Status:
TERMINATED
A Multiple Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AVE8112 in Patients With Parkinson's Disease
Lead Sponsor:
Michael J. Fox Foundation for Parkinson's Research
Collaborating Sponsors:
Sanofi
Conditions:
Parkinson's Disease
Eligibility:
All Genders
35-70 years
Phase:
PHASE1
Brief Summary
This is a randomized, double-blind, placebo-controlled, multiple-ascending dose study of orally administered AVE8112 in patients with Parkinson's Disease (PD).
Detailed Description
This is a randomized, double-blind, placebo-controlled, multiple-ascending dose study of orally administered AVE8112 in patients with Parkinson's Disease (PD). Sequential cohorts of eight patients wit...
Eligibility Criteria
Inclusion
- Aged 35 to 70, inclusive, with a diagnosis of PD, currently being treated with a stable regimen (at least 4 weeks) of anti-parkinsonian drugs which include at least one L 3,4 dihydroxyphenylalanine (L DOPA)-containing therapy with or without dopamine agonist at Screening.
- Patients must have at least two of the following: resting tremor, bradykinesia, rigidity (must have either resting tremor or bradykinesia), or gait disturbances as assessed during physical/neurological exam at the Screening visit.
- A diagnosis of PD for 10 years or less at Screening.
- Hoehn and Yahr stage I - III.
- Male or female age 30 years or older at time of PD diagnosis.
- Body Mass Index (BMI) of approximately ≥18 to ≤32 kg/m2; and a total body weight \> 50 kg (l10 lbs).
- Female patients must be of non-childbearing potential.
Exclusion
- Clinically significant history or evidence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, neurological, immunological, or psychiatric disorder(s) as determined by the Investigator or designee.
- Female patients that are breastfeeding or female patients with a positive serum pregnancy test.
- Use of cholinergic medications or those with cholinergic effects.
- History of orthostatic hypotension or symptomatic drop in SBP.
- Any subject who has advanced Parkinson's Disease.
- Evidence of severe depression (score of \>10 on Quick Inventory of Depressive Symptomatology - Self Rated \[QIDS-SR\]).
- Personal and/or familial history of a significant suicide attempt.
Key Trial Info
Start Date :
January 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2015
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT01803945
Start Date
January 1 2013
End Date
June 1 2015
Last Update
October 6 2015
Active Locations (2)
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1
California Clinical Trials
Glendale, California, United States
2
PARAXEL International
Baltimore, Maryland, United States