KW-6002 to Treat Parkinson's Disease

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00006337
• Date of registration: 04/10/2000
• Prospective Registration: No
• Primary sponsor: National Institute of Neurological Disorders and Stroke (NINDS)
• Public title: KW-6002 to Treat Parkinson's Disease
• Scientific title: Adenosine A2A Blockade With KW-6002 in Parkinson's Disease
• Date of first enrolment: October 2000
• Target sample size: 16
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00006337
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

United States

Key inclusion & exclusion criteria

Males and females between the ages of 30-80.

Carry the diagnosis of idiopathic Parkinson's disease based on the presence of a
characteristic clinical history and neurologic findings.

Patients with relatively advanced disease (Hohen and Yahr stage II-IV in the off state).

Patients with Parkinson's disease who have been treated with levodopa for at least one
year.

Patients with Parkinson's disease who require levodopa/carbidopa dosing at qid or more
frequent intervals.

Will have been receiving a stable regimen of treatment for Parkinson's disease for at
least 4 weeks prior to study admission.

Patients with Parkinson's disease who have associated motor response complications,
including wearing-off fluctuations and peak-dose dyskinesias.

Must be able to provide written informed consent.

Patients with non-idiopathic parkinsonism or parkinsonian variants (e.g. juvenile
Parkinson's disease; atypical parkinsonism; secondary parkinsonism; progressive
supra-nuclear palsy; Shy-Drager syndrome; olivopontocerebellar atrophy will be excluded.

Patients with a clinically significant illness of any organ system, including hepatic,
renal, pancreatic, cardiovascular, endrocrinologic, gastrointestinal, respiratory, and
neurologic system (except for those with Parkinson's disease) who may require a change in
the treatment of that illness during the trial, or that may compromise the safety of the
patient volunteer during the trial, or that may affect the ability of the volunteer to
complete the trial will be excluded.

No presence or history of any medical condition that can reasonably be expected to subject
the patient to unwarranted risk, including cancer (except basal cell carcinoma or
surgically excised carcinoma in situ of the cervix) as well as liver or pancreatic enzyme
test results above the upper limit of normal.

Patients who have had bilateral intracranial neurosurgical procedures such as nuclear
ablation, stimulator implantation or tissue transplantation will be excluded.

Patients with a history of seizures, including one or more infantile febrile seizures, or
with a history of neuroepileptic malignant syndrome will be excluded.

Patients who, for any reason, are judged by the investigator to be inappropriate for the
study (including volunteers who are unable to communicate or to cooperate with the
investigator) will be excluded.

Patients with significant dementia (MMSE 25 or less), major psychotic illness, history of
drug or alcohol abuse within past two years, and those who require drug therapy for a
DSM-IV major depressive episode will be excluded.

Patients who satisfy DSM-IV criteria for alcohol or other drug abuse or dependence within
two years of being exposed to KW-6002 will be excluded.

Patients who have been treated with a centrally acting dopamine antagonist drug, including
neuroleptic agents, metoclopramide and buspirone within three months (within six months
for depot formulations) because of the potential liability for extrapyramidal side effects
will be excluded.

Patients taking nonselective monoamine oxidase inhibitors (phenelzine, isocarboxazid,
tranylcypromine) will be excluded.

Patients who have taken terfenadine, astemizole, cisapride, simvastatin, lovastatin,
felodipine, or nifedipine within seven days before being exposed to KW-6002 will be
excluded.

Patients who have previously been exposed to KW-6002 or who have been treated with any
other investigational agents within 12 weeks (or within five half-lives for
investigational agents with a half-life of longer than 2 weeks) of being exposed to
KW-6002 will be excluded.

Patients with unacceptable prior/concomitant medications as will patients who have taken
an investigational drug within the 2 months prior to randomization will be excluded.

Pregnant will be excluded.

Females who are of childbearing potential must be using a reliable method of contraception
at the time they agree to study participation and must agree to continue using a reliable
method of contraception include hormonal products (e.g. approved oral contraceptives or
long-term injectable or implantable contraceptives), double barrier methods (e.g. condom
plus diaphragm; condom plus spermicidal foam; condom plus spermicidal sponge). an
intra-uterine device or tubal ligation.

All female volunteers of child-bearing potential must have a negative urine pregnancy test
on the day before first exposure to KW-6002.

No patients taking any medications listed in Section 6.2, Forbidden Medications.



Age minimum: N/A
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Parkinson's Disease

Intervention(s)

Drug: IV Levodopa

Drug: KW-6002

Secondary ID(s)

010001

01-N-0001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors