to avoid absorption through the gastrointestinal tract. This study will investigate the effectiveness, side effects, and dosage of copper histidine treatment for patients with copper deficiency. It will also collect medical history information from patients to allow researchers to study possible genetic and nongenetic origins of copper deficiency. This study will include 100 subjects, all of whom will be children and adults who have been diagnosed with Menkes disease, occipital horn syndrome, or other unexplained copper deficiency. Patients will receive a prescribed dose of copper histidine, which will be administered daily as an injection. During the study, patients will be admitted to the NIH Clinical Center on an outpatient basis to evaluate their response to the copper histidine treatment. These evaluations will take place every 8 months, with a final evaluation performed after 3 years of treatment. During the outpatient visits, patients will be required to give blood and urine samples for testing and undergo ultrasound testing. They will also undergo brain MRI scans at the initial visit and at the 16-month and 36-month visits. Patients who agree will give additional blood samples for genetic research purposes.
NCT00811785 ↗	Molecular Bases of Response to Copper Treatment in Menkes Disease, Related Phenotypes, and Unexplained Copper Deficiency	Completed	National Center for Complementary and Integrative Health (NCCIH)	Phase 3	2009-02-27	Menkes disease and occipital horn syndrome are two forms of copper deficiency that must be diagnosed and treated very early in life to prevent serious developmental problems. However, these and other forms of copper deficiency are not very well understood, and further research is needed to determine whether certain treatments are useful in treating copper deficiency. One such treatment is copper histidine, a copper replacement that can be injected directly into the body to avoid absorption through the gastrointestinal tract. This study will investigate the effectiveness, side effects, and dosage of copper histidine treatment for patients with copper deficiency. It will also collect medical history information from patients to allow researchers to study possible genetic and nongenetic origins of copper deficiency. This study will include 100 subjects, all of whom will be children and adults who have been diagnosed with Menkes disease, occipital horn syndrome, or other unexplained copper deficiency. Patients will receive a prescribed dose of copper histidine, which will be administered daily as an injection. During the study, patients will be admitted to the NIH Clinical Center on an outpatient basis to evaluate their response to the copper histidine treatment. These evaluations will take place every 8 months, with a final evaluation performed after 3 years of treatment. During the outpatient visits, patients will be required to give blood and urine samples for testing and undergo ultrasound testing. They will also undergo brain MRI scans at the initial visit and at the 16-month and 36-month visits. Patients who agree will give additional blood samples for genetic research purposes.
NCT00811785 ↗	Molecular Bases of Response to Copper Treatment in Menkes Disease, Related Phenotypes, and Unexplained Copper Deficiency	Completed	Cyprium Therapeutics, Inc.	Phase 3	2009-02-27	Menkes disease and occipital horn syndrome are two forms of copper deficiency that must be diagnosed and treated very early in life to prevent serious developmental problems. However, these and other forms of copper deficiency are not very well understood, and further research is needed to determine whether certain treatments are useful in treating copper deficiency. One such treatment is copper histidine, a copper replacement that can be injected directly into the body to avoid absorption through the gastrointestinal tract. This study will investigate the effectiveness, side effects, and dosage of copper histidine treatment for patients with copper deficiency. It will also collect medical history information from patients to allow researchers to study possible genetic and nongenetic origins of copper deficiency. This study will include 100 subjects, all of whom will be children and adults who have been diagnosed with Menkes disease, occipital horn syndrome, or other unexplained copper deficiency. Patients will receive a prescribed dose of copper histidine, which will be administered daily as an injection. During the study, patients will be admitted to the NIH Clinical Center on an outpatient basis to evaluate their response to the copper histidine treatment. These evaluations will take place every 8 months, with a final evaluation performed after 3 years of treatment. During the outpatient visits, patients will be required to give blood and urine samples for testing and undergo ultrasound testing. They will also undergo brain MRI scans at the initial visit and at the 16-month and 36-month visits. Patients who agree will give additional blood samples for genetic research purposes.
NCT04977388 ↗	NORTHERA (DROXIDOPA) for Dysautonomia in Adult Survivors of Menkes Disease and Occipital Horn Syndrome	Recruiting	Stephen G. Kaler, MD	Phase 1/Phase 2	2021-07-12	The purpose of this study is to evaluate whether Northera (Droxidopa) is safe and effective in young adults with Menkes disease who survived the most severe complications of their illness or adults with occipital horn syndrome (OHS), who have trouble with intermittent low blood pressure and other symptoms of dysautonomia. The outcomes and information from this study may help adult survivors of Menkes disease and individuals with OHS lead more normal day-to-day lives.

Clinical Trial Conditions for COPPER HISTIDINATE

Condition Name

Condition Name for COPPER HISTIDINATE
Intervention	Trials
Menkes Disease	2
Occipital Horn Syndrome	2
Unexplained Copper Deficiency	1

Condition MeSH

Condition MeSH for COPPER HISTIDINATE
Intervention	Trials
Ehlers-Danlos Syndrome	2
Cutis Laxa	2
Menkes Kinky Hair Syndrome	2
Syndrome	1

Clinical Trial Locations for COPPER HISTIDINATE

Trials by Country

Trials by Country for COPPER HISTIDINATE
Location	Trials
United States	2

Trials by US State

Trials by US State for COPPER HISTIDINATE
Location	Trials
Ohio	1
Maryland	1

Clinical Trial Progress for COPPER HISTIDINATE

Clinical Trial Phase

Clinical Trial Phase for COPPER HISTIDINATE
Clinical Trial Phase	Trials
Phase 3	1
Phase 1/Phase 2	1

Clinical Trial Status

Clinical Trial Status for COPPER HISTIDINATE
Clinical Trial Phase	Trials
Completed	1
Recruiting	1

Clinical Trial Sponsors for COPPER HISTIDINATE

Sponsor Name

Sponsor Name for COPPER HISTIDINATE
Sponsor	Trials
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	2
National Center for Complementary and Integrative Health (NCCIH)	1
Cyprium Therapeutics, Inc.	1

Sponsor Type

Sponsor Type for COPPER HISTIDINATE
Sponsor	Trials
NIH	3
Industry	1
Other	1