Evaluation of the Long-Term Safety, Tolerability, and Efficacy of Perampanel (E2007) as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Subjects With Motor Fluctuations
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This is a multicentre, open-label extension study to evaluate the long-term safety, tolerability, and efficacy of Perampanel (E2007) as an adjunctive therapy in levodopa treated PD subjects with motor fluctuations. All subjects who have completed E2007-E044-213 or E2007-G000-309 will be candidates for entering this extension trial, provided that they meet the inclusion/exclusion criteria and have completed the core study, up to and including the final efficacy visit.
Condition | Intervention | Phase |
---|---|---|
Parkinson's Disease |
Drug: Perampanel |
Phase 3 |
Study Type: | Interventional |
Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
Official Title: | A Multi-Centre, Open Label Extension Study to Evaluate the Long-Term Safety, Tolerability, and Efficacy of Perampanel (E2007) as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Subjects With Motor Fluctuations |
- The long-term safety and tolerability of Perampanel (E2007) in subjects with Parkinson's disease (PD) who experience end-of-dose "wearing off" motor fluctuations.
- Long-term, 1-year maintenance of Perampanel (E2007) efficacy in subjects with PD who experience end-of-dose "wearing-off" motor fluctuations including the duration of OFF time during the waking day, and ON period dyskinesias.
Estimated Enrollment: | 726 |
Study Start Date: | July 2007 |
Study Completion Date: | April 2008 |
Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 30 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
INCLUSION CRITERIA:
Male or female subjects with idiopathic PD who have fulfilled the entry criteria to studies E2007-G000-309 or E2007-E044-213.
Subjects must have completed the core efficacy study up to and including the final efficacy and follow up visits as applicable.
Subjects with mild or moderate AEs thought to be related to Perampanel (E2007) can be entered into the study if the investigator considers it safe.
EXCLUSION CRITERIA:
- Show evidence of clinically significant disease (i.e., severe cardiovascular or pulmonary disease, bronchial asthma, endocrine disease, history of peptic ulcer disease, history of myocardial infarction with residual atrial nodal or ventricular arrhythmias) that, in the opinion of the investigator, could affect either the patient's safety or the conduct of the study.
- Pregnant or lactating women.
- Women of childbearing potential (WOCBP) unless infertile (including surgically sterile) or practicing effective contraception (e.g., intrauterine device [IUD] or barrier method plus hormonal method). These subjects must have a negative urine pregnancy test at Visit 1 or 2 as indicated by entry into the study. These subjects 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 amenorrhoeic for at least 1 year to be considered of non-child bearing potential as determined by the investigator.
- Subjects with a past (within the past 5 years) or present history of drug or alcohol abuse as per Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition (DSM IV) criteria.
- Antipsychotics are permitted as necessary. Subjects may be taking anti-depressant medication, however the dose must be stable for 4 weeks prior to their first study visit (the visit at which the inclusion and exclusion criteria are done with the patient).
- Subjects with a past (within one year) or present history of major depression, suicidal ideation, or suicide attempts.
- Subjects with unstable abnormalities of the hepatic, renal, cardiovascular, respiratory, gastrointestinal, haematological, endocrine, or metabolic systems that might complicate assessment of the tolerability of the study medication.
- Subjects with significantly elevated liver enzymes (abnormal bilirubin or serum transaminase levels of more than 1.5 times the upper limit of the normal range).
- Subjects with current or prior treatment (within 4 weeks prior to the Screening Visit) with medication known to induce the enzyme CYP3A4.
- Clinically significant ECG abnormality, and/or prolonged QTc (defined as QTc ≥ 450 msec).
- Current or prior treatment (within 4 weeks prior to entry visit) with tolcapone, methyldopa, budipine, or reserpine.
- Subjects with previous stereotactic surgery (e.g., pallidotomy) for PD or with planned stereotactic surgery during the study period
- Subjects receiving or with planned (next 12 months) deep brain stimulation.
- Subjects with conditions affecting the peripheral or central sensory system unless related to PD (such as mild sensory or pain syndromes limited to OFF periods) that could interfere with the evaluation of any such symptoms caused by the study medication.
- Subjects have received an investigational product (other than E2007 or entacapone 200 mg) within 4 weeks prior to Screening
- Any condition that could, in the opinion of the investigator, place the subject at increased risk or is likely to prevent completion of the study.
- Subjects with any condition that would make the subject, in the opinion of the investigator, unsuitable for the study.
- Patients on pergolide or cabergoline.
No publications provided
ClinicalTrials.gov Identifier: | NCT00505622 History of Changes |
Other Study ID Numbers: | E2007-G000-318 |
Study First Received: | July 9, 2007 |
Last Updated: | May 7, 2008 |
Health Authority: | European Union: European Medicines Agency Singapore: Health Sciences Authority Taiwan: Department of Health Hong Kong: Department of Health South Korea: Korea Food and Drug Administration (KFDA) Israel: Ministry of Health India: Drugs Controller General of India South Africa: Medicines Control Council |
Additional relevant MeSH terms:
Parkinson Disease Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Movement Disorders Neurodegenerative Diseases Levodopa |
Antiparkinson Agents Anti-Dyskinesia Agents Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on October 17, 2012