Trial · NCT00001262
Copper Histidine Therapy for Menkes Diseases
NCT00001262, Phase 1, Phase 2, Completed, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); results first posted 2015-10-30
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Copper Histidine Therapy for Menkes Diseases. Trials, record NCT00001262. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00001262
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Copper Histidine Therapy for Menkes Diseases
- NCT number
- NCT00001262
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 60 participants, actual
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Conditions
- Kinky Hair Syndrome
- Interventions
- Copper Histidine
- First posted
- 1999-11-04
- Last updated
- 2015-10-30
- Results first posted
- 2015-10-30
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Gross Motor Development at 36 Mos of Age or at Death (Mos) | 36 months or death | This was measured based on the Denver Developmental Screening Test (DDST) I or II for age-appropriate gross motor development in apparently normal healthy subjects at specific ages (in months). The DDST employs a grid to assess expected developmental milestones in relation to chronologic age. |
| Primary | Fine Motor Adaptive Development at 36 Mos of Age or at Death (Mos) | 36 months or death | This was measured based on the Denver Developmental Screening Test (DDST) I or II for age-appropriate fine motor development in apparently normal healthy subjects at specific ages (in months). The DDST employs a grid to assess expected developmental milestones in relation to chronologic age. |
| Primary | Personal-Social Development at 36 Mos of Age or at Death (Mos) | 36 months or death | This was measured based on the Denver Developmental Screening Test (DDST) I or II for age-appropriate personal-social development in apparently normal healthy subjects at specific ages (in months). The DDST employs a grid to assess expected developmental milestones in relation to chronologic age. |
| Primary | Language Development at 36 Mos of Age or at Death (Mos) | 36 months or death | This was measured based on the Denver Developmental Screening Test (DDST) I or II for age-appropriate language development in apparently normal healthy subjects at specific ages (in months). The DDST employs a grid to assess expected developmental milestones in relation to chronologic age. |
| Secondary | Somatic Growth Percentiles at 3 Years of Age (or at Age of Death) - Weight Percentile | 36 months or death | |
| Secondary | Somatic Growth Percentiles at 3 Years of Age (or at Age of Death) - Length Percentile | 36 months or death | |
| Secondary | Somatic Growth Percentiles at 3 Years of Age (or at Age of Death) - Head Circumference Percentile | 36 months or death |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Gross Motor Development at 36 Mos of Age or at Death (Mos) | 36 months or death | Other - months | MEAN | |
| PRIMARY | Fine Motor Adaptive Development at 36 Mos of Age or at Death (Mos) | 36 months or death | Other - Months | MEAN | |
| PRIMARY | Personal-Social Development at 36 Mos of Age or at Death (Mos) | 36 months or death | Other - Months | MEAN | |
| PRIMARY | Language Development at 36 Mos of Age or at Death (Mos) | 36 months or death | Other - Months | MEAN | |
| SECONDARY | Somatic Growth Percentiles at 3 Years of Age (or at Age of Death) - Weight Percentile | 36 months or death | Other - Percentile | MEAN | |
| SECONDARY | Somatic Growth Percentiles at 3 Years of Age (or at Age of Death) - Length Percentile | 36 months or death | Other - Percentile | MEAN | |
| SECONDARY | Somatic Growth Percentiles at 3 Years of Age (or at Age of Death) - Head Circumference Percentile | 36 months or death | Other - Percentile | MEAN |
Source ClinicalTrials.gov
Results by group21
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Gross Motor Development at 36 Mos of Age or at Death (Mos) | Early | 13.743 | Standard Deviation 12.200 | Other - months | |
| Gross Motor Development at 36 Mos of Age or at Death (Mos) | Late | 2.455 | Standard Deviation 2.154 | Other - months | |
| Gross Motor Development at 36 Mos of Age or at Death (Mos) | Mild | 15.667 | Standard Deviation 9.815 | Other - months | |
| Fine Motor Adaptive Development at 36 Mos of Age or at Death (Mos) | Early | 16.200 | Standard Deviation 12.762 | Other - Months | |
| Fine Motor Adaptive Development at 36 Mos of Age or at Death (Mos) | Late | 2.409 | Standard Deviation 1.652 | Other - Months | |
| Fine Motor Adaptive Development at 36 Mos of Age or at Death (Mos) | Mild | 17.667 | Standard Deviation 13.204 | Other - Months | |
| Personal-Social Development at 36 Mos of Age or at Death (Mos) | Early | 17.657 | Standard Deviation 13.482 | Other - Months | |
| Personal-Social Development at 36 Mos of Age or at Death (Mos) | Late | 3.364 | Standard Deviation 3.499 | Other - Months | |
| Personal-Social Development at 36 Mos of Age or at Death (Mos) | Mild | 17.667 | Standard Deviation 15.308 | Other - Months | |
| Language Development at 36 Mos of Age or at Death (Mos) | Early | 15.800 | Standard Deviation 12.034 | Other - Months |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Early | 35 | |
| Overall Study | STARTED | Late | 22 | |
| Overall Study | STARTED | Mild | 3 | |
| Overall Study | COMPLETED | Early | 25 | |
| Overall Study | COMPLETED | Late | 8 | |
| Overall Study | COMPLETED | Mild | 3 | |
| Overall Study | NOT COMPLETED | Early | 10 | |
| Overall Study | NOT COMPLETED | Late | 14 | |
| Overall Study | NOT COMPLETED | Mild | 0 |
Source ClinicalTrials.gov
Adverse events6
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Death | Nervous system disorders | Early | 10 | 35 | 10 |
| serious | Death | Nervous system disorders | Late | 11 | 22 | 11 |
| serious | Death | Nervous system disorders | Mild | 0 | 3 | 0 |
| serious | Dehydration | Nervous system disorders | Early | 1 | 35 | 1 |
| serious | Dehydration | Nervous system disorders | Late | 0 | 22 | 0 |
| serious | Dehydration | Nervous system disorders | Mild | 0 | 3 | 0 |
Source ClinicalTrials.gov
Adverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Early | ||
| Total, all-cause mortality | Late | ||
| Total, all-cause mortality | Mild | ||
| Total, other adverse events | Early | 0 | 35 |
| Total, other adverse events | Late | 0 | 22 |
| Total, other adverse events | Mild | 0 | 3 |
| Total, serious adverse events | Early | 10 | 35 |
| Total, serious adverse events | Late | 11 | 22 |
| Total, serious adverse events | Mild | 0 | 3 |
Source ClinicalTrials.gov
Papers15
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00001262
GET https://conductscience.org/api/trials/v1/NCT00001262/results?page=2