Use of Zolpidem in Parkinson's Disease

NCT01351168 | Withdrawn Phase 2

• 1 other identifier: ZOL-PD
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Levodopa treatment is associated with long-term complications. Dopamine deficiency is associated with abnormal activity in certain parts of the brain. Zolpidem may change this abnormal activity and, by doing so, may work in a different way than levodopa to help parkinsonism. The working hypothesis for this aim is that ZLP is superior to placebo in acutely improving motor symptoms of PD. The investigators will conduct a randomized,controlled, double-blind, cross-over study in 40 patients with PD. Each patient will receive placebo, levodopa and 2 doses of ZLP in a randomized order on 4 different occasions, about one week apart.

Conditions

Parkinson's Disease

Keywords

Parkinson's disease; zolpidem

Outcome Measures

Primary Outcomes (1)

• UPDRS

  Unified Parkinson's Disease Rating Scale

  Subjects rated using the UPDRS at the Screening visit and then at each of the 4 study visits (1-2 weeks apart). During the study visits subjects will be rated every 30 minutes until they return to baseline.

Study Arms (4)

Sugar pill

PLACEBO COMPARATOR

Drug: sugar pill

Levodopa

ACTIVE COMPARATOR

Drug: Levodopa

Zolpidam second dose

EXPERIMENTAL

Drug: Zolpidem second dose

Zolpidam first dose

EXPERIMENTAL

Drug: Zolpidem first dose

Interventions

Levodopa DRUG

CD/LD 25/100, 2 tablets test dose based on subject's current CD/LD dosing; single randomized testing day

Also known as: Sinemet

Levodopa

Zolpidem first dose DRUG

Zolpidem will be given at 10 mg on randomized testing day. The randomization is such that the first dose of Zolpidem given to any subject will always be 10 mg

Also known as: Ambien

Zolpidam first dose

Zolpidem second dose DRUG

Zolpidem will be given at 7.5mg or 15 mg depending on the response from the first zolpidem dose.

Also known as: Ambien

Zolpidam second dose

sugar pill DRUG

a sugar pill (placebo) will all be given orally in identical capsules to the other study drugs

Also known as: Placebo

Sugar pill

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects will have Idiopathic Parkinson's disease according to diagnostic criteria of the United Kingdom Parkinson's Disease Society Brain Bank.
• Subjects will be capable and willing to provide written informed consent prior to participation.
• Subjects will be ambulatory (in ON- and OFF-states) men and women, between the ages of 30 and 75 years.
• Subjects will be on levodopa therapy, with a good response and indisputable motor fluctuations.
• All other PD medications are allowed.
• Subjects will be on a stable regimen of PD medications for 2 weeks prior to screening.
• Subjects will be required to come with a caregiver who can accompany the subject to/from each study visit. Note: Subjects will not be allowed to drive home.
• Female subjects will be advised to use adequate birth control throughout the study as the effects of ZLP on the fetus are unknown. Adequate birth control methods include surgical sterilization, a partner who has had a vasectomy, oral contraceptives, condom plus spermicidal cream/jelly, cervical cap plus spermicidal cream/jelly, diaphragm plus spermicidal cream/jelly, or intrauterine device (in place for at least 3 months) plus spermicidal cream/jelly. Abstinence is considered an acceptable contraceptive regimen. If a subject becomes pregnant during the study, it is important that they contact the study physician immediately.

You may not qualify if:

• Neurodegenerative diseases.
• Tremor predominant PD, with a score of \> 2 in more than one body part.
• Inability to tolerate being off levodopa for 12 hours.
• A score on the Montreal Cognitive Assessment (MoCA) of less than 26.
• Pregnancy or lactation.
• History of drug or alcohol abuse.
• Known or suspected sensitivity to the investigational study drugs.
• Other known medical or psychiatric condition that may compromise participation in the study or that judged by the site investigator could disqualify a subject from entering the study.
• Participation in another investigational drug study whereby they received experimental drug \< 30 days prior to start of this study.

Sponsors & Collaborators

• Rush University Medical Center: lead

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Levodopa; carbidopa, levodopa drug combination; Zolpidem; Sugars

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Dihydroxyphenylalanine; Catecholamines; Amines; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins; Tyrosine; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbohydrates

Study Officials

• Leo Verhagen, MD PhD

  Rush University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: May 9, 2011
• First Posted: May 10, 2011
• Last Updated: December 3, 2012

Record last verified: 2012-11

Locations

US (1)