At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 23 enrolled
Drug / intervention
pridopidine (90 mg)drug
Likely dose
pridopidine 90 mg single dose (Cohort 1); optional lower doses 0.5–45 mg in Cohorts 2–3AI-extracted
Key inclusion· 3
- ✓Good physical health by medical and psychiatric history, with suicidality assessment and physical examination
- ✓Men who are potentially fertile (not surgically or congenitally sterile)
- ✓For HD patients: confirmed diagnosis of Huntington's disease with onset after age 18
Key exclusion· 6
- ✕Prior ionizing radiation or radioactive substance exposure from clinical research or medical treatment within past 10 years
- ✕MRI contraindication
- ✕History of alcohol, narcotic, or other substance dependence within past 2 years
- ✕Severe motor impairment that might cause imaging artifacts (HD patients)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase I, Open-Label, Single-Dose, Adaptive (S)-(-)-[18F]Fluspidine and [18F]Fallypride Positron Emission Tomography Study to Evaluate Sigma-1 and Dopamine-2 Receptor Occupancy by Pridopidine in the Human Brain of Healthy Volunteers and in Patients With Huntington's Disease
In Brief
A Phase 1 clinical trial evaluating pridopidine (90 mg) for Health Volunteers, Huntington Disease. Completed, enrolled 23 participants across 1 site.
Detailed Summary
The purpose of this study is to demonstrate engagement of pridopidine with S1R and D2R (optional) in the living human brain. No formal statistical analysis will be conducted
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealth Volunteers, Huntington Disease
CountriesGermany
Collaborators--
Timeline
Phase 1CompletedFinished
2017201820192020202120222023202420252026
First PostedJan 2017
Enrollment StartApr 2017
Primary CompletionFeb 2018
TodayJul 2026
First PostedJan 12, 2017
Enrollment StartApr 19, 2017
Primary CompletionFeb 9, 2018
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 9.5 years ago
Interventions
pridopidine (90 mg)drug
single dose will be administered in Cohort 1. Other optional cohorts 2 and 3 may include single dose 0.5 mg, 1 mg, 2.5 mg, 5 mg, 10 mg, 22.5 mg, 45 mg, or 90 mg. The dose will be selected based on the results obtained from Cohorts 1 and 2.