NIPH Clinical Trials Search

Basic Information

Recruitment status
Health condition(s) or Problem(s) studied	Parkinson's disease
Date of first enrollment	12/09/2005
Target sample size
Countries of recruitment
Study type	Interventional
Intervention(s)	investigational material(s) Generic name etc : AD-810N (zonisamide) INN of investigational material : Therapeutic category code : 116 Antiperkinsonism agents Dosage and Administration for Investigational material : oral

Outcome(s)

Primary Outcome	[Efficacy]Primary variable- Unified Parkinson's Disease Rating Scale (UPDRS) Part III total score [Safety]- Adverse events
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum	>= 20age old
Age maximum	<= 79age old
Gender	Both
Include criteria	[Major inclusion criteria] 1) Patients who have been treated with L-DOPA for 6 months or longer with sufficient effects observed from the beginning of administration and have received the L-DOPA at a constant dose for at least 6 weeks prior to the start of administration of the investigational drug (4 weeks after the start of the observation period) 2) Age: >=20 and <80 3) Gender: Male or Female 4) Inpatient/Outpatient status: Either 5) Patients who have given written informed consent 6) Patients who can comply with the study schedule [Major exclusion criteria] 1) Patients with Parkinson's syndrome other than Parkinson's disease 2) Patients with epilepsy 3) Patients with a history of treatment with zonisamide (including those currently receiving zonisamide) 4) Patients with a complication or having a medical history of serious hepatic diseases 5) Patients with serious cardiac or renal disease, or who have other serious complications 6) Patients with psychiatric symptoms, such as serious confusion, hallucinations, delusions, abnormal behavior 7) Patients with severe dementia 8) Patients with history of neuroleptic malignant syndrome 9) Pregnant women, women possibly pregnant, women who wished to become pregnant and nursing women 10) Patients with cancer and/or a history of cancer 12) Patients otherwise considered by the investigator or subinvestigator to be ineligible for participation in the study
Exclude criteria