Randomized Single-blind Placebo Controlled Comparative Trial of Pramipexole and Bromocriptine in Parkinson's Disease

NCT00240409 | Completed Phase 3

• 1 other identifier: 248.516
• Study Type: interventional
• Target: 208
• Locations: 1 country
• Sites: 7

Brief Summary

The objective of this study was to investigate the efficacy and safety of Pramipexole Tablets in patients with Parkinson's disease (who can be treated with L-DOPA concomitantly) in a single blind, comparative method using Bromocriptine tablets as comparators (phase III comparative trial)

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

• Totalled score according to Part III of UPDRS (motor examination) Totalled score according to Part II of UPDRS (activities of daily living)

Secondary Outcomes (1)

• Totalled score of UPDRS Part IV, UPDRS Part I, the Modified Hoehn and Yahr Staging, Parkinson Dyskinesia Scale, and patient records.

Interventions

Pramipexole DRUG

Bromocriptine DRUG

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 30-80 years
• Patients with idiopathic Parkinson's disease corresponding to stages II-IV according to the classification of Hoehn and Yahr during an "on" period, and/or patients in whom the individual optimized dosage of levodopa (and decarboxylase inhibitor) causes motor fluctuations characterized as end-of-dose phenomena or "wearing-off" effects for at least 30 days prior to initial administration of study medication and whose daily total "off" time is at least 2 hours and no more than 6 hours during waking time.
• Patients able to keep an accurate patient diary of the times of "on"- and "off"-periods during waking hours. Family members, guardians or nursing personnel may assist the patient.
• Informed Consent (consent in writing)

You may not qualify if:

• Patients with atypical parkinsonian syndromes due to drugs, metabolic disorders , encephalitis, or degenerative disease.
• Dementia that could impair compliance with medication, impair maintenance of accurate patient diaries, and/or preclude the signing of informed consent.
• History of psychosis except that which was elicited by treatment with levodopa or dopamine agonists unless the patient remains psychotic and in the opinion of the investigator would be unable to participate in the study.
• History of active epilepsy within the last two years prior to Visit 2.
• Patients with second or third degree AV block or sick sinus syndrome.
• Patients with resting heart rate below 50 beats per minute.
• Patients with congestive heart failure classified as functional Class III or IV by the New York Heart Association.
• Patients with myocardial infarction within six months of randomization.
• Patients with other clinical significant heart conditions which would negatively impact on the patient completing the study.
• Clinically significant kidney disease which may prevent the patient from completing the study and/or an elevation in either blood creatinine or urea nitrogen \>1.5 times the laboratory normal.
• Clinically significant liver disease which may prevent the patient from completing the study and/or an elevation in either total bilirubin, SGPT, or SGOT of \>1.5 times the laboratory normal.
• Retinopathia pigmentosa
• Presence of active neoplastic disease
• Patients with surgery within 180 days of Visit 2 which in the opinion of the investigator would negatively impact on the patient's participation in the clinical study or a history of stereotaxic brain surgery.
• At screening supine systolic blood pressure less than 100mmHg or evidence of a 20 mmHg decline in systolic blood pressure at one minute after standing compared with the previous supine systolic blood pressure obtained after 5 minutes of quiet rest in the supine position if the decline in blood pressure upon standing is associated with symptoms. Blood pressure at study entry (supine and standing) is expressed as the average of the second and third measured values.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (7)

First Hospital of Beijing University

Beijing, 100034, China

Location

Beijing Tian Tan Hospital

Beijing, 100050, China

Location

Beijing Hospital

Beijing, 100730, China

Location

Peking Union Medical College Hospital

Beijing, 100730, China

Location

General Hospital of PLA

Beijing, 100853, China

Location

Shanghai Rui Jin Hospital

Shanghai, 200025, China

Location

Hua Shan Hospital, Fu Dan University

Shanghai, 200040, China

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Pramipexole; Bromocriptine

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)

Benzothiazoles; Thiazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Ergotamines; Ergot Alkaloids; Alkaloids; Ergolines; Heterocyclic Compounds, 4 or More Rings

Study Officials

• Boehringer Ingelheim Study Coordinator

  Boehringer Ingelheim Shanghai

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 14, 2005
• First Posted: October 18, 2005
• Study Start: July 1, 2003
• Primary Completion: August 1, 2004
• Study Completion: August 1, 2004
• Last Updated: November 4, 2013

Record last verified: 2013-11

Locations

CN (7)