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Safety and Efficacy Study of Recombinant Human Insulin-Like Growth Factor-I/Recombinant Human Insulin-Like Growth Factor Binding Protein-3 (rhIGF-I/rhIGFBP-3) In Myotonic Dystrophy Type 1

Primary Purpose

Myotonic Dystrophy Type 1

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

rhIGF-I/rhIGFBP-3

placebo

About this trial

This is an interventional supportive care trial for Myotonic Dystrophy Type 1

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria (list is not inclusive):

A diagnosis of DM1, confirmed by DM1 genetic mutation
Ability to walk 30 feet - assistance with cane and/or leg bracing permitted
Able to self-administer study medication by subcutaneous injection or caregiver is available to administer study medication

Exclusion Criteria (list is not inclusive):

Congenital DM1
Weight greater than 100 kg or body mass index greater than 30 kg/m2
Prior treatment with glucocorticoids, anabolic steroids, testosterone, growth hormone, investigational agent within 60 days of screening
Current diagnosis or history of malignancy expect for surgically cured skin cancer or pilomatricoma
Changes in lipid lowering medications during the 3 months prior to screening
Diaphragmatic weakness such that patients are unable to tolerate the supine position, or swallowing impairment such that patients are unable to maintain nutrition without use of gastrostomy.
Major psychiatric illness (major depression, bipolar disorder or schizophrenia) within twelve months of screening
History of non-compliance with other therapies

Sites / Locations

University of California Irvine Medical Center; MDA, ALS and Neuromuscular Center
University of California, Davis
University of Kansas Medical Center
Johns Hopkins Hospital
University of Minnesota
Washington University Medical School
University of Rochester, Neuromuscular Disease Center
Ohio State University Medical Center
Oregan Health and Science University
Universit of Texas Medical Branch
University of Texas Health Science Center
University of Utah

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

rhIGF-I/rhIGFBP-3

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Change From Baseline to Week 24 in Distance Walked as Assessed by the Six-minute Walk Test (6MWT) Distance

The 6MWT measured the distance in meters that participants were able to walk over a total of six minutes. After a 10 minute resting period, the participants completed the 6MWT on a hard, flat surface at baseline and at Week 24.

Change From Baseline in Daily Step Count

The number of steps taken per day was measured using a step activity monitor for 7 days at baseline and again at Week 24. Change from baseline scores were measured where a negative change from baseline indicates a decrease in the number of daily steps.

Peak Activity Index: Change From Baseline in Number of Steps Walked Per Minute During the 30 Minute Period of Fastest Walking

The peak activity index measures the number of steps walked in the 30 minutes of fastest walking that occurred in a 24 hour period. This was measured using a step activity monitor for 7 days at baseline and again at Week 24. Change from baseline scores were measured where a positive change from baseline indicates an improvement in the number of steps walked during the 30 minute period of fastest walking.

Sustained Activity Index: Change From Baseline in the Highest Number of Steps Walked Per Minute Over 20 Minutes of Activity

The sustained activity index measures the highest number of steps sustained over a continuous 20 minute period. This was measured using a step activity monitor for 7 days at baseline and again at Week 24. Change from baseline scores were measured where a positive change from baseline indicates an improvement in the number of steps walked over 20 minutes of activity.

Change From Baseline in the Percentage of Time That Participants Spent Inactive

Change from baseline scores were measured where a negative change from baseline indicates less time spent inactive.

Change From Baseline in Time Taken for Participants to Ascend and Descend 4 Stairs

Participants were timed on their ability to climb up 4 stairs and timed separately to climb down 4 stairs at baseline and at week 24. The stairs were free-standing or the same flight of stairs was used at each assessment. Change from baseline scores were measured where a positive change from baseline indicates an improvement in the time taken for paticipants to ascend or descend 4 stairs.

Change From Baseline in Time Taken to Traverse 30 Feet

Participants were timed on their ability to travel 30 feet on the same surface at each assessment at baseline and at Week 24. Change from baseline scores were measured where a positive change from baseline indicates an improvement in the time taken to travel 30 feet.

