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Tyrosine Kinase Inhibitor
Group 1 for Huntington's Disease (Tasigna HD Trial)
Phase 1
Waitlist Available
Research Sponsored by Georgetown University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Written informed consent
Capable of providing informed consent and complying with study procedures. Subjects who are unable to provide consent may use a Legally Authorized Representative (LAR).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights
Tasigna HD Trial Summary
This study is evaluating whether nilotinib may have positive impacts for individuals with Parkinson's disease.
Tasigna HD Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTasigna HD Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
CSF levels of biomarkers linked to Disease symptoms Chorea and behavioral symptoms
Number of participants experiencing any Adverse events and Serious Adverse Events
Number of participants tolerating the drug by the ability of remaining on treatment
Side effects data
From 2014 Phase 3 trial • 267 Patients • NCT0127519628%
Thrombocytopenia
27%
Leukopenia
23%
Platelet count decreased
22%
Lipase increased
21%
White blood cell count decreased
19%
Nasopharyngitis
19%
Eyelid oedema
14%
Anaemia
14%
Neutropenia
14%
Diarrhoea
13%
Hypophosphataemia
13%
Rash
12%
Alanine aminotransferase increased
12%
Neutrophil count decreased
11%
Haemoglobin decreased
11%
Pyrexia
11%
Vomiting
11%
Nausea
10%
Upper respiratory tract infection
10%
Hypokalaemia
9%
Blood creatine phosphokinase increased
8%
Hypertriglyceridaemia
8%
Blood phosphorus decreased
8%
Face oedema
7%
Aspartate aminotransferase increased
7%
Arthralgia
7%
Cough
6%
Myalgia
6%
Blood bilirubin increased
6%
Dizziness
5%
Influenza
4%
Hyperglycaemia
3%
Headache
3%
Hyperbilirubinaemia
2%
Abdominal pain upper
2%
Bilirubin conjugated increased
2%
Low density lipoprotein increased
2%
Apolipoprotein B increased
2%
Gamma-glutamyltransferase increased
2%
Hypercholesterolaemia
1%
Oesophageal squamous cell carcinoma
1%
Ovarian rupture
1%
Thrombocytosis
1%
Anal abscess
1%
Ankle fracture
1%
Blast cell count increased
1%
Intervertebral disc protrusion
1%
Cervix carcinoma stage 0
1%
Non-Hodgkin's lymphoma recurrent
1%
Cerebral haemorrhage
1%
Hydrothorax
1%
Thrombocytopenic purpura
1%
Bone marrow failure
1%
Granulocytopenia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Imatinib 400 mg qd
Nilotinib 300 mg Bid
Tasigna HD Trial Design
1Treatment groups
Experimental Treatment
Group I: Group 1Experimental Treatment1 Intervention
Ten (10) participants will receive an oral dose of 150mg Nilotinib once daily for 3 months (group 1). If Nilotinib 150 mg per mouth daily dose is tolerated by the 1st group of 10 participants for 3 months, another 10 participants will receive an oral dose of 300mg Nilotinib once daily (group 2) for 3 months.
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Who is running the clinical trial?
Georgetown UniversityLead Sponsor
341 Previous Clinical Trials
126,492 Total Patients Enrolled
Frequently Asked Questions
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