Trial · NCT00233519
Effects of SomatoKine (Iplex)Recombinant Human Insulin-like Growth Factor-1/Recombinant Human Insulin-like Growth Factor-binding Protein-3 (rhIGF-I/rhIGFBP-3) in Myotonic Dystrophy Type 1 (DM1)
NCT00233519, Phase 1, Phase 2, Completed, University of Rochester; results first posted 2010-02-01
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Effects of SomatoKine (Iplex)Recombinant Human Insulin-like Growth Factor-1/Recombinant Human Insulin-like Growth Factor-binding Protein-3 (rhIGF-I/rhIGFBP-3) in Myotonic Dystrophy Type 1 (DM1). Trials, record NCT00233519. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00233519
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effects of SomatoKine (Iplex)Recombinant Human Insulin-like Growth Factor-1/Recombinant Human Insulin-like Growth Factor-binding Protein-3 (rhIGF-I/rhIGFBP-3) in Myotonic Dystrophy Type 1 (DM1)
- NCT number
- NCT00233519
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 17 participants, actual
- Lead sponsor
- University of Rochester
- Conditions
- Myotonic Dystrophy
- Interventions
- SomatoKine/IPLEX
- First posted
- 2005-10-05
- Last updated
- 2012-06-25
- Results first posted
- 2010-02-01
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Number of Study Participants Who Safely Tolerated Somatokine | 24 weeks | Safety and tolerability was measured via interval laboratory studies,electrocardiograms, echocardiograms, ultrasounds of the abdomen and pelvis, dual energy x-ray absorptiometry (DEXA) studies, chest and neck x-rays, and serial physical examinations. The participants had six inpatient evaluations at the University of Rochester General Clinical Research Center (Weeks 0, 8, 16, 24, 28, and 40) and nine outpatient evaluations. Patients also completed side effects diaries to record any adverse events in the interval time between inpatient and outpatient evaluations. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Number of Study Participants Who Safely Tolerated Somatokine | 24 weeks | participants | NUMBER |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Number of Study Participants Who Safely Tolerated Somatokine | Cohort 1- Two Escalating Doses of iPlex | 6 | participants | ||
| The Number of Study Participants Who Safely Tolerated Somatokine | Cohort 2-Three Escalating Doses of iPlex | 9 | participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort 1- Two Escalating Doses of iPlex | 7 | |
| Overall Study | STARTED | Cohort 2-Three Escalating Doses of iPlex | 10 | |
| Overall Study | COMPLETED | Cohort 1- Two Escalating Doses of iPlex | 6 | |
| Overall Study | COMPLETED | Cohort 2-Three Escalating Doses of iPlex | 9 | |
| Overall Study | NOT COMPLETED | Cohort 1- Two Escalating Doses of iPlex | 1 | |
| Overall Study | NOT COMPLETED | Cohort 2-Three Escalating Doses of iPlex | 1 |
Source ClinicalTrials.gov
Adverse events134
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 |
|---|---|---|---|---|---|---|
| other | Abdominal pain | Gastrointestinal disorders | Cohort 1- Two Escalating Doses of iPlex | 1 | 6 | 2 |
| other | Abdominal pain | Gastrointestinal disorders | Cohort 2-Three Escalating Doses of iPlex | 0 | 9 | 0 |
| other | Alopecia | Skin and subcutaneous tissue disorders | Cohort 1- Two Escalating Doses of iPlex | 0 | 6 | 0 |
| other | Alopecia | Skin and subcutaneous tissue disorders | Cohort 2-Three Escalating Doses of iPlex | 1 | 9 | 1 |
| other | ankle fracture | Musculoskeletal and connective tissue disorders | Cohort 1- Two Escalating Doses of iPlex | 0 | 6 | 0 |
| other | ankle fracture | Musculoskeletal and connective tissue disorders | Cohort 2-Three Escalating Doses of iPlex | 1 | 9 | 1 |
| other | Atrial flutter | Cardiac disorders | Cohort 1- Two Escalating Doses of iPlex | 0 | 6 | 0 |
| other | Atrial flutter | Cardiac disorders | Cohort 2-Three Escalating Doses of iPlex | 1 | 9 | 1 |
| other | Basal Cell Carcinoma | Skin and subcutaneous tissue disorders | Cohort 1- Two Escalating Doses of iPlex | 0 | 6 | 0 |
| other | Basal Cell Carcinoma | Skin and subcutaneous tissue disorders | Cohort 2-Three Escalating Doses of iPlex | 1 | 9 | 1 |
1 to 10 of 134Source ClinicalTrials.gov
See all 134 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort 1- Two Escalating Doses of iPlex | ||
| Total, all-cause mortality | Cohort 2-Three Escalating Doses of iPlex | ||
| Total, other adverse events | Cohort 1- Two Escalating Doses of iPlex | 3 | 6 |
| Total, other adverse events | Cohort 2-Three Escalating Doses of iPlex | 7 | 9 |
| Total, serious adverse events | Cohort 1- Two Escalating Doses of iPlex | 0 | 6 |
| Total, serious adverse events | Cohort 2-Three Escalating Doses of iPlex | 1 | 9 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 20837825 | DERIVED |
Source PubMed
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U54NS048843 | Paul D. Wellstone Muscular Dystrophy Cooperative Research Center | THORNTON, CHARLES A | UNIVERSITY OF ROCHESTER | NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE | 2003 to 2017 |
Source NIH RePORTER
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Cohort 1- Two Escalating Doses of iPlex vs Cohort 2-Three Escalating Doses of iPlex: The Number of Study Participants Who Safely Tolerated Somatokine | Trial comparisons |
| Cohort 1- Two Escalating Doses of iPlex vs Cohort 2-Three Escalating Doses of iPlex: serious adverse events | Trial comparisons |
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/NCT00233519
GET https://conductscience.org/api/trials/v1/NCT00233519/events?page=2