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AN EXTENSION OF THE MONDRIAN STUDY: OPEN SAFETY EXTENSION OF STUDY SLV308 S308.3.002 IN PATIENTS WITH PARKINSON DISEASE EXPERIENCING MOTOR FLUCTUATIONS

AN EXTENSION OF THE MONDRIAN STUDY: OPEN SAFETY EXTENSION OF STUDY SLV308 S308.3.002 IN PATIENTS WITH PARKINSON DISEASE EXPERIENCING MOTOR FLUCTUATIONS

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REPEC
Registry ID
PER-070-07
Enrollment
30
Registered
2007-10-24
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

SLV308 Type of group
Oral gelatin capsules of-SLV308
Placebo Type of group
Placebo orally for 36 months

Sponsors

SOLVAY PHARMACEUTICALS,
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: • Subjects who have signed informed consent to participate in the safety extension study. • Subjects who have completed study S308.3.002.

Exclusion criteria

Exclusion criteria: • Subjects with abnormal medically significant results [electrocardiogram (ECG, physical examination, EA) at the end of the maintenance phase (Visit M3 Week 12 maintenance) of study S308.3.002.

Design outcomes

Primary

MeasureTime frame
Outcome name:To measure the motor state (time ON / OFF and dyskinesias) the diaries of the subject are used to complete at home. Measure:Reduction of the OFF time recorded in the newspaper of the subject. Timepoints:During the study—

Secondary

MeasureTime frame
Outcome name:Adverse events, concomitant medications, vital signs, physical examination, ECG and laboratory evaluations. Measure:Safety and tolerability Timepoints:During the study—

Contacts

Public ContactGabriela Celina Loyola

IQVIA RDS Peru S.R.L

gabriela.loyola@quintiles.com222-0060 anexo 20

Outcome results

None listed

Source: REPEC (via WHO ICTRP)