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

Stopped early · Phase 1 · Has a placebo group

Conditions studied: Parkinson's Disease

In brief

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

Key facts

Study ID

NCT01803945

Run by

Michael J. Fox Foundation for Parkinson's Research

People needed

32

Starts

2013-01-01

Expected to finish

2015-06-01

Last updated by the study team

2015-10-06

Who can join

Age: 35 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• California Clinical Trials — Glendale, California, United States
• PARAXEL International — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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