Change From Baseline in Purdue Pegboard Test Scores

The Purdue Pegboard Test consists of a board with two sets of 25 holes, 4 concave cups, and a number of small metal pins. Participants were required to pick up the pins from a holder and place them in the holes as quickly as possible over 30 seconds with their dominant hand. The score was calculated as the number of pins placed into holes in 30 seconds and was measured at baseline and Week 24. Change from baseline scores were measured where a positive change from baseline indicates an improvement in the number of pins placed in the board.

Change From Baseline in Forced Vital Capacity (FVC) Volume While Sitting or Lying Down

FVC is the volume of air that can be forcibly exhaled from the lungs after taking the deepest breath possible, as measured by spirometry.

Change From Baseline in Forced Vital Capacity (FVC) Percent Predicted While Sitting or Lying Down

FVC is the volume of air that can be forcibly exhaled from the lungs after taking the deepest breath possible, as measured by spirometry.

Change From Baseline in Manual Muscle Test (MMT) Scores

The MMT was used to assess muscle strength in the distal muscles and the proximal muscles. Distal muscles assessments included wrist extension, wrist flexion, ankle dorsiflexion and plantarflexion. Proximal muscle assessments included shoulder abduction, elbow extension, elbow flexion, hip extension, hip abduction, hip flexion, knee extension and knee flexion. In MMT, each muscle assessment was given a score of 0 to 5, where 0 indicated 'no contraction palpable' and 5 indicated 'normal strength'. The scores from each muscle were summed and the maximum overall score of all measured muscles was 140, the maximum distal score was 40 and the maximum proximal score was 80. Higher scores indicated higher muscle strength. Change from baseline scores were measured where a positive change from baseline indicates an improvement in muscle strength.

Change From Baseline in Selective Reminding Test T-Scores (Total Word and Delayed Words)

The Selective Reminding Test measures verbal learning and memory and involves remembering a verbal list of 12 words. Participants were required to recall the 12 words presented. Words that were missed on recall were presented again, and the process was repeated until all 12 words were correctly recalled. The total word list recall and delayed recall were calculated as T-scores. Raw scores were converted to T-score using available normative data. Change from baseline T-scores were measured where a positive change from baseline indicates improvement in performance.

Change From Baseline in Selective Reminding Test Raw Scores (Cued Recall and Recognition)

The Selective Reminding Test measures verbal learning and memory and involves remembering a verbal list of 12 words. Participants were required to recall the 12 words presented. Words that were missed on recall were presented again, and the process is repeated until all 12 words were correctly recalled. The cued recall scores ranged from 0-11 and multiple choice recognition scores ranged from 0-12. Change from baseline scores were measured where a positive change from baseline indicates an improvement in verbal recall and memory.

Change From Baseline in Rey Complex Figure (RCF) Test Scores

The Rey Complex Figure Test (RCFT) assesses visuospatial construction ability and visual memory through four different tests: copy (copying a complex geometric figure), immediate recall of the figure (drawing figure from memory at 3 minutes), delayed recall (drawing figure at 30 minutes after initial copy), and recognition score (selecting individual parts of the figure from sketches provided). Copy performances are divided into 18 components with a maximum score of 2 each. The maximum score for each figure is 36.

Change From Baseline in Letter-Number Sequencing (LNS) Test Scores

The LNS test from the Welchsler Adult Intelligence Scale-III was used to assess working memory. The test required that participants recall, in order, numbers and letters presented in an unordered sequence. The number of items is 21. With each item being marked 0 if reported incorrectly or 1 if reported correctly, the maximum score is 21. Raw scores were converted into T-scores using available normative data. Change from baseline T-scores were measured where a positive change from baseline indicates improvement in performance.

Change From Baseline in Trail Making Test (TMT) Scores

The TMT assesses executive function, sequencing, mental flexibility, visual spanning speed and motor function. In TMT Part A, the participant had to draw lines in the correct order between 25 numbers randomly arranged on the page. In TMT Part B, the participant had to draw lines between 25 numbers and letters in alternating order (e.g., 1-A-2-B...etc). Times for Part A and Part B were used to derive T-scores which can range from a minimum of 0 and a maximum of 100. Raw scores were converted into T-scores using available normative data. Change from baseline T-scores were measured where a positive change from baseline indicates improvement in performance.

