AFF008E: Observational Phase 1b Follow-up Extension Study for Patients With Parkinson's Disease After Immunization With AFFITOPE® PD01A

Parkinson's Disease Clinical Trial

Official title:

AFF008E:Observational Follow-up Extension Study to Evaluate Long-term Safety and Tolerability of Immunization With AFFITOPE® PD01A Applied During AFF008 in Patients With Parkinson's Disease.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01885494
• Other study ID #: AFF008E
• Secondary ID: 2013-001774-20
• Status: Completed
• Phase: N/A
• First received: June 21, 2013
• Last updated: August 14, 2015
• Start date: June 2013

Study information

• Verified date: August 2015
• Source: Affiris AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Austrian Medicines and Medical Devices Agency
• Study type: Observational

Clinical Trial Summary

AFF008E is set-up to assess the long term effects of the 4 PD01A vaccinations that have been applied during AFF008 with regard to safety as well as immunological-, radiological and clinical activity. Accordingly, during AFF008E, no further vaccine dose will be applied. Instead, patients who were participating in AFF008 will be assessed for another 52 weeks at the occasion of 4 quarterly visits. This is offered to patients who received PD01A vaccinations but also to the patients who served as controls in AFF008. Thus, AFF008E will ensure standardized and controlled management of individuals who have received PD01A as part of AFF008, the Phase I study analyzing for the first time in humans this first in class candidate.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 41 Years to 66 Years

Eligibility

Inclusion Criteria:

• Written informed consent signed and dated by the patient

• Participation in AFF008

Exclusion Criteria:

• History of questionable compliance to visit schedule; patients not expected to complete the clinical trial

• Participation in the active treatment phase of another clinical trial except AFF008 within 13 weeks before Visit 1 and for the whole study duration

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Locations

Country	Name	City	State
Austria	Studienzentrum der PROSENEX, AmbulatoriumbetriebsgesmbH an der Confraternität-Privatklinik Josefstadt, Skodagasse 32	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Affiris AG

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tolerability and Safety	These will be based on the following parameters: Withdrawal criteria (continuation decision) Number of patients who withdraw due to adverse events Reason for withdrawal; Occurrence of any serious adverse event possibly, probably or definitely related to the study vaccine at any time during the study.; Occurrence of any adverse events possibly, probably or definitely related to the study vaccine	52 weeks	Yes
Secondary	Immunological and Clinical Efficacy	Immunological parameters: -Titer of antibodies specific for the immunizing peptide, keyhole limpet hemocyanin (carrier protein), a-Synuclein, ß-Synuclein as assessed by Enzyme-Linked Immunosorbent Assay; Clinical efficacy variables: Motor symptoms: Movement Disorder Society Unified Parkinson's Disease Rating Scale III; Investigator's Global Evaluation scale Non-motor symptoms; Parkinson's Disease Quality of Life-39 / Parkinson's Disease Non Motor Symptoms; Movement Disorder Society Unified Parkinson's Disease Rating Scale II; Cognitive scales; Smell identification test; Movement Disorder Society Unified Parkinson's Disease Rating Scale Ia (Caregiver-based assessment); Geriatric Depression Scale Biomarker data; Change in Dopamine Transporter - Single Photon Emission Computed Tomography signal (compared to AFF008 results); Assessment of change of volume of relevant brain regions (compared to AFF008 results)	52 weeks	No