A Fourteen-Week Placebo-Controlled Dose-Response Efficacy and Safety Study of NS 2330 in Early Parkinson's Disease Patients (Study for Proof of Concept in Early Parkinson's Disease of a Triple Reuptake Inhibitor, NS 2330 / SCEPTRE)

Boehringer Ingelheim logo

Boehringer Ingelheim

Status and phase

Completed
Phase 2

Conditions

Parkinson Disease

Treatments

Drug: NS 2330

Study type

Interventional

Funder types

Industry

Identifiers

NCT00148486
1198.100

Details and patient eligibility

About

To demonstrate efficacy and dose-response of NS 2330 versus placebo in patients with early Parkinson's Disease in 14 weeks of treatment, and to investigate the safety and tolerability of NS 2330 in these patients.

Sex

All

Ages

40 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Parkinson's disease for <5 years, non-demented, no or <6 months of levodopa and none during trial. Off levodopa, DA agonists, and psychotropics for 30 days before screening. Amantadine, anticholinergics allowed if at stable dosage. Hoehn & Yahr stage I-III. Depression allowed, but no other chronic disease that is unstable or might interfere with ability to participate.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

Trial contacts and locations

55

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Data sourced from clinicaltrials.gov

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