Trials / Completed
CompletedNCT02618941
Follow-up Study to Assess a Second Boost Immunization With AFFITOPE® PD01A With Regard to Safety and Clinical Activity (AFF008AA)
Phase IB Follow-up, Controlled, Parallel Group, Single-center Study to Assess a Second Boost Immunization With AFFITOPE® PD01A With Regard to Safety/Tolerability, Immunological and Clinical Activity in Patients Who Have Participated in the AFF008 Program
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 26 (actual)
- Sponsor
- Affiris AG · Industry
- Sex
- All
- Age
- 40 Years – 68 Years
- Healthy volunteers
- Not accepted
Summary
This is a follow-up study to assess safety and clinical activity of continued AFFITOPE® PD01A vaccinations in patients with Parkinson's disease. Patients, who have already participated in the AFF008 program will be involved and will receive a second boost immunization with AFFITOPE® PD01A. One study site in Vienna (Austria) will be involved. In addition, up to 6 patients will be offered participation within an untreated control Group.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | AFFITOPE® PD01A | s.c. injection |
Timeline
- Start date
- 2016-02-02
- Primary completion
- 2017-02-28
- Completion
- 2017-02-28
- First posted
- 2015-12-02
- Last updated
- 2017-06-05
Locations
1 site across 1 country: Austria
Source: ClinicalTrials.gov record NCT02618941. Inclusion in this directory is not an endorsement.