A Multiple Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AVE8112 in Patients With Parkinson's Disease

• Status: Terminated
• Trial end date: 2015-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a randomized, double-blind, placebo-controlled, multiple-ascending dose study of orally administered AVE8112 in patients with Parkinson's Disease (PD).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Michael J. Fox Foundation for Parkinson's Research
• Collaborator: Sanofi

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.