A phase 1, randomized, double blind, placebo controlled, multiple ascending dose, safety and pharmacodynamic study of MDV1634 in patients with Parkinson*s disease.

A phase 1, randomized, double blind, placebo controlled, multiple ascending dose, safety and pharmacodynamic study of MDV1634 in patients with Parkinson*s disease. - MAD study with MDV1634 in patients with Parkinson*s disease.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON42429

Enrollment

Registered

2015-05-06

Start date

2015-06-01

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

paralysis agitans Parkinson's disease

Interventions

MDV1634 or placebo.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Male and female volunteers Parkinson disease 30-75 years of age BMI 18-35 kg/m2, inclusive

Exclusion criteria

Exclusion criteria: CYP2D6 genotype indicating poor or intermediate metabolizer status; Montreal Cognitive Assessment score

Design outcomes

Primary

Measure	Time frame
To evaluate the safety and tolerability of MDV1634 in patients with Parkinson*s disease.	—

Secondary

Measure	Time frame
To evaluate the pharmacokinetics of MDV1634 in patients with Parkinsons disease To evaluate the effect of MDV1634 on biomarkers of Parkinsons disease. To evaluate the relationship between MDV1634 pharmacokinetics and biomarkers and/or safety outcomes in patients with Parkinson*s disease.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)