Change From Baseline in the Stroop Color Word Test Scores

The Stroop Color Word Test measures selective attention and cognitive flexibility. The test has three parts, the Word test (reading words), the Color test (naming the ink color in which words are displayed) and the Color-Word test (saying the ink color not reading the word). An interference score was calculated from the Color, Word and Color-Word scores and is an indication of how well a person can complete a task while disregarding interfering information. Raw scores were converted into T-scores using available normative data. Scores range from 0 to 100. Change from baseline T-scores were measured where a positive change from baseline indicates improvement in performance.

Change From Baseline to Week 24 Scores on the Beck Depression Inventory II (BDI-II) Questionnaire

BDI-II is a validated self-reported instrument of 21 questions which are each scored 0-3. Total scores range from 0-63, with higher score totals indicating more severe depression symptoms. {0-9: indicates minimal depression; 0-18: indicates mild depression; 19-29: indicates moderate depression; 30-63: indicates severe depression. Lower scores indicate no or minimal depression, with a maximum total score of 63.

Change From Baseline in Average Fasting Glucose Concentration in the Blood

Participants were administered 75 grams (g) glucose solution prior to administration of the first dose of IPlex™ and after administration of the last dose. A 2-hour oral glucose tolerance test (OGTT) was performed under fasted conditions.

Change From Baseline in Average Fasting Insulin Concentration in the Blood

Participants were administered 75 g glucose solution prior to administration of the first dose of IPLEX™ and after administration of the last dose. A 2-hour OGTT was performed under fasted conditions.

Change From Baseline in Qualitative Insulin Sensitivity Check Index (QUICKI)

The QUICKI is based on fasting glucose and insulin measurements and are calculated using the following equation: QUICKI = 1/[ log(fasting glucose in mg/dL) + log (fasting insulin in uU/mL) ]

Change From Baseline in Insulin Sensitivity Index-Matsuda (ISI-Matsuda)

The ISI-Matsuda is based on the average glucose and insulin values obtained during the entire oral glucose tolerance test and are calculated using the following equation: ISI = 10,000 / √ [ fasting glucose (mg/dL) x fasting insulin(uU/mL) x mean glucose x mean insulin ]

Change From Baseline in Total Blood Cholesterol Level

A negative change from baseline indicates a decrease in total blood cholesterol level.

Change From Baseline in Total Blood Low-density Lipoproteins (LDL) Level

A positive change from baseline indicates an increase in total blood LDL level.

Change From Baseline in Total Blood High-density Lipoproteins (HDL) Level

A negative change from baseline indicates a decrease in total blood HDL level.

Change From Baseline in Total Blood Triglycerides Level

A negative change from baseline indicates a decrease in total blood triglycerides level.

Change From Baseline in Gastro-esophageal Reflux Disease (GERD) Symptom Frequency Questionnaire (GSFQ) Scores

The GSFQ contains 6 questions that assess the frequency of certain GERD symptoms and their impact on daily life. Scores were converted and reported out of 100 with higher scores indicative of more frequent and intense GERD symptoms. Change from baseline scores were measured where a negative change from baseline indicates less frequent and intense GERD symptoms.

Change From Baseline in Gastrointestinal Symptom Rating Scale for Irritable Bowel Syndrome (GSRS-IBS) Questionnaire Scores

The GSRS-IBS has 13 questions aimed at identifying the frequency and intensity of IBS symptoms during the past week. Answers are given a score from 1 (no discomfort at all) to 7 (very severe discomfort). A total score was calculated and ranged from 0 to 78. A lower score indicates less discomfort from IBS symptoms. Change from baseline scores were measured where a positive change from baseline indicates increased discomfort from IBS symptoms.

Change From Baseline in Swallowing Disturbance Questionnaire (SDQ) Scores

The SDQ had 15 questions relating to the oral phase and pharyngeal phase of swallowing. Answers for 14 questions were assigned a number (0-3) based on a 4-point verbal scale (never, seldom, frequently, very frequently) and the last question was a yes or no question about respiratory infections. A higher score is indicative of greater swallowing issues with 44.5 as the highest possible score. A total score of ≥ 11 suggests impairment. Change from baseline scores were measured where a positive change from baseline indicates increased swallowing impairment.

