Huntington's Disease Clinical Trial
Official title:
Premanifest Huntington's Disease: Creatine Safety & Tolerability Extension Study
The purpose of this clinical trial is to extend the Pre-Crest study (Protocol # (NCT00592995) to further assess the long-term safety and tolerability of up to 30 grams daily creatine in individuals at-risk for Huntington's Disease (HD) and to assess whether biomarkers responsive to creatine in symptomatic individuals are informative in premanifest individuals over a longer duration.
Extensive evidence exists that neurodegeneration begins many years before HD can be diagnosed clinically. Therefore, it is most desirable to begin a neuroprotective therapy before or during this premanifest period with the aim of delaying onset, as well as slowing functional decline. Cellular energy depletion is present early in HD and can be ameliorated by creatine, which helps regenerate cellular ATP. Preclinical evidence for creatine's potential neuroprotective effects in animal models of HD has been well-documented. Before the clinical efficacy of creatine can be tested in premanifest HD, its long-term safety and tolerability must be assessed in these individuals and its ability to favorably modify biomarkers of HD should also be confirmed. This extension trial will continue to follow eligible individuals who completed the PreCREST study on open-label creatine (up to 30 grams daily) for long term safety and tolerability. Additional biological and imaging biomarkers of disease progression and potential response to treatment will also be assessed. ;
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04120493 -
Safety and Proof-of-Concept (POC) Study With AMT-130 in Adults With Early Manifest Huntington's Disease
|
Phase 1/Phase 2 | |
| Completed |
NCT02956148 -
Follow-up Measurement of Brain PDE10A Enzyme Levels in Huntington´s Disease Gene Expansion Carriers
|
Early Phase 1 | |
| Terminated |
NCT02494778 -
A Study Evaluating if Pridopidine is Safe, Efficacious, and Tolerable in Patients With Huntington's Disease
|
Phase 2 | |
| Completed |
NCT02197130 -
Randomized, Placebo Controlled Study Of The Efficacy And Safety Of PF-02545920 In Subjects With Huntington's Disease
|
Phase 2 | |
| Completed |
NCT02208934 -
Study To Assess the Safety and Tolerability of Single Ascending Oral Doses of PBF-999 in Healthy Young Male Volunteers
|
Phase 1 | |
| Completed |
NCT02216474 -
Brain Stimulation in Movement Disorders
|
N/A | |
| Completed |
NCT01806896 -
Study Evaluating The Safety, Tolerability And Brain Function Of 2 Doses Of PF-0254920 In Subjects With Early Huntington's Disease
|
Phase 2 | |
| Completed |
NCT01502046 -
Neuroprotection by Cannabinoids in Huntington's Disease
|
Phase 2 | |
| Terminated |
NCT00712426 -
Creatine Safety, Tolerability, & Efficacy in Huntington's Disease (CREST-E)
|
Phase 3 | |
| Completed |
NCT00670709 -
Examination of Quantitative Electroencephalographic (QEEG) Biomarkers in Huntington's Disease
|
||
| Completed |
NCT00029874 -
Minocycline in Patients With Huntington's Disease
|
Phase 1/Phase 2 | |
| Terminated |
NCT02231580 -
Study Exploring Safety, Pharmacokinetic and Pharmacodynamic of BN82451 in Male Huntington's Disease Patients
|
Phase 2 | |
| Completed |
NCT02215616 -
A Clinical Study in Participants With Huntington's Disease (HD) to Assess Efficacy and Safety of Three Oral Doses of Laquinimod
|
Phase 2 | |
| Not yet recruiting |
NCT02551705 -
Functional Imaging of Social Cognition in Premanifest Huntington's Disease
|
N/A | |
| Active, not recruiting |
NCT02101957 -
Multicentric Trial of the Treatment of Huntington's Disease by Cysteamine (RP103)
|
Phase 2/Phase 3 | |
| Completed |
NCT00975481 -
A Study To Evaluate The Abuse Potential Of Single Oral Doses Of Dimebon (Latrepirdine) In Healthy Recreational Polydrug Users
|
Phase 1 | |
| Completed |
NCT01521832 -
Escalating Dose Study in Healthy Volunteers With SEN0014196
|
Phase 1 | |
| Completed |
NCT00990613 -
A Study Evaluating The Absorption Of Dimebon Into The Body From A Dimebon Solution Applied To The Skin
|
Phase 1 | |
| Completed |
NCT00387270 -
Safety Study of the Novel Drug Dimebon to Treat Patients With Huntington's Disease
|
Phase 1/Phase 2 | |
| Completed |
NCT00095355 -
Effects of Lithium and Divalproex`on Brain-Derived Neurotrophic Factor in Huntington's Disease
|
Phase 2 |