NCT01803945

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).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jan 2013

Typical duration for phase_1

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 26, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 4, 2013

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

October 6, 2015

Status Verified

April 1, 2015

Enrollment Period

2.4 years

First QC Date

February 26, 2013

Last Update Submit

October 2, 2015

Conditions

Parkinson's Disease

Keywords

Parkinson's diseasecognitive impairmentmovement disorder

Outcome Measures

Primary Outcomes (1)

  • Maximum Tolerated Dose (MTD)

    Continuous; Patients will be assessed for a period of 28 days

Secondary Outcomes (2)

  • Pharmacodynamics

    Continuous; Patients will be assesed for a period of 28 days

  • Pharmacokinetics

    Continuous; Patients will be assessed for a period of 28 days

Study Arms (2)

Placebo Group

PLACEBO COMPARATOR

Sequential cohorts of eight patients with PD will be administered ascending oral doses of AVE8112 (n=6) or placebo (n=2) once a day for 14 days. Patients will be assessed in clinic for 30 hours following the initial oral dose of AVE8112 or placebo

Drug: Placebo

AVE8112

ACTIVE COMPARATOR

Sequential cohorts of eight patients with PD will be administered ascending oral doses of AVE8112 (n=6) or placebo (n=2) once a day for 14 days. Dosing for subsequent cohorts will only proceed, and the dose level selected, after the safety and tolerability of the previous cohort has been reviewed. Doses are planned to be 1.0, 2.0, 3.0, and 4.0 mg once a day for 14 days. These are planned treatments, but doses may be modified based on safety review of previous cohort(s). In addition, cohorts may be added to reconfirm a previously administered dose, and/or a titration strategy may be employed to reach a desired dose. Patients will be assessed in clinic for 30 hours following the initial oral dose of AVE8112 or placebo

Drug: AVE8112

Interventions

AVE8112DRUG
AVE8112
PlaceboDRUG
Placebo Group

Eligibility Criteria

Age35 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

California Clinical Trials

Glendale, California, United States

Location

PARAXEL International

Baltimore, Maryland, United States

Location

MeSH Terms

Conditions

Parkinson DiseaseCognitive DysfunctionMovement Disorders

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesSynucleinopathiesNeurodegenerative DiseasesCognition DisordersNeurocognitive DisordersMental Disorders

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 26, 2013

First Posted

March 4, 2013

Study Start

January 1, 2013

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

October 6, 2015

Record last verified: 2015-04

Locations

US(2)