Change From Baseline in Short Form (36) (SF-36) Questionnaire Scores

The SF-36 is a 36-item questionnaire that evaluates quality of life through physical and mental health across eight scales, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability. Change from baseline scores were measured where a positive change from baseline indicates an improvement in quality of life.

Change From Baseline in Brief Pain Inventory (BPI) Questionnaire - Severity Scores

The BPI contains 15 questions that assess the severity of pain and its impact or interference on functions of daily life. Pain severity was measured as the mean of 7 items of the questionnaire on an 11-point scale where 0 indicates no pain and 10 indicates the worst pain. A higher score indicates greater pain. Categories assessed include worst pain in 24 hours and average pain. Change from baseline scores were measured where a positive change from baseline indicates a worsening in pain.

Change From Baseline in Brief Pain Inventory (BPI) Questionnaire - Interference Scores

The BPI contains 15 questions that assess the severity of pain and its impact or interference on functions of daily life. Pain interference is measured as the mean of 7 items on an 11-point scale where 0 indicates no interference and 10 indicates complete interference. A higher score indicates greater impairment due to pain. Change from baseline scores were measured where a positive change from baseline indicates a worsening of interference due to pain.

Secondary Outcome Measures

Full Information

NCT ID

NCT00577577

First Posted

December 18, 2007

Last Updated

December 8, 2021

Sponsor

Insmed Incorporated

Collaborators

Muscular Dystrophy Association

1. Study Identification

Unique Protocol Identification Number

NCT00577577

Brief Title

Safety and Efficacy Study of Recombinant Human Insulin-Like Growth Factor-I/Recombinant Human Insulin-Like Growth Factor Binding Protein-3 (rhIGF-I/rhIGFBP-3) In Myotonic Dystrophy Type 1

Official Title

A Placebo Controlled, Randomized, Double-Blind Phase II Clinical Trial to Evaluate Tolerability, Safety and Efficacy Endpoints After Administration of Recombinant Human Insulin-Like Growth Factor-I/Recombinant Human Insulin-Like Growth Factor Binding Protein-3 (rhIGF-I/rhIGFBP-3) for 24 Weeks in Adults With Myotonic Dystrophy Type 1

Study Type

Interventional

2. Study Status

Record Verification Date

December 2021

Overall Recruitment Status

Completed

Study Start Date

December 2007 (Actual)

Primary Completion Date

December 29, 2008 (Actual)

Study Completion Date

December 29, 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Insmed Incorporated

Collaborators

Muscular Dystrophy Association

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

To investigate the effects of rhIGF-I/rhIGFBP-3 treatment for 24 weeks on endurance, ambulation, cognitive functioning, insulin resistance, lipid levels, muscle function and strength, pain, gastrointestinal functioning, and quality of life endpoints in DM1 patients

Detailed Description

Efficacy Measures: Endurance, Ambulation, Cognitive function, Insulin resistance, Cholesterol and triglycerides, Muscle function and strength, Pain, Gastrointestinal function, Quality of life MINIMUM INCLUSION CRITERIA A diagnosis of DM1, confirmed by DM1 genetic mutation Age 21 to 65 years (inclusive) Ability to walk 30 feet - assistance with cane and/or leg bracing permitted Able to self-administer study medication by subcutaneous injection or caregiver is available to administer study medication

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Myotonic Dystrophy Type 1

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

69 (Actual)

8. Arms, Groups, and Interventions

Arm Title

rhIGF-I/rhIGFBP-3

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

rhIGF-I/rhIGFBP-3

Intervention Description

1.0 mg/kg rhIGF-I/rhIGFBP-3 or placebo daily, subcutaneous injections from baseline through the last day of the end of study visit.

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

1.0 mg/kg rhIGF-I/rhIGFBP-3 or placebo daily, subcutaneous injections from baseline through the last day of the end of study visit.

