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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 October 2015
• Main ID: NCT01803945
• Date of registration: 26/02/2013
• Prospective Registration: No
• Primary sponsor: Michael J. Fox Foundation for Parkinson's Research
• Public title: A Multiple Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AVE8112 in Patients With Parkinson's Disease
• Scientific title: A Multiple Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AVE8112 in Patients With Parkinson's Disease
• Date of first enrolment: January 2013
• Target sample size: 32
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT01803945
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
• Phase: Phase 1

Countries of recruitment

United States

Key inclusion & exclusion 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.



Age minimum: 35 Years
Age maximum: 70 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Parkinson's Disease

Intervention(s)

Drug: AVE8112

Drug: Placebo

Primary Outcome(s)

Maximum Tolerated Dose (MTD) [Time Frame: Continuous; Patients will be assessed for a period of 28 days]

Secondary Outcome(s)

Pharmacodynamics [Time Frame: Continuous; Patients will be assesed for a period of 28 days]

Pharmacokinetics [Time Frame: Continuous; Patients will be assessed for a period of 28 days]

Secondary ID(s)

MJFF AVE8112 MAD PD

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Sanofi