Phase 2
N=10
Creatine Safety & Tolerability in Huntington's Disease
Huntington's Disease (HD)
Bottom Line
View on ClinicalTrials.gov: NCT01412151 ↗Enrolled (actual)
10
Serious AEs
40.0%
Results posted
Dec 2012
Primary outcome: Primary: Tolerability — 5 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Creatine monohydrate (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Nov 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Tolerability |
5 | — |
| SECONDARY Clinical Measures Resources Not Available to Complete Secondary Analyses. |
— | — |
| SECONDARY Biological Markers of Disease Progression |
— | — |
Summary
The purpose of this study is to extend findings from the creatine dose-finding study (CREST-UP1) in Huntington's disease to evaluate the long-term safety, tolerability, and clinical impact of high dose creatine.
Eligibility Criteria
Inclusion Criteria
- Individuals who have completed the CREST-UP1 study.
- Individuals who are able to take oral medication.
- Individuals capable of providing informed consent and complying with trial procedures.
Exclusion Criteria
- History of known sensitivity or intolerability to creatine.
- Clinical evidence of unstable medical illness in the investigator's judgment.
Additional eligibility criteria apply.
Data sourced from ClinicalTrials.gov (NCT01412151). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.