Primary Outcome Measure Information:

Title

Change From Baseline to Week 24 in Distance Walked as Assessed by the Six-minute Walk Test (6MWT) Distance

Description

Time Frame

Baseline and Week 24

Title

Change From Baseline in Daily Step Count

Description

Time Frame

Baseline and Week 24

Title

Peak Activity Index: Change From Baseline in Number of Steps Walked Per Minute During the 30 Minute Period of Fastest Walking

Description

Time Frame

Baseline and Week 24

Title

Sustained Activity Index: Change From Baseline in the Highest Number of Steps Walked Per Minute Over 20 Minutes of Activity

Description

Time Frame

Baseline and Week 24

Title

Change From Baseline in the Percentage of Time That Participants Spent Inactive

Description

Change from baseline scores were measured where a negative change from baseline indicates less time spent inactive.

Time Frame

Baseline and Week 24

Title

Change From Baseline in Time Taken for Participants to Ascend and Descend 4 Stairs

Description

Time Frame

Baseline and Week 24

Title

Change From Baseline in Time Taken to Traverse 30 Feet

Description

Time Frame

Baseline and Week 24

Title

Change From Baseline in Purdue Pegboard Test Scores

Description

Time Frame

Baseline and Week 24

Title

Change From Baseline in Forced Vital Capacity (FVC) Volume While Sitting or Lying Down

Description

FVC is the volume of air that can be forcibly exhaled from the lungs after taking the deepest breath possible, as measured by spirometry.

Time Frame

Baseline and Week 24

Title

Change From Baseline in Forced Vital Capacity (FVC) Percent Predicted While Sitting or Lying Down

Description

FVC is the volume of air that can be forcibly exhaled from the lungs after taking the deepest breath possible, as measured by spirometry.

Time Frame

Baseline and Week 24

Title

Change From Baseline in Manual Muscle Test (MMT) Scores

Description

Time Frame

Baseline and Week 24

Title

Change From Baseline in Selective Reminding Test T-Scores (Total Word and Delayed Words)

Description

Time Frame

Baseline and Week 24

Title

Change From Baseline in Selective Reminding Test Raw Scores (Cued Recall and Recognition)

Description

The Selective Reminding Test measures verbal learning and memory and involves remembering a verbal list of 12 words. Participants were required to recall the 12 words presented. Words that were missed on recall were presented again, and the process is repeated until all 12 words were correctly recalled. The cued recall scores ranged from 0-11 and multiple choice recognition scores ranged from 0-12. Change from baseline scores were measured where a positive change from baseline indicates an improvement in verbal recall and memory.

Time Frame

Baseline and Week 24

Title

Change From Baseline in Rey Complex Figure (RCF) Test Scores

Description

Time Frame

Baseline and Week 24

Title

Change From Baseline in Letter-Number Sequencing (LNS) Test Scores

Description

Time Frame

Baseline and Week 24

Title

Change From Baseline in Trail Making Test (TMT) Scores

Description

Time Frame

Baseline and Week 24

Title

Change From Baseline in the Stroop Color Word Test Scores

Description

Time Frame

Baseline and Week 24

Title

Change From Baseline to Week 24 Scores on the Beck Depression Inventory II (BDI-II) Questionnaire

Description

Time Frame

Baseline and Week 24

Title

Change From Baseline in Average Fasting Glucose Concentration in the Blood

Description

Time Frame

Baseline - Pre-dose and 30, 60, 90 and 120 minutes post glucose solution; Week 24 - Pre-dose and 30, 60, 90 and 120 minutes post glucose solution

Title

Change From Baseline in Average Fasting Insulin Concentration in the Blood

Description

Time Frame

Baseline - Pre-dose and 30, 60, 90 and 120 minutes post glucose solution; Week 24 - Pre-dose and 30, 60, 90 and 120 minutes post glucose solution

Title

Change From Baseline in Qualitative Insulin Sensitivity Check Index (QUICKI)

Description

The QUICKI is based on fasting glucose and insulin measurements and are calculated using the following equation: QUICKI = 1/[ log(fasting glucose in mg/dL) + log (fasting insulin in uU/mL) ]

Time Frame

Baseline and Week 24

Title

Change From Baseline in Insulin Sensitivity Index-Matsuda (ISI-Matsuda)

Description

Time Frame

Baseline and Week 24

Title

Change From Baseline in Total Blood Cholesterol Level

Description

A negative change from baseline indicates a decrease in total blood cholesterol level.

