Phase 3
Completed N=752
Efficacy, Safety, and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients With Motor Fluctuations
Source: ClinicalTrials.gov NCT00368108 ↗Enrolled (actual)
752
Serious AEs
6.9%
Results posted
Feb 2013
Primary outcomePrimary: Mean Change From Baseline in Total Daily OFF Time (Hours) to Week 20 (Including Last Observation Carried Forward [LOCF] Data) — -0.96; -0.93; -0.76 Hours
Summary
This is a multi-center, randomized, double-blind, placebo-controlled, parallel-group study of E2007 in levodopa treated Parkinson's disease patients with motor fluctuations.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline in Total Daily OFF Time (Hours) to Week 20 (Including Last Observation Carried Forward [LOCF] Data) |
-0.96; -0.93; -0.76 | — |
| SECONDARY Mean Change From Baseline in Scale UPDRS Part II (ADL) Score in Total Daily OFF Time to Week 20 (Including LOCF Data) |
-0.85; -0.81; -1.40 | — |
| SECONDARY Mean Change From Baseline in UPDRS Part III (Motor) Score in ON State (Hours) to Week 20 (Including LOCF Data) |
-2.15; -1.69; -3.29 | — |
| SECONDARY Mean Change From Baseline in Total Daily ON Time (Without Dyskinesias or With Non-troublesome Dyskinesias) (Hours) to Week 20 (Including LOCF Data) |
0.73; 0.78; 0.28 | — |
Eligibility Criteria
INCLUSION CRITERIA
- Male or female patients with idiopathic Parkinson's Disease fulfilling the United Kingdom (UK) Parkinson's disease Society Brain Bank diagnostic criteria 7, with a good response to levodopa.
- Patients must have been diagnosed with idiopathic PD at > 30 years of age.
- Patients must have predictable motor fluctuations of the wearing "OFF" type.
- Patients must rate between II-IV on the Hoehn & Yahr scale when in an "OFF" state.
- Patients must be taking optimized levodopa therapy.
EXCLUSION CRITERIA
- Pregnant or lactating women.
- Women of child bearing potential unless infertile (including surgically sterile) or practicing effective contraception (eg, abstinence, intrauterine device or barrier method plus hormonal method). These patients must have a negative serum beta-human chorionic gonadotrophin (B-HCG) test at the Screening visit, and a negative urine pregnancy test at the Baseline visit (Day 0). These patients must also be willing to remain on their current form of contraception for the duration of the study. Postmenopausal women may be recruited but must be amenorrheic for at least one year to be considered of non-child bearing potential as determined by the Investigator.
- Patients with a past or present history of drug or alcohol abuse as per Diagnostic and Statistical Manual - 4th edition (DSM IV) criteria.
- Patients with a past (within one year) or present history of suicidal ideation or suicide attempts.
- Patients with unstable abnormalities of the hepatic, renal, cardiovascular, respiratory, gastro-intestinal, hematological, endocrine or metabolic systems which might complicate assessment of the tolerability of the study medication.
Data sourced from ClinicalTrials.gov (NCT00368108). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.