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STUDY PHASE 2, DOUBLE-BLIND, DOSE SEARCH, CONTROLLED WITH PLACEBO TO EVALUATE THE SAFETY AND EFFICACY OF SCH 420814 AS A MONOTHERAPY IN SUBJECTS WITH EARLY PARKINSON DISEASE.

STUDY PHASE 2, DOUBLE-BLIND, DOSE SEARCH, CONTROLLED WITH PLACEBO TO EVALUATE THE SAFETY AND EFFICACY OF SCH 420814 AS A MONOTHERAPY IN SUBJECTS WITH EARLY PARKINSON DISEASE.

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
REPEC
Registry ID
PER-037-03
Enrollment
Unknown
Registered
2003-07-31
Start date
Unknown
Completion date
Unknown
Last updated
2023-09-04

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

Conditions

None listed

Interventions

SCH 420814 5 mg Type of group
A 5 mg capsule of SCH 420814 + 3 placebo capsules will be administered in the morning. Group name:placebo Type of group
Four placebo capsules in the morning.

Sponsors

SCHERING PLOUGH RESEARCH INSTITUTE,
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. The subjects must be at least 30 years old, they can be both sexes and of any race. 2. Must have a diagnosis of mild idiopathic Parkinson´s disease according to what is defined by the Hoehn and Yahr criteria. 3. Women should not be able to conceive. 4. They must be candidates for symptomatic therapy. 5. Subjects may have received a dopamine or L-dopa agonist as monotherapy for no more than 6 months before selection. 6. Subjects receiving a dopamine or L-dopa agonist should relize gradually of said medication before randomization. 7. Those who receive selegiline, amantadine, coenzyme Q10 and / or anticholinergics must remain on a stable regimen for at least 4 weeks before of the selection. The subjects must stay in the stable regime throughout the study.

Exclusion criteria

Exclusion criteria: 1. Subjects who have any form of atypical parkinsonism or drug induced. 2. Subjects with any form of dementia (score 20 mm Hg after 2 minutes. 7. Subjects with the following PS measurements at any time during the course of the study (confirmed by a second measurement).

Design outcomes

Primary

MeasureTime frame
Outcome name:the score of part III (motor score) of the UPDRS. Duration of clinical effect. Moment of initiation with a dopamine agonist or L-dopa. Measure:Average change from the beginning to the end of the treatment in the score of part III (motor score) of the UPDRS at the time point of 1 hour after the dose. Timepoints:6 weeks—

Secondary

MeasureTime frame
Outcome name:Score of part II of the UPDRS Measure:Average change with respect to the start in part II of the UPDRS. Timepoints:6 weeks—

Countries

Argentina, Australia, Chile, Colombia, Costa Rica, Guatemala, South Africa, United States

Contacts

Public ContactJorge Timoteo

SCHERING PLOUGH DEL PERU S.A.

jorge.timoteo@spcorp.com710-3653

Outcome results

None listed

Source: REPEC (via WHO ICTRP)