Time Frame

Baseline and Week 24

Title

Change From Baseline in Total Blood Low-density Lipoproteins (LDL) Level

Description

A positive change from baseline indicates an increase in total blood LDL level.

Time Frame

Baseline and Week 24

Title

Change From Baseline in Total Blood High-density Lipoproteins (HDL) Level

Description

A negative change from baseline indicates a decrease in total blood HDL level.

Time Frame

Baseline and Week 24

Title

Change From Baseline in Total Blood Triglycerides Level

Description

A negative change from baseline indicates a decrease in total blood triglycerides level.

Time Frame

Baseline and Week 24

Title

Change From Baseline in Gastro-esophageal Reflux Disease (GERD) Symptom Frequency Questionnaire (GSFQ) Scores

Description

Time Frame

Baseline and Week 24

Title

Change From Baseline in Gastrointestinal Symptom Rating Scale for Irritable Bowel Syndrome (GSRS-IBS) Questionnaire Scores

Description

Time Frame

Baseline and Week 24

Title

Change From Baseline in Swallowing Disturbance Questionnaire (SDQ) Scores

Description

Time Frame

Baseline and Week 24

Title

Change From Baseline in Short Form (36) (SF-36) Questionnaire Scores

Description

Time Frame

Baseline and Week 24

Title

Change From Baseline in Brief Pain Inventory (BPI) Questionnaire - Severity Scores

Description

Time Frame

Baseline and Week 24

Title

Change From Baseline in Brief Pain Inventory (BPI) Questionnaire - Interference Scores

Description

Time Frame

Baseline and Week 24

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria (list is not inclusive): A diagnosis of DM1, confirmed by DM1 genetic mutation Ability to walk 30 feet - assistance with cane and/or leg bracing permitted Able to self-administer study medication by subcutaneous injection or caregiver is available to administer study medication Exclusion Criteria (list is not inclusive): Congenital DM1 Weight greater than 100 kg or body mass index greater than 30 kg/m2 Prior treatment with glucocorticoids, anabolic steroids, testosterone, growth hormone, investigational agent within 60 days of screening Current diagnosis or history of malignancy expect for surgically cured skin cancer or pilomatricoma Changes in lipid lowering medications during the 3 months prior to screening Diaphragmatic weakness such that patients are unable to tolerate the supine position, or swallowing impairment such that patients are unable to maintain nutrition without use of gastrostomy. Major psychiatric illness (major depression, bipolar disorder or schizophrenia) within twelve months of screening History of non-compliance with other therapies

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Richard Moxley, M.D.

Organizational Affiliation

University of Rochester Neuromuscular Disease Center

Official's Role

Study Chair

Facility Information:

Facility Name

University of California Irvine Medical Center; MDA, ALS and Neuromuscular Center

City

Orange

State/Province

California

ZIP/Postal Code

92868

Country

United States

Facility Name

University of California, Davis

City

Sacramento

State/Province

California

ZIP/Postal Code

95817

Country

United States

Facility Name

University of Kansas Medical Center

City

Kansas City

State/Province

Kansas

ZIP/Postal Code

66160

Country

United States

Facility Name

Johns Hopkins Hospital

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21287

Country

United States

Facility Name

University of Minnesota

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55455

Country

United States

Facility Name

Washington University Medical School

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

Facility Name

University of Rochester, Neuromuscular Disease Center

City

Rochester

State/Province

New York

ZIP/Postal Code

14642

Country

United States

Facility Name

Ohio State University Medical Center

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43210

Country

United States

Facility Name

Oregan Health and Science University

City

Portland

State/Province

Oregon

ZIP/Postal Code

97239

Country

United States

Facility Name

Universit of Texas Medical Branch

City

Galveston

State/Province

Texas

ZIP/Postal Code

77555-0539

Country

United States

Facility Name

University of Texas Health Science Center

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Facility Name

University of Utah

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84112

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Safety and Efficacy Study of Recombinant Human Insulin-Like Growth Factor-I/Recombinant Human Insulin-Like Growth Factor Binding Protein-3 (rhIGF-I/rhIGFBP-3) In Myotonic Dystrophy Type 1

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