A Long-Term Follow-up Safety Study for Patients with Parkinson’s Disease (PD) Implanted with the Drug Delivery System (DDS) and/or Who Received Treatment in the Main Study and/or Extension Study

Phase 1

• Conditions: Idiopathic Parkinson's Disease; MedDRA version: 21.1Level: LLTClassification code 10013113Term: Disease Parkinson'sSystem Organ Class: 100000004852; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2017-005170-19-FI
• Lead Sponsor: Renishaw Neuro Solutions Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-12-07
• Study Completion: 2021-08-27
• Last Update Posted: 27 May 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

1. Patients who completed Visit 4, implantation of the DDS, in the main study (HP-CD-CL-2002).
2. Patients that fulfil any of the following criteria:
a. Discontinued the main study (HP-CD-CL-2002) after Visit 4, or, the extension study (HP-CD-CL-2003), or,
b. Completed the main study (HP-CD-CL-2002) having received 6 doses of treatment, but did not continue in the extension study (HP-CD-CL-2003), or,
c. Patients that completed also the extension study, receiving a total of 12 doses of treatment (HP-CD-CL-2003).
3. Provision of informed consent. The patient is judged by the investigator to be alert and oriented to person, place, time and situation when giving the informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

None.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified