Extension study to Assess the Benefit and Safety of Administering Intermittent GDNF Infusions in Parkinson's Disease (PD)

Phase 1

• Conditions: Parkinson's disease; MedDRA version: 18.1 Level: LLT Classification code 10034008 Term: Parkinson's syndrome System Organ Class: 100000004852; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2013-001881-40-GB
• Lead Sponsor: orth Bristol NHS Trust (NBT)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-08-05
• Last Update Posted: 30 April 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 42

Inclusion Criteria

In order to qualify for entry into the study, subjects MUST meet all of the following criteria:
1. Enrolled and completed treatment in the Pilot or Primary Study Stages of Study 2553.
2. Females of childbearing potential must have a negative pregnancy test at study entry and be willing to use an approved (by the PI or designee) form of contraception until the end of the study.
3. Males with female partners of childbearing potential must be willing to use condoms for contraception until the end of the study.
4. Provision of 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 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 12

Exclusion Criteria

Subjects who meet any of the following criteria will NOT be eligible for inclusion in the study:
1. Discontinued treatment early in Study 2553.
2. Had any significant (in the opinion of the PI or designee) protocol deviation in Study 2553; this includes receipt of any disallowed anti-parkinsonian treatment or any investigational treatment.
3. Presence of clinically significant (in the opinion of the PI) depression.
4. MoCA score < 24 at the final assessment in Study 2553.
5. Any new medical condition which might impair outcome measure assessments or safety measures including ability to undergo MRI scanning.

Study & Design

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