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Clinical Trial of Apomorphine Subcutaneous Infusion in Patients With Advanced Parkinson's Disease

NCT02006121 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 107

Last updated 2019-07-08

Study results available
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Summary

The primary objective of the trial was to investigate the efficacy of apomorphine continuous subcutaneous infusion compared to placebo in Parkinson's Disease patients with motor fluctuations not well controlled on medical treatment.

The secondary objective of the study was to investigate the safety and tolerability of apomorphine continuous subcutaneous therapy.

Conditions

Interventions

DRUG

Apomorphine hydrochloride

Apomorphine hydrochloride 5 mg/ml solution for infusion in pre-filled syringe

DRUG

Placebo

Sodium chloride 9 mg/ml

Sponsors & Collaborators

  • Britannia Pharmaceuticals Ltd.

    lead INDUSTRY

Principal Investigators

  • Regina Katzenschlager, Doz. Dr. · Donauspital KH SMZ Ost, Neurologie

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-03
Primary Completion
2016-06-06
Completion
2017-06-08

Countries

  • Austria
  • Denmark
  • France
  • Germany
  • Netherlands
  • Spain
  • United Kingdom

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02006121 on ClinicalTrials.gov