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Trial record 33 of 184 for:    "huntington disease"

Creatine Safety & Tolerability in Huntington's Disease (CREST-X)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01412151
Recruitment Status : Completed
First Posted : August 9, 2011
Results First Posted : December 28, 2012
Last Update Posted : March 9, 2018
Sponsor:
Information provided by (Responsible Party):
Steven M. Hersch, Massachusetts General Hospital

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Huntington's Disease (HD)
Intervention Drug: Creatine monohydrate
Enrollment 10
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Creatine Monohydrate
Hide Arm/Group Description Twice daily with a meal mixed in a liquid for a total daily dosage of 30 grams. Daily dosage adjustments (e.g. reductions, suspensions, rechallenges) were allowed to manage adverse events.
Period Title: Week 0 - 306 - Treatment Period
Started 10
Completed 5
Not Completed 5
Reason Not Completed
Death             1
Withdrawal by Subject             1
Withdrawal by Investigator             3
Period Title: Week 306 - 310 - Washout Period
Started 5
Completed 3
Not Completed 2
Reason Not Completed
Withdrawal by Subject             2
Arm/Group Title Creatine Monohydrate
Hide Arm/Group Description Twice daily with a meal mixed in a liquid for a total daily dosage of 30 grams. Daily dosage adjustments (e.g. reductions, suspensions, rechallenges) were allowed to manage adverse events.
Overall Number of Baseline Participants 10
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
<=18 years
0
   0.0%
Between 18 and 65 years
10
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants
48.2  (8.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
Female
5
  50.0%
Male
5
  50.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 10 participants
10
1.Primary Outcome
Title Tolerability
Hide Description Proportion of subjects able to complete treatment
Time Frame 306 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Creatine Monohydrate
Hide Arm/Group Description:
Twice daily with a meal mixed in a liquid for a total daily dosage of 30 grams. Daily dosage adjustments (e.g. reductions, suspensions, rechallenges) were allowed to manage adverse events.
Overall Number of Participants Analyzed 10
Measure Type: Number
Unit of Measure: Participants
5
2.Secondary Outcome
Title Clinical Measures Resources Not Available to Complete Secondary Analyses.
Hide Description

Components of the UHDRS (Unified Huntington Disease Rating Scale)

data was not collected or analyzed for this outcome measure.

Time Frame 310 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
data was not collected or analyzed for this outcome measure.
Arm/Group Title Creatine Monohydrate
Hide Arm/Group Description:

Creatine monohydrate: Creatine taken twice daily for a total of 30 grams daily dosage or subject's highest tolerated dose.

Data not analyzed.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Biological Markers of Disease Progression
Hide Description Biological indicators that creatine treatment might affect the progression of HD: serum creatine levels, neuroimaging, metabolomic and gene expression analysis
Time Frame 310 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
data was not collected or analyzed for this outcome measure.
Arm/Group Title Creatine Monohydrate
Hide Arm/Group Description:
Creatine monohydrate: Creatine taken twice daily for a total of 30 grams daily dosage or subject's highest tolerated dose
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 310 Weeks
Adverse Event Reporting Description Adverse events were assessed clinically (symptoms reported by the subject or signs detected on examination/through ancillary testing - vital signs, EKG, laboratory tests etc). Stable chronic conditions (e.g. diabetes, arthritis) present prior to the start of the study that did not worsen during the trial were not considered adverse events.
 
Arm/Group Title Creatine Monohydrate
Hide Arm/Group Description Twice daily with a meal mixed in a liquid for a total daily dosage of 30 grams. Daily dosage adjustments (e.g. reductions, suspensions, rechallenges) were allowed to manage adverse events.
All-Cause Mortality
Creatine Monohydrate
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Creatine Monohydrate
Affected / at Risk (%) # Events
Total   4/10 (40.00%)    
Gastrointestinal disorders   
Small Intestinal Obstruction *  1/10 (10.00%)  1
Infections and infestations   
Cellulitis *  1/10 (10.00%)  1
Pneumonia *  2/10 (20.00%)  2
Sepsis *  1/10 (10.00%)  1
Skin Infection *  1/10 (10.00%)  1
Psychiatric disorders   
Agitation *  1/10 (10.00%)  1
Depression with Suicidal Ideation *  1/10 (10.00%)  1
Respiratory, thoracic and mediastinal disorders   
Pneumonia Aspiration *  1/10 (10.00%)  1
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Creatine Monohydrate
Affected / at Risk (%) # Events
Total   9/10 (90.00%)    
Gastrointestinal disorders   
Diarrhea *  5/10 (50.00%)  7
Infections and infestations   
Infection *  1/10 (10.00%)  5
Injury, poisoning and procedural complications   
Fall *  7/10 (70.00%)  9
Psychiatric disorders   
Agitation *  5/10 (50.00%)  9
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Steven M. Hersch, MD, PhD
Organization: Massachusetts General Hospital
Phone: 617-726-1254
Publications:
Responsible Party: Steven M. Hersch, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01412151     History of Changes
Other Study ID Numbers: 2005P000530
First Submitted: August 5, 2011
First Posted: August 9, 2011
Results First Submitted: November 28, 2012
Results First Posted: December 28, 2012
Last Update Posted: March 